Tanaman Herbal

Use of and Familiarity With Dietary Supplement Information References by Practicing Pharmacists Mario M. Zeolla, PharmD, BCPS; Jennifer Cerulli, PharmD, BCPS Authors and Disclosures Published: 11/24/2008 Print This

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Abstract and Introduction Abstract Objective: To survey practicing pharmacists regarding their use of and familiarity with six dietary supplement information references. Methods: Pharmacists attending a March 2005 continuing education program at the Albany College of Pharmacy on interactions between drugs and dietary supplements were surveyed about their use of and views on dietary supplement information references. Included in the survey were six references: Physicians Desk Reference (PDR) for Herbal Medicines; Facts and Comparisons: Review of Natural Products; German Commission E Monographs; Natural Medicines Comprehensive Database (online or

textbook format); Micromedex: AltMedDex; and The Natural Therapeutics Pocket Guide. The survey was repeated by mail 1 year after the program. Results: Of the 91 attendees at the program, 58 completed the survey, and 25 individuals returned the 1-year survey. Of those completing the surveys, 80% had more than 10 years in practice, 95% had bachelor's degrees, and most practiced in community or institutional pharmacies. At baseline, fewer than 40% had "heard of" four of the six references. Pharmacists were most familiar with PDR for Herbal Medicines and Factsand Comparisons: Review of Natural Products. Familiarity rates increased at 1 year for five of the six references, though, again, overall rates were low and differences from baseline were not statistically significant for any of the six references. Usage rates increased for two references (Facts and Comparisons: Review of Natural Products and Natural Medicines Comprehensive Database) at 1 year and declined for the remaining four. Conclusion: Experienced pharmacists in both community and institutional settings infrequently use and are unfamiliar with dietary supplement information references, including those found in studies to be of the highest quality. Education on the availability and features of these references could benefit pharmacists and potentially change usage patterns. Introduction The use of dietary supplements in the United States has increased dramatically since the early 1990s. One study found that 73% of Americans reported using a supplement in the previous 12 months.[1] As experts in drug information, pharmacists are often sought by patients and other health care providers to answer questions relating to these agents. Studies suggest that pharmacists perceive a lack of available high-quality dietary supplement information and that some pharmacists may not use or have access to such resources.[2] Many dietary supplement information references are now available in both hard-copy and electronic formats to assist pharmacists in this role. Studies evaluating the quality of these references provide guidance regarding which are most reliable and useful.[3,4] The extent to which pharmacists in diverse practice settings are familiar with or use those references deemed most useful is not fully known.

Use of and Familiarity With Dietary Supplement Information References by Practicing Pharmacists Mario M. Zeolla, PharmD, BCPS; Jennifer Cerulli, PharmD, BCPS Authors and Disclosures Published: 11/24/2008 •

Print This

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• • • • • •

Abstract and Introduction Objectives and Methods Results Discussion Limitations Conclusion

•

References

Information from Industry

Assess clinically focused product information on Medscape. Click Here for Product Infosites – Information from Industry.

Abstract and Introduction Abstract Objective: To survey practicing pharmacists regarding their use of and familiarity with six dietary supplement information references. Methods: Pharmacists attending a March 2005 continuing education program at the Albany College of Pharmacy on interactions between drugs and dietary supplements were surveyed about their use of and views on dietary supplement information references. Included in the survey were six references: Physicians Desk Reference (PDR) for Herbal Medicines; Facts and Comparisons: Review of Natural Products; German Commission E Monographs; Natural Medicines Comprehensive Database (online or textbook format); Micromedex: AltMedDex; and The Natural Therapeutics Pocket Guide. The survey was repeated by mail 1 year after the program. Results: Of the 91 attendees at the program, 58 completed the survey, and 25 individuals returned the 1-year survey. Of those completing the surveys, 80% had more than 10 years in practice, 95% had bachelor's degrees, and most practiced in community or institutional pharmacies. At baseline, fewer than 40% had "heard of" four of the six references. Pharmacists were most familiar with PDR for Herbal Medicines and Factsand Comparisons: Review of Natural Products. Familiarity rates increased at 1 year for five of the six references, though, again, overall rates were low and differences from baseline were not statistically significant for any of the six references. Usage rates increased for two references (Facts and Comparisons: Review of Natural Products and Natural Medicines Comprehensive Database) at 1 year and declined for the remaining four. Conclusion: Experienced pharmacists in both community and institutional settings infrequently use and are unfamiliar with dietary supplement information references,

including those found in studies to be of the highest quality. Education on the availability and features of these references could benefit pharmacists and potentially change usage patterns. Introduction The use of dietary supplements in the United States has increased dramatically since the early 1990s. One study found that 73% of Americans reported using a supplement in the previous 12 months.[1] As experts in drug information, pharmacists are often sought by patients and other health care providers to answer questions relating to these agents. Studies suggest that pharmacists perceive a lack of available high-quality dietary supplement information and that some pharmacists may not use or have access to such resources.[2] Many dietary supplement information references are now available in both hard-copy and electronic formats to assist pharmacists in this role. Studies evaluating the quality of these references provide guidance regarding which are most reliable and useful.[3,4] The extent to which pharmacists in diverse practice settings are familiar with or use those references deemed most useful is not fully known.

Beware of scams and health fraud Scammers have perfected ways to convince you that their alternative medicine products are the best. These opportunists often target people who are overweight or who have medical conditions for which there is no cure, such as multiple sclerosis, diabetes, Alzheimer's disease, cancer, HIV/AIDS and arthritis. Remember if it sounds too good to be true, it probably is. Be alert for these red flags: •

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Big promises. Advertisements call the product a "miracle cure" or "revolutionary discovery." If that were true, it would be widely reported in the media and your doctor would recommend it. Pseudomedical jargon. Although terms such as "purify," "detoxify" and "energize" may sound impressive and may even have an element of truth, they're generally used to cover up a lack of scientific proof. Cure-alls. The manufacturer claims that the product can treat a wide range of symptoms, or cure or prevent a number of diseases. No single product can do all this. Testimonials. Anecdotes from individuals who have used the product are no substitute for scientific proof. If the product's claims were backed up with hard evidence, the manufacturer would say so. Guarantees and limited offers. These pitches are intended to get you to buy before you can evaluate the product's claims.

Choose practitioners wisely Take care when choosing an alternative medicine practitioner. Picking a name out of the phone book isn't the safest way to select a practitioner. Instead, try these tips from the National Center for Complementary and Alternative Medicine (NCCAM):

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Talk with your doctor. Ask your conventional doctor for recommendations. He or she can also be a source of advice about any recommendations you get from an alternative medicine practitioner. Contact a local hospital or medical school. They often keep lists of area CAM practitioners. Some have their own CAM practitioners on staff. Check the national association. Alternative medicine associations will often provide a list of certified practitioners in your area. To find the addresses and phone numbers of these associations, check the Directory of Health Organizations online compiled by the National Library of Medicine. Call your local health department. Ask if they know of state or local certifying, licensing or accreditation bodies for the alternative medicine practice you're considering. Ask questions. Ask CAM practitioners about their education, training, licenses and certifications. Ask if they specialize in particular diseases or health conditions and whether they frequently treat people with problems similar to yours. Also ask what treatments cost — and find out if your health insurance covers them.

CAM starts with complementary Ideally the various forms of treatments you select should work together with the care of your conventional doctor. You may find that certain alternative treatments help you maintain your health and relieve some of your symptoms. But continue to rely on conventional medicine to diagnose a problem and treat diseases. Don't change your conventional treatment — such as your dose of prescribed medication — without talking to your doctor first. For your safety, tell your doctor about all alternative treatments you use. Different standards for reporting ADRs to herbal remedies and conventional OTC medicines: face-to-face interviews with 515 users of herbal remedies Joanne Barnes,1 Simon Y Mills, Neil C Abbot,2 Martin Willoughby,2 and Edzard Ernst1 1 Department of Complementary Medicine, Postgraduate Medical School, University of Exeter, 25 Victoria Park Road, Exeter EX2 4NT, UK 2 Centre for Complementary Health Studies, Amory Building, University of Exeter, Exeter EX4 4RJ, UK Correspondence: Joanne Barnes, Department of Complementary Medicine, Postgraduate Medical School, University of Exeter, 25 Victoria Park Road, Exeter EX2 4NT. Received September 19, 1997; Accepted January 6, 1998. This article has been cited by other articles in PMC. •

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Abstract Aims To determine whether adverse drug reactions (ADRs) to herbal remedies would be reported differently from similar ADRs to conventional over-the-counter (OTC) medicines by herbal-remedy users. Methods Face-to-face interviews (using a structured questionnaire) with 515 users of herbal remedies were conducted in six pharmacy stores and six healthfood stores in the UK. The questionnaire focused on the likely course of action taken by herbal-remedy users after experiencing an ADR associated with a conventional OTC medicine and a herbal remedy. Results Following a ‘serious’ suspected ADR, 156 respondents (30.3%) would consult their GP irrespective of whether the ADR was associated with the use of a herbal remedy or a conventional OTC medicine, whereas 221 respondents (42.9%) would not consult their GP for a serious ADR associated with either type of preparation. One hundred and thirtyfour respondents (26.0%) would consult their GP for a serious ADR to a conventional OTC medicine, but not for a similar ADR to a herbal remedy, whereas four respondents (0.8%) would consult their GP for a serious ADR to a herbal remedy, but not for a similar ADR to a conventional OTC medicine. Similar differences were found in attitudes towards reporting ‘minor’ suspected ADRs. Conclusions Consumers of herbal remedies would act differently with regard to reporting an ADR (serious or minor) to their GP depending on whether it was associated with a herbal remedy or a conventional OTC medicine. This has implications for herbal pharmacovigilance, particularly given the increasing use of OTC herbal remedies. The finding that a high proportion of respondents would not consult their GP or pharmacist following ADRs to conventional OTC medicines is also of concern. Keywords: herbal medicines, drugs, nonprescription, drug monitoring, adverse drug reaction reporting systems, alternative medicine •

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Introduction In the UK, herbal remedies (or ‘phytomedicines’) are increasingly being used by the general public on a self-selection basis to replace or complement conventional medicines [1]. The use of herbal remedies is widespread across Europe—in 1991, the total over-thecounter (OTC) market for herbal remedies was £1.45 billion [2]. Another source

estimated that, in 1992, the herbal market of the European Community was worth US$2.4 billion [3]. More recently, the market for licensed herbal medicines in the UK was estimated to be worth £38 million in 1996, representing over half of the total market for complementary remedies [4]. One of the reasons for the popularity of herbal remedies is the belief among many users and suppliers of herbal remedies that these preparations are natural and therefore ‘safe’ [1]. This, however, is a misconception—herbal remedies can produce adverse drug reactions (ADRs) [5, 6], some of which can be serious and even fatal [7, 8]. However, because users believe that such remedies are ‘safe’, individuals experiencing ADRs may not associate these with their use of herbal remedies [7]. A further complication is that, in the UK, the majority of herbal remedies are self-prescribed [1], and many individuals may be reluctant to tell their general practitioner (GP) that they are using them [7]. Even if ADRs are reported by patients, their GPs may not be fully briefed about the use and effects (adverse or otherwise) of herbal remedies. The European Union (EU) has commissioned research into this problem through its BIOMED (Biomedical and Health Research) programme. As part of that programme, this study was designed to determine whether ADRs to herbal remedies would be reported differently from similar ADRs to conventional OTC medicines, and to identify experiences of ADRs to herbal remedies and how they are perceived by consumers. •

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Methods Customer interview Experienced interviewers, recruited and trained for this task by a market research company, were provided with study questionnaires, photographs and lists of examples of herbal remedies, other complementary remedies and conventional OTC medicines, and a list of examples of ADRs. These materials were used to assist interviewers and interviewees in identifying what was and what was not a herbal remedy. The list of ADRs was used as a prompt if consumers were unsure what was meant by a ‘side-effect’, or if they answered that they had never experienced any ‘side-effects’ to herbal remedies. Interviewers were instructed to position themselves at an appropriate distance from the herbal remedies counter in the respective stores, and to approach customers who had purchased herbal remedies or those who had browsed the herbal remedies section. Customers were asked if they would be willing to be interviewed as part of a study on herbal remedies. Those agreeing to be interviewed were asked if they ever use herbal remedies; if they answered, ‘No’ the interview was terminated. If a customer answered, ‘Yes’, the interviewer continued with the questionnaire (written consent was not obtained); interviews took around 8 min. All questionnaires were analysed at the University of Exeter.

Two types of outlet—Boots the Chemists Ltd (BTC) and Holland & Barrett (H & B), representing a pharmacy setting and healthfood store setting, respectively—were chosen. Interviews were conducted in six BTC stores with a high turnover of herbal remedies (Manchester, Leeds, Newcastle, Milton Keynes, London, Cardiff) and in six H & B stores near the selected BTC stores (Manchester, Leeds, Newcastle, Milton Keynes, London, Swansea). The study was conducted in September, 1996. An interviewer was present in the selected stores on 2 consecutive days for 8h per day in BTC stores, and 4h per day in H & B stores. The study was weighted more towards BTC customers than H & B customers to reflect market share [4]. Data collected A structured questionnaire for customer interviews was designed and developed for this survey by researchers at the University of Exeter. Copies of the questionnaire are available on request. Respondents were asked what herbal remedies they used, how often, and for what condition. The same questions were asked for conventional OTC medicines. Respondents were also asked if they ever used vitamins, minerals or dietary supplements, or other ‘natural’ health remedies (e.g. homoeopathic medicines, aromatherapy oils). Data on how respondents choose their herbal remedies and from where they obtain them, were also collected. In addition, respondents were asked if they had ever experienced any ‘sideeffects’ after taking herbal remedies and, if so, were asked to provide the following details: name of herbal remedy; associated ‘side-effect’; severity (mild, moderate or severe); if they reported the ‘side-effect’ and to whom; if they stopped taking the remedy because of the ‘side-effect’. Respondents were also asked for demographic information (gender, age, occupation); social grade and ethnic group were assessed by the interviewer. The key part of the interview sought to obtain information on what action respondents would take if they experienced (a) a ‘serious side-effect’ (for the purposes of this survey, this was defined as symptom(s) that were ‘worrying or alarming’), and (b) a ‘minor sideeffect’ (defined as symptom(s) that ‘caused some discomfort, but were not alarming’) to a conventional OTC medicine and to a herbal remedy. Respondents were allowed to select one or more of the following responses: continue taking [the preparation] and see if symptom(s) resolved; stop taking immediately; consult your doctor; consult your pharmacist; consult another health care practitioner; other action. Prior to conducting the full survey, a pilot survey was conducted. Thirty-two herbal remedy users were interviewed by one interviewer in the BTC store in Leeds. Following the pilot study, a minor alteration was made to the questionnaire (the order of the two questions on the action respondents would take following a serious and a minor ADR was reversed). Data from the full survey were entered via a semiautomated Foxbase application into a spreadsheet for analysis. The data from the pilot study were not included in the final analysis. •

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Results Six hundred and ninety individuals agreed to be interviewed. Of these, 175 (25.4%) stated that they did not use herbal remedies and therefore these interviews were terminated. Five hundred and fifteen face-to-face interviews with users of herbal remedies were conducted: 336 in BTC stores and 179 in H & B stores. Females predominated (82% overall). The ethnic origin of respondents was predominantly Caucasian (91%); Afro-Caribbean (2%), Indian/Pakistani (2%) and Chinese/Japanese (1%) ethnic groups were also represented. The age distribution of respondents was: <20 years, 2%; 20–29 years, 15%; 30–39 years, 20%; 40–49 years, 24%; 50–59 years, 19%; 60 years, 20%. There were no marked differences in age distribution between the two types of stores. Sixty-two per cent of all respondents (58.0 and 68.2% for BTC and H & B respondents, respectively) used one or more herbal remedies regularly, whereas 38% (42.0 and 31.8% for BTC and H & B respondents, respectively) used one or more herbal remedies occasionally (respondents were allowed to name a maximum of three remedies). Eightyone per cent of all respondents (83 and 77% for BTC and H & B respondents, respectively) were also regular or occasional users of conventional medicines; 78% (79 and 77% for BTC and H & B respondents, respectively) stated that they used vitamins, minerals and/or food supplements; 49% (51 and 45% for BTC and H & B respondents, respectively) stated that they used other ‘natural’ health remedies (e.g. essential oils used in aromatherapy, homoeopathic remedies). Respondents choose their herbal remedies on the basis of a friend's or family member's recommendation (31% of replies), on the basis of their own knowledge (40% of replies) and on the basis of a pharmacist's recommendation, on a prescription or recommendation from their doctor, and on the recommendation, or supplied by, a herbal medicine practitioner (6% of replies for each). There were no marked differences between BTC respondents and H & B respondents with regard to choosing herbal remedies except that H & B respondents were more likely than BTC respondents to choose herbal remedies recommended by a complementary health practitioner other than a herbalist (23/179 vs 11/336 for H & B vs BTC respondents, respectively; χ2=17.37; P<0.001). Attitudes towards reporting ADRs Table 1 shows the numbers of respondents who would take a particular course of action after experiencing a suspected ADR to a herbal remedy and to a conventional OTC medicine. The data are presented in a manner that allows the numbers of respondents who would act differently for ADRs to herbal remedies than for similar ADRs to conventional OTC medicines to be identified. Table 1 Number of respondents (% of total) that would choose a particular course of action after experiencing a suspected ADR to (i) a conventional OTC medicine and (ii) a herbal remedy. Participants responded yes or no for each type of preparation. The four (more ...)

Following a serious ADR, 156 respondents (30.3% of all replies) would consult their GP irrespective of whether the ADR was associated with the use of a herbal remedy or a conventional OTC medicine; 221 respondents (42.9%) would not consult their GP for a ‘serious’ ADR associated with either type of preparation. One hundred and thirty-four respondents (26.0%) would consult their GP for a serious ADR to a conventional OTC medicine, but not for a similar ADR to a herbal remedy, whereas four respondents (0.8%) would consult their GP for a serious ADR to a herbal remedy, but not for a similar ADR to a conventional OTC medicine. Similar differences were found in the attitudes of herbal-remedy users towards reporting ‘minor’ ADRs associated with herbal remedies and for similar ADRs to conventional OTC medicines. Subgroup analysis of respondents interviewed in BTC stores and those interviewed in H & B stores revealed the following differences between the two groups. Following a serious ADR, significantly more BTC respondents than H & B respondents would consult their GP irrespective of whether the ADR was associated with a conventional OTC medicine or a herbal remedy (113/336 vs 43/179 for BTC vs H & B respondents, respectively; χ2=5.11; P<0.05). For minor ADRs, the result was reversed—H & B respondents were more likely than were BTC respondents to consult their GP irrespective of whether the ADR was associated with a conventional OTC medicine or a herbal remedy (19/179 vs 14/336 for H & B vs BTC respondents, respectively; χ2=8.10; P<0.01). However, BTC respondents were more likely to consult a pharmacist than were H & B respondents for minor ADRs irrespective of whether the ADR was associated with a herbal remedy or a conventional OTC medicine (31/336 vs 4/179 for H & B vs BTC respondents, respectively; χ2=9.01; P<0.01). Subgroup analysis of ‘young’ respondents (<30 years of age) and ‘old’ respondents (>50 years) did not reveal a significant effect of age on ADR reporting for either serious or minor ADRs. Perceptions and experience of ADRs associated with herbal remedies Thirty-one respondents stated that they had experienced ADRs to herbal remedies. However, six of these reports referred to non-herbal complementary remedies. A further three reports cannot definitely be called herbals (‘Vitalax’, ‘Keratine’ and a product the name of which was written illegibly). Excluding the latter three reports gives a total of 22 respondents (4.3%) who reported having experienced an ADR associated with the use of a herbal remedy. Of these, four respondents (0.8% of total) rated the adverse effect as ‘severe’, eight (1.6%) rated it as ‘moderate’, nine (1.7%) rated it as ‘mild’ and one entry was missing. Of the four reports rated ‘severe’, two were reported (both to a doctor); two were not reported. One ‘severe’ report (‘asthma symptoms’ associated with the use of Royal Jelly† reported to a doctor) gives cause for concern. In total, four (18%) of the 22 respondents who reported ADRs claimed to have informed their GP (we have not received replies to our letters attempting to verify these reports), 16 (73%) stopped taking the medicine concerned and six (27%) did not stop taking the preparation. •

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Discussion This is the first study to provide evidence that herbal remedy users would be less likely to consult their GP for suspected ADRs (serious or minor) to herbal remedies than for similar ADRs to conventional OTC medicines. This has implications for herbal pharmacovigilance and implies that many suspected ADRs to herbal remedies will go unmonitored. There may be several reasons for this finding. Herbal remedies are largely used on a selftreatment basis and some users may not realize that they can consult their GP about ADRs to such products. Others may be reluctant to admit herbal-remedy use to their GP by consulting him/her for suspected ADRs, while some users may feel it is more appropriate to consult the herbal practitioner from whom the remedies were obtained. In a study of unconventional medicine use involving 1539 adults in the US, Eisenberg et al. reported that of 34% respondents who reported using at least one unconventional therapy in the previous year, 72% did not inform their doctor of their use of the therapy [9]. There is an increasing amount of research into patients’ attitudes towards complementary therapies and the reasons why people choose to use such therapies as well as, or instead, conventional medicine [10]. This is an important and complex area which is likely to have implications for ADR reporting. The present study appears to have uncovered differences between two groups of users of herbal remedies with regard to their attitudes towards reporting ADRs. BTC respondents would be more likely than H & B respondents to consult their GP for a serious ADR irrespective of whether it was associated with a herbal remedy or a conventional OTC medicine, and would be also more likely to consult a pharmacist for a minor ADR irrespective of whether it was associated with a herbal remedy or a conventional OTC medicine. Why there should be this difference in willingness to consult a health professional is a matter of debate. It may reflect H & B customers disenchantment with the orthodox approach to health care, or it may simply be that a health care professional is present on site in BTC stores. †Although not strictly a herbal remedy, royal jelly is included here as it falls into category 3 (natural substance, e.g. royal jelly and herbal products) as defined by the Ministries of Agriculture Fisheries and Food (MAFF) report on Dietary Supplements and Health Foods. Whatever the reason, the findings of the present survey raise concerns not only with regard to reporting of ADRs associated with herbal remedies, but also for those associated with conventional OTC medicines. Even for a ‘serious’ ADR, only 290 respondents (56.3%) would consult their GP; for ‘minor’ ADRs associated with conventional OTC medicines, only 108 respondents (21.0%) would do so. Also, less than 10% of respondents would consult a pharmacist for a ‘serious’ or ‘minor’ ADR associated with a conventional OTC medicine. Even those suspected ADRs which are reported to a GP and which meet ADR-reporting criteria may not be reported on to national pharmacovigilance centres. In the UK, hospital physicians have been shown to grossly under-report ADRs that meet CSM criteria [11]; there is no evidence to suggest that GPs are any more diligent in this area. Furthermore,

deficiencies in the reporting process may be even more likely to occur with herbal remedies [7]. The UK Medicines Control Agency's (MCA) and Committee on Safety of Medicine's (CSM) Yellow Card scheme already requests reports relating to suspected ADRs to all (i.e. both licensed and unlicensed) herbal remedies [12], yet (perhaps because they are not aware of this request) reporting by doctors is still limited [13]. In April 1997, the MCA extended the Yellow Card scheme to include hospital and (in certain regions) community pharmacists [13]; community pharmacists are seen as having a critical role in areas of limited reporting by doctors, e.g. over-the-counter medicines, and licensed and unlicensed herbal products [14]. There is an increasing awareness of the need to monitor the safety of herbal remedies [7]. Our findings lend support both to the MCA/CSM decision to extend its Yellow Card reporting scheme to pharmacists, and to the European Scientific Co-operative for Phytotherapy's (ESCOP) pharmacovigilance system for herbal remedies (PhytoNet). In the latter, suspected ADRs to herbal remedies may be reported via a password-protected, Internet-based reporting system which is being targeted at all health professionals who use herbal remedies. In conclusion, consumers of herbal remedies would act differently with regard to reporting an ADR (serious or minor) to their GP, depending on whether the ADR was associated with a herbal remedy or a conventional OTC medicine. This implies that many ADRs to herbal remedies may go unmonitored. Our findings illustrate the need for greater public awareness that ADRs to herbal remedies can occur, and that such events should be reported to an appropriate authority. Professionals also need to be aware of the potential for herbal remedies to cause ADRs and routinely question their patients about their use of such remedies. In the longer term, further research to investigate the safety and efficacy of herbal remedies is needed so that the risk/benefit ratio of using a particular herb for a specific condition can be determined. Acknowledgments This study was conducted as part of the European Union as part of a BIOMED (Biomedical and Health Research) programme entitled, Determining European standards for the safe and effective use of phytomedicines; J. Barnes holds the Boots Research Fellowship in Complementary Medicine. We would like to express our appreciation of the contribution to data collection of the late Mr Jeff Shaw of the market research company Bemrose Shaw Berridge and Partners Ltd, Derby. •

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References

1. Newall CA, Anderson LA, Phillipson JD. Herbal medicines. A guide for health-care professionals. 1. London: The Pharmaceutical Press; 1996. pp. 3–12. 2. Fisher P, Ward A. Complementary medicine in Europe. Br Med J. 1994;309:107–111. [PubMed] 3. News item. Scrip. 1993. p. 22. 4. Anonymous. Complementary medicines. London: Mintel International Group Ltd; 1997. p. 14. 5. Abbot NC, Ernst E, White AR. Complementary medicine. Nature. 1996;381:361. [PubMed] 6. De Smet PAGM. Health risks of herbal remedies. Drug Safety. 1995;13((2)):81–93. [PubMed] 7. De Smet PAGM. An introduction to herbal pharmacovigilance. In: De Smet PAGM, Keller K, Hänsel R, Chandler RF, editors. Adverse Effects of Herbal Drugs. Vol. 3. Berlin, Heidelberg: Springer-Verlag; 1997. pp. 1–13. 8. Ernst E, de Smet PAGM. Risks associated with complementary therapies. In: Dukes MNG, editor. Meyler's Side Effects of Drugs. 13. Amsterdam: Elsevier; 1996. p. 1427. 9. Eisenberg DM, Kessler RC, Foster C, Norlock FE, Calkins DR, Delbanco TL. Unconventional medicine in the United States. Prevalence, costs, and patterns of use. New Engl J Med. 1993;328:246–252. [PubMed] 10. Vincent C, Furnham A. Complementary medicine. A research perspective. Chichester: Wiley; 1997. Chapter 5: Knowledge, attitudes and beliefs of patients of complementary practitioners; pp. 97–118. 11. Smith CC, Bennet PM, Pearce HM, et al. Adverse drug reactions in a hospital general medical unit meriting notification to the Committee on Safety of Medicines. Br J Clin Pharmacol. 1996;42:423–429. [PubMed] 12. Anonymous. Extension of the Yellow Card scheme to unlicensed herbal remedies. Current Problems Pharmacovigilance. 1996;22:10. 13. Anonymous. Extension of the Yellow Card scheme to pharmacists. Current Problems Pharmacovigilance. 1997;23:3. 14. Anonymous. Pharmacy ADR reporting now official. Pharm J. 1997;258:582.

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COUNTERING THE SIDE EFFECTS OF MODERN MEDICAL THERAPIES WITH CHINESE HERBS by Subhuti Dharmananda, Ph.D., Director, Institute for Traditional Medicine, Portland, Oregon All medical treatments, whether ancient or modern, are associated with a certain degree of risk for adverse effects, often called side effects. In general, the more drastic the intervention, the more likely and more severe the adverse outcomes. Thus, massage therapy and dietary modifications-examples of external and internal therapies which are usually not considered drastic-have relatively few and minor adverse effects.

Nonetheless, there are strong massage techniques and radical dietary modifications that can yield adverse effects, even if the overall outcome is positive. By contrast, surgery and potent drugs-examples of external and internal therapies that are usually deemed invasive or drastic-have more frequent and more serious adverse effects. Still, the overall outcome may be far better than if these techniques were not employed or if gentler alternatives were attempted. Chinese herbal therapies that have been used in China over the past 2,000 years include toxic herbs, herbs used in large doses, and herbs that are intended to produce strong reactions so as to save the patient from a serious disease. A relatively small group of Chinese herbs have been used to counteract the adverse effects of other herbs for many centuries; this aspect of Chinese medical practice has continued with the introduction of Western medical therapies. There was a great increase in this area of Chinese medicine during the 1970's (continuing into the present) as the result of intensive adoption of Western medical therapies for cancer (chemotherapy, radiation, and surgery) which almost always produce significant adverse effects.

PERSPECTIVE In the practice of traditional Chinese medicine, certain adverse effects of treatments have long been known and accepted; some of the adverse consequences are, in fact, the desired actions: •

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Acupuncture may cause pain or bleeding. An acupuncture needle reaction (deqi), described as soreness, numbness, or distending feeling, but interpreted by many Westerners as discomfort and pain, is deemed an essential part of effective acupuncture therapy in China; persistence of this reaction is considered an adverse effect of excessive stimulation. Bleeding was a necessary consequence of some early acupuncture practices (using the needles to lance boils) and remains an intended result of certain techniques Moxibustion causes pain and blistering. By the traditional method of application, moxibustion also causes scarring. All these reactions are deemed essential to successful moxa treatment according to the traditional texts. Cupping causes pain and bruising; bruising is taken as a sign of good effect; Herbs can cause nausea and, if not selected properly, worsening of the disease (or death, according to the traditional commentaries). Further, there can be allergic reactions to herbs. Some herbs used in China are highly toxic, and the dosage of low-toxicity herbs used in some treatments is sufficiently high to produce nonspecific toxic reactions, such as dizziness, thirst, and gastro-intestinal distress. In some cases, vomiting, diarrhea, or sweating are intended consequences of the herbal therapies, indicating that the therapy is having an effect.

Little has been done about adverse effects of the physical Chinese medical therapies, other than to administer them in a more gentle manner, an adjustment often made in the West (e.g., use finer needles and less stimulation for acupuncture; perform moxibustion

only to the point of heating the skin, with no blistering or scarring, etc.). Avoidance of herbs that are problematic is a common approach taken in the West (e.g., eliminate toxic herbs, reduce the dosage of non-toxic herbs, cease administering herbs that appear to cause a reaction). Still, counteracting the adverse effects of herbs has always been a major concern in China and there is a considerable amount of accumulated knowledge and experience in this field that can be transposed to the problem of countering drug side effects. Modern research has helped expand upon the efforts made by traditional doctors in the past. Some Chinese doctors have argued that the side effects of herbal therapies actually arise from a failure to formulate a prescription appropriate to the full diagnostic picture and with proper compensation for any herbal toxicities. This view would suggest that welltrained, competent, and experienced practitioners can avoid side effects for virtually all their patients. Such an opinion is consistent with the idea that individual herbs may produce side effects, but that those effects can be reduced through proper formulation. This idea is extended to the administration of drugs in carefully designed formulations (with herbs and/or other drugs). However, it is always possible that individuals will have unique and unpredictable reactions to herbal ingredients within a formula (4, 33). Also, such claims of the ability to avoid adverse effects are an ideal that cannot consistently be met, especially by average practitioners who have limited training and experience.

USING SWEET HERBS TO COUNTER SIDE EFFECTS A long-standing principle of Chinese medical practice is that sweet-tasting herbs counter the toxicity and adverse effects of other herbs. One of the fullest elaborations of this principle was reported in Anticancer Medicinal Herbs (1) among historical references to the action of Sophora subprostrata (shandougen): The drug [S. subprostrata] removes toxic materials in many drugs....It is said in the Elucidation of Materia Medica that 'It neutralizes toxicity with its sweet taste and eliminates heat with its cold nature. Toxic drugs are usually hot and sweet, and toxicity is removed spontaneously when combined with drugs that are cold, sweet, and bitter.' The ability of sweet-tasting substances to counteract toxicity has been mentioned in the Shennong Bencao Jing (ca. 100 A.D.) and relied upon extensively in the formulations of the Shanghan Lun (ca. 220 A.D.), especially in relation to incorporating licorice and jujube. In this case, a concern is mentioned about hot drugs, which was one of the big concerns about the herbs used in ancient times. Hot herbs attained a special status in Chinese medical practice as a result of the concept, developed in Zhang Zhongjing's Shanghan Lun (220 A.D.), that cold was the major disease-causing influence. The principle of using cold-natured and bitter-tasting herbs to counter all kinds of hot toxins was elucidated at least as early as the Neijing Suwen (ca. 100 B.C.). In the event that a

cold toxic herb is to be utilized instead, a sweet and bitter taste with warming nature would be the most likely quality of the herb(s) used to counteract toxicity. Raw licorice root is sweet, bitter, and neutral, and in the same plant family as sophora (Leguminosae; this is the family of beans, also called legumes). It is well known for its toxicity-relieving properties for both hot and cold natured herbs. In the Shoushi Baoyuan (1616 A.D.), it is said that: "licorice is always employed to dissolve all possible poisonous effects of drugs (19)." The detoxifying effect of licorice is described this way in the Oriental Materia Medica (2): "Glycyrrhizin [a major active constituent of licorice] and its calcium salt possess detoxifying action on bacterial toxins (diphtherin, tetanin), poisonous foods and drugs, and toxins of metabolic products. Glycyrrhizin, when degraded, yields glucuronic acid, which in the liver will combine with toxic materials to form glucuronide to produce a detoxifying action." In the Selected Compilation of Materia Medica, it is reported that: "When extremely hot and extremely cold drugs are prescribed, licorice must be added to mediate the intensity (1)." An example of this technique is represented in the traditional formula Liuyi San (Six to One Powder, referring to the ratio of amounts of the two ingredients). The principal ingredient, talc, is used to clear summer heat and promote diuresis; according to the Chinese-English Manual of Commonly Used Prescriptions in Traditional Chinese Medicine (35): "A small amount of licorice is added to inhibit the cold and slippery action of talc." Another example is Sini Tang, which contains the toxic and hot herb aconite, along with ginger and licorice. According to the Chinese-English Manual of Commonly Used Prescriptions in Traditional Chinese Medicine, licorice serves to "inhibit the toxicity of crude aconite when it is used together with ginger." Jujube, a sweet herb commonly combined with licorice in formulas, is described (1) this way in the Annotation of Shen Nong's Herbal: "The herb, being sweet in taste, removes poison of any substance, and is used to harmonize drugs in a prescription." The book Chinese-English Manual of Commonly Used Herbs in Traditional Chinese Medicine (36), lists this action of jujube: "moderate the potency of drugs: for counteracting the toxicity or side effects of potent drugs, such as genkwa, euphorbia, lepidium, etc. Recently, also used for anaphylactoid purpura and bronchial asthma." Among the pharmacological actions of jujube listed in this text is "protect the liver from damage." The use of jujube to counter side effects of genkwa, euphorbia, and lepidium was evident in the Shanghan Lun formulas. In Commonly Used Chinese Herb Formulas with Illustrations (37), the traditional formula Tingli Dazao Xiefei Tang (Lepidium and Jujube Combination) is listed. The two herbs that comprise the formula are described as follows: "Lepidium is bitter, cold, slippery, and sharp in nature. It opens and drains the lungs, purges fire, and expels sputum. To prevent its violent action from harming the lungs, lepidium is subordinated to jujube, which soothes the stomach and harmonizes the action of lepidium so that normal respiration is not harmed." Genkwa and euphorbia appear together in a single prescription of the Shanghan Lun called Shizao Tang,

literally, Ten Jujubes Decoction. According to Formulas and Strategies (3), "The name of this formula is a tribute to the importance of the ten jujubes which are taken to moderate the harsh, downward-draining action of the other herbs, and thereby protect the stomach qi." The hot, spicy herb evodia is a key ingredient of Wuzhuyu Tang (Evodia Combination); according to Formulas and Strategies: "The envoy, sweet jujube, moderates the acrid, drying properties of the chief and deputy ingredients [evodia and ginger]. Honey, which is sweet and neutral, is described in the Oriental Materia Medica to have these properties: "strengthens the middle warmer, moistens dryness, controls pain, removes toxins." In the text's section on applications, it is mentioned that honey treats aconitine toxification. Aconitine is the main active constituent of aconite, which is the herb that causes more toxicity problems than any other used in China (because of its high frequency of use and high toxicity). Soybeans are another legume that have a sweet taste and detoxifying quality. According to Chinese Dietary Therapy (48): "For poisoning or untoward reactions caused by taking poisonous food by mistake or hot-natured drugs, take soy bean milk, or soy bean in a decoction made with licorice." An example of utilizing several of these sweet-tasting herbs together to counter modern drug side effects is the combination of Gancao Fen Mi Tang (Licorice and Honey Decoction) with Gan Dou Tang (Licorice and Soja Decoction), made with licorice, oryza (guya, rice sprout), honey, and soja (dandouchi, processed black soybean; sweet and bitter tasting). In a clinical trial (14), patients undergoing chemotherapy for various types of cancer were administered this combination of herbs or, as a control, just the chemotherapy. Among those receiving the herbs, the white blood cell count either remained above 5.0 (million/liter or thousand/ml) or quickly recovered to that level after chemotherapy in 77% of the patients, and remained above 4.0 or quickly recovered to that level after chemotherapy in 13%. The comparable figures for the controls were 66% and 5% respectively. Along similar lines, the ancient formula of the Shanghan Lun, Zhizi Gancao Shi Tang, can be adopted to treat adverse reactions to drugs. The formula is comprised of just three herbs: licorice, soja, and gardenia. Gardenia adds a bitter and cooling component to the therapy described above. This prescription has been utilized as an adjunct to cancer therapy in Japan (especially for esophageal cancer, since the traditional use of the herb formula included swellings in the throat), and for reactions to herbs and drugs such as allergy reaction (urticaria) and nausea. Other processed soybean products, such as miso, have the reputation of protecting against adverse effects of chemicals and radiation. Dolichos, another legume (hyacinth bean), is described (1) in Properties of Medicinal Herbs: "Dolichos is sweet in taste and slightly warm in nature, removes toxic materials of all herbs and plants and is administered through chewing the raw drug or in decoction." A formula used for countering the immune suppression in cancer patients (1)

is made with dolichos, astragalus, codonopsis, rehmannia, and tortoise shell (note: all these herbs have a sweet taste). Dolichos is traditionally applied in the treatment of summer heat syndrome, and its action there may be to alleviate bacterial toxins that cause nausea, vomiting, and diarrhea. According to the Oriental Materia Medica, dolichos is also useful for "alcohol intoxication." Phaeseolus (ludou; mung bean), another legume, is mentioned in the Chinese-English Manual of Commonly Used Herbs in Traditional Chinese Medicine as being able to "relieve metallic and drug poisoning: for preventing and treating the poisoning of lead, arsenic, alcohol, and aconite." Oriental Materia Medica simply states that phaseolus "removes all toxins." A traditional prescription, Mahuang Lianqiao Chixiaodou Tang (Ma-huang, Forsythia, and Phaseolus Combination) uses one type of phaseolus (chixiaodou), along with ginger, jujube, licorice, morus bark, forsythia, and ma-haung to treat pruritis. It was recently shown to treat skin reactions to paint and other toxic and allergenic materials (5). Both types of phaseolus are characterized as having a sweet taste. According to Chinese Dietary Therapy, phaseolus is applied as follows: "For poisoning or untoward reactions caused by taking hot-natured drugs, such as Sichuan aconite [chuanwu] or croton seed, take powdered mung bean steeping in boiling water or together with licorice." In a clinical report on the treatment of aconite poisoning (23), successful alleviation of severe symptoms was attained by combining the standard Western medical method, including use of the plant drug atropine, with ginger and a decoction of licorice and phaseolus (ludou). The licorice plus phaseolus decoction was also applied in the treatment of side effects of the patent remedy Xiaohuoluo Dan, which contains aconite (24). In a report on 93 cases of acute poisoning by various substances, Ludou Jiedu Tang was used (30). It is comprised of phaseolus, licorice, lonicera, imperata, dendrobium, rhubarb, salvia, and bamboo shavings. All patients improved with treatment, with 63 rapidly resolved. All these ingredients, except rhubarb and salvia are sweet; all the herbs except licorice are cooling. The flower of pueraria (of the Leguminosae), a sweet-tasting herb, is said to treat "fidgets and thirst after alcoholic intoxication;" this property is also attributed to mung bean flowers. With these several examples of Leguminosae plants with sweet-taste counteracting toxins and side effects, it is not surprising that when modern Chinese researchers sought new therapies for counteracting the side effects of cancer drugs, the polysaccharides of astragalus (a member of this plant family, traditionally recognized as having a sweet taste) were evaluated. The polysaccharides were isolated for testing first because they were found to be the sweet fraction of the herb extract. It was soon shown that they counteract the immune-suppressing side effects of cancer therapies (15, 22). Today, astragalus is one of the most commonly used herbs for this purpose. An example of a sweet formula developed to treat bone marrow suppression (a common side effect of both cancer drugs and radiation therapy) is the Astragalus-Jujube

Combination (Qi Zao Granule), applied to treating white blood cell suppression from various causes (16). The formula is comprised of astragalus, jujube, hoelen, and millettia (jixueteng). Millettia (from various sources, including the genera Millettia, Macuna, and Spatholobus) is also a member of the Leguminoseae; its taste is sweet and bitter; hoelen, a sweet-tasting tree mushroom, contains polysaccharides similar to those found in astragalus. According to the clinical report, patients with white blood cell counts below 3.5 were treated for 20-30 days with this mixture (given twice per day). 56% of the patients had their white cell counts increased by at least 4.0 above the initial value and 24% had the white cell counts increased at least 1.0 above the initial value; granulocytes similarly increased. The figures for the response of the control group were 25% and 5% respectively. An expanded version of that formula was clinically tested for cancer patients with impaired immune functions (47). The prescription, Shengxue Tang (Generate Blood Decoction), is made with 30 grams each of astragalus and millettia, and 10-15 grams each of hoelen, lycium fruit, pseudostellaria, ligustrum, and cuscuta (the latter four herbs replacing jujube in the Astragalus-Jujube Combination to yield the new formula; all have a sweetish taste, except ligustrum, which is bitter; lycium contains polysaccharides similar to those found in astragalus). The total formula is notably sweet, with a mild bitter taste, and is slightly warming in nature. According to the clinical report, 242 cancer patients, mostly having stomach or intestinal cancer, and being diagnosed as having spleen-qi deficiency, were administered this formula in an attempt to restore impaired immune functions (patients had been treated by surgery, some by chemotherapy). After only a few days of treatment (each course of therapy was only 2-3 day), macrophage phagocytosis, lymphocyte transformation rates, E-rosette formation rates, and killing ability of natural killer cells of peripheral blood were significantly increased. Yet another version of this formula, labeled Fuzheng Zengxiao Fang, was also tested (21). It is comprised of astragalus, millettia, lycium fruit, ligustrum, pseudostellaria, atractylodes, asparagus, and carthamus (thus, hoelen and cuscuta in Shengxue Tang are replaced by atractylodes, asparagus, and carthamus here). Atractylodes and asparagus are sweet herbs, and both are used to regulate the stomach functions as well as to tonify qi and yin (respectively); carthamus is bitter and vitalizes blood circulation. Patients with tumors affecting the upper body (head, neck, chest; mainly lung, esophagus, and lymphatic cancers) were divided into two groups, one receiving the herbal combination in decoction form daily for four weeks. All received radiation therapy (which is considered to have a burning, therefore hot, impact, and damage the qi and yin while producing blood stasis). It was reported that those taking the herb formulas had significantly less fatigue, gastro-intestinal distress, and loss of body weight; they also had far less inhibition of white blood cells. It can be seen from the above descriptions that sweet-tasting formulas (particularly those that include herbs of the legume family, such as licorice, astragalus, soja, and millettia) are not only theoretically useful, based on the traditional concept of taste and action, but are also applied in modern clinical work to counter the side effects of toxic drugs with apparent good result. The traditional selection of ingredients also implies that the diet of

persons who need to take toxic drug therapies should rely more heavily on legumes, such as soy bean products and mung beans, which can be prepared with rice and other nourishing grains.

USING STOMACH PROTECTORS Licorice, astragalus, and jujube are herbs that enhance the stomach functions. The importance of protecting the stomach from the effects of drugs, and enhancing stomach functions that might be impaired by the drugs, has long been a principle of traditional Chinese medicine. For example, in a discussion of drug poisoning in the Zhangshi Yitong (1695 A.D.), the author, Zhang Lu, argues strongly that the stomach must be protected and that the stomach functions that are damaged must be restored. Zhang's concern was that (19): "The stomach influences [qi] are thrown into disorder by drugs, and, as a result, food and drinks will no longer be transformed into flesh and skin, and the bones will no longer be the firm framework propping up the body." He concluded: "To treat this illness of drug poisoning, one must do away with all the bitter, cold, descending, draining herbs, and also the acrid, hot, ascending, and stimulating herbs, as well as those that have strong and violent nature and taste. Only small doses of substances that warm and nourish the stomach, such as ginseng and astragalus, are appropriate." Of course, in the case of modern drug therapies, it is not always possible to eliminate the drastic substances; still, the recommendation here is to use sweet herbs, such as ginseng and astragalus, to assure that the stomach can recover. This principle would also apply to treatment of patients who have just completed a course of drug therapy and are suffering from the adverse consequences of both the disease that was being treated and the drugs that were applied. Herbs that are considered to have particularly cold properties are believed to have the side effect of impairing the stomach functions. An example is gypsum (shigao), which is often described as having an extremely cold property. Despite the extreme nature, it is deemed an important mineral agent to be applied in cases of fire syndromes, such as heatstroke, lung disease, skin eruption, and high fever. One of the best known formulas relying on gypsum is the White Tiger Decoction (Gypsum Combination, Baihu Tang). It includes the two fire-purging herbs gypsum and anemarrhena, with oryza and licorice. Oryza is sweet and warm. According to Formulas and Strategies (3), oryza and licorice "prevent the extremely cold properties of the other ingredients from injuring the middle burner." Further traditional modifications of this formula listed in the Shanghan Lun include Baihu Jia Renshen Tang that adds ginseng to improve the function of the stomach and spleen, and Zhuye Shigao Tang, in which anemarrhena is replaced by three herbs: pinellia, ophiopogon, and bamboo leaves. This latter formula has been adopted recently to treat the gastro-intestinal side effects of cancer therapies. In a clinical trial (20), this formula was made as a decoction and patients were instructed to drink it in the morning and night, except on the day of chemotherapy (for persons who have a severe reaction to chemotherapy, it would be given a day before the therapy and starting again two days

afterward; this avoids any possible interaction between the herbs and the orallyadministered chemotherapy drugs). The formula could be modified slightly for specific symptomatic presentation. The patients being treated had bone cancer, and were being treated by polydrug therapies such as VAC (vincristine, cisplatin, and adriamycin), or with methotrexate, cyclophosphamide, etc. In general, only 3-5 doses of the herbs were needed for each cycle of chemotherapy (typical 2-3 week interval between chemotherapy administrations). Of 18 patients so treated, it was reported that 5 had virtually no adverse reactions to the chemotherapy (e.g., nausea, vomiting, dry mouth, sore throat, oral ulceration, etc.) and that 10 had much less reaction than before. Bamboo leaves and ophiopogon have a sweet taste and cold nature. The side effects of the chemotherapy were interpreted as damaging the stomach and yielding stomach-heat reactions, hence the use of gypsum, ophiopogon, and bamboo in this formula for enhancing and normalizing stomach functions. A traditional formula for clearing lung heat, Morus and Lycium Bark Formula (Xiebai San; literally, Drain the White Powder, where white is the color representing the lungs), is comprised of two heat-clearing herbs, morus bark and lycium bark, and two herbs to protect the stomach, oryza and licorice. According to the Chinese-English Manual of Commonly Used Prescriptions in Traditional Chinese Medicine: "The four drugs used together can purge the lung heat but does not damage the healthy energy." Protecting the stomach from cold is commonly mentioned in the literature, but protecting the stomach from the heating effects of herbs is also deemed important. Even the commonly-used spicy herb ginger (fresh ginger, shengjiang or dry ginger, ganjiang), is described as having the potential to cause heating and drying of the stomach; this is also true of the warm and spicy herbs pinellia and citrus. The potential problem for the stomach is compensated for by adding licorice and/or jujube. In fact, the stomachbenefiting combination of ginger, jujube, and licorice is used in about 20% of the formulas of the Shanghan Lun and the companion volume Jingui Yao Lue (220 A.D.). A formula combining dry ginger and licorice (honey-fried) is mentioned in the Jingui Yao Lue. Referring to the dry ginger in this formula, Formulas and Strategies mentions that: "its acrid, hot nature can easily deplete the source qi. To prevent this, honey-fried licorice is added to tonify the qi. Together, these herbs warm and strengthen the stomach...."

RECENT RESEARCH EFFORTS The main effort aimed at finding ways of counteracting side effects of Western medical therapies with Chinese herbs was initiated during the 1970's in an effort to deal with the increasing use of Western medicines to treat cancer. The use of Chinese herbs for treating cancer alone had limited success, as most traditional physicians working at the new hospital facilities set up by the government beginning in the 1950's would attest. Modern medical cancer therapies are usually difficult to tolerate. Surgery, which can be quite invasive, is the one that causes the least systemic damage, but it is not always a reasonable option. Chemotherapy and radiation therapy cause a number of adverse

effects. Of particular concern are: leukopenia (loss of white blood cells due to bone marrow inhibition); reduced appetite and impaired ability to take in nourishing foods; and general weakness (and accompanying depression, lack of exercise, and inability to pursue health-promoting activities). In the attempt to integrate traditional Chinese and modern medicine, the concept arose of relying on the Western therapy as the primary means of killing cancer cells, while using Chinese herbs to protect the bone marrow, improve the appetite and digestion, and increase energy. The Chinese medical aspect of this integrated method was termed Fu Zheng Therapy, where fuzheng means "to support normality." Its actions are to nourish, tonify, and invigorate the body's beneficial qi to help overcome any perverse qi that might be associated with the cancer, the therapies for cancer, and pathogenic influences that attack the body that has been weakened. In a 1981 report by Tu Gouri (56), the direction and results of this work were summarized: In recent years, the treatment of malignant tumors with combined methods of traditional Chinese medicine and western medicine has made much progress. Tonics play a part in the therapeutic effect....Patients with advanced malignant tumor usually have the symptoms of deficiency in qi and blood, deficiency of liver and kidney, and dysfunction of spleen and stomach. Tonics may improve the general condition and the immune function of the patients, enhance resistance against diseases, and prolong their surviving period. Furthermore, tonics also have protective effect against immune suppression, lowering of leukocyte count, suppression of bone marrow, and decrease of plasma cortisol level induced by radiotherapy and chemotherapy. All these benefit the treatment of malignant tumor. The number of clinical journal reports about Fu Zheng Therapy is large, and there have even been books describing this approach, such as the one completed in 1988 and published in English in 1992, Cancer Treatment with Fu Zheng Pei Ben Principle (6). Here, peiben means to shore up the root, meaning to protect the fundamental essence of the body from debilitation; guben is a term sometimes used instead: to firm up the root). If one accepts the findings of any of the Chinese studies, it is evident that cancer patients can experience fewer side effects and, generally speaking, feel better; they can often increase their survival time (compared to persons not using Fu Zheng Therapy). The herbal basis of Fu Zheng Therapy is, fundamentally, to select ingredients to tonify the qi and yang, nourish the yin and blood, improve digestive function, and, if need be, address specific symptoms that have arisen (either because of the cancer, the cancer therapy, or another influence). The particular ingredients of Fu Zheng Therapies are diverse, though they tend to be sweet and slightly bitter in taste, and the formulas tend to be slightly warming in nature (see section on General Trends in Drug Effects, below, for more on the warming nature of the therapies). In pursuing the laboratory investigation of herbs for cancer therapy, there is one class of active constituents that stands out. These are the immune-modulating polysaccharides (they are actually polysaccharide-peptide combinations) obtained from numerous herbs,

but first investigated among the medicinal mushrooms. Most people in the field of natural healing have heard of some of these materials: ganoderma (lingzhi, Japanese: reishi), lentinus (xianggu, Japanese: shiitake), polyporus (zhuling, related Japanese mushroom: miitake), and coriolus (yunzhi; this is the source of the Japanese drug product called PSK, polysaccharide krestin). Although there have been claims made about the superiority of one source or another, it appears that the mechanism of action of these polysaccharides, also found in astragalus, lithospermum, prunella, lycium fruit, and other non-mushroom herbs, is the same. The dosage that is needed in clinical application when using oral administration is approximately 3.5 grams of polysaccharides per day. The mushrooms typically contain less than 8% polysaccharides by dry weight, which means that one must ingest the extract of at least 40 grams of the dried mushrooms each day. Because the mushroom extracts that are made into commercially available products are usually quite expensive, and because some commercial preparations have little or no polysaccharides (as is the case with the tinctures), the natural tendency is for these to be used far below the clinically useful dosage, therefore with relatively little effect. This is not, however, because of any basic defect in the treatment strategy. An example of successful treatment was reported (54) for polysaccharides from coriolus in the adjunctive treatment of breast cancer patients. The patients took 9 capsules per day of polysaccharide peptides of coriolus, said to be similar to the drug product PSK. This provided 3.6 grams of the material per day. There was no significant drop in blood counts among 11 patients studied during three cycles of chemotherapy; additionally, half of the patients reported an improvement in appetite. In the laboratory animals, experimental tumor cell lines usually cause substantial immune impairment, which is rectified by the polysaccharides, causing the tumor to shrink under the attack of the immune system. In humans, cancer-induced immune suppression is less common; instead, the problem of weakened immunity arises from the cancer therapies. Thus, although the polysaccharide extracts of mushrooms were originally developed as treatments for cancer, currently, these (and similar polysaccharides from other plants) are being used as adjunct therapies to protect the patient's stomach, liver, and bone marrow from toxic effects of drugs and damage due to radiation therapy, as in the abovementioned clinical evaluation. Westerners first learned about Fu Zheng Therapy when a conference on immuneregulating therapies was held in China (1983) with the support of the M.D. Anderson Medical Center (Houston, Texas) and Newport Pharmaceuticals (Newport, California). At this conference, Dr. Sun Yan presented his data on two of the Chinese herbs that had been shown to be of benefit, astragalus and ligustrum. Subsequently, additional work was done by Dr. Sun during a visit to the M.D. Anderson facilities. Eventually, a polysaccharide fraction of astragalus (fraction 3, F-3) was isolated as the most potent of the herb's polysaccharides. Unfortunately, because of the inability to patent this type of compound, additional work was not pursued in the U.S. Herb companies have, nonetheless, provided astragalus, ligustrum, the combination of the two (alone or with

additional herbs), and even the F-3 component as natural products. Unfortunately, as indicated above, the dosage administered is usually too low to attain the desired effects. Astragalus plus ligustrum was developed as a cancer adjunct therapy in China, especially to accompany chemotherapy. The Zhenqi Tonic Drink, comprised of these two herbs in liquid extract form (not tincture, however), was evaluated in patients with advanced gastric cancer receiving chemotherapy (mitomycin 5-FU). The herb drink was given to some patients twice daily for eight weeks during chemotherapy. The authors of the study reported that the tonic could reduce the incidence of toxicity, leukopenia, and thrombocytopenia (28). The fact that research on these two herbs held such a prominent position has led to inclusion of astragalus and ligustrum in many fuzheng formulations, such as the previously mentioned Shengxue Tang and Fuzheng Zengxiao Fang. Evaluations of herbs that protect against the immune-suppressing action of radiation therapy begin with studying the ability of herbs to protect animals exposed to whole-body potentially lethal radiation, and develop into clinical trials. In a report on this subject (55), the following herbs were reported to be of benefit to the immune system of cancer patients in clinical trials: eleuthero ginseng, tremella (a medicinal mushroom with immune modulating polysaccharides), sophora, and Qi Zao Granule (astragalus, jujube, millettia, and hoelen).

CLINICAL REPORTS OF TREATING SIDE EFFECTS WITH FU ZHENG THERAPY While research efforts continue to aim at analyzing specific herbs and their active constituents, most of the recorded information about treating cancer patients with integrated therapy involves application of complex herbal formulas, not unlike those used for treating other diseases. The basic principles of treating cancer therapy side effects are outlined in the book Cancer Treatment with Fu Zheng Pei Ben Principle. The author, Pan Mingji, based on his long clinical experience, devised a general formula for prevention and treatment of side effects of various chemotherapeutic drugs. This formula, called Yiqi Buxue Jianpi Tang (Decoction to Support the Qi, Nourish the Blood, and Benefit the Spleen), is similar to the prescriptions described above for treating immune-suppression, with astragalus, licorice, lycium fruit, ligustrum, millettia, atractylodes, hoelen, and codonopsis as ingredients. However, Pan Mingji shows a preference throughout his book for very large formulas (both a large number of ingredients and a large dosage of each ingredient). His general fuzheng prescription also includes rehmannia, ho-shou-wu, polygonatum, glehnia, ophiopogon, euryales, and dioscorea (the formulation to be adjusted, as needed, by adding specific herbs for the toxicity symptoms encountered, sometimes reducing the dosage of other herbs to compensate). According to Pan, the formula is administered

along with chemotherapy and during any intervals between therapeutic courses, until symptoms disappear. The overall results of clinical applications are not indicated, though a few case studies are presented in his book. Clinical trials of cancer therapies, with more specific evaluations of outcomes, have been published in several Chinese medical journals. Due to flaws in research methodology, the outcomes must be interpreted with caution; due to difficulties in evaluating the limited data described in the journals, only a cursory outline of results is given here. Still, the information about what herbs are administered, how they are administered, and what general types of improvements are claimed to result is of interest to practitioners here, especially those who have limited experience treating cancer patients. There are three main approaches to treating side effects of cancer therapy that are evident in a survey of the Chinese literature: 1. Attempting to improve overall outcomes. In the clinical trials, it is common to find that patients with many different types of cancer and undergoing many different Western medical therapies are included in the study and are administered a basic protective herbal therapy, sometimes modified for specific symptoms. The claimed outcomes are fewer side effects, better ability to complete therapy, improvements in tumor shrinkage, and increased survival time. 2. Correcting immune suppression. In clinical trials, the level of white blood cells is monitored; in some cases, more specific immune assays are followed, such as monitoring the numbers of CD4 and CD8 cells (involved in cellular immunity) and levels of immunoglobulins (involved in humoral immunity). Since immune suppression may be reason to prematurely terminate or delay Western medical therapies, and since impaired immunity may result in life-threatening infections, this particular side effect of cancer therapy has been deemed an important area of concern. 3. Overcoming nausea and other digestive disturbance caused by cancer therapies. Nausea is a common reaction to chemotherapy and often results in reduced appetite and resulting loss of nutritional status and body weight. Risks associated with malnutrition and wasting are substantial and may be fatal for patients undergoing cancer treatment. Further, nausea and loss of appetite may lead to a situation where a patient is unwilling or unable to consume herbs for their other benefits. Sometimes the herb treatments are given with the Western medical therapy, but other times they are given afterward, to help recover from the adverse effects of Western medical therapies. An example of a traditional herb formula that has been recruited to the task of overcoming cancer side effects is Ginseng and Tang-kuei Ten Combination (Shichuan Dabu Tang). The formula:

1. tonifies qi, relying on the base prescription: Four Major Herbs Combination; Si Junzi Tang, comprised of ginseng (or codonopsis), licorice (honey baked), hoelen, and atractylodes; 2. nourishes blood, relying on the base prescription: Tang-kuei Four Combination; Siwu Tang, comprised of tang-kuei, cnidium, peony, and rehmannia (cooked); 3. invigorates qi and yang, with astragalus and cinnamon bark. The formulation, with dosage ranges as used to accompany cancer therapies is: Shiquan Dabu Tang astragalus 15-30 g codonopsis 10-15 g hoelen 10-20 g atractylodes 10-15 g licorice 5-10 g tang-kuei 10-15 g peony 10-15 g cnidium 10-15 g rehmannia 10-15 g cinnamon bark 5-10 g This formula has come to the attention of Westerners through some English-language publications, such as the popular book that reviews alternative cancer therapies by Michael Lerner (Choices in Healing: Integrating the best of conventional and complementary approaches to cancer), where it is listed by the Japanese name Jizendaihoto. Isamu Adachi presented information (17) about using this formula for treating advanced breast cancer patients at a conference on Oriental Medicine held in Japan in 1990, which was relayed by Lerner. Adachi reported on 130 patients entering the study during the period 1985-1987, indicating that patients treated with this formula had a better survival rate than a control group not treated with the formula. The difference was noted after 18 months following the cancer therapy (survival rates were about the same until that time, but better with the herb treated group thereafter) and the improvement was still evident at three years (duration of monitoring at the time of the report). In a recent report by Wang Yuran (7), 60 patients with a variety of cancers, mainly lung and esophageal cancer, were treated first with chemotherapy or radiation, and subsequently suffered from immune suppression. They were then administered a modified version of Shiquan Dabu Tang (added herbs were polygonatum, lycium fruit, ho-shou-wu, cornus, lotus seed, millettia, and dioscorea). This formula is quite similar to the one recommended by Pan Mingji, having 11 of the same herbs, but with lotus seed replacing the related herb euryale (these herbs have virtually the same properties), and with the blood tonics tang-kuei, peony, and cnidium replacing the yin tonics ligustrum, glehnia, ophiopogon, and cornus. After 30 days administration of the herbs, Wang reported that there were statistically significant improvements in total white blood cells, natural killer-cell rate, and ratios of CD2, CD4, and CD8 (to reveal better cellular immune functions; humoral immune functions did not change much, except an

improvement in IgG). Of course, one would expect a certain natural improvement in immune functions after the Western medical therapies were completed, so we don't know to what extent these improvements were due to the herbs. A simplified Shiquan Dabu Tang was tested in tablet form by Zhang Yikang and Xiao Ainong (8). Patients with various cancers were treated with radiation and/or chemotherapy and simultaneously given Bao Yuan Pian (Tablet for Preserving the Original Qi), comprised of ginseng, astragalus, licorice, and cinnamon bark. Tablets of the extract were given three times daily while a control group received a vitamin tablet. The effects were evaluated according to two related criteria: one was that the patients were able to complete the medical therapies (which requires maintaining sufficient immune status as well as tolerating the adverse symptomatic effects of the therapies), and the other was maintaining a relatively high WBC count. According to the report, the treated group had a better outcome (88% able to complete therapy and maintain good WBC counts) than the control group (61%). Bao Yuan Pian focused on the qi and yang invigorating principles of Shiquan Dabu Tang. A modified Shiquan Dabu Tang recipe, with peony, cnidium, and cinnamon bark deleted and adenophora and salvia added, was used to treat gastric cancer patients with advanced stage of disease (68). The patients had undergone surgery and were then treated with chemotherapy along with the herbs. A control group received chemotherapy plus herbs that were aimed specifically at alleviating gastric distress, with citrus, magnolia bark, cardamon, oryza, and malt. Those treated with the modified Shiquan Dabu Tang had significantly increased CD8 levels and reduction in the high platelet-aggregation rate that is characteristic of advanced cancer patients; the survival time of this group was greater than that of the control group. Another treatment that may be considered a modification of Shiquan Dabu Tang is the one described by Cheng Huiha, et al., (9), using astragalus plus Liu Junzi Tang. Like Shiquan Dabu Tang, it incorporates Si Junzi Tang plus astragalus, but it does not include the blood nourishing herbs or cinnamon bark, and instead contains pinellia and citrus, two herbs that promote digestive functions and help alleviate nausea and vomiting. Patients with primary hepatic cancer were treated by chemotherapy infused directly into liver arteries by catheter, and were given the herbal formula orally (each batch taken in two divided doses per day, 6 batches per week, 30-40 batches per treatment. The herbs were taken during the overall course of chemotherapy but not for three days before or during each catheter administration of the drugs (typically four times per patient). According to the authors, the use of herbs led to lessening of: nausea, vomiting, pain in the liver region, and WBC decline. There was a slight improvement in the shrinkage of the tumor as well. Countering immune suppression due to thiamazole (methimazole) or propylthiouracil (thyroid-inhibiting drugs used for treatment of hyperthyroidism, such as Grave's disease), was also accomplished by using a modification of Shiquan Dabu Tang, in which hoelen, cnidium, and cinnamon were deleted (these are the three herbs of the traditional formula that are most often sacrificed in Fu Zheng Therapy to make room for various additions)

and millettia and buffalo horn added. In the study of its effects, a control group used Western medicine, such as leucogen (nupigen) and vitamins. Patients continued using the thyroid drugs, except two who had such severe leukocyte-inhibition that they stopped. Patients treated with the herbs had significant increases in hemoglobin, white blood cells, and platelets, indicating restoration of bone marrow functions. The control group treated with Western medicine showed some improvements in these parameters, but to a much lesser degree. Shiquan Dabu Tang has become so well known as a treatment for minimizing cancer therapy side effects and post-cancer therapy recovery of immune functions that it was used in a clinical trial (10) as the control treatment to test a new herbal therapy. The formula, Yangyin Shengbai Yin (Support the Yin, Generate White Blood Cells), is made with an unusual mixture of herbs (compared to most Fu Zheng Therapies) aimed at treating qi, blood, and yin deficiency, and digestive disturbance. Of 14 ingredients used, only three were commonly found in other formulations, namely hu-chang, tang-kuei, and peony. According to the report, Yangyin Shengbai Yin and Shiquan Dabu Tang were both associated with substantial improvements in WBC counts, but the former group had a better total effective rate (87%) than the latter (69%) after three weeks of treatment. This difference may not reveal any flaw in Shiquan Dabu Tang or benefit in the alternative formula because the control group was too small and the trial was not blinded. A more representative Fu Zheng formulation that is not a strict derivative of Shiquan Dabu Tang is that presented by Zhang Haifan in a study (11) on the side effects of cancer therapy in patients with many types of cancer. His formula is: Huten Tang astragalus hu-chang millettia lycium fruit atractylodes hoelen tang-kuei psoralea cuscuta licorice

40 g 30 g 30 g 15 g 12 g 30 g 15 g 15 g 20 g 10 g

This formula, which is similar to Shengxue Tang mentioned earlier, is relatively devoid of the yin-nourishing herbs (lycium is a blood tonic that nourishes yin), but does contain yang-tonic herbs (psoralea and cuscuta) as well as qi tonics (the combination of astragalus, atractylodes, hoelen, and licorice). Hu-chang and millettia (which are both used in modern China to boost white blood cells) were deemed main herbs in the formula. This prescription is an elaboration of one described for leukopenia due to radiotherapy (1) which is comprised of 30 grams each of hu-chang, millettia, and tangkuei (all used for building blood), along with 9 grams of licorice. In this instance, Zhang initiated the herb therapy 3-5 days prior to starting chemotherapy and continued it until

one week after finishing chemotherapy. The effectiveness of the therapy was evaluated by considering a broad set of indicators, such as red and white blood cell levels, extent of gastro-intestinal reactions, avoiding loss of hair, and improving tumor shrinkage. According to the author, 39% of the patients had an excellent outcome, and 43% had a notably effective response, while only 7% failed to respond at all, yielding a benefit that seems comparable with other claims that have been made for Fu Zheng Therapy. In a clinical trial (61) involving cancer patients with severely lowered white blood cell production due to chemotherapy agents, a formula focusing on qi and blood nourishing herbs was given: Fuzheng Shengbai Tang astragalus 30 g codonopsis 30 g atractylodes 12 g hoelen 12 g tang-kuei 9g psoralea 12 g ligustrum 12 g polygonatum 30 g ho-shou-wu 15 g The formula was modified with additional herbs to treat specific manifestations. These herbs were given when chemotherapy was stopped, in order to help restore the reduced leukocyte levels. The control group received leucogen. The Chinese herb group was reported to have greater recovery of white blood cell counts and also showed significant improvement in other chemotherapy symptoms, such as nausea, poor appetite, weariness, and thin stools. The same basic principle was utilized in another trial (62) that focused mainly on upper body tumors (lung, breast, and stomach), with the following formulation: Fuzheng Guben Fang astragalus 40 g atractylodes 15 g licorice 20 g pseudostellaria 30 g tang-kuei 15 g peony 15 g rehmannia 20 g ho-shou-wu 40 g gelatin 20 g oldenlandia 30 g millettia 30 g ligustrum 20 g

Here, ho-shou-wu and gelatin are additional blood tonics and oldenlandia serves as an anticancer herb that increases leukocyte counts. The formulation was modified to address specific symptoms. The herbs were given along with chemotherapy, while a control group received Western drugs, vitamins, and berbamine (an herbal leukocyte raising alkaloid derived from sankezhen, Berberis soulieana) along with the chemotherapy. According to the report, the Fuzheng formula prevented the decline in leukocytes better than the control treatment, and the patients also had fewer other side effects, such as nausea and weariness. Zhang Xinqi and his colleagues (25) described another fuzheng formula that relied more heavily on nourishing the kidney and liver. It contains: astragalus codonopsis lycium fruit psoralea cuscuta ligustrum drynaria rehmannia cornus

30 g 15 g 15 g 15 g 10 g 10 g 10 g 10 g 10 g

The herbs were administered once per day for 7 days, given after the occurrence of leukopenia from chemotherapy or radiation therapy. A patient group was randomly assigned to receive or not receive the herbs; chemotherapeutic agents included cyclophosphamide, cisplatin, 5-FU, and adriamycin. According to the report, improvements were noted in nausea, lassitude, dizziness, and insomnia, and the leukocyte counts improved markedly (from an average of 2.8 to an average of 5.9). A similar approach was presented by Liu Jiaxiang in a lecture on combining Chinese and Western therapies (18). He described the case of post-operative treatment of stomach cancer (stage III). The herb formula given was Jianpi Yisheng Tang comprised of codonopsis, atractylodes, cuscuta, ligustrum, lycium, and psoralea (all these herbs are in the above formula). This formula invigorates the spleen and the kidney and was utilized to "lessen the toxic and side-reactions of the drugs" that were given to the patients (a triple drug combination). The effectiveness was rated by survival time, with 99% of patients surviving one year, 79% surviving three years, and 55% surviving 5 years; these survival rates are considerably higher than those attained by surgery plus chemotherapy alone. In a case (42) of cardiac distress (palpitation, small and slow pulse with irregular intervals, premature systole occurring occasionally, lower-wall myocardial ischemia) caused by the cancer therapy adriamycin (doxorubicin), the attending physician applied a modified Baked Licorice Combination (Zhigancao Tang), which is traditionally employed to treat cardiac irregularities. The formula applied was 20 grams licorice, 30 pieces jujube, 10 grams ginseng, 15 grams fresh ginger, 10 grams cinnamon twig, 30

grams rehmannia, and 15 grams cannabis seed. After six days of using this decoction the patients symptoms were eliminated; then, when adryiamycin therapy was begun again, she was given the decoction along with it and the cardiac irregularities did not occur. This formula has a notable sweet taste, and, like Bao Yuan Pian, contains ginseng, cinnamon, and licorice. The above examples reveal the following: 1. Herbal therapies may be applied along with cancer therapies or after the completion of cancer therapy. 2. Treatment times with the specific formulas mentioned are a few weeks. 3. High dosage decoctions are usually utilized, with daily doses of 100-200 grams. 4. Tonic herbs and herbs that are uniquely reputed to raise blood counts are relied upon most heavily. 5. Sweet-tasting formulas with warming nature are the rule. 6. Specific ingredients vary somewhat; astragalus is the most frequently included. The other common herbs are: the qi tonics codonopsis, atractylodes, and licorice; the blood tonics tang-kuei, peony, rehmannia, and lycium fruit; the yang tonics psoralea and cuscuta; and the blood cell raising hu-chang, ligustrum, and millettia that belong to miscellaneous categories of herbal therapy. 7. The claimed benefits are fewer side effects from cancer therapy, faster and better recovery of immunity after completion of the therapy, and improved outcomes measured in terms of survival time.

TREATING SPECIFIC SYMPTOMS OF CHEMOTHERAPY Several clinical trials published in the medical literature focused on the specific herbal treatment of nausea and vomiting. These included modified versions of Inula and Hematite Combination (Xuan Fu Dai Zhe Tang; (59)), Six Major Herbs Combination (Liu Junzi Tang, (60)), Ginseng Stomach Combination (Renshen Yangwei Tang; (65)), and Bamboo and Gypsum Combination (Zhuye Shigao Tang; (67)). Beneficial results were described in each of the clinical reports. Acupuncture therapy is sometimes used instead of herbs, relying on standard point selections, such as using ST-26 or PC-6. In fact, in one clinical trial (64) these two points were needled along with LI-4 and LI-11 to counteract numerous side effects of chemotherapy and radiation therapy (with daily acupuncture six days each week). This treatment, carried on for three weeks, was reportedly able to help alleviate the symptoms of loss of appetite, nausea and vomiting, abdominal distention and diarrhea, as well as helping with dizziness, insomnia, and lassitude. In another study (66), these same four acupoints, along with other points, were used to treat gastrointestinal reactions to cancer therapies, administering acupuncture daily for ten days. The treatment was claimed to alleviate vomiting, diarrhea, nausea, and fullness and distention. Unfortunately, daily acupuncture is rarely possible in the current Western setting.

Oral ulceration, a common effect of some chemotherapies, was treated with success (26) by the following herbal combination: astragalus licorice phellodendron trichosanthes root forsythia tien-chi ginseng bletilla

30 g 6g 8g 15 g 20 g 4 g [as powder] 15 g [as powder]

The first five herbs are decocted (200 mls decocted to yield 50 mls finished, strained liquid) and the powders are then added and the mixture homogenized; this mixture is given several times daily. The taste is quite bitter so honey is added to ameliorate that problem. The herbs were administered for 3-9 days as needed to resolve the condition. It was reported that 76% of the patients had their oral ulcerations resolved (compared to a control group receiving vitamins and Western drugs, with 23% resolved). Although clinical results were not mentioned, the following formula is of interest for reference purposes in the treatment of oral ulceration and pharyngeal ulceration following chemotherapy (52): astragalus Sophora subprostrata rehmannia isatis root scrophularia coptis lonicera

15-30 g 15 g 15-30 g 12-15 g 9g 6g 15 g

This prescription is prepared as a decoction and taken in two divided doses, morning and evening. As with the above formula, this one is derived from treatment of sore throat and oral ulceration that might arise from other causes, such as infection. The high dose of astragalus is one of the key differences in addressing the side effects rather than infection-caused inflammation. In a section below, formulas for treating similar symptoms due to radiation therapy are mentioned.

OTHER CASES OF COUNTERING SIDE EFFECTS OF WESTERN DRUGS

While Fu Zheng Therapy has been the primary focus of countering side effects, the use of Chinese herbs to overcome the toxicity of other types of drugs has also been investigated, to a limited extent. In traditional literature, the ferns have been reported to counteract toxicity. According to one report (39), Stenoloma chusanum (wujue, of the Polypodiaceae; known as a "universal antidote") was shown in laboratory animal studies to reduce the toxicity of arsenic. Another member of the Polypodiaceae, drynaria, has been shown to counteract the ototoxicity of kanamycin (40). The tests were done in guinea pigs, with extensive testing of the ears (including light microscope and scanning electron microscope) after the experimental period. Animals were treated with 300 mg/kg of kanamycin and the extract from 15 grams/kg of drynaria. At this time, the active constituents of drynaria that might contribute to this effect have not been established; however, drynaria is known to contain naringenin, which is a flavonoid. A rarely used relative of drynaria, onychium (leaves of O. japonicum), is reported in Modern Study and Application of Materia Medica (46) to be an antidote to several kinds of poisoning, including arsenic, mercury, DDT, and plant-drug poisoning. This herb is closely allied with another fern, pteris (fengweicao), for which the leaves are also used; according to the Oriental Materia Medica, pteris is sweet, with a mild bitter flavor, a cold property, and diuretic action (thus, having an effect on the kidneys and, possibly, on the elimination of toxins). Pyrrosa (shiwei; bitter, sweet, and slightly cold), another member of the Polypodiaceae that is employed as a diuretic, is mentioned in Chinese-English Manual of Commonly Used Herbs in Traditional Chinese Medicine to be "effective for cyclophosphamide-induced leukopenia in mice." In Treatment of Cancer by Integrated Chinese-Western Medicine, a simple formula for leukopenia is 30 grams each of pyrrosia, jujube, and dendrobium. Cnidium (chuanxiong) contains an active constituent, ligustrazine, that has been employed for numerous medical purposes (especially for cardiovascular disorders), and has been shown to inhibit toxicity of certain drugs. In another study of ototoxicity of kanamycin (27), evaluated in guinea pigs, the authors of the investigation concluded that part of the toxicity process was due to lipid peroxidation, which could be treated by antioxidants. They used ligustrazine in order to successfully reduce kanamycin ototoxicity; this compound has antioxidant activity. Gentamicin, a drug often used as a last resort for infections, is given by intravenous administration and may cause nephritis. In an attempt to counteract this, Chinese physicians have tried the combination of astragalus (30 grams per day taken orally in decoction form) and ligustrazine (80 mg/day by IV). This treatment was reported to improve the kidney functions (29). The anticancer plant drug camptothecin (obtained from Camptotheca acuminata) is highly toxic, but the toxicity may be reduced, according to the Chinese-English Manual of Commonly Used Herbs in Traditional Chinese Medicine, by glycyrrhizin from licorice and by cnidium. A new type of immune-based therapy with injection of IL-2 (interleuken-2, a cytokine) tends to cause kidney toxicity. A decoction of astragalus, millettia, dioscorea, leonurus fruit, and imperata (dioscorea, leonurus fruit, and imperata all have a sweet taste), 30 grams each, was given to patients in an effort to counter that toxicity (41). It was reported

that this treatment was effective (all 150 patients showed normal values of kidney function; in the control group, 15% of patients showed abnormalities that could be normalized by giving them the decoction for one week). In laboratory animal experiments (53), it was shown that cordyceps could inhibit the renal toxicity of cyclosporine A. Centella asiatica (jixiecao) is reported in the Chinese-English Manual of Commonly Used Herbs in Traditional Chinese Medicine to relieve drug poisoning. Specifically, mushroom poisoning, Gelsemium elegans (a very poisonous herb; the alkaloid is a spinal poison), cassava (used as a source of starch, it contains hydrocyanic acid), Derris trifoliata (a poisonous herb used as an insecticide, containing rotenone), organic phosphorus, and arsenic. For treatment of poisoning, the juice of fresh jixiecao leaves is recommended, using 500-1,500 grams of herb for a one day dose. Numerous Chinese herbs have been shown to have liver-protective actions in laboratory tests where liver toxins (notably carbon tetrachloride) are administered. In Pharmacology and Applications of Chinese Materia Medica, the following commonly used herbs were said to have a hepatoprotective property: atractylodes, mentha, bupleurum, tang-kuei, rehmannia, hoelen, licorice, lycium fruit, magnolia bark, astragalus, forsythia, ganoderma, gentiana, dandelion, schizandra, capillaris, alisma, and gardenia. The Modern Study and Application of Materia Medica also lists liverprotecting herbs, most of which are the same, but also included are: salvia, rehmannia, and hu-chang. In a search for herbs that would be useful in treating viral hepatitis, Hiroshi Hikino (31) first determined their anti-hepatotoxic activity (liver protection against a calcium transport drug; calcium flooding is thought to be one of the mechanisms of hepatic inflammation in viral and toxic hepatitis). Aside from glycyrrhizin in licorice, the following herbs were found to inhibit liver damage: curcuma, atractylodes, capillaris, swertia (a relative of gentiana), dianthus, tetrapanax, ginseng, and schizandra. Similarly, Zhou Qingjun (32) examined herbs that protect against carbon tetrachloride damage and found these to be effective: schizandra, sedum, ganoderma, astragalus, tangkuei, salvia, scute, capillaris, licorice, and Sophora subprostrata. Several of the liverprotective herbs have been used in the formulas for protecting against immunesuppression side effects, notably atractylodes, tang-kuei, licorice, lycium fruit, astragalus, rehmannia, and hu-chang. Numerous pharmaceutical drugs are known to adversely affect the liver. In one Chinese clinical trial (12), patients suffering from hepatotoxicity from isoniazide, erythromycin, griseofulvin, ibuprofen, and furadantin were treated with a combined Western and Chinese medical approach. The Western part was an IV drip with coenzyme A (200 units), ATP (60 mg), and inosine (400 mg), as well as a tablet containing vitamin B6 (20 mg), ATP (20 mg), and polyenzyme mixture (600 mg) (one tablet taken three times per day). The Chinese portion was a decoction of 10 grams scute, 20 grams sedum, 12 grams hu-chang, 15 grams lysimachia, 10 grams dandelion, and 20 grams capillaris, in two divided doses per day. A control group received the Western portion but not the Chinese herbs. Both the groups had improvements in the hepatic inflammation and bile

accumulation, but the Chinese herb group had more patients with complete normalization of liver enzyme levels. Inositol and its derivative inosine, used in the above-mentioned experiment, are deemed protective of the liver (often given in Chinese treatments for viral hepatitis, usually as part of a Western medical approach). Additionally, in one laboratory study (38) inositol was reported to antagonize multiple toxic actions of cyclophosphamide in mice. Inositol is extracted from the leaf of Apocynum venetum (luobuma), which is a folk remedy for hepatitis and nephritis. Allergy reactions are a problem with some drugs (actually, the problem is more with the sensitivity of the patient rather than the inherent nature of the drug); in most cases, this is simply resolved by changing to a different drug. However, in recent years there has been a situation where changing drugs was not a workable solution. In patients infected by HIV who had developed AIDS, a prophylactic treatment for potentially fatal pneumocystis infection was administered. The most effective drugs, sulfa drugs, caused allergic skin rashes, often severe, in some persons. Ultimately, this was resolved by administering corticosteroids (e.g., prednisone) along with the drug; this solution is not entirely satisfactory because the steroids have side effects including immune-suppression. Several non-toxic Chinese herbs have been shown to inhibit allergy reactions (see: Treatment of allergy with Chinese herbs). In Modern Study and Application of Materia Medica, the following commonly used herbs were reported to inhibit allergy reactions: mume, earthworm, moutan, placenta, astragalus, stephania, licorice, ma-huang, chin-chiu, bupleurum, cicada, atractylodes, tribulus, and ginseng. Certain herbs mentioned in Modern Study and Application of Materia Medica for anti-allergy effects were also mentioned above as being used for protecting against immune-deficiency side effects and liver damage from chemical exposure, notably astragalus, licorice, and atractylodes. In fact, the formula Shichuan Dabu Tang contains these three herbs and others that have been described in this section: ginseng, tang-kuei, cnidium, and rehmannia. In fact, Shiquan Dabu Tang has been shown helpful in treatment of refractory urticaria (58), a skin condition that is often the result of repeated exposure to allergens. This formula is clearly worthy of consideration when faced with treating all kinds of adverse reactions to drugs.

GENERAL TRENDS IN DRUG EFFECTS AND SIDE EFFECTS Side effects vary from drug to drug, so the approach to compensating for the effects needs to be tailored appropriately. Still, among commonly-used drugs that are of concern with regard to side effects, there is a trend towards them having a cooling action. Western drug therapies are frequently employed for their inhibitory effects. For example, one can immediately think of drugs that inhibit bacteria, cancer cell growth, stomach acid, and nerve impulses (e.g., beta blockers). In general, and keeping in mind the diversity of

drugs that will generate some exceptions, these inhibitory effects correspond to having cooling actions, even if some of the drug side effects are of a hot nature (e.g., causing mouth ulceration). Hence, antibiotics, understood in Western terms as treatments for bacterial infection, often alleviate fever (a hot condition) and colored discharge (a traditional sign of heat). Cancer drugs clearly reveal their side effects before their positive effects (tumor shrinkage), and induce lowered blood-cell production, lowered appetite, lowered energy, and other inhibitory actions that would be interpreted as involving a lowering of qi and yang. Steroidal drugs that inhibit inflammatory processes are used in Chinese pharmacology experiments to induce laboratory animal models of yang deficiency, because of their ability to impair the adrenal cortical output of hormones, which corresponds to a weakening of yang. Much of the effort to overcome the effects of prolonged drug therapy involves the application of qi- and yang-tonifying herbs (warming the spleen and kidney). In the article by Zhang Xinqi (25) about cancer therapies, the situation was summed up this way: "The leukopenia caused by chemo-or radiotherapy is classified to the deficiency type of illness which is referred to as the morbid condition showing deficiency of genuine qi, lowered body resistance, and declining of function. Then, supplementing qi and nourishing the blood, warming and invigorating the spleen and kidney are the essential therapeutic principles for remitting the toxic and side effect of chemo- and radiotherapy." By contrast, short-term drug effects (e.g., acute toxicity after a single exposure or very few exposures) may be treated with traditional "antitoxin" herbs, which are usually cooling in nature. From time to time, a yin- or blood-nourishing herb is found to have properties similar to the qi- and yang-tonifying herbs. For example, lycium fruit, noted for nourishing yin and blood, contains polysaccharides that have the same effects as those found in qi- and yangtonifying herbs, such as astragalus and epimedium. Thus, while there are no strict rules, and while the complex formulas for treating side effects usually contain a mix of herbs having different therapeutic actions, the above analysis helps explain why a large portion of the herbs and formulas for treating adverse effects (in modern clinical trials) are qi and yang tonics and are warming in nature. Even when the drug therapy produces symptoms of thirst and dryness, qi-tonifying herbs may be used since the spleen qi generates fluids (pseudostellaria is one of the favored herbs for tonifying qi when there is thirst and dryness; American ginseng is sometimes substituted). An exception is protection against liver toxicity, which tends to rely more on cooling herbs. Liver toxicity reactions often appear as damp-heat, thus indicating the use of cool and bitter herbs. Yin-nourishing therapies may be an essential ingredient in the treatment of patients who are elderly or who have been ill for a long time. It is generally accepted that such patients will suffer from yin-deficiency syndrome, regardless of the particular drugs being utilized. Because the drugs have an impairing action on the stomach and spleen (as well as other organs), the yin deficiency will be worsened.

POST-SURGICAL TREATMENTS

Despite the great advances in surgical techniques, persons undergoing any major surgery often experience the problem of blood stasis, the direct result of cutting through numerous vessels. Surgical interventions are somewhat like injuries, like a stab-wound, though far less traumatic due to the finely-honed knives, the skill of the surgeons, and the specific aim of not causing harm. Therefore, unlike treatments strictly aimed at woundhealing, the emphasis in post-surgical therapy is only partly focused on vitalizing blood, with much greater focus on strengthening the individual. Surgical interventions themselves usually cause some weakening of the qi, partly the result of any prolonged anesthesia and partly the result of damage to the normal interaction of the organs via the natural blood circulation. However, the qi of patients requiring surgery may already be weak. Surgical interventions often cause temporary weakening of the blood due to the blood loss that occurs during the procedure; patients may also suffer from blood deficiency due to malnourishment. When the lymphatic system is damaged by surgery, as is often the case with breast cancer surgery (in which the lymph nodes are removed), fluid accumulation arises. Finally, in cases of cancer therapy, there is a concern about cancer cells that are left behind (either at the original tumor site or that have already metastasized). As examples of helping the patient recover from surgery, the following are offered. The first example is the post-surgical treatment of breast cancer. The herb formula outlined below was presented by Pan Mingji. It has the purpose of promoting early recovery from surgical trauma, enhancing immune functions, and inhibiting residual cancer cells: astragalus pseudostellaria white ginseng peony tang-kuei tien-chi ginseng [taken separately as powder] placenta polyporus hoelen asparagus

15 g 15 g 4.5 g 10 g 9g 1.5 g 12 g 15 g 15 g 15 g

In addition to the above herbs, which tonify qi, nourish blood, vitalize blood, and drain dampness, herbs for inhibiting tumor cells were also included: prunella (15 g), trichosanthes fruit (20 g), oldenlandia (15 g), cremastra (12 g), lonicera (12 g), and toad skin (10 g). The total dosage of herbs is about 200 grams, though just over half of it is aimed at the recovery from surgery. The herbs are to be made as a decoction and consumed in two or three divided doses. One or two additional herbs may be added to address specific symptoms. According to Pan, for cases of the incision not healing well, use 30 grams each of astragalus and salvia; 20 grams each of tang-kuei and wild chrysanthemum; and 10 grams each of catechu, licorice, and atractylodes for several days in place of the above formula.

A second example is the surgical treatment of gynecological disorders, such as ovarian cysts and uterine fibroids. Since malignant tumor cells are not a concern, the anti-cancer herbs (such as oldenlandia and cremastra) are not required. Because the treatment involves the lower body rather than the upper body, herbs for nourishing the kidney and liver are relied upon more than herbs for benefiting the spleen and lungs (qi-tonic herbs). A formula, Yomeishu, given as a medicinal wine, was described by Toshifumi Takabayashi and his colleagues (13). The formula (proportions not given) is: rehmannia cinnamon bark epimedium eucommia cistanche ginseng

clove leonurus turmeric lindera agkistrodon siler

This formula nourishes the kidney and liver, tonifies qi and vitalizes blood. It was tested among a group of 100 post-operative patients, of which 24 had radical hysterectomies, 66 had simple hysterectomies, and 10 had oopherectomies; half of all patients received the formula. Those receiving the formula, which was administered during the three months after surgery, showed faster recovery and improvements in virtually all symptoms monitored. One can guess that the proportions of most of the herbs are roughly equal (e.g., 9-15 grams in decoction form), with lesser amounts of cinnamon bark, ginseng, clove, siler, and agkistrodon (e.g., 3-6 grams in decoction form). Both formulas rely primarily on tonification therapy and have only a small component aimed at overcoming blood stasis. Surgical treatment of stomach cancer, one of the common types of abdominal surgery for cancer, is frequently mentioned in the medical literature and mainly treated by herbs that tonify qi and aid digestion.

THE PROBLEM OF RADIATION BURNS Radiation therapy causes damage to the tissues adjacent to those being targeted, which is similar to the experience of a burn. In terms of herbal therapies, tonics like those used for countering immune suppression and drug toxicity turn out to be of benefit. The general theory is that the spleen function needs to be improved to assure adequate nutrition to help heal the burn (43). For example, Zhang Yin (44) reported on successful treatment of patients with severe burns (not from radiotherapy but from fire), using the following formulas: Shen Fu Tang ginseng 16 g jujube 5 pieces aconite 9g

fresh ginger

3 slices.

Modified Yupingfeng San astragalus 30 g atractylodes 9g jujube 5 pieces siler 9g wheat 16 g longan 16 g In another report (44), reviewing 1,000 cases of burns treated topically and orally, the decoction applied orally was derived from Ginseng and Astragalus Combination (Buzhong Yiqi Tang), Four Major Herbs Combination (Siwu Tang), and Tang-kuei and Astragalus Combination (Danggui Buxue Tang). In laboratory animal studies (51), it was reported that Ginseng and Astragalus Combination, Minor Bupleurum Combination (Xiao Chaihu Tang), and Shiquan Dabu Tang all offered significant protection from radiation. The herbs were administered for three weeks prior to beginning radiation exposure and continuing throughout radiation exposure. Ginseng, astragalus, licorice, and jujube are common components of these various formulas. Although clinical reports about treating the oral and esophageal damage due to radiation burns have not appeared in the medical literature, Chinese doctors have mentioned remedies that they believe to be effective. For example, in Prevention and Treatment of Carcinoma in Traditional Chinese Medicine (49), the author, Jia Kun, describes treating a woman with breast cancer who had just undergone radiation therapy. This treatment had left her with symptoms of sore throat, cough, dry mouth, and pain when swallowing food. To his basic formula for treating her overall condition, he added trichosanthes root (or a related herb, bulbostemma, tubeimu) and sophora root (30 grams each). A patent remedy, Bi Yan Ling Pian (nose throat effective tablets) contains Sophora subprostrata, codonopsis, scrophularia, ophiopogon, oldenlandia, and selaginella (shishangbo, an antitumor herb used for lung, nasopharyngeal, and esophageal cancers), and was developed to be used for "acute and chronic pharyngitis and a subsidiary after radiotherapy." According to the package insert (50): "The rate of effectiveness for side effects after radiation therapy, such as nausea, bad appetite, dry and sore throat, nose bleeding, and oral erosion is 89%." In an attempt to ward off side effects of radiation therapy, the following formula was mentioned in Treatment of Cancer by Integrated Chinese-Western Medicine for use starting 3-4 days prior to initiating the radiation treatments: astragalus atractylodes Sophora subprostrata rehmannia forsythia isatis root

15-30 g 9g 15-30 g 15-30 g 15-30 g 15-30 g

scrophularia trichosanthes fruit belamcanda shen-chu

9g 15-30 g 9-15 g 15-30 g

Most of the herbs in this formula are aimed at treating inflammation of the lungs, esophagus, and oral cavity. Shen-chu helps protect against loss of appetite.

DO HERBS THAT COUNTER SIDE EFFECTS ALSO COUNTER DESIRED EFFECTS? A concern raised by medical doctors regarding the use of herbs to counter side effects is whether or not the desired effects of the therapies will also be countered. For example, will the herb formula that prevents leukopenia (bone marrow inhibition) induced by the drug also prevent the drug from inhibiting the tumors? In general, this is not a problem, as revealed by the clinical outcomes reported by the Chinese: not only are the side effects lessened, but the survival rates improve. To understand how this works, the situation can be illustrated by the use of immuneenhancing polysaccharides to counter the leukopenia induced by cancer therapies. The action of the polysaccharides is to maximize the effectiveness of the bone-marrow production of white blood cells, in much the way a medical doctor might apply a stem cell growth stimulating factor (e.g., Nupigen). The mechanism of action is via stimulation of various immune system components, through a cascade of events that take place within the immune system. The polysaccharides do not stimulate other cell lines, nor do they protect bone marrow cells by directly blocking the entrance of cancer drugs into cells. Therefore, while the polysaccharides will be able to partially counteract the bone marrow suppression induced by chemotherapy (or radiation), they will not counteract the suppression of or damage to cancer cells. On the other hand, there are some Western medical interventions (not for cancer) relying on immune-suppressive drugs, such as cyclophosphamide, that are specifically intended to stop bone marrow production of immune cells. In that case, the use of the immuneenhancing polysaccharides is inappropriate, as it can counteract the intended action of the drugs (e.g., halting immune attack against grafted cells). Chinese herbs applied to counteract side effects are usually aimed at improving the functional status of the organs, tissues, or cells that are subject to the side effects and are not aimed at reducing the absorption, distribution, or utilization of the drug. Thus, as another example, herbal therapies used to overcome the nauseant action of cancer drugs are aimed at rectifying the functions and condition of the stomach, but are not aimed at impairing the overall function of the drug towards inhibiting rapidly growing cells.

An example of an area of concern that can be addressed relatively easily is the use of antioxidant herbs, herbal components, and vitamins in patients undertaking radiation therapy. Some recent popular publications have cautioned patients to avoid this approach, as it might impair the ability of radiation to destroy the tumor cells. Radiation has two major effects at the target site: 1. In the zone of highest density of radiation, the cells are either literally torn up by the energy of the radiation, which smashes into critical components, notably the large DNA strands, or they are sufficiently damaged that the cell recognizes itself as being unrepairable and apoptosis (programmed cell death) is initiated. 2. As the distance from the focus of radiation increases, the total destruction of cells diminishes and the main effect of radiation is generation of damaged molecules, many of them in the state of free radicals (oxidized state). These free radicals can lead to the ultimate destruction of the cells over time (within hours, or even days), though they are present in large numbers only for a few minutes, since they are highly reactive molecules. When conducted properly, radiation is focused on the tumor mass and its cells are either immediately damaged beyond repair (#1 above), or eventually damaged beyond repair (#2 above). Radiation is usually administered several times to assure that none of the tumor cells escape destruction. Antioxidants, when administered in high dosages, enhance the natural antioxidant system that the body maintains. This enhancement is not enough to counteract the massive number of free radicals generated at the tumor site, but it is enough to help counteract the small numbers of extra free radicals at a distance from the tumor site, namely, in the healthy cells that receive unintended but unavoidable collateral damage (by either being in the path of radiation in front of or behind the tumor, or by being to the side of the radiation path, where the peripheral rays and deflected rays pass). Thus, antioxidants can reduce some of the side effects of the radiation, but they would be woefully inadequate to stop the radiation effects at the focus of the treatment, the tumor, even if that were the aim of their use. One may get the impression that antioxidants can protect all cells from radiation if one examines certain animal studies, but these studies are not indicative of what happens under directed radiation to the tumors. If animals are irradiated (full body irradiation is given), those that receive antioxidants (and other herbs with beneficial properties) will survive better than those who do not receive these substances. However, these experiments are not performed with the tumor-cell-smashing focused radiation, but with a lower level radiation more similar to that experienced by the healthy tissues outside the primary focus of radiation. This whole body radiation can be lethal, but antioxidants protect against the outcome up to certain high levels of radiation. In a literature review and summary of natural health care interventions to aid cancer patients, Paul Reilly (63) mentions several instances where substances reduce the adverse actions of cancer therapies while preserving the desired actions. These favorable

combinations with drugs included the antioxidant vitamins A, C, and E with adriamycin and the antioxidant glutathione with cisplatin. Favorable combinations with radiation therapy included vitamin A, beta carotene, and vitamin E. Thus, one must consider carefully the target of the drugs (or other therapy) and the nature of the herbal effects in order to understand the potential of herbs to counter any intended effect of the drugs. According to the Chinese clinical reports, patients receiving herbs with chemotherapy or radiation not only experience fewer side effects, but also have better short-term and long-term outcomes in relation to their disease.

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29. Wang Yongjun, et al., Treatment and prevention of nephrotoxicity of gentamicin using astragalus and ligustrazine, Chinese Journal of Nephrology 1992; 8(4): 222-223. 30. Chen Bin and Sun Jiping, Treatment of 93 cases of acute poisoning mainly with Ludou Jiedu Tang, Shaanxi Traditional Chinese Medicine 1991; 12(6): 251. 31. Hiroshi Hikino, Chinese medicinal plants used against hepatitis, Chang HM, et al., (eds.), in Advances in Chinese Medicinal Materials Research, 1985 World Scientific Publishing Company, Singapore, 205-214. 32. Zhou Qingjun, Chinese medicinal herbs in the treatment of viral hepatitis, Chang HM, et al., (eds.), in Advances in Chinese Medicinal Materials Research, 1985 World Scientific Publishing Company, Singapore, 215-219. 33. Wang Yunmo and Hu Yuejuan, Toxicity and side effects of some Chinese medicinal herbs, Chang HM, et al., (eds.), in Advances in Chinese Medicinal Materials Research, 1985 World Scientific Publishing Company, Singapore, 109-124. 34. Won Sick Woo, Crude drugs acting on drug metabolizing enzyme activity, Chang HM, et al., (eds.), in Advances in Chinese Medicinal Materials Research, 1985 World Scientific Publishing Company, Singapore, 125-146. 35. Ou Ming (ed.), Chinese-English Manual of Commonly Used Herbs in Traditional Chinese Medicine, 1989 Joint Publishing Company, Hong Kong. 36. Ou Ming (ed.), Chinese-English Manual of Commonly Used Prescriptions in Traditional Chinese Medicine, 1989 Joint Publishing Company, Hong Kong. 37. Hong-Yen Hsu and Chau-Shin Hsu, Commonly Used Chinese Herb Formulas with Illustrations, 1980 rev. ed., Oriental Healing Arts Institute, Long Beach, CA. 38. Hang Bingqian, et al., Effect of inositol on cyclophosphamide toxicity, Journal of the China Pharmaceutical University 1988; 19(4): 305-306. 39. Yang Jingge, Zhou Li, and Liu Mingxun, Antidotal effects of Stenoloma chusanum against arsenic and ammonium poisoning, China Journal of Chinese Materia Medica 1989; 14(3): 174-176. 40. Zhang Fuiru, et al., An experimental study on drynaria applied to prevent ear toxicity from kanamycin, Journal of the Norman Bethune University of Medical Science, 1993; 19(2): 164-165. 41. Sun Jiaqi, et al., Chinese herbs used to counteract the IL-2 kidney toxicity side effect, Chinese Journal of Traditional Chinese and Western Medicine 1995; 15(3): 180. 42. Li Ruizhi, et al., Utilizing Zhigancao Tang to relieve doxorubicin's adverse effects, Chinese Journal of Chinese Materia Medica, 1995; 20(1): 56-57. 43. Luo Chengqun, et al., Nutritional support for extensive burned patients with spleen and stomach invigorating medicines, Chinese Journal of Integrated Traditional and Western Medicine 1990; 10(1): 30-31. 44. Zhang Yin, Application of qi tonification method in treating burns, Journal of New Chinese Medicine 1986; 18(2): 23-25. 45. Xiao Jianxu and Liang Guangcui, Clinical report of 1,000 cases of burns treated with Chinese drugs, Beijing Journal of Traditional Chinese Medicine 1989; 1: 3031.

46. Dong Zhi Lin and Yu Shu Fang, Modern Study and Application of Materia Medica, 1990 China Ocean Press, Beijing. 47. Rao Xieqing, et al., Observation on immunofunction of spleen-deficiency tumor patients treated with Sheng Xue Tang, Chinese Journal of Traditional and Western Medicine 1991; 11(4): 218-219. 48. Liu Jilin and Peck G, Chinese Dietary Therapy, 1995 Churchill Livingstone, London. 49. Jia Kun, Prevention and Treatment of Carcinoma in Traditional Chinese Medicine, 1985 Commercial Press, Hong Kong. 50. Guangzhou First Chinese Medicine Factory, Biyinling Pian, not dated (ca. 1985). 51. Morio Yonezawa, et al., Radiation protection by Chinese medicinal herbs, Oriental Healing Arts International Bulletin 1987; 12(1): 39-49. 52. Zhang Daizhao, Treatment of Cancer by Integrated Chinese-Western Medicine, 1989 Blue Poppy Press, Boulder, Colorado. 53. Zhao Xuezhi, Experimental study on effect of Cordyceps sinensis on renal protection, urinary enzymes, and nephrotoxicity of cyclosporine A in rats, Chinese Journal of Integrated Traditional and Western Medicine 1997; 3(3): 213216. 54. Shiu WCT, Leung TWT, and Tao M, Clinical study of PSP on peripheral blood counts during chemotherapy, Phytotherapy Research 1992; 6: 217-218. 55. Hu B and But PPH, Chinese materia medica for radiation protection, Abstracts of Chinese Medicine 1987; 1(3): 475-490. 56. Tu Guorui, The use of tonics in China-past, present, and future, (monograph) 1981 Academy of Traditional Chinese Medicine, Beijing. 57. Lu Weiming, Clinical investigation on treatment with integrated traditional and Western medicine in hyperthyroidism with leukocytopenia induced by sulfourea drugs, Chinese Journal of Integrated Traditional and Western Medicine 1998; 18(1): 18-20. 58. Deng Wenlong and Gong Shirong, Progress in studies on Shiquan Dabu Tang, Zhongchengyao Yanjiu, 1987; 12: 34-35. 59. Ma Zhuyuan, Xuanfu Daizhe Tang modified in treating 31 patients showing gastro-intestinal reactions in chemotherapy for tumors, Sichuan Journal of Traditional Chinese Medicine 1997; 15(11): 24 60. Gao Jian, et al., Observation of Bupi Zhitu Tang in treating vomiting caused by tumor chemotherapy, Chinese Journal of Integrated Traditional and Western Medicine on Stomach/Spleen, 1995; 3(1): 19-20. 61. Li Ninghong, et al., Clinical observation of leukopenia induced by chemotherapy treated with Fuzheng Shengbai Tang, Chinese Journal of Integrated Traditional and Western Medicine, 15(2): 104-105. 62. Wang Jie, et al. A study on Fuzheng Guben Fang against adverse reactions induced by chemotherapy, Journal of the Beijing College of Traditional Chinese Medicine 1993; 16(1): 39. 63. Reilly P, Integrating naturopathic treatments with conventional oncology care {presentation summary}, 1998 Seattle Cancer Treatment and Wellness Center.

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APPENDIX 1: Survey of Herb Side Effects Since the treatment of drug side effects with Chinese herbs began with the treatment of herb side effects, a brief review of the related concerns is warranted. There are three basic types of problems: 1. There are adverse reactions to the herbs that are essentially non-toxic. Such adverse reactions may not affect everyone, but herbal formulations may take into account the tendency for reactions to occur. 2. There are the toxic herbs that are of concern to any potential users. These herbs are not used in the Western practice of Chinese medicine, but have long been used in China. 3. There are cases where herbs that are otherwise non-toxic produce severe reactions in a small number of users. These are unexpected reactions, but they can occur. Such reactions may also be more prevalent when new methods of administration are developed, such as intravenous injection of herbal extracts or ingestion of highly concentrated active constituents of herbs. An outline of the principal side effects of commonly-used herbs that can have adverse reactions without being specifically toxic was presented by Toyohiko Kikutani in the International Journal of Oriental Medicine (4). With some modifications of his commentaries and some additions, the problems are: 1. Surface-relieving herbs and formulas may produce itching skin or rashes as the response to dilation of the surface blood vessels and the presence of essential oils with irritant actions. According to Kikutani, herbs that are potentially problematic

2.

3.

4.

5.

6.

include cinnamon twig, ma-huang, chiang-huo, tu-huo, siler, schizonepeta, and perilla leaf. Surface-relieving herbs, such as siler and schizonepeta, are frequently used in formulas to treat skin rashes. The dilating action of these herbs is often compensated for by including peony in the formulas, as often mentioned in relation to the elegant formulation principle behind Cinnamon Combination (Guizhi Tang). Fire-purging herbs included in several prescriptions may inhibit the skin rashes, and sweet herbs, especially the combination of jujube and licorice (components of Cinnamon Combination), also limit the adverse effects of surface relievers. Diuretic herbs may induce frequent urination, and may lead to constipation by removing water from the intestines. The main diuretic herbs are hoelen, polyporus, stephania, atractylodes, and alisma. Such effects are counter-balanced by including herbs to recirculate the fluids (e.g., cinnamon twig in Hoelen Five Formula, Wuling San), or by including an astringent herb (e.g., schizandra) to limit excretion and to help generate fluids. Constipation is avoided by including moistening herbs (e.g., apricot seed) or mild laxatives (e.g., gardenia). Blood-vitalizing herbs may cause increased uterine bleeding, including bleeding between menstrual periods; this is especially true when there are fibroids present, which are to be treated by blood-vitalizing herbs. The herbs moutan, persica, red peony, carthamus, rhubarb, typhus, and tang-kuei are often found in the bloodvitalizing prescriptions and may contribute to such side effects. Blood-vitalizing herbs are often used to treat bleeding, following the theory that blood stasis leads to bleeding, but hemostatic herbs (e.g., agrimony, thistle) are included in many of the prescriptions to avoid the undesired increase in bleeding. Blood-nourishing formulas may cause loss of appetite, nausea, loose stool, or vomiting. Tang-kuei, cnidium, zizyphus, and cooked rehmannia are the herbs that are most often the cause of such problems due to the presence of oily compounds. This effect can be countered, in some cases, by inclusion of aromatic herbs such as aquilaria, cardamon, citrus, or ginger. At the Ming Dynasty pharmacy, Tong Ren Tang, that still operates in Beijing, cardamon is automatically added to most formulas containing cooked rehmannia, even if not specified in the doctor's prescription. Purgative formulas may cause abdominal cramping and loose stool or diarrhea. Rhubarb is the main purgative of Chinese medicine; senna leaf, aloe, and prunus are alternative purgatives. However, gardenia, persica, apricot seed, and mirabilitum, as well as some others herbs (e.g., bupleurum used in doses of 20 grams or more; ho-shou-wu; hu-chang; and cistanche) might be used for various purposes without intending to be purgative, yet produce an unintended purgative action and accompanying side effect of intestinal discomfort. Purgative effects are ameliorated by adding warming herbs that disperse moisture (e.g., including dry ginger or aconite with rhubarb). Fire-purging formulas may cause loss of appetite and loose stool. Coptis, gardenia, forsythia, gentiana, and raw rehmannia are examples of ingredients that may produce this effect. Gentiana is of particular concern to Chinese physicians because this herb frequently causes reactions in patients with various deficiency syndromes. As an example of an herbal therapy disrupting the stomach function,

dichroa, an herb traditionally used to treat malaria (and recently to treat giardia), tends to cause nausea and even vomiting in nearly all users. Therefore, antinauseant herbs are combined with it. According to Pharmacology and Applications of Chinese Materia Medica (5), the emetic effect may be reduced by "using it with pinellia, pogostemon, or citrus." These are herbs traditionally used to open and settle the stomach. It is reported that by combining dichroa with pogostemon, the incidence of nausea and vomiting on the first day of medication was reduced to 40% and that this incidence gradually decreased over several days so that only 20% of patients reported these reactions. It should be noted that most of the heat-clearing herbs classified in the subdivision of removing toxins (herbs used in cancer therapies, for snake bites, and viral infections) usually do not produce this adverse reaction. As mentioned above, stomach-protecting herbs, such as oryza and licorice may be used to protect the stomach from cold natured herbs; a small amount of warming herbs may compensate the extreme cold nature of the other ingredients. 7. Chill-dispelling and yang-tonifying formulas may cause feverish feeling, headache, nose bleeds, palpitations, sensation of pressure in the chest, or hyperactivity. Cinnamon bark, aconite, and evodia are examples of chilldispelling herbs that may be problematic. Coptis is added to some prescriptions to counter these effects. While problems may be avoided by proper diagnosis, imbalance in the kidney system can lead to unpredictable responses to yang tonic herbs (e.g., deer antler, morinda, or curculigo). This is usually compensated by inclusion of a large dose of cooked rehmannia (or mixed cooked and raw rehmannia), which will prevent the kidney yang from becoming overly agitated. 8. Minerals may cause gastric discomfort, loss of appetite, and (with long-term use) aching of muscles. Materials high in minerals, such as seaweeds, sea shells, and dragon bone, as well as mineral agents (e.g., gypsum, fluorite, magnetite) may also inhibit stomach function (by reducing stomach acid) and cause some disturbance when used in high dosage. This problem may be countered, to some extent, by inclusion of sprouted wheat or barley (malt), licorice (not suggested for seaweeds, however), or warm spicy herbs, such as raphanus or sinapis. Gallus is reported to help restore natural levels of stomach acid production. 9. Ma-huang formulas may produce tachycardia, insomnia, increased blood pressure, or excessive sweating. Persons who are hypersensitive to the herb may experience such responses with relatively low doses. In addition, herbs with cardiotonic glycosides, such as periploca and cynanchum, can cause heart palpitations or arrhythmias (an effect that is a toxic reaction if large enough amounts are used). In general, avoidance of the herb is the rule, though counterbalancing effects of other herbs, such as coptis, are a potential solution. 10. Saponin-rich formulas may cause headaches, nervousness, spontaneous bleeding, and changes in appetite. Bupleurum, platycodon, and ginseng are examples of saponin-rich herbs. Also, several of the folk remedies for arthritis used in China contain herbs high in saponins. These problems are traditionally interpreted as the result of blood deficiency and rising yang, which is compensated by incorporating blood nourishing herbs (e.g., tang-kuei and peony), and by including herbs that settle the yang (e.g., dragon bone).

11. Polysaccharide-rich formulas may cause abdominal bloating, flatulence, and mushy or loose stool. Astragalus and ganoderma may present this problem. The concern that qi-tonic herbs may cause a stagnancy syndrome in individuals with poor spreading of central qi is largely attributable to experience with the use of astragalus. Further, the polysaccharides in some members of the Leguminosae, such as licorice, albizzia, erythrina, soja, and dolichos, might cause similar problems. Citrus, ginger, cardamon, or other spicy herbs may help counteract such reactions. 12. Formulas with large amounts of licorice can cause sodium/potassium imbalance, resulting in edema and heart palpitations or arrhythmias. Glycyrrhizin in licorice promotes adrenal production of aldosterone, which produces this effect. Nonetheless, processed licorice, used in large doses in the Chinese clinical application of Baked Licorice Combination (Zhigancao Tang) is prescribed in the treatment of heart irregularities. Sodium/potassium imbalance might also occur with therapies that produce a diuretic or laxative effect. For example, senna-leaf based weight-loss formulas can have this adverse reaction. High dosage of licorice and strong laxative therapies should be used for a limited duration. Nonetheless, kidney warming formulas have been used by Chinese physicians to compensate for high dose licorice when its use is deemed important. 13. Hormone-influencing formulas can cause changes in the menstrual cycle; ginseng, tang-kuei, deer antler, epimedium, and bupleurum may have such influences. Changes in length of the cycle, amount of bleeding, the possibility of mid-cycle bleeding, or changes in fertility might be associated with their use. While these herbs can be used in formulas intended to alter the menstrual cycle, they can also be used in treatments for which no menstrual changes are expected or desired. Some women who recently entered menopause may resume menstrual bleeding as a result of using tonic herb formulas. These effects are not necessarily problematic, but rather need to be understood so that the changes that occur are not surprising or disturbing. According to traditional thinking, if the formulation strategy is correct, including proper consideration of yin/yang balancing, then the menstrual cycle will remain regular. 14. Some herbs may cause changes in blood-sugar levels during the first hour or two after ingestion, producing a feeling of dizziness, hunger, or other sensations. Xanthium, platycodon, bupleurum, and morus leaf are examples of herbs not usually used to treat diabetes (where blood-sugar lowering is a desired action) that may produce a reduction in blood sugar. This problem is usually corrected by adjusting the time of taking herbs in relation to meals, and, if necessary, adjusting the diet to compensate. 15. Materials containing tough gelatinous substances, as found in turtle and tortoise shell, deer antler, donkey skin (gelatin), and fish swim bladder, may cause lowerintestinal cramping when imbalances of intestinal flora and weak digestion permit adverse bacterial digestion of the materials to occur in the intestines. This is compensated by treating spleen/stomach deficiency, gallbladder stagnation, and qi disturbances simultaneously with administering the herbs of concern.

Wang Yunmo and Hu Juanyue (33) surveyed the recent Chinese medical literature and reported on toxicity and side effects of Chinese herbs. They pointed out that: Generally, toxic actions are related to overdosage, or overly long period of drug administration, due to accumulation. Anaphylaxis is associated with allergic constitution. Poisoning and hypersensitivity is a quantitative action, while allergy is a qualitative sensitive effect. People with idiosyncrasy may show urticaria, pyrexia, and rashes in spite of small dosage, even a little amount. Combining laboratory animal studies with some medical reports of adverse effects, the report detailed potential toxic effects of herbs in terms of their contents (alkaloids, glycosides, proteins, etc.); by their site of toxic action (nervous system, respiratory system, digestive system, cardiovascular system, urinary system); and by allergic reactions (including anaphylaxis). As for treatment of such reactions, the authors relied mainly on Western medical techniques. They also advised taking care in prescribing herbs, including: 1. Before administration, understand clearly the properties, actions, dosage, and the side effects of the Chinese medicinal herbs. A doctor's duty is first to make a prescription, and then to provide patients with proper directions. 2. Prescribe according to clinical signs and symptoms, avoid incorrect use, point out the mistaken idea that there is no toxicity and are no side effects from Chinese medicinal herbs. It should be remembered that they can be toxic, especially their active components [when given in isolation and in doses larger than present in crude herb preparations]. 3. Don't use any popular prescription without doctor's direction. 4. Ask the allergic history of the patients and the members of their family before administration, especially when using Chinese medicinal herbs via injection. 5. Take care of intolerance signs and idiosyncratic reactions to the herbal drugs used by the patients. The drug should be stopped when the phenomena of itching, fever, erythema, shortness of breath, asthma, and general discomfort have happened. 6. After coming to an understanding of which herb caused the side effects in the patient, one should stop administering the herb or its compound prescriptions. 7. Make use of appropriate therapeutic procedures as soon as acute poisoning or anaphylaxis appears.

APPENDIX 2: Possible Reactions Between Herbs and Drugs In the Chinese medical literature, reports of adverse interactions between drugs and herbs are not found even though there appears to be openness in the reporting of adverse reactions to herbs themselves. Yet, it is well-established that some pharmaceutical products should not be combined with other pharmaceutical products due to production

of adverse effects, and that mixing certain pharmaceuticals with commonly-consumed substances can also have a negative impact on the drug therapy. As examples of the latter: •

•

•

•

Tetracycline should not be taken with milk or milk products because the casein in milk binds the tetracycline and reduces its absorption. Digoxin should not be taken with high fiber foods, which interfere with its absorption. Several vegetables, especially green vegetables, should not be taken (or, the amount consumed should not be changed) by patients undergoing anticoagulation therapy because the vegetables contain varying amounts of vitamin K, a coagulation promoter. Alcohol should not be consumed with many drugs, because it alters the drug metabolism or action. In some cases, severe liver toxicity reactions can occur when alcohol is combined with drugs. Grapefruit should not be consumed with many drugs (e.g., Seldane), because its flavonoid (naringenin, the same one found in drynaria) inhibits a drugmetabolizing enzyme, thus allowing the level of certain drugs in the blood to attain higher levels and remain high longer (which increases potential for toxic effects of some drugs).

There are also concerns raised by practitioners of traditional Chinese medicine, about interactions between herbs and commonly ingested substances: •

•

Some herbs are not to be cooked in an iron pot, presumably because the iron that is leached from the pot during cooking inhibits the herb's actions by binding to active constituents and rendering them less absorbable. Some herbs are not to be taken with sour-tasting substances, particularly vinegar, because it would impair the herb's actions, possibly by adjusting the functional relationship, as described in the tradition of Chinese medicine, between the liver and the spleen.

The question naturally arises whether or not herbs, which contain chemical substances not inherently different than those comprising pharmaceuticals and those found in foods, might on occasion yield undesired interactions with drugs, with each other, or with various commonly consumed substances. There are four basic types of problems that might be encountered: 1. Interaction in the gastrointestinal system prior to absorption. The main concern is binding of a drug to an herb substance, thereby rendering the drug less absorbable. It has been suggested that ginger counteracts some cases of nausea because its oleoresin binds up toxins in the digestive system that produce the reaction of nausea. These resins could potentially bind to pharmaceuticals. Also, it has been shown that some herbs inhibit the absorption of cholesterol-presumably by complexing with the cholesterol and reducing its ability pass through the boundaries of the gastro-intestinal tract. Drugs having an oily nature or structure

similar to cholesterol might similarly be bound and have their absorption or absorption rate reduced. It has been proposed that one of the ways in which licorice can reduce aconite toxicity is by binding with aconitine and making it less absorbable or active. Tannins, a component of ordinary tea and some astringent Chinese herbs, can bind up alkaloids to make them less available. The potential for inhibiting absorption of drugs is dependent on the dosage of herbs (a small dose could only bind a little of the drug, a large dose could bind more) and the temporal proximity of the ingestion of the two materials (the longer the separation between taking the drug and another substance, the less chance of any binding). In the case of tetracycline and binding to casein in milk, patients are instructed not to consume milk at the same time or in close proximity of the time when tetracycline is ingested, but it is not necessary to avoid consuming milk or milk-based products at other times. In a few cases, herbal ingredients might make a drug more easily absorbed, thus raising the potential for toxic reactions to the drug. It is known, for example, the flavonoids enhance the absorption of vitamin C and, in turn, vitamin C enhances the absorption of iron; a similar situation could exist with certain drugs. Although the incidence of absorption problems from herbs is likely to be low, one could avoid this interaction by taking herbs and drugs at least an hour apart. 2. Alteration of drug metabolizing enzymes. Drugs (and herbs) are often eliminated from the system by the action of enzyme systems that break them down into components that are more easily excreted. If the enzyme system is inhibited, the drug will remain in the body longer, and thus its effects will be greater (with repeated doses of drugs, the toxicity of the drug could become a problem). It has been shown in laboratory experiments (34) that some Chinese herbs inhibit the drug metabolizing enzymes (on much rarer occasions, an herb is found to stimulate the enzymes). The effect of those herbs (when used in a dosage that is sufficient to significantly affect the enzyme activity) on drugs metabolized by those enzymes is to make it possible to use a lower dosage of the drug and still get the same level of effect. This is a potential benefit. It has been reported in the Japanese literature, for example, that use of bupleurum formulas can reduce the dosage of corticosteroids necessary to treat various inflammatory diseasesinhibition of drug metabolizing enzymes might be the mechanism by which this is accomplished (it is also possible, however, that anti-inflammatory actions of the herbs make the requirement for steroids lower). Similarly, it has been suggested that rehmannia-based formulas can reduce the amount of insulin needed by diabetics; the mode of action has not been determined, but might include longer survival of insulin in the blood stream. The alteration of drug-metabolizing enzymes probably occurs only with high-dosage herb therapies. Individuals suffering from liver or kidney diseases may be more susceptible to such problems since the enzyme systems and elimination mechanisms may already be inhibited. To avoid this problem, when using high dosage forms of herbs (decoctions or isolated active constituents), one should introduce the herbs gradually, building up the dosage over time, and closely observing any changes that occur. 3. Target-cell binding. Some drugs act by binding to surface components of cells, an action which then induces an alteration of cellular functions. If an herb

component binds to the same surface component without having the same effect on cellular functions, then it could reduce the effectiveness of the drug therapy by preventing the drug from having its intended effect. The technique of blocking "receptor" sites on a cell surface is an important strategy in many new drug therapies, but unintentional blocking by ingestion of herbs could limit the effect of some drugs. One of the proposed mechanisms of action of the isoflavones (such as those found in soy beans) is that they influence some of the estrogen receptors on cell surfaces. Target-binding effects are strictly dose dependent and very specific for the drug in question. It is difficult to know whether or not a problem can arise, but the problem should be limited to the high dosage forms of herbs. 4. Alternative pathways. If a drug therapy has a particular end result (physiologic action) produced by one mechanism, and the herb therapy used at the same time produces the same physiologic action but by a different mechanism, the total effect could be greater than that desired. This enhanced or "synergistic" action would allow a reduction of the amount of drug ingested, but if the drug dose were not reduced, side effects might be generated. An example of a potential problem (theoretical, not yet reported) would be the ingestion of an anti-coagulant drug and simultaneous ingestion of a blood-vitalizing herb formula. If the two act by different mechanisms, the reduction of clotting could be sufficient to render the individual susceptible to spontaneous bleeding (if they acted by the same mechanism, the drug effect might be so much greater than the herb effect that the herb would appear to cause no effect at all, though additive action would still be possible). Licorice, which can lead to increased potassium secretion might enhance the potassium excreting action of certain diuretic drugs (e.g., Lasix), resulting in irregular heart rhythm. Thus, one might avoid matching a drug and an herb therapy that have a very similar specific outcome, unless one is seeking to increase the intensity of the outcome. While no one may actually suffer from a problem of drug and herb interaction, the potential is there and might be increased with the continued introduction of both new herbs and new drugs. Prudent measures to avoid potential problems would include: 1. taking the herbs and drugs at different times so that they don't mix before absorption; 2. starting out with low to moderate herb dosage to allow time to check for potential interactions and to make suitable adjustments if deemed necessary after about one week of therapy; 3. using some caution in administering herb formulas that have a focused effect (as opposed to a very broad action obtained from some combinations) that is the same as the drug effect. Chinese herbalists routinely combine a huge variety of herbs together; at present there does not appear to be any reason to avoid mixing together any combination deemed suitable for the individual being treated. According to an ancient concept, there are a few herb incompatibilities (when the two herbs are combined, the results are toxic). However,

recent testing has failed to show that there is any significant adverse effect from the combination of those herbs. Laboratory work with a number of animals and single-cell organisms has not revealed any toxicity or other problem when the purported incompatibilities are combined. It may be assumed that the doctrine of incompatible herbs arose from a few observations of negative reactions of patients to herbal formulas with a mistaken conclusion as to the cause. Once incompatibilities were reported in the medical literature, doctors generally avoided using the combination (which might have revealed its lack of toxicity) and simply recited the cautionary statements. The majority of incompatibilities involved at least one herb that had toxic effects, and it could have been the effect of that herb in one or more individuals that gave rise to the concern about the combination of herbs. Because of the diversity of active components in an herb formula, and the relatively low dosage of each individual component compared to the dosage of a chemical in a pharmaceutical product, the potential problems of herb/drug interactions are usually not a serious problem. September 1998 Chinese herbs

Herbs have been used medicinally by all cultures throughout history. The World Health Organization (Who) estimates that 4 billion people, making up 80 percent of the world population, presently use herbal medicine for some aspect of primary health care. An increasing number of Americans are using herbal medicine to treat their health conditions.

An herb is a plant or plant part valued for its medicinal, aromatic or savory

qualities. Herb plants produce and contain a variety of chemical substances that act upon the body. Many drugs commonly used today are of herbal origin, such as digitalis, derived from foxglove. Indeed, about 25 percent of the prescription drugs dispensed in the United States contain at least one active ingredient derived from plant material. WHO notes that of 119 plant-derived pharmaceutical medicines, about 74 percent are used in modern medicine in ways that correlate directly with their traditional uses as plant medicines by native cultures. Major pharmaceutical companies are currently conducting extensive research on plant materials gathered from the rain forests and other places for their potential medicinal value. History of Chinese Herbal Medicine Why should I use Chinese herbal medicine? How does the Chinese herbalist construct a formula? Can Chinese herbal formulas replace western drugs? Are Chinese herbs safe? What about drug/herb interactions? Raw Herbs, Powders, Tinctures and Pills A Brief History of Chinese Herbal Medicine As one of the main branches of Traditional Chinese Medicine (TCM), Chinese herbal medicine's origins are found many millenniums ago in shamanic or folk traditional medicine. It became formalized during the Han dynasty in China (200 BCE to 200 CE) when several important herbal texts were written. In the first century of the common era the Divine Farmer's Materia Medica, the first herbal text was compiled that classified individual herbs and listed their medicinal function. This text is the archetype for the Chinese tradition of herbology.[1] During the forth century of the common era, the most celebrated classic of herbal prescriptions was written, the Treatise on Cold Damage and Prescriptions from the Golden Cabinet.[2] About twenty percent of Chinese herbal prescriptions used today come from these two texts, which stress combining acupuncture with medicinal herbs. By 225 CE herbal anesthesia was being used for surgical operations.[3] [History of Chinese Medicine] Chinese herbal medicine has continued developing since then. Modern physicians rely on Chinese herbs for treating an array of clinical conditions ranging from headaches, allergies, colds and flu, digestive disorders, gyn conditions, dermatological conditions, traumatology, and chronic disease such as Parkinson's disease, hepatitis, cancer, HIV and AIDS . Whereas convention medicine uses drug therapy to treat pain and disease, Chinese medicine utilizes classical herbal formulas to address both internal and external health conditions.

Chinese Herbal Formulas: Why Should I Use Them? Chinese herbs work synergistically with acupuncture. Used safely and medically for over 2,000 years, Chinese herbs have minimal side effects when prescribed correctly by a trained herbalist. What makes Chinese herbs particularly safe and effective is the art of combining herbs to form a carefully balanced prescription, or herbal formula. (Chinese herbs are rarely taken individually.) These individualized formulas not only treat the patient's main, presenting problem but also address associated, secondary problems. Chinese herbal formulas are based on standard, classical prescriptions that have been tried and tested through millenniums of clinical use, and are modified to fit the individual needs of the patient. The herbalist modifies the prescription by taking out unnecessary herbs or those with redundant functions and adding herbs to address any additional symptoms the patient has. Nourishing and harmonizing herbal formulas serve as excellent tonics, strengthening those weakened by overwork, serious illness, childbirth or poor diet and irregular eating. Herbs with a cooling action can counteract fevers, night sweating and hot flashes. Similarly, herbs with a warming action can help those who feel cold. They work on the mind (shen, in Chinese) as well as the body, treating stress, anxiety, depression and insomnia. Herbs can be used for acute and chronic conditions, e.g. colds, allergies, digestive disorders, menstrual conditions, rashes and pain . How does the herbalist construct a Chinese herbal formula? The medicinal use of each Chinese herb is determined by the herb's properties, therapeutic functions and by the herb's ability to influence certain channels (where Qi flows) or organs. TCM herbalists combine herbs to form synergistic pairs that enhance their common herbal function. They also include herbs with different therapeutic functions when designing formulas to treat a particular complexity, or subtlety in a patient's condition. One to three of the herbs in the formula are considered the 'chief' herbs that direct the formula to treating the main symptom or problem. Additional herbs are called 'assistant' herbs. Assistants support the chief herbs in treating the main problem and perform other necessary functions or treat additional symptoms, that are not addressed by the chiefs. Assistant herbs help the body to absorb and assimilate the herbs ingested, and counteract any potential adverse

side effects that could be caused by the more powerful herbs used. Often a third type of herbal function is used in the formula, called the 'envoy' or 'messenger herb'. Envoys direct the formula to the particular area of the body requiring treatment, such as the back, knee or chest. Envoys are particularly useful in pain formulas. For example, certain herbs hone to the forehead, top or back of the head, a useful function for treating headaches. Can Chinese Herbs Replace Western Drugs? Yes. Many conditions treated by western drugs can also be successfully treated with Chinese medicine. Examples include: hypertension, headaches and pain conditions, fibromyalgia, allergies and sinus infections, acid reflux disease, bowel problems (IBS and Crohn's disease), bladder infections , herpes, skin conditions, menstrual cramping, Perimenopausal syndrome , Parkinson's disease, insomnia, anxiety and depression. Patients and their physicians are often discouraged by the undesirable side effects of western medications, or the prospect of having to remain on these drugs for long term periods. Especially for chronic conditions, Chinese medicine often offers superior clinical results and longer lasting treatment than does conventional medicine. When beginning TCM treatments, patients on western drugs may continue taking their medications. As the condition improves, they begin titrating (weaning) off the drug under their prescribing doctor's supervision. Once they are completely off the drug and symptom free, the patient is released from regular TCM visits. Are Chinese Herbs Safe? The minimization of side effects while maintaining clinical efficacy is the chief benefit of Chinese herbal formulas. While strong medicine, Chinese herbs are slower acting than drug therapy. Their comparatively gentler action reduces the potential for side effects drugs cause. Using single herbs require higher dosages to achieve therapeutic effect, thus increasing potential of side effects. By combining herbs with similar functions that moderate each other's actions into an herbal formula, Chinese herbalists are able to the lower the dosages of individual herbs so to minimize the likelihood of side effects. Although rare, when side effects do occur they are generally limited to gas, indigestion or changes in bowel habits and will stop when the herb's use is discontinued. To prevent future recurrence, the TCM herbalist can modify the formula by adding herbs that improve digestive function in order to counteract the harsh property of the herbs. What about interactions between drugs and herbs? Because drugs are strong, powerful medicine, they have a tendency to

negatively interact with each other and with other substances, such as food or herbs. What causes interactions is a biochemical process described as competition for binding sites on cells. Cells have something called binding sites that enable them to absorb substances and nutrients through the cell wall into the interior cell body. Each cell has a limited number of binding sites that substances can lock onto in order to pass through the cell wall. When many different substances try to gain entrance to the cells simultaneously, they flood the available binding sites and are unable to get in. This causes problems of interactions. Taking herbs and drugs two hours apart from each other will usually eliminate the cause of this scenario. The interval allows one substance to use the available binding site to gain entry to the cells. After the substance passes through the cell wall the binding site is available for a second substance to be ingested by the cell; therefore, interactions do not occur. Though in the majority of cases it is safe to combine western drugs with Chinese herbs, there are exceptions to this rule particularly in the case of drugs with narrow therapeutic margins, such as Cumadin. These drugs have a small dosing range that can easily be affected by changes in body chemistry. In this case, the introduction of Chinese herbs will affect the dosing of the drug. Actually, there are herbs that can be combined successfully with Cumadin; however, in these instances the prescribing physicians (conventional doctors and TCM practitioners: acupuncturists or Chinese herbalists) should work together to insure patient safety. Raw Herbs, Powdered Herbs, Pills and Tinctures Herbs come in many forms, and patients should work with their herbalist to determine their optimal delivery method. Traditionally in China , herbs were made as teas, or herbal decoctions (a.k.a. raw herbs). The individual parts of plants, minerals or shells are simply cut and dried in preparation for decoction and storage. The herbalist weighs out each ingredient individually, and prepares a packet of 'sticks and twigs' for the patient to brew at home into a tea. The patient drinks one cup of tea twice a day, and a packet lasts for two days. In modern times other forms of processing herbs have become available. The dried, bulk herbs can be processed into a concentrated powder (a.k.a. granulated herbs, or granules). The herbalist still doses and weighs out each herb individually, giving the patient a container containing the powdered herbal formula. The patient mixes the powder with warm water, taking the herbs two or three times daily. Herbs can be extracted in alcohol to make an herbal tincture. The patient places a few dropperfuls of the tincture in warm water and

drinks the solution. Another common form of herbal delivery is pills. In this case, herbal manufacturers process commonly used herbal formulas into tea pills or tablets. The formula is decocted, concentrated and mixed with a binder to form the pills. Traditionally, the raw herbs were powdered and mixed with honey to form pills. Raw herbs (teas) are the most common and traditional way for herbs to be delivered in China . They are also considered to be the most effective form. However; though many satisfied western patients cook and drink these teas, some don't like the herbs' earthy or malty flavor, others do not want, or lack facilities to cook the herbs twice a week. Granulated (powdered) herbs generally satisfy these concerns. They are not quite as strong or powerful as the raw herbal teas, but they are a common delivery method and offer satisfactory results. Tinctures, though convenient, are less easily individualized or modified by the herbalist, so are not as precisely targeted as the raw and granulated herbal formulas. Many Chinese herbalists object to the alcohol extraction method. Finally pills, while tasteless and easily swallowed, cannot be individualized and therefore are more broad-spectrum and less specifically targeted than the individualized raw or powdered formulas. In addition, because the pills are small, the patient must swallow a large number of them several times a day to achieve a therapeutic dose near to that of raw herbs. So pills are weaker and less effective than the other forms of herbal preparation. In addition to taking herbs internally, herbs can also be delivered externally in the forms of soaks, liniments and plasters, or even herbal suppositories. External herbs are used to treat skin conditions, traumatic injuries and muscle or joint pain. Asheville Center for Chinese Medicine has a large herbal pharmacy of over 250 herbs in both raw and granulated forms. If needed, herbal tinctures and pills may be special ordered. Kath Bartlett, MS, LAc will work with you to determine the herbal delivery method that best suits you and your lifestyle.

[1] Dan Bensky and Andrew Gamble, Chinese Herbal Medicine: Materia Medica (Seattle: Eastland Press, 1993), p. 4-5 [2] 'Golden Cabinet' refers to the herbal formulas' precious ability to restore life's vital health.

[3] Surgical anesthesia continues in use in TCM hospitals today. Bill Moyer's PBS series Healing and the Mind shows an open-heart surgery being preformed with acupuncture anesthesia. Only about one third of the usual dosage of drugs is used. The patient is lucid and can speak coherently while the surgery is preformed. The acupuncture points used are the basis of the NADA (National Auricular Detoxification Association) protocol for treating addictions.

An introduction to Chinese herbs by Subhuti Dharmananda, Ph.D., Institute for Traditional Medicine, Portland, Oregon The herbal tradition of China is valued scientifically, as well as being a fascinating and popular tradition. Scientists working in China and Japan during the past four decades have demonstrated that the herb materials contain active components that can explain many of their claimed actions. Modern drugs have been developed from the herbs, such as treatments for asthma and hay fever from Chinese ephedra, hepatitis remedies from schizandra fruits and licorice roots, and a number of anticancer agents from trees and shrubs. Several popular formulations produced in China, called "patent medicines," are relied upon daily by millions of Chinese (in China and abroad), such as the Bupleurum Sedative Pills and Women's Precious Pills that invigorate the energy, nourish the blood, calm tension, and regulate menstruation, and Yin Chiao Jie Du Pian, which is a reliable treatment for the early stages of common cold, sore throat, and influenza. More than three hundred herbs that are commonly used today have a history of use that goes back at least 2,000 years. Over that time, a vast amount of experience has been gained that has gone towards perfecting their clinical applications. According to Chinese clinical studies, these herbs, and others that have been added to the list of useful items over the centuries, can greatly increase the effectiveness of modern drug treatments, reduce their side-effects, and sometimes replace them completely. In China, the two most common methods of applying herb therapies are to make a decoction (a strong tea that must be simmered for about an hour or more) and to make large honey-bound pills. Both of these forms meet with considerable resistance in Western countries. The teas are deemed too time-consuming, smelly, and awfultasting to justify their use, and the honey pills (boluses) are sticky, difficult to chew, and bad tasting. Thus, modern forms that are more acceptable have been developed for most applications. The two popular forms to replace the standard Chinese preparations are extract powders (or granules) and smooth, easy-to-swallow tablets or capsules. The extracts are made by producing a large batch of tea and then removing the water and producing a powder or tiny pellets; the resulting material is swallowed down with some water or mixed with hot water to make a tea. Tablets and capsules contain either powdered herbs or dried extracts or a combination of the two. Despite the convenience, one must take a substantial quantity of these prepared forms (compared to the amount of drugs one takes). For example, doses of the dried extracts range from 1-2 teaspoons each time, two to three times per day, and the

tablets or capsules range from about 3-8 units each time, two to three times per day. The herb materials used in all these preparations are gathered from wild supplies or cultivated, usually in China (some come from India, the Mid-East, or elsewhere). There are an estimated 6,000 species in use, including nearly 1,000 materials derived from animal sources and over 100 minerals, all of them categorized under the general heading "herbs." Herbs are processed in various ways, such as cleaning, soaking, slicing, and drying, according to the methods that have been reported to be most useful. These materials are then combined in a formulation; the ingredients and amounts of each item depend on the nature of the condition to be treated. In some cases, a practitioner of Chinese medicine will design a specific formulation for an individual patient, which might be changed frequently over a course of treatment. In other cases, one or more formulas already prepared for ingestion without modification are selected for use. The outcome is monitored, and the determination of whether to continue the current formula, change to another, or discontinue use is made on the basis of actual versus desired outcomes and the obvious or subtle effects of using the herbs. As a general rule, acute ailments (those that arise suddenly and are to be treated right away) are treated for a period of 1-30 days. If an outbreak of influenza or eruption of herpes virus is caught early enough, a one or two day treatment will prevent further development of the disease. In the case of acute active hepatitis causing jaundice, a treatment of 15-30 days may be necessary. For chronic diseases (those that have persisted for several months or years), the treatment time is often dependent on the dosage used and the ability of the individual to undertake all necessary steps to overcome the disease (perhaps changing diet, lowering stress, and increasing exercise). When a high-dosage therapy is applied, most chronic ailments can come under control (and some are cured) by a treatment of about three months duration. If the daily dosage is lowered (because of inability to take the higher doses), the treatment time increases-perhaps to 6-12 months. Examples of chronic ailments are autoimmune disorders and degenerative diseases associated with aging. In some cases, herbs are taken daily, for an indefinite period, just as some drugs are taken daily. This is typically the situation when there are genetic disorders or permanent damage that cannot be entirely reversed, problems of aging, and ailments that have been left for too long without effective treatment. The main reason that more Westerners are turning to Chinese herbs rather than local herbs is because of the vast scope of experience in using the Chinese materials. In every province of China, there are large schools of traditional Chinese medicine, research institutes, and teaching hospitals, where thousands of practitioners each year gain training in the use of herbs. The written heritage of Chinese medicine is quite rich. Ancient books are retained, with increasing numbers of commentaries. New books are written by practitioners who have had several decades of personal experience or by compilers who scan the vast diverse modern literature and arrange the results of clinical trials into neat categories. American practitioners are usually trained at any one of about 45 colleges in the U.S., with a three- or four-year series of courses that include basic Oriental medical theory, acupuncture, and herb prescribing. Certification is offered at the national level and licensing or registration is offered now by most states. Many doctors from

China have come to the U.S. and currently offer professional services throughout the country, but most often in the larger cities. Continuing education is provided through numerous symposia offered by the colleges and professional organizations devoted to Oriental medicine. Often, these meetings focus on the treatment of specific diseases or training in the use of a specialized acupuncture technique or valuable herb formula. Chinese herbs are provided in the U.S. as food supplements, not as drugs. Thus, they are not strictly regulated by the FDA except for monitoring the cleanliness of manufacturing facilities (for those materials made in the U.S.; for the imported items, FDA monitors only the listing of ingredients to help ensure no toxic herbs are being used). Random testing of crude herb materials and herb products made in the U.S. indicate that they are free of harmful bacteria and chemical contaminants. Imported products must be used with some caution, as some of them are problematic, yet get past the investigators. There are a few patent remedies that are labeled with only herb ingredients, but also contain several Western drugs. Some patents from China contain only Western drugs (and say so on the box, in Chinese), but purchasers may be unaware of this because they are told only that this is an effective remedy that came from China. Thus, imported Chinese herb products should be taken solely on the basis of a prescription from a trained health professional. Adverse responses to Chinese herbs are monitored at the Institute for Traditional Medicine through its contacts with numerous practitioners around the country and subscriptions to technical journals published in China and Japan. Negative interactions with Western drugs have not been noted for any of the common herb materials when used in the normal dosage range. A few people experience allergic reaction to individual herbs, a problem that often cannot be predicted in advance since these are idiosyncratic responses. A more common reaction is a gastrointestinal response, which might include constipation or diarrhea, nausea or bloating. Such reactions may occur if the individual has poor digestive functions, or if the herbal formula is not quite right for the needs of the individual. Taking the herbs at a different time in relation to meals may be helpful in resolving some of the gastro-intestinal reactions. In a few cases, use of Chinese herb formulas may cause dizziness, headache, agitation, sleepiness, hungry feeling, lowered appetite, sensation of heat or cold, or other sensory reactions. If such responses persist after about three days of using the herbs, it may be necessary to change formulas. Successful treatments based on the application of Chinese herbs are also monitored at the Institute. However, most American practitioners find themselves too busy (because of the small number of practitioners in this country) to prepare detailed reports of their successful cases; thus, it is necessary to rely primarily on the largescale clinical trials conducted in China for the purpose of learning about the success rates. Such clinical reports, published in the Chinese language, are abstracted and published in English by the Chinese University of Hong Kong. These reports, and other translated materials, are compiled by the Institute and sent to practitioners in a variety of formats, including a technical series called Clinical Tips. Trials supported by the Institute for Traditional Medicine in the U.S. that have generated successful outcomes include treatment of HIV/AIDS, multiple sclerosis, and

endometriosis. Following are some examples of common ingredients of Chinese formulas that have become widely used because of their reliable action, the quick results usually experienced, and the diversity of therapeutic activities that can be obtained from each. These reviews serve as examples of what Chinese doctors must know. It will be noted that the dosage range is often very large, reflecting various uses and different methods of application. FIFTEEN COMMONLY-USED CHINESE HERBS Astragalus (huangqi) The long tap roots of astragalus are, today, the most commonly used herb material in China. Astragalus normalizes immune responses (used for immune deficiency, allergies, and autoimmunity), benefits digestive functions, and treats disorders of the skin from burns to carbuncles. Astragalus is used as a promoter of the functions of several other herbs, such as salvia and tang-kuei (mentioned below). It is used in the treatment of AIDS and hepatitis, for chronic colitis, senility, and cardiovascular diseases. Cancer patients who take this herb can often avoid the white blood cell deficiencies (leukopenia) that occur with chemotherapy. The root is rich in polysaccharides and flavonoids that produce the beneficial effects. Astragalus may be used by itself, usually as a liquid extract, or in combination with other herbs in the form of teas, pills, or tablets. Dosage is from 1-60 grams per day, depending on the application and form. Caution: some individuals may experience flatulence and abdominal bloating from use of astragalus. Atractylodes (baizhu) The rhizomes of atractylodes are considered very important to the treatment of digestive disorders and problems of moisture accumulation. The herb helps move moisture (and nutrients) from the digestive tract to the blood, reducing problems of diarrhea, gas, and bloating, and helps move moisture from the body tissues to the bladder for elimination, alleviating edema. The herb is frequently included in tonic prescriptions, and the herb is rarely used by itself. Dosage is from 200 milligrams in capsules and tablets to 15 grams per day in the form of decoction. Caution: persons suffering from a hot and dry condition may experience worsening of those symptoms if large amounts of atractylodes are used. Bupleurum (chaihu) The thin roots of bupleurum are one of the most frequently used herbs in the Japanese practice of Oriental medicine. Doctors in Japan have found it useful in the treatment of liver diseases, skin ailments, arthritis, menopausal syndrome, withdrawal from corticosteroid use, nephritis, stress-induced ulcers, and mental disorders. The roots are rich in saponins that reduce inflammation and regulate hormone levels. The herb is not used by itself, but rather in formulas with about four to twelve ingredients, made as teas, pills, or tablets. Dosage ranges from a few hundred milligrams of powder to about 15 grams in tea per day. Caution: some individuals may experience dizziness or headaches from use of bupleurum. Cinnamon (guizhi and rougi) The twigs (guizhi) and bark (rougi) of this large tropical tree are said to warm the body, invigorate the circulation, and harmonize the energy of the upper and lower

body. Modern studies demonstrate that cinnamon reduces allergy reactions. Traditionally, cinnamon twig is used when the peripheral circulation is poor and cinnamon bark is used when the entire body is cold. If the upper body is warm and the lower body is cold, then cinnamon will correct the imbalance. Cinnamon is usually cooked together with other herbs to make a warming tea, or powdered with other herbs to make a pill or tablet that regulates circulation of blood. Dosage is 0.33 grams of bark and up to 9 grams of twig per day. Caution: large amounts of cinnamon are irritating to the liver and should not be used by those with inflammatory liver disorders. Coptis (huanglian) This rhizome (underground stem) is one of the most bitter herbs used in Chinese medicine. It is rich in alkaloids that inhibit infections and calm nervous agitation; it is usually combined with other bitter-tasting herbs, such as phellodendron, scute, and gardenia, to promote these actions. Examples of its many uses include treatment of skin diseases, intestinal infections, hypertension, and insomnia. Coptis is a close relative of an extremely bitter and very useful American herb, goldenseal. Because of its taste, coptis is most often used in the form of pills or tablets. Typical dosage is from a few hundred milligrams of powder to 3 grams in decoction per day. Caution: regular use of coptis in large dosage may cause diarrhea. Ginger (jiang) The fibrous rhizome of this herb is highly spicy and said to benefit digestion, neutralize poisons in food, ventilate the lungs, and warm the circulation to the limbs. Today, ginger is commonly used as a spice in cooking; as a medicine it has been shown helpful in counteracting nausea from various causes including morning sickness, motion sickness, and food contamination. Many herbalists use ginger in the treatment of cough (it acts as an expectorant) and common cold. Ginger is used in making teas and the powder is encapsulated for easy consumption. Typical dosage is from a few milligrams used as an assistant in herb formulas to about 3 grams per day in making decoctions. Instant tea granules (sugar or honey base) are available. Caution: persons who suffer from dryness-dry cough, thirst, dry constipation, etc.-may find that ginger worsens the condition. Ginseng (renshen) The root has long been cherished as a disease-preventive and a life preserver. It calms the spirit, nourishes the viscera, and helps one gain wisdom. Modern applications include normalizing blood pressure, regulating blood sugar, resisting fatigue, increasing oxygen utilization, and enhancing immune functions. Traditionally, the root is cooked in a double boiler to make a tea, used either alone or with several other herbs. Today, teas can be made quickly from carefully prepared extracts in liquid or dry form; ginseng powder is made into tablets or encapsulated, and ginseng formulas are available in numerous forms for easy consumption. Typical dosage is 0.5-3.0 grams. Higher doses may be used over the short term for specific therapeutic actions: in China 30 grams is recommended to treat shock (sudden hypotension). Caution: excessive consumption of ginseng can lead to nervousness and may produce hormonal imbalance in women. Hoelen (fuling) This herb is a large fungus that grows on pine roots. It is used to alleviate irritation

of the gastro-intestinal system and, like atractylodes, it helps transport moisture out of the digestive system into the blood stream and from the various body tissues to the bladder. When bits of the pine root are included in the herb material it is called fushen; the combination of the fungus and pine produces a mild sedative action. This herb, because it is quite mild, is mostly used in making decoctions or dried decoctions, with a dosage equivalent of about 10-15 grams per day. The herb is nontoxic and rarely causes any adverse effects. Licorice (gancao) The roots have an extremely sweet taste (but are also bitter) and are said to neutralize toxins, relieve inflammation, and enhance digestion. In Europe, a drug has been made from licorice extract that heals gastric ulcers. Licorice is used by Chinese doctors in the treatment of hepatitis, sore throat, muscle spasms, and, when baked with honey, for treatment hyperthyroidism and heart valve diseases. Traditionally, licorice is thought to enhance the effectiveness of herb formulas and is used to moderate the flavor of herb teas; as a result, it is found in about one-third of all Chinese herb prescriptions. Licorice powder is encapsulated for easy consumption or mixed with other herbs and tableted. Dosage is from very small amounts (a few hundred milligrams) to 15 grams per day in decoction used to treat viral hepatitis. Caution: excessive consumption of licorice over an extended period to time can cause sodium/potassium imbalance with symptoms of tachycardia and/or edema. Ma-huang (mahuang) The stem-like leaves when taken in a dose of several grams stimulate perspiration, open the breathing passages, and invigorate the central nervous system energy. It has been shown that most of these effects are due to two alkaloid components, ephedrine and pseudoephedrine, both of them having been made into modern drugs (for asthma and sinus congestion, respectively). In addition, the stimulating action of ma-huang has led to its use as a metabolic enhancer (burns calories more quickly) for those who are trying to lose weight. Ma-huang also has anti-inflammatory actions useful in treating some cases of arthralgia and myalgia. Ma-huang can be made into a tea, or used in extract form; powdered ma-huang is rarely used. Dosage range is 1-9 grams/day, usually in two or three divided doses. Caution: the stimulant effect of ma-huang can cause insomnia and agitation; persons with very high blood pressure may find this symptom worsened by use of ma-huang. Peony (baishao and chihshao) The root of this common flower is used to regulate the blood. It relaxes the blood vessels, reduces platelet sticking, nourishes the blood, and promotes circulation to the skin and extremities. The root of both wild and cultivated peonies are used. The wild peony yields "red peony" (chihshao) a fibrous root that is especially used for stimulating blood circulation. The cultivated peony yields "white peony" (baishao) a dense root that nourishes the blood. Peony is often combined with tang-kuei, licorice, or other herbs mentioned here to enhance or control their effects. The dosage range is from 0.5-15 grams per day. Peony rarely causes any adverse reactions. Rehmannia (dihuang) The root of this herb is a dark, moist herb that is extensively used to nourish the

blood and the hormonal system. It is frequently used in the treatment of problems of aging, because of its ability to restore the levels of several declining hormones. There are two forms of the herb that are currently used: one, designated shengdihuang or raw rehmannia, is given to reduce inflammation and is included in many formulas for autoimmune disorders; the other is designated shoudihuang or cooked rehmannia, and is used as a nourishing tonic. Often, the two forms are combined together in equal proportions to address inflammatory problems that are related to the lack of adequate levels of regulating hormones. The herb is mainly used in making decoctions or dried decoctions, with a dosage of 10-30 grams per day. Caution: persons with weak digestion and tendency to experience loose stool or diarrhea may find that this herb, especially cooked rehmannia, worsens those symptoms. Rhubarb (dahuang) This large root was one of the first herbs that the Western world imported from China. It serves as a very reliable laxative, and also has other benefits: enhancing appetite when taken before meals in small amounts, promoting blood circulation and relieving pain in cases of injury or inflammation, and inhibiting intestinal infections. Rhubarb also reduces autoimmune reactions. The impact of rhubarb is influenced by how it is prepared; if it is cooked for a long period of time, the laxative actions are reduced but other actions are retained. Typical dosage is 0.5-3 grams per day. Caution: rhubarb, alone or in formulas, should not be used by those with irritable bowel conditions, as it may cause cramping and diarrhea. Salvia (danshen) The deep red roots of this Chinese sage plant have become an important herb during the past two decades even though it was used for centuries before that. It is applied in almost all cases where the body tissues have been damaged by disease or injury; thus, it is given for post-stroke syndrome, traumatic injury, chronic inflammation and/or infection, and degenerative diseases. It is best known for its ability to promote circulation in the capillary beds-the so-called microcirculation system. In addition, salvia lowers blood pressure, helps reduce cholesterol, and enhances function of the liver. It may be consumed alone or with other herbs, in wines, teas, pills, or tablets; dosage is 1-20 grams per day. Salvia rarely causes any adverse reactions. Tang-kuei (danggui) The root has been long respected as a blood-nourishing agent. It has its highest rate of use among women because tang-kuei will help to regulate uterine blood flow and contraction, but when employed in complex formulas it can be used by both men and women to nourish the blood, moisten the intestines, improve the circulation, calm tension, and relieve pain. Tang-kuei is frequently said to have estrogenic effects, but this is not a valid claim. The recommended dosage for tang-kuei is 0.5-9 grams per day. Tang-kuei may be made as a tea or cooked with chicken to make soup (the taste is quite strong), but it is often used today as a powder, encapsulated or made into tablets, alone or with other herbs. Caution: some individuals find that tang-kuei causes nausea or loose stool. EXAMPLES OF HERB COMBINING TO MAKE AN EFFECTIVE TREATMENT

An ancient formula prescribed for the initial stage of an infectious disease is Cinnamon Combination. It includes cinnamon, peony, licorice, and ginger. It is said that the cinnamon (twig) and peony coordinate the circulation at the surface of the body (where disease is believed to enter) and relaxes tense muscles. Ginger and licorice improve the digestive functions and improve the body's healing energy. An ancient formula used to treat chronic illness is Ginseng and Tang-kuei Ten Combination. It includes astragalus, ginseng, atractylodes, hoelen, licorice, cinnamon, tang-kuei, peony, and rehmannia. Astragalus, ginseng, atractylodes, hoelen, and licorice promote digestive functions, increase the energy, nourish the internal organs, and enhance weakened immune responses. Cinnamon (bark) warms up the weakened metabolism. Tang-kuei, peony, and rehmannia nourish the blood. Another ancient formula, used for a variety of diseases and function disorders, is Minor Bupleurum Combination. It includes bupleurum, ginseng, ginger, hoelen, and licorice. Bupleurum harmonizes the circulation between the internal organs and the body surface, it alleviates stress in the chest and abdomen, and it reduces inflammation. As indicated above, ginseng, ginger, hoelen, and licorice benefit the digestive processes and increase energy. All of these formulas are widely used today, often by making some slight modifications to address the particular needs of the individual or the characteristics of the disease. For example, Cinnamon Combination (with appropriate modifications) has been used in Chinese clinical trials for treatment of frostbite, pernicious vomiting of pregnancy, and appendicitis. Ginseng and Tang-kuei Ten Combination has been applied to treatment of side-effects of cancer therapy and for prevention of cancer recurrence after successful treatment. Minor Bupleurum Combination is one of the formulas frequently given in cases of chronic hepatitis B infection, and it is also used for inflammation of the stomach and pancreas.

Hank Fu Home Story about Ginseng Chinese herbs Chinese herbs An insight into Chinese medicine Message from Ron Teeguarden Chinese drug therapy Chinese herbal medicine Does herbal medicine work?

Herbal medicine introduction Medicated Diet Chinese medicinals and side effects Chinese Medicine Overview Collecting herbs The origins of Chinese medicine Herb drug History of Chinese medicine What is the difference? Introduction to Chinese herbs Modern and Chinese medicine Philosophy of herbs My view of Chinese medicine Learning about herbs Is it safe? Prevention of herb-drug interaction Taoism and Chinese traditional medicine American incarnation of Chinese medicine The characters and functions of Chinese medicine drugs The duty of Oriental and Western medicine Questions about Chinese traditional medicine Understanding Chinese medicine Yin and Yang Five element theory Foundations of chemistry of ancient China Preparation of herbs The Processing of Chinese Herbs for Medicinal Preparations Chinese herb medicine FAQ Color significance in Oriental herbs Ginseng and Astragalus combination How to take Chinese herbs? How to cook Chinese herbs? Herb Safety The principles of formula writing The prescriptions of Chinese herbs medicine The eight principles What does the treatment involve? Toxicity and interactions issues in Chinese herbal medicine What is Qi in Chinese medicine? Yoga and Oriental medicine Deal with insurance companies Visiting herbal doctors Becoming a herbalist Drug regulators Books to read Rhubarb Research

Individual Cases Some things to remember Get all answers for any questions Chinese Medicinals & Side Effects by Bob Flaws Many Western practitioners think that Chinese medicinals are safe because they are "herbs" and, therefore, natural. This opinion is both naïve and potentially dangerous. Happily, recent publicity about Chinese herbs containing aristolochic acid has helped to raise the consciousness of many Western practitioners regarding the safety of Chinese medicinals. As I have been saying for years, Chinese medicinals are safe and effective only when they are prescribed correctly. This is one of the reasons why I always use the term "Chinese medicinals" (the actual translation of zhong yao) as opposed to "Chinese herbs" ( which is zhong cao). I believe Chinese medicinals need to be considered just as potentially dangerous as Western medicinals if they are prescribed erroneously. Recently, Chinese doctors in China have begun to show more interest in the issue of adverse reactions (or side effects) from Chinese medicinals. There have been a number of articles on this subject in recent issues of Chinese medical journals in all probability prompted by the "aristolochia issue." One such article was written by Chen De-xin and published in the August 2000 issue of Fu Jian Zhong Yi Yao (Fujian Chinese Medicine & Medicinals). Titled "A Brief Discussion of the Adverse Effects of Chinese Medicinals & How to Prevent Them," Chen describes seven ways Chinese medicinals may cause adverse reactions or side effects. I believe that Western practitioners should pay more attention to these seven ways Chinese medicinals may cause unwanted side effects and adverse reactions. 1. In appropriate for the patient's pattern As Chen says, the treatment methodology of Chinese medicine is to base treatment on pattern discrimination. This means that, "If there is cold, heat it; if there is heat, chill it; if there is repletion, drain it, and if there is vacuity, supplement it." This is the fundamental heteropathic principle beneath the professional prescription of Chinese medicinals. If a Chinese medicinal does not match the patient's pattern, it may cause adverse reactions. This is because anything that is strong enough to push a person towards health when truly needed must also be strong enough to push a person out of balance if not needed. In medicine there are no panaceas, and you cannot have it both ways. For instance, prescribing a warming medicinal to a patient with a heat pattern may adversely increase evil heat. Chen's example of this most basic and fundamental mistake is to prescribe Radix Panacis Ginseng (Ren Shen) or Cornu Parvum Cervi (Lu Rong), both supplementing and boosting medicinals, to someone with an evil repletion pattern. In that case, these medicinals may cause the adverse reactions of chest oppression and abdominal distention. Other examples from my own experience are prescribing yang supplements to a patient who is not yang vacuous and bitter, cold medicinals with a spleen vacuity. In the first case, such erroneous prescription may result in unwanted oral sores and

sore throat, while in the second case, it may result in unwanted diarrhea. 2. Excessive dose It is also possible for Chinese medicinals to cause adverse reactions if they are appropriately indicated but their dosage is simply too large. As an example of this, Chen says that Caulis Akebiae (Mu Tong) may cause acute kidney failure if its dosage is too high even when otherwise correctly selected. Chen also says that excessively large doses of Herba Asari Cum Radice (Xi Xin), Semen Gingkonis Bilobae (Ying Guo), Semen Pruni Armeniacae (Xing Ren), and Radix Aconiti (Wu Tou) may all cause poisoning. 3. Prolonged administration Prolonged administration of certain Chinese medicinals may cause unwanted side effects or adverse reactions, again even if otherwise correctly chosen. For instance, prolonged administration of Cinnabar (Zhu Sha), Haemititum (Dai Zhe Shi), and the ready-made medicine Liu Shen Wan (Six Spirits Pills) may all cause damage to the liver and kidneys, while prolonged administration of Royal Jelly (Feng Wang Jiang) to children may cause premature sexual development. 4. Wrong combinations Most Chinese medical practitioners are required to learn a list of traditionally "forbidden" medicinal combinations. These describe those medicinal combinations which are likely to cause adverse reactions. In general, the erroneous combination of such medicinals increases the toxicity inherent in one or both medicinals. As an example of this, Chen says that the combination of Thallus Algae (Kun Bu) and Herba Sargassii (Hai Zao) with Cinnabar (Zhu Sha) may cause iatrogenic colitis. However, Chen also goes on to point out that such wrong combinations may include a Chinese medicinal and a Western drug. For instance, Rhizoma Alismatis (Ze Xie) with antisterone, spironolactone, or other such diuretics may result in hyperkalemia (i.e., too much potassium in the blood). Unfortunately, there are not yet well-vetted traditional lists of such Chinese medicinal-Western drug reactions. 5. Wrong processing Pao zhi is the Chinese medical term for the processing of medicinals. Such processing changes the nature and functions of medicinals, either eliminating or reducing something negative or enhancing and supplementing something positive about the medicinal being processed. For instance, uncooked Rhizoma Pinelliae Ternatae (Ban Xia) has toxins which can promote vomiting, whereas processing this medicinal removes these toxins. In that case, the processed medicinal is used to actually stop vomiting. Therefore, which form of Ban Xia one uses, uncooked or processed, is extremely important, and using the wrong one may result in unwanted vomiting. This is why Philippe Sionneau, the author of Pao Zhi: An Introduction to the Use of Processed Chinese Medicinals, regards differently processed forms of the same medicinal as different medicinals. Another example of adverse reactions from wrong processing is if the fine hairs on Folium Eriobotryae Japonicae (Pi Pa Ye) are not removed. After ingestion, Chen says that this may result in itchy throat and dry cough and, if severe, may cause edematous swelling of the throat. 6. Wrong decoction The standard of care in terms of method of administration for most Chinese medicinal formulas in standard professional Chinese medicine is the water-based

decoction. This means that the Chinese medicinals are boiled in water and that the resulting medicinal liquid is drunk. Different Chinese medicinals have different instructions in terms of how long they should be decocted prior to administration. In some cases, wrong cooking simply destroys the medicinal's therapeutic effect, such as overcooking Radix Ligustici Wallichii (Chuan Xiong) and Ramulus Uncariae Cum Uncis (Gou Teng). However, in other cases, wrong cooking may result in failure to eliminate toxicity and thus the causation of side effects or adverse reactions. For instance, if Radix Lateralis Praeparatus Aconiti Carmichaeli (Fu Zi) is not cooked long enough, its inherent toxicity may not be eliminated. Similarly, cooking Cinnabar (Zhu Sha) along with the other medicinals in a decoction may increase the absorption of Zhu Sha's inherent toxins. 7. Individual bodily differences Individuals vary in terms of their age, sex, and constitutions. Therefore, the effects of a certain medicinal at a certain dose may not be the same from patient to patient. Some patients will be more sensitive to the constituents of a certain medicinal and other patients will be less sensitive. For instance, babies' and childrens' viscera and bowels are not completely developed and mature. Therefore the prolonged administration of otherwise nontoxic Chinese medicinals may cause poisoning reactions. This is why it is commonly said in Chinese medical pediatrics that one should stop administering medicinals when the baby's condition is cured by half. Similarly, the liver and kidney function in the elderly is typically decreased and, therefore, their bodies cannot breakdown and excrete medicinal constituents as easily as healthy middle-aged adults. This means that the effects of medicinals in the elderly are stronger and can easily lead to adverse reactions if those medicinals are overprescribed. Further, Chinese medicinals must also be adjusted and their use varied in women who are lactating, menstruating, or pregnant. Conclusion As we Western practitioners of Chinese medicine try to gain doctoral status for our profession, I believe it is also incumbent upon us to grant the full status of medicines to our so-called herbs. This means that we should recognize the full potential power of the ingredients we prescribe, both to do good and to do harm. Far too often I have heard from patients who have been told that an adverse reaction could not have been caused by the Chinese medicinals they were prescribed because those medicinals were "natural," "herbs," or "holistic." I believe we need to grow beyond such naïve, simplistic, and down-right wrong opinions. If we want increased respect from the public for our art, then I also think we need to pay increased respect to our medicinals. As Chen's article implies, Chinese medicinals are not safe because they are mostly made from herbal sources. They are not safe because they are natural. Water and salt are both natural, both are absolutely essential to human life, and both can kill you if taken inappropriately. And they are not safe because they are Chinese. They are only safe (and effective) when prescribed on the basis of a correct pattern discrimination in the right dose for the right length of time and processed and administered in the right way. Copyright © Blue Poppy Press, 2001. All rights reserved.

Prevention of Herb-Drug Interaction By John Chen, Ph.D., Pharm. D., OMD, L.Ac. The practice of medicine is now at a crossroads: there are countless patients being treated simultaneously with both Western and Oriental medicine. It is quite common for a patient to seek herbal treatment while taking several prescription medications. Safety has become a major issue. Reasonably enough, patients want to know about compatibility and possible interactions when taking herbs and prescription drugs simultaneously. Such specific questions, unfortunately, are often difficult (if not impossible) to answer. There are very few studies published in English to document the safety and effectiveness of combining herbs with prescription drugs. However, with some general insights in pharmacology, one can foresee possible interactions and thus take precautions to avoid incompatibilities. A possible interaction refers to the possibility that one substance may alter the bioavailability or the clinical effectiveness of another substance when two or more substances are given concurrently. The net result may be an increase or a decrease in effect of one or both substances. Most of the possible interactions may be classified into two major categories: pharmacokinetic and pharmacodynamic interactions. Pharmacokinetic Interactions Pharmacokinetic interaction refers to the fluctuation in bioavailability of herb-drug molecules in the body as a result of changes in absorption, distribution, metabolism and elimination. Absorption Absorption is the physical passage of herbs or drugs from the outside to the inside of the body. The majority of all absorption occurs in the intestines, where herbs or drugs must pass through the intestinal wall to enter the blood. Several mechanisms may interfere with the absorption of drugs through the intestines. The absorption of herbs may be adversely affected when the herbs are given together with some drugs, due to binding in the G.I. tract. Drugs such as Questran (cholestyramine), Colestid (colestipol) and Carafate (sucralfate) may bind to certain herbs, forming an insoluble complex, and decrease absorption of both substances because the size of the insoluble complex is too big to pass through the intestinal wall. The absorption of herbs may be adversely affected when the herbs are given together with some drugs that change the pH of the stomach. Drugs such as antacids, Tagamet (cimetidine), Pepcid (famotidine), Axid (nizatidine), Zantac (ranitidine) and Prilosec (omeprazole) may neutralize, decrease, or inhibit the secretion of the stomach acid. With the subsequent decrease of stomach acid, herbs may not be broken down properly, leading to poor absorption in the intestines. To minimize the risk of interaction, it is best if the drugs and the herbs are taken separately by approximately two hours. Lastly, drugs that affect the G.I. motility may affect the absorption of herbs. G.I. motility is the rate at which the intestines contract to push the content from the stomach to the rectum. Slower G.I. Motility means the herbs stay in the intestines for a longer period of time and there will be an increase in absorption. Conversely,

faster G.I. Motility means the herbs stay in the intestines for a shorter period of time and there may be a decrease in absorption. Drugs such as Reglan (metoclopramide) and Propulsid (cisapride) increase G.I. Motility and possibly decrease absorption of herbs; and drugs such as Haldol (haloperidol) decrease G.I. Motility and may increase absorption of herbs. Therefore, it may be necessary to decrease the dosage of herbs when the patient takes a drug that decreases the G.I. Motility and increases overall absorption; and increase the dosage of herbs when the patient takes a drug that increases the G.I. Motility and decreases overall absorption. Distribution After absorption, herbs or drugs need to be presented to the affected area to exert their effect. Distribution refers to the process in which herbs or drugs are carried and released to different parts of the body. At the present time, most drugs and herbs do not appear to have any clinically significant interactions affecting distribution and can be safely taken together. Interactions occur during the distribution phase if the drug has a narrow range of safety index and is highly protein-bound. For example, Coumadin (warfarin) is an anticoagulant medication that is very highly bound to protein and has a very narrow range of safety index. Coumadin (warfarin) interacts with various drugs, vitamins, herbs, and foods via different mechanisms. Some known examples that interact with Coumadin (warfarin) include aspirin, ibuprofen, vitamin K, some types of tea, green leaf vegetables, etc. These items interact with Coumadin (warfarin) by either enhancing its effectiveness and thus leading to prolonged bleeding, or by decreasing its effectiveness and thus increasing the risk of blood clots in the vessels, both of which may be quite dangerous to the patient. This is why patients who are taking Coumadin (warfarin) need to be exceedingly cautious when taking herbs concurrently. Unfortunately, it is extremely difficult to predict whether an individual herb will interact with Coumadin (warfarin), because there are very few tests or experiments documenting such interactions. The best precautionary measure is close observation of the patient's condition. If the patient shows abnormal signs of bleeding and bruises, then the dosage of herbs may need to be adjusted and the patient's medical doctor should be contacted immediately. Metabolism Most herbs and drugs are metabolized by the liver to inactive derivatives. The rate at which the liver metabolizes these herbs and drugs determines the length of time these herbs or drugs stay active in the body. If the liver were induced to speed up its metabolism, herbs and drugs would be inactivated at a faster pace and the overall effectiveness of ingested substances would be lower. On the other hand, if the liver were induced to slow down its metabolism, herbs and drugs would be inactivated at a slower pace and the overall effectiveness of the substances would be higher. In general, drugs that induce liver metabolism do not exert an immediate effect. The rate of liver metabolism changes slowly over several weeks. Therefore, the effect of increased liver metabolism is not seen until weeks after the initiation of drug therapy. Some examples include Dilantin (phenytoin), Tegretol (carbamazepine), phenobarbitals, and rifampin. These drugs speed up liver metabolism. Therefore, the herbs may be inactivated faster and their overall effectiveness may be lower.

Under such circumstances, the patient may need a higher dose of herbs to achieve the desired effectiveness. On the other hand, drugs that inhibit liver metabolism have an immediate onset of action. The rate of liver metabolism may be greatly impaired within a few days. Therefore, there is a higher risk of herbs accumulating inside the body as the function of the liver to inactivate them is compromised. Examples of drugs that slow down or inhibit liver metabolism include, but are not limited to, Tagamet (cimetidine), erythromycin, ethanol, Diflucan (fluconazole), Sporonox (itraconazole) and Nizoral (ketoconazole). Therefore, the herbs may be inactivated more slowly and the overall effectiveness may be prolonged. In this case, one may need to lower the dosage of herbs to avoid unwanted side effects. Elimination In addition to the liver, the kidney is also responsible for eliminating herbs and drugs from the body. If the kidney(s) were damaged, then the rate of elimination by the kidneys would be slowed down leading to an accumulation of herbs and drugs in the body. Important examples of drugs that damage the kidneys include amphotericin B, methotrexate, tobramicin and gentimicin. As a safety precaution, it may be necessary to lower the dose of herbs to avoid unnecessary and unwanted side effects. Summary of Pharmacokinetic Interactions The pharmacokinetic interactions listed in this section include both theoretical and actual interactions. Though such interactions are possible, the extent and severity of each interaction will vary depending on the specific circumstances, such as dosage, sensitivity, body weight, and metabolic rate. Pharmacodynamic Interactions Pharmacodynamic refers to the study of how drugs actually behave inside the human body. A pharmacodynamic interaction refers to the fluctuation in bioavailability of ingested substances as a result of synergistic or antagonistic interactions between herb/drug molecules. Pharmacodynamic interactions are generally more difficult to predict and prevent than pharmacokinetic interactions. Most of the pharmacodynamic interactions known now are documented through actual cases-as opposed to laboratory experiments. The best way to prevent pharmacodynamic interactions is to follow the patient closely and monitor all clinical responses including signs, symptoms, and any abnormal reactions. Examples of pharmacodynamic interaction include additive and antagonistic interactions. An additive effect occurs when two drugs of similar properties show additive or exponential increase in clinical effects when given together. An antagonistic effect occurs when two drugs of similar properties show lessened or no clinical effect when given together. Herb-to-Herb Interactions Cases of pharmacodynamic interactions have also been documented in Oriental Medicine. The additive effect is generally referred to as mutual accentuation (xiang xu) or mutual enhancement (xiang shi), such as the combination of Gypsum (Shi Gao) and Rhizoma Anemarrhenae (Zhi Mu) to "clear heat and purge" fire. The antagonistic effect is generally referred to as mutual counteraction (xiang wei), mutual suppression (xiang sha) or mutual antagonism (xiang wu), such as the

combination of Semen Raphani (Lai Fu Zi) and Radix Ginseng (Ren Shen), in which the effect of the latter herb is decreased. In addition, classic Chinese texts state numerous herb-to-herb interactions, such as the Eighteen Incompatibles (Shi Ba Fan) and Nineteen Counteractions (Shi Jiu Wei). Eighteen Incompatibles (Shi Ba Fan) is a classic list of eighteen herb-to-herb interactions. Nineteen Counteractions (Shi Jiu Wei) is a classic list of nineteen herbal combinations in which the herbs counteract each other. Combinations of such herbs will likely lead to adverse side effects and/or toxic reactions. The list of Eighteen Incompatibles (Shi Ba Fan) includes: Radix Glycyrrhizae (Gan Cao) is incompatible with Radix Euphorbiae Kansui (Gan Sui), Radix Euphorbiae seu Knoxiae (Da Ji), Flos Genkwa (Yuan Hua) and Herba Sargassum (Hai Zao); Rhizoma Aconiti (Wu Tou) is incompatible with Bulbus Fritillariae Cirrhosae (Chuan Bei Mu), Bulbus Fritillariae Thunbergii (Zhe Bei Mu), Fructus Trichosanthis (Gua Lou), Rhizoma Pinelliae (Ban Xia), Radix Ampelopsis (Bai Lian) and Rhizoma Bletillae (Bai Ji); Rhizoma et Radix Veratri (Li Lu) is incompatible with Radix Ginseng (Ren Shen), Radix Glehniae (Bei Sha Shen), Radix Adenophorae (Nan Sha Shen), Radix Sophorae Flavescentis (Ku Shen), Radix Salviae Miltiorrhizae (Dan Shen), Radix Scrophulariae (Xuan Shen), Radix Paeoniae Alba (Bai Shao), Radix Paeoniae Rubra (Chi Shao) and Herba Asari (Xi Xin). The list of Nineteen Counteractions (Shi Jiu Wei) includes: Sulfur (Liu Huang) & Mirabilitum (Mang Xiao); Mercury (Shui Yin) & Arsenolite (Pi Shuang); Rhizoma Euphorbiae E. (Lang Du) & Lithargyrum (Mi Tuo Seng); Semen Crotonis (Ba Dou) & Semen Pharbitidis (Qian Niu Zi); Flos Caryphyili (Ding Xiang) & Radix Curcumae (Yu Jin); Nitrum (Ya Xiao) & Rhizoma Sparganii (Shan Ling); Cornu Rhinoceri (Xi Jiao) & Rz. Aconiti Kusnezoffii (Cao Wu); Cornu Rhinoceri (Xi Jiao) & Rhizoma Aconiti (Chuan Wu); Radix Ginseng (Ren Shen) & Rhizoma Trogopterorum (Wu Ling Zhi); and Cortex Cinnamomi (Rou Gui) & Hallositum Rubrum (Chi Shi Zhi). Herb-to-Drug Interactions Pharmacodynamic types of herb-to-drug interactions are best identified by analyzing the therapeutic effect of the herbs and drugs. Concurrent use of herbs and drugs with similar therapeutic actions will undoubtedly pose potential risk of herb-to-drug interactions. The increase in treatment effect interferes with optimal treatment outcome as the desired effect becomes more unpredictable and harder to obtain with precision. The highest risk of clinically significant interactions occurs between herbs and drugs that have sympathomimic effects, cardiovascular effects, diuretic effects, anticoagulant effects and anti-diabetic effects. Herbs with sympathomimic effects may interfere with anti-hypertensive and antiseizure drugs. The classic example of an herb with sympathomimic effects is Herba Ephedrae (Ma Huang), which contains ephedrine, pseudoephedrine, norephedrine and other ephedrine alkaloids. Herba Ephedrae (Ma Huang) may interact with many other drugs and disease conditions and should always be used with caution in patients who have hypertension, seizures, diabetes, thyroid conditions, etc. Concomitant use of diuretic herbs and diuretic drugs may have additive or synergistic effects, making hypertension more difficult to control or hypotensive

episodes more likely. The dosage of herbs and/or drugs must be adjusted to achieve optimal treatment outcome. Commonly used diuretic herbs include Poria Cocos (Fu Ling), Polypori Umbellati (Zhu Ling), Semen Plantaginis (Che Qian Zi), and Alismatis Orientalis (Ze Xie). Herbs with anticoagulant effects include herbs that have blood-activating and blood-stasis-removing functions. Such herbs may interfere with anticoagulant drugs, such as Coumadin (warfarin), to prolong the bleeding time. Herbs that interfere with Coumadin (warfarin) include Salviae Miltiorrhizae (Dan Shen), Angelica Sinensis (Dang Gui), Ligustici Chuanxiong (Chuan Xiong), Persicae (Tao Ren), Carthamus Tinctorii (Hong Hua) and Hirudo seu Whitmania (Shui Zhi). The synergistic interaction between herbs and Coumadin (warfarin) may be advantageous for the patient as the dosage of both the herbs and the drugs can be reduced without compromising clinical effectiveness. The reduction in dosage will also decrease the frequency and severity of side effects of the drugs. Optimal treatment, however, is directly dependent on careful titration of the herb and drug, cooperation from the patient, and communication between the doctors who prescribe the herbs and the drugs. Anti-diabetic herbs may interfere with anti-diabetic drugs by the enhancing hypoglycemic effects. The dosage of herbs and drugs must be balanced carefully to effectively control the blood glucose level without causing hyper- or hypoglycemia. Herbs with definite hypoglycemic effects include the following pairs of herbs: Anemarrhena Asphodeloidis (Zhi Mu) and Gypsum Fibrosum (Shi Gao); Scrophularia Ningpoensis (Xuan Shen) and Atractylodes (Cang Zhu); and Dioscorea Oppositae (Shan Yao) and Astragalus Membranacei (Huang Qi) Teratogenic Herbs Teratogenic herbs are known to have the tendency or likelihood of causing danger or harm to the fetus during pregnancy and thus leading to birth defects or spontaneous abortion. Teratogenic herbs are classified into two categories: prohibited and use with caution. Prohibited herbs are very potent and very toxic. The use of these herbs during pregnancy is prohibited to avoid possible harm to the fetus. Prohibited herbs include Semen Crotonis (Ba Dou), Semen Pharbitidis (Qian Niu Zi), Radix Euphorbiae (Da Ji), Mylabris (Ban Mao), Radix Phytolaccae (Shang Lu), Moschus (She Xiang), Rhizoma Sparganii (San Leng), Rhizoma Zedoariae (E Zhu), Hirudo seu Whitmania (Shui Zhi) and Tabanus (Meng Chong). Herbs that should be used with caution are herbs that are pungent and warm in nature and have the functions to activate Qi, activate Blood circulation, and remove blood stasis. They are also very potent in nature and should be avoided during pregnancy whenever possible. The use of these herbs should be limited only to later stages of pregnancy and only when the benefits of using the herbs outweigh the risks. Herbs that should be used with caution include Semen Persicae (Tao Ren), Flos Carthami (Hong Hua), Rz. et Rx. Rhei (Da Huang), Fructus Aurantii (Zhi Shi), Radix Aconiti (Fu Zi), Rhizoma Zingiberis (Gan Jiang), and Cortex Cinnamomi (Rou Gui). Conclusion Historically, herbs and drugs have been two very different treatment modalities that

have rarely, if ever, been used together. The line that separates herbs and drugs, however, has been blurred in recent decades with the increased accessibility to the lay public of different treatment modalities. It is not uncommon for one patient to seek care from several doctors for an ailment. As a result, a patient may easily be taking multiple drugs, herbs and vitamins concurrently. It becomes very difficult to predict whether the combination of all these medications will lead to unwanted side effects and/or interactions. It is imprudent to assume that there will be no interactions. On the other hand, it is just as unwise to abandon treatment simply for the fear of possible interactions. The solution to this situation is in the understanding of drug-drug and drug-herb interactions. With understanding of these mechanisms, one can recognize potential interactions and take proper actions to prevent their occurrence. John K. Chen, Ph.D., Pharm.D., OMD, L.Ac. is a recognized authority on western pharmacology and Chinese herbal medicine. He graduated from the University of Southern California (USC) School of Pharmacy and South Baylo University of Oriental Medicine. He also received extensive postgraduate training in China specializing in herbology and internal medicine. Dr. Chen currently teaches herbal medicine at USC, Chinese herbology at South Baylo University, and western pharmacology at Yo San University and Emperor's College. He is the Chair of the Herbal Medicine Committee for the American Association of Oriental Medicine (AAOM) and an herbal consultant for the California Association of Acupuncture and Oriental Medicine (CAAOM). Dr. John Chen is the president and founder of Lotus Herbs, and is available for medical consultations through the Lotus Herbal Consultation Line. Tel: (626) 916-1070; Fax: (626) 917-7763; Lotus Herbs: 1124 North Hacienda Blvd. La Puente, CA 91744. Copyright 1998 All rights reserved. Written by Dr. John K. Chen, Ph.D., Pharm.D., OMD, L.Ac.

Chinese Herbs Introduction: China is perhaps unique in the world in its long commitment to preventative medicine through the use of herbal tonics. The tonic herbs have several uses, including direct treatment of acute ailments, building strength in the recovery process, balancing the body's energy and preventing disease from occurring. These herbs are combined to make tonic soups providing nourishment and gentle stimulation to the organs. The Chinese herbs are becoming more readily available in the West, and many of the ones described here can be purchased in herb store around the United States. To make the herbal soup, combine six to seven grams (about one -quarter ounce) of each of the desired herbs in a large nonmetallic pot. Use a quarter of water per once of herbs and simmer for an hour. Drink one cup of the tea, once per day, reheating the soup each day until it is all used. Always include some licorice in the formula.

They are never cooked in a water-soluble metal container as this will dilute their properties. For the more difficult diseases involving deficiency, they should be regularly used over a long period of time to help "build up the deficiency," the primary therapeutic principle of Chinese medicine. This is in contrast to Western herbalists who, coming from a tradition of excess meat eating and the use of rich foods, advocate a more eliminative approach to health. Classify the herbs according to their tonic capacities. Yang or energy tonics include the following: aconite, astragalus, don sen, ginseng, eleuthero, ephedra, fu ling, licorice, ho shou wu, pai shu, and savia(dang shen). Yin or blood tonics include: dong quai, ho shou wu, lycii, rehmannia, peony, and tienchi. There are also some herbs that are Yin-cooling, thus helping to detoxify the blood and remove inflammation and beat from the internal organs and body in general. These include: bupleurum, honeysuckle, chrysanthemum, and rehmannia (raw). Herbs that are stimulating and warming to metabolic functions include: cinnmon, ginger, aconite, and citrus peel (especially tangerine). These have more extreme warming or stimulating action and also help digestion. Other herbs that help to build warmth include rehmannia, don sen, eleuthero, astragalus and tienchi. A basic combination used as weekly soup stock in many traditional Chinese families is a follows: Astragalus- 5 grams Don sen- 8 grams Fu Ling- 5 grams Ginger- 5grams Jujube date- 5grams Licorice- 2grams (to harmonize) The portions are subject to individual variation. Once could substitute ginseng root for don sen, add 1.5 grams of aconite to increase the metabolic stimulant action , logan berries and /or lycii in addition to or along with jujube date. So there are many possibilities for adjusting this basic combination to suit one's particular needs. Those who suffer from anemia, poor circulation and menstrual irregularities should use combinations using dong quai as the major herb. The basic combination for stimulating and tonifying the Yin-blood is don sen and astragalus on hand to tonify Yang-energy, they also keep a quantity of dong quai and fresh ginger root to tonify Yin-blood. Again this basic combination that is frequently used over and beyond the simple dong quai and ginger mentioned above is: Don Quai- 6 grams (to tonify the blood ) Ligusticum-4 grams (to tonify and move the blood) Peony- 4 grams ( antispasmodic, helps move the blood) Rehmannia - 4 grams (tonifies the blood, helps the kidneys) To this basic formula ginger, dried citrus peel, cinnamon or aconite can be added in small amounts to help catalyze and move the energy of the herbs. The above formulas are especially good for deficiencies and are best taken in the form of Chinese herb soup. This is done by simply cooking the above ingredients in one or two quarter of water for one hour. Strain if you don't want to encounter pieces of Chinese herbs in your soup broth.

Add two to four ounces of lean pork, beef, or a whole chicken to the broth and continue cooking. Add some whole grains, vegetables and salt to taste. One or two bowls of this soup mixture should be taken daily for chronic deficiencies. For maintenance, serve this delicious soup to the family on a weekly basis. Following is a combination of herbs that utilizes elements from both the Yang and Yin tonics: Ginseng-2 grams stragalus -2 grams Dong Quai-2 grams Fu Ling-2 grams Aconite-1.5 grams (one slice of the root ) Rehmannia-2 grams Ho Shou Wu -2 grams Lycii -2 grams Logan berries (Dragon's Eyes)-2 grams Pai Shu - 2 grams Jujube date - 2 grams Ginger (fresh) - 2 or 3 slices Licorice - 1 or 2 grams Chrysanthemum - 1 gram ( as a cooling detoxifying herb).

Chinese herbs WU JIA PI Rids the joints, bones and muscles of Wind Dampness, which causes arthritis and rheumatism. It also alleviates Damp Cold conditions or deficiency of the liver and kidneys, which causes weak bones. HUO XIANG Unblocks the digestion, cures bloating, nausea and fatigue and in combination with other herbs, gastric flu. YI ZHI REN A warming herb, this controls leaking fluids from the kidneys and is therefore good for incontinence. It is also useful to control spermatorrhea, or uncontrollable leaking sperm. BAI ZHI Good for sinusitis headaches, boils and white vaginal discharge. DANG GUI A blood tonic, which is also good for menstrual problems, palpitations, blurred

vision and abdominal pain. BAI ZHU Treats deficiency in chi: tones the spleen and strengthens the function of the stomach. Good for digestive disorders and water retention, also for restless foetus. HUANG QI For chi-deficiency disorders such as fatigue or loss of appetite. Also for combatting viruses, post-natal fever and loss of blood. MU XIANG Revitalises the chi: good for abdominal pain, swelling and nausea, lack of appetite and dysentery. HUO MA REN This is the ungerminated cannabis seed, without the narcotic effect. Use for constipation and digestive disorders when in a weakened state, e.g. after childbirth or a surgical operation. HONG HUA Use for conditions connected with stasis of the blood, such as menstrual problems, growths, fibroids and skin diseases such as scarlet fever. GUI ZHI Use for flu and colds, especially with excessive sweating. Also for menstrual cramps and shortness of breath. CHEN PI An important herb for revitalising the chi, and is believed to 'awaken the Spleen'. Use for abdominal pain and bloating, fatigue, loose motions, vomiting and belching. DANG SHEN Similar to ginseng in effect: use for lung/respiratory problems such as coughs and shortness of breath and lack of vitality. YI YI REN Use to dispel water retention and pus-filled sores. Good for digestive problems and stops diarrhoea. SHAN ZHU YU Controls the leaking of bodily fluids: use for heavy periods, incontinence and spermatorrhea. Also good for shock and dizziness. HUANG LIAN Use for high fever, delirium and infectious diseases. Also for conjunctivitis and certain vaginal infections. SHAN ZHA For digestive disorders after too much fatty food. Stops diarrhoea - even dysentery. TU SU ZI Use for premature ejaculation, impotence, incontinence, vaginal discharge and to prevent miscarriage. Also for disturbed vision and dizziness. XIANG FU Use for PMS (including tender breasts), loss of appetite, vomiting, diarrhoea and trapped wind (gas). TIAN MA Use for arthritic pain, migraines, childhood fits, spasms and tantrums. DU ZHONG

Use to prevent miscarriage, soothe a restless foetus and for weak or painful lower back. Promotes good circulation. ZHE BEI MU Use as a decongestant and expectorant where phlegm is difficult to bring up. GAN CAO Use for coughing, shortness of breath, throat infections and abdominal or leg cramps. Warning: this may cause high blood pressure if taken for a long time. FANG FENG Use for flu and colds, arthritic pain, trembling and numbness - as in Parkinson's disease. CHUAN XIONG Use for blood disorders including menstrual problems, poor circulation, difficult childbirth, besides migraines and dizziness. JIN YIN HUA Use against food poisoning, especially salmonella and for mastitis, bacterial or viral tonsillitis and conjunctivitis. GOU QI ZI Use for late onset diabetes, weak knees, bad back, sore eyes, failing eyesight and tubercular coughs. MAI MEN DONG Use for fevers with parched throat, dry coughs, diabetes and failing vision. BAI SHAO Use for dizziness, headaches and abdominal pain, and for menstrual pain, leaking sperm and vaginal discharge. REN SHEN (Popular in the west as 'ginseng') Use to revitalise body and mind, specifically for fatigue, loss of appetite, bloating, difficulties in breathing, sweating and weak limbs. Warning: too much ginseng, or doses taken for more than six weeks, can cause insomnia, nausea and high blood pressure. SAN QI Traditionally carried by soldiers to stem bleeding, this is used for nosebleeds, vomiting blood, bloody stools, and all bleeding caused by trauma. It also alleviates pain. HUANG BAI, HUANG BO Use for menopausal hot flushes or excess sweating, yellow smelly vaginal discharge, swollen and painful legs, leg ulcers and drug withdrawal. BAN XIA Use for nausea, bloating and excess phlegm in the digestive and respiratory tracts. JIE GENG Use for coughs and difficulty in breathing, and for laryngitis. YUAN ZHI Use for insomnia, impaired memory, palpitations and abscesses and sore breasts. Also for serious underlying psychological disorders such as anxiety and bottled-up emotion.

HE SHOU WU Used for vaginal discharge, premature ejaculation, malaria, hardening of the arteries, dizziness, blurred vision - and to prevent hair going grey. YE JIAO TENG Use for weakness, soreness, rashes, insomnia or disturbed sleep, irritability and lack of appetite. FU LING Good for all symptoms associated with Dampness, including urinary problems and water retention. Also for dizziness and headaches. XING REN Use for coughs and difficulties with breathing. Warning: it may be too strong for some children, and may cause diarrhoea. TAO REN This exceptionally strong remedy is used for tumours and enlarged organs such as the liver, besides abscesses and constipation. Warning: do not take during pregnancy. SHENG DI HUANG Use for high fevers, night sweats, constipation, irritability and insomnia. Also for vomiting blood and diabetes. SHU DI HUANG This important remedy is used for menstrual problems, insomnia, night sweats, diabetes, tinnitus, lower back pain, deafness and premature greying. DA HUANG (Rhubarb) Use for lack of menstruation, appendicitis and constipation. Warning: do not use during pregnancy, and exercise caution when taking during menstruation and after giving birth. WU WEI ZI Use for wheezy coughs, asthma, incontinence, vaginal discharges, early morning diarrhoea, diabetes, palpitations, disturbed sleep and several phobias including fear of the paranormal and agoraphobia. HUANG QIN Use for high fevers, irritability, thirst, dysentery, bloody stools and nosebleeds. HAN FANG JI Good for hot swollen joints, as in rheumatoid arthritis, and water retention, especially in the lungs. SUAN ZAO REN Calms the heart function, and is good for palpitations, anxiety, insomnia, night sweats, menopausal symptoms such as hot flushes, and drug withdrawal.

Does herbal medicine work? Herbal medicines have been used widely for a large number of conditions over many thousands of years. Herbalists tend to treat chronic, benign conditions such as allergic disease (asthma and eczema), hormonal problems such the menopause, premenstrual syndrome and painful, irregular or difficult periods, headache (including migraine), irritable bowel, and arthritis (both rheumatoid and osteoarthritis). In practice many herbalists will combine their suggested herbal remedies with dietary recommendations and a variety of nutritional supplements. The aim of the herbal medicine, particularly in these chronic, persistent complaints, is to generally improve your well-being, and perhaps slow down or modify the natural history of the illness from which you are suffering. Herbs can also be used to relieve depression or help sleep. Herbal medicines almost invariably work through the same biochemical and physiological pathways as conventional medications. Echinacea root (American coneflower root) The use of echinacea in the treatment of bacterial and viral infections is well established and there has been much research interest in the immuno-stimulating properties of this plant. Taking echinacea persistently seems to work far less well than taking it when you have an acute infection. Feverfew (Tanacetum parthenium) Several good clinical studies have demonstrated the effectiveness of feverfew in preventing migraine attacks. Ginger (Zingiber officinale) Ginger has been shown to have a number of actions but it is probably best known for its effects in avoiding nausea and vomiting; there has been considerable interest in this in view of its lack of side effects in comparison with conventional antiemetics. Ginkgo biloba The main indications for Ginkgo biloba are diseases of the circulatory system,

particularly peripheral vascular disease in which the arteries are narrowed by the deposition of fat in the arterial wall. Ginkgo biloba can also help to improve circulation in the brain and so has been used to treat both depression and Alzheimer's disease with some degree of success. In Western countries standardised extracts from the leaves are available in tablet, liquid and intravenous formulations, and in France and Germany these extracts are among the most commonly prescribed medications. Milk thistle (Silybum marianum) The seeds of milk thistle have been used medicinally for over 2,000 years; this herb is useful in a whole range of liver and gall bladder conditions. St John's Wort (Hypericum perforatum) St John's Wort has long been used for its anti-inflammatory, mild sedative and analgesic properties, although recent research has demonstrated that it does have some anti-viral properties as well. St John's Wort has caught the public interest as the, "natural answer to Prozac", and there is no doubt from the clinical trials available that it acts very effectively as a mild antidepressant, although it is currently impossible to patent and make medicinal claims on the basis of traditional use. Valerian root The sedative action of valerian is well established and the herb compares very favourably with other conventional sleeping tablets in the treatment of insomnia. Kava kava Several well conducted clinical trials have shown that Kava is useful in the treatment of mild anxiety. Chinese herbal remedies Chinese herbal mixtures have been shown to be particularly useful in the treatment of eczema, especially childhood eczema. Reproduced with the kind permission of BMA Publications from Professor George Lewith's book, Understanding Complementary Medicine.

Herb-drug Interactions by Paul Bergner Interactions between medicinal herbs and drugs is a topic that is poorly studied in

the scientific literature. It is a major concern for the clinical herbalist, however, especially for elder patients, who are likely to be taking multiple prescription drugs. Here are a few recent reports of possible drug-herb interactions Kava and Xanax Kava (Piper methysticum) has gained recent popularity in North America due to its relaxing effects, both as a recreational herb and as a treatment for anxiety (See MH Vol 8, No 1). European research has shown that it may make an effective substitute for members of the benzodiazepine class of anti-anxiety drugs, which includes Valium. A recent case report, however, suggests caution before using kava along with benzodiazepine drugs. A patient apparently lapsed into a "semicomatous state" due to an interaction between kava and the drug alprazolam (Xanax) (Almeida and Grimsley). The benzodiazepines generally lose effect within 8-12 hours, but secondary metabolites capable of interacting with other substances linger in the blood for 24 or more hours afterwards. Interactions between alcohol and the benzodiazepine drugs are well-known - alcohol potentiates their effects - but herbal interactions have not been studied or previously recorded. Ginkgo and blood thinners Interactions between blood-thinning herbs and pharmaceutical medications with the same action present perhaps the greatest risk of drug-herb interactions in modern practice. The risk is due to the gravity of the underlying condition that requires a blood-thinner, and to the fragile dose range and serious side effects of of the pharmaceutical drugs themselves. The drugs must be given in high enough doses to prevent the formation of life-threatening clots, but can cause serious and lifethreatening bleeding disorders if given in too high a dose. A blood thinning herb can act like "the straw that broke the camel's back" by thinning the blood enough to allow the drug to provoke a serious bleeding disorder. The risk is probably greatest with heparin, warfarin, and coumarin derivatives, but recent anecdotes indicate that interactions may also occur between blood thinning herbs and such mild pharmaceutical blood-thinners as aspirin. Gingko biloba extract (GBE) is a popular phytopharmaceutical in Europe, where it is a prescription medicine, and in the U.S., where it is available in health food stores. A recent case report in the New England Journal of Medicine describes a case of spontaneous bleeding into the eye from the iris within a week of onset of daily GBE supplementation in a patient who had been taking aspirin to prevent a heart attack. GBE constituents have demonstrated blood thinning activity (Kleinjen) and a previous case report showed that it may cause bleeding disorders in a healthy patient even in the absence of anticoagulant medication (Rowan and Lewis). I have also received case reports from two practitioners about retinal hemorrhage in patients taking ginkgo without other drugs, and one case of clotting problems during kidney dialysis (recurring with rechallenge). In the current case, a 70-year old male had been taking aspirin (one 325 mg tablet daily) for three years following coronary bypass surgery. He began taking two 40mg tablets of GBE (50:1 extract), and one week later exhibited blurred vision with a red streak visible inside the eye. The patient had no previous history of eye disorders or recent eye trauma. The patient stopped taking the GBE, but continued to take the aspirin. No bleeding recurred over a three month follow-up period.

Chinese red sage A case report of potentiation of the effects of warfarin by the Chinese herb dan-shen (Salvia miltiorrhiza) recently appeared. Dan-shen is considered to enter the heart and pericardium channels and is primarily used as a cardiovascular herb in China. In traditional Chinese medical terms it invigorates blood circulation and nourishes the blood, among other activities. The article reports a case of dansheninduced severe and dangerous abnormalities of clotting in a patient with rheumatic heart disease taking warfarin simultaneously. References Almeida JC, Grimsley EW. Coma from the health food store: interaction between kava and alprazolam. Ann Intern Med. 1996 Dec 1;125(11):940-941 Kleijnen J, Knipschild P. Ginkgo biloba. Lancet 1992;340:1136-9. Rosenblatt M, and Mindel J. Spontaneous Hyphema Associated with Ingestion of Ginkgo biloba Extract NEJM (1997)336;15:1108 Rowin J, Lewis SL. Spontaneous bilateral subdural hematomas associated with chronic Ginkgo biloba ingestion. Neurology 1996;46:1775-6. Yu CM, Chan JC, Sanderson JE. Chinese herbs and warfarin potentiation by 'danshen'. J Intern Med 1997 Apr; 241(4):337-339 Copyright 1997 by Paul Bergner. All right reserved

Interactions between modern and Chinese medicinal drugs: a general review. American Journal of Chinese Medicine, Spring, 2003, by K.F. Cheng, K.S. Leung, P.C. Leung Abstract: While the use of health food and over-the-counter drugs for health promotion and adjuvant therapy is becoming increasingly popular, the concern about adverse effects is mounting. The possible adverse effects that may arise from drug interactions between these herbal preparations and standard modern therapy are equally worrying. Herbal toxicity and adverse effects are well documented in classical Chinese medicinal volumes. Interactions between herbal preparations and standard modern therapy are unknown. Extensive work needs to be done before useful guidelines can be established. However, based on available reports and clinical observations, some commonly used herbs and Chinese medicines have already demonstrated the need for special attention when used together with modern therapy. This paper analyzes the important material already available, and

would serve as a preliminary checklist for patients who are taking herbal preparations, while at the same time receiving treatment from modern medicine. Keywords: Chinese Herbs; Adverse Effects. Introduction With the legal recognition of the importance of traditional Chinese medicine in Hong Kong, its practice is becoming more and more diverse. Some hospitals have already started practicing Chinese herbal medication. The potential of the integration of Chinese and modern medicine in future medical practice must, therefore, not be underestimated. Hence, the unavoidable interaction between Chinese and modern medicine needs to be understood. Will such therapies enhance or worsen the treatment outcome, or even be harmful? This is the question awaiting to be answered by those who have been inspired. On the other hand, traditional Chinese medicine has increasingly been practiced in the Western society. It is known that such usage has already caused serious complications in anesthetics in a number of occasions (The American Society of Anesthesiologists, 2001). For this reason, the interactions between Chinese medicine and anesthetics should not be ignored. The Relationship Between Dosage and Toxicity It has been found that many Chinese (or herbal) medicine or modern drug therapies are only beneficial to a patient if they are given at certain dosages. When they are used at other dosages instead, they turn out to be noxious. The famous Chinese doctor Zhang Zhi He of the Yuan Dynasty (about 1300 AD) has once wrote in Enlightening Case Reports (Ru Men Shi Qing [TEXT NOT REPRODUCIBLE IN ASCII]) (Zhang, 1300) "Toxicity is a property of all drugs-not just that poisons are toxic. One must not forget herbs such as Liquorice (Radix Glycyrrhizae) and Radix Sophorae Flavescentis can be toxic too. Undesirable outcomes follow any type of overdosages." There is, in fact, no such thing as a nontoxic drug. Both toxic and curative potentials are properties of all drugs. The key to successful treatment is to select the right drug, the right dosage and the right administration. For every drug, there is a direct relationship between its dosage and the severity of its toxicity or side effects. The interaction of Chinese and modern medicine may be synergistic; it may also be antagonistic, or even be noxious. Simultaneous practice of Chinese and modern medicine may complicate the control of dosages of any patient's long-term medications. It has already been reported that the traditional Chinese medicine for diabetic control, if used with insulin injection or oral antidiabetics, may cause hypoglycemia (The American Society of Anesthesiologists, 2001). The interactions between Chinese herbs and modern drugs are a common issue, yet reports on them are very rare. According to research on 1000 elderly patients admitted through the accident and emergency department, 538 of them have used over 1087 types of drugs, and 30 of them have been affected by the side-effects of these drugs (Doucet et al., 1996). In fact, either within the hospital or outside, when patients self-prescribe, multi-drug therapies are commonly practiced. Prescribed drugs, proprietary drugs, vitamins, herbal medicines, food, etc. may all interact and affect the treatment outcome.

Interaction Between Chinese and Modern Medicine Some drug interactions have been investigated by in vitro and in vivo experiments, but results obtained have been inconsistent. St. John's wort, an herb commonly used in Western societies, was shown to suppress monoamine oxides in vitro, but such observations were absent in in vivo studies. Hence, there is insufficient evidence of the antioxidant activity of St. John's wort causing hypertensive crisis. However, recently, it was reported in Switzerland that St. John's wort may interact with other drugs, e.g. the simultaneous administration of St. John's wort with digoxin, amitriptyline or theophylline may reduce the effectiveness of the three drugs. When two patients with heart transplantation were given St. John's wort while receiving their cyclosporin treatment, they both had severe rejections within three weeks. When the patients discontinued the herbal drug, the cyclosporin blood concentrations increased (Ruschitzka et al., 2000). Some medications from natural products possess monoamine oxides inhibitory activity, e.g. Cornu cervi pentotrichum, Fructus crataegi, Radix polygoni multiflori, etc. (Yang, 1996). If tyramine-containing food, e.g. cheese, pickled fish, chocolate, yeast, liver, beer, red wine or yoghurt is taken when the above natural products are used, hypertension, palpitation, headache, nausea, etc. may result (Wang et al., 2000). Potential Integration of Chinese and Modern Medicine Using Chinese herbal medicine as food supplements or health food is very popular. A survey done in America reported that among adults taking regular prescriptions, 18% also took at least one extra type of herbal medicine or high-dosages of vitamins, and 61% of them did not notify their doctor (Eisenberg et al., 1998). In Britain, a survey of 515 individuals receiving herb medications showed that 26% had to seek for medical advice due to discomfort caused by interactions between the herbal and prescribed medication (Barnes et al., 1998). Many patients would not ask for medical help even when they experienced serious drug complications because they were afraid of disapproval. For this reason, as a doctor, one should use a friendly holistic approach to make it easy for patients to report about the usage of non-prescribed drugs, such that an accurate tailor-made prescription could be made. Moreover, such drug histories could be useful as references when adverse effects might appear in future. Appropriate integration of Chinese and modern medicine may have synergistic effects such that treatment outcome is enhanced and side-effects are suppressed. For example, in the case of tonsillitis, co-administration of Radix Isatidis (Banlangen) with Trimethoprin (TMP) significantly enhances the immune system, the outcome may be much better than administration of either drug alone. Flos Lonicerae (Jinyinhua) increases the effectiveness of penicillin on drug-resistant Staphylococcus aureus, the synergistic interactions of Rhizoma Coptidis (Huanglian), Cortex Phellodendri (Huangbo) and tetracycline, acheomycin, aspirin, TMP often initiated a better outcome in the treatment of diarrhoea and malaria. The co-administration of Liquorice and Streptomycin reduced the toxicity of the latter on the auditory nerve (Zhu, 1991). Conversely, disastrous outcomes may follow inappropriate usage of Chinese and modern medicine: antagonistic interactions resulting in reduced or loss of curative

potential, enhanced side-effects, or even death. For example, co-administration of digoxin and Liu Shen Pill (Liushenwan) led to repeated ventricular extrasystoles (Zhu, 1991); mixing Cinnabaris (Zhusha) containing Chinese Medicine with halogen compounds can be extremely toxic (Zhang, 1997). Hemophiliacs, patients on anticlotting treatment and those who have been scheduled for operations should refrain from taking ginkgo, danshen, danggui, garlic and papaya. The coadministration of herbal ephedrine and monoamine oxidase inhibitors increases the risks of hypertensive crisis and cerebral vascular accidents. Some herbal medicine, even when used alone, should not be overdosed. Aloe vera is one of these, commonly used but not suitable for all. Children and those with ill health, if overdosed on Aloe vera, present with hypersensitive reaction--erythema, psoriasis, and even nausea and diarrhorrea-like symptoms. In particular, pregnant women and those menstruating should not use Aloe vera since it may increase the vascularity of the female organs, stimulate uterine mobilities, and cause epigastric pain and severe bleeding. Patients suffering from haemorrhoids and epistaxis could suffer from enhanced symptoms by taking Aloe vera (Tan, 2001). Conclusion The interactions mentioned above make up merely a small percentage of possible drug interactions. A lot of work is still awaiting to be done in a systematic search for the interactions between Chinese and modern drugs. Hence, when practicing the integration of Chinese and modern medicine, one should watch out for the reactions of patients to the drugs and integrate this information to the overall planning in the therapy. While trying to maximize treatment efficiency by including alternative medicine, it is of utmost importance that patient safety should come before all else.

INTRODUCTION TO A PAGAN PHILOSOPHY OF HERBS (The following was compiled from several sources on the Web.) Herbs are "Magick". They have been the primary source of medicines for people of

every culture and were considered magickal or spiritual by many of them. An ancient earth based spiritual belief system concerning herbs appears in many ancient cultures and civilizations such as Celtic, Chinese, India, and Native American philosophies just to name a few. Their religious beliefs shaped their view and relationship with the Great Spirit, and the relationships between their citizens. This was a belief system which also demonstrated a wholistic view of illness, and utilized herbs according to religious belief. You could say that an earth centered-nature religion still permeates herbalism today. We believe that herbalism is part of the RELIGION of NATURE, representing a balance of mind, body and spirit and relies on an intuition as well as science. Pagans work with Nature, respecting and worshipping the spiritual forces they observe. Nature is perceived as the domain of the gods and of spirits. Nature religions teach a philosophy of divine linking between all of the earth's inhabitants. This philosophy recognizes that humanity and the rest of creation can become aware of the "oneness of creation". Herbalism is one vehicle we can use to express the oneness of creation, and foster the divinity of nature. The art and science of herbal medicine is, for many people, the realization that we are ALL A PART OF GAIA. - The Earth. We teach that The Earth is a living entity with senses, intelligence, memory and the capacity to act. Ayruveda, an Indian Science of Health, declares the Hindu concept of oneness: "...people everywhere, are beginning to understand concepts like Gaia, the ONENESS of the organism of earth. This happens by Pitta, the force of the intellect, or Vishnu the preserver (a Hindu god), who keeps balance on earth between the spiritual and demonic." In The Elements of Herbalism by Hoffman, it states: "Healing is a Gaian quality, as it is a personal expression of balance and wholeness. The relationship between healing plants and people, can be seen as Gaia in action----the context of ecological embrace." Herbal healing is "an expression of very real and practical links with Gaia, there is an activation of ecological cycles for healing. A unique opportunity is created by the simple act of taking herbal medicines----such healing, goes beyond the treatment of pathologies and alleviation of bodily suffering-rather, it is in the realm of the transcendental, the ineffable transformation that comes through the touch of the Great Spirit. According to Cunningham's Wicca-a Guide for the Solitary Practitioner, Wicca is a "religion, centering around reverence for nature, as seen in the Goddess and the God. The Goddess is nature, the Universal Mother. The God is the consort of the Goddess."

In The Roots of Healing-A Woman's Book of Herbs, it states: "We understand that the primary "LIFE FORCE" of earth is contained within plants. We trust in earth's healing abilities, and therefore, have continued to call upon herbs for nutritional, medicinal, and spiritual help. Our reverence for the mysteries of birth, life, death, and renewal, guides us to live in harmony with nature, closely following her rhythms. We are connected to changing seasons, the weather, and the cycles of the moon----We are known in our communities as herbalists, midwives, witches, nurses, and wise women----We have continued to practice our healing arts despite centuries of persecution by religious organizations, governments, and medical establishments----Over time, I realized that a presence of unconditional love was emanating from earth herself through herbs. This presence, I came to realize, is divine female wisdom, the great Goddess." We believe our religion is a positive, shamanistic, nature religion, with two main deities honored and worshipped in our rites: the Goddess (the female aspect and a deity related to the ancient Mother Goddess in her triple aspects of maiden, mother and crone) and her consort, the Horned God (the male aspect). Witchcraft is considered, by many, to be both a monistic and pantheistic religion. In simple terms, it is a positive nature based religion, preaching brotherly love, and harmony with, and respect for, all life forms. It is very similar to Native American spirituality." According to the late Scott Cunningham, "Earth is a manifestation of divine energy, and reveals her secrets 'to Wiccans', who listen to the earth. To be outdoors, is to be in the temple and surrounded by sanctity." To Summarize: Witchcraft is the Natural way of looking at the Earth and all its inhabiatants. Herbcrafting is the Natural way of helping to keep the balance.

Is it Safe? The safety of herbal remedies has been the subject of much debate. Herbal medicines must be produced to good manufacturing practice and must be free from adulteration. Medications manufactured in the Westernised industrial nations or grown by herbalists themselves are almost certainly completely safe. Problems may occur with some patented medicines imported from Asia and the Far East, or sometimes with the pure herbal products which may not be always as pure as one might expect. There are case reports of fatal events occurring in consequence of herbal products taken inappropriately; an outbreak of kidney disease occurred after taking "Chinese herbs" prescribed by a slimming clinic in Belgium some 10 years ago. Herbs may also interact with conventional medication. Reproduced with the kind permission of BMA Publications from Professor George Lewith's book, Understanding Complementary Medicine.

The Characters and Functions of Traditional Chinese Drugs Each drug has its own specific characters. In traditional Chinese medicine, the different characters of drugs are employed to treat diseases, rectify the hyperactivity or hypoactivity of yin or yang, and help the body restore its normal physiological functions, consequently curing the diseases and restoring health. The various characters and functions of these drugs concerning medical treatment include drugs' properties, flavors, actions of lifting, lowering, floating and sinking, channel tropism, toxicity, etc. The theory of characters and functions of traditional Chinese drug is based on the theories of yin and yang, viscera, channels and collaterals, and treatment principles of traditional Chinese medicine, and has been developed and summed up throughout a long history of medical practice. This theory provides the basis for drug analysis and application. 1. Properties and Flavors of Traditional Chinese Drugs Properties and flavors are also known as four properties and five flavors. Every drug has its property and flavor. "Property" refers to the cold, hot, warm or cool nature of a drug. These properties of drugs are so sorted out according to the different actions of the drugs on the human body and their therapeutic effects. For example, drugs that cure heat syndrome (yang syndrome) have a cold or cool property, whereas drugs that cure cold syndrome (yin syndrome) have hot or warm property. Drugs of cold and cool natures and drugs of warm and hot natures are of opposite properties. A cold-natured drug is different from a cool-natured one only in degree, and so is a warm-natured drug from a hot-natured drug. Most of the cool- or cold

-natured drugs have the effects of clearing heat purging fire, removing toxic substances, and nourishing yin, and are used to cure heat syndromes. On the contrary, drugs of warm or hot nature usually have the effects of dispersing cold, warming up the interior, supporting yang, and treating collapse, and are therefore used to treat cold syndromes. In addition to the four properties mentioned above, there is the fifth, the neutral or mild one. When a drug is neither hot nor cold in nature, it is said to be neutral. It can be used for either hot or cold syndromes. Yet, drugs of neutral nature usually tend to be either slightly hot or slightly cold. That is why drugs are generally said to be of four properties only. "Flavors" refers to the tastes of drugs, i. e. pungent, sweet, sour, bitter, salty, tasteless and astringent. Since sweet and tasteless usually coexist, and since sour and astringent drugs have the same effects, pungent, sweet, sour, bitter and salty tastes are the cardinal flavors and are habitually known as five flavors. Drugs of different flavors and different compositions show different pharmacological and therapeutic actions, while drugs of the same taste usually have similarities in effect and even in composition. The flavors don't necessarily refer to the real tastes of the drugs. Sometimes they are sorted out according to drugs' actions other than tastes. Therefore, the flavors of some drugs described in books on materia medica are often different from their true tastes. Various flavors have different effects. They are explained separately as follows: Pungent flavor: Drugs that are pungent in flavor have the effects of dispersing exopathogens from superficies of the body and promoting the circulation of the vital energy and blood. Pungent drugs are usually used for the treatment of superficial and mild illnesses due to affection by exopathogens, stagnation of vital energy, blood stasis, etc. Sweet flavor: Drugs of sweet flavor have the effects of nourishing, replenishing, tonifying, or enriching the different parts or organs of the body, normalizing the function of the stomach and spleen, harmonizing the properties of different drugs, relieving spasm and pain, etc. Drugs of sweet flavor are usually effective in treating syndromes of deficiency type, dry cough, constipation due to dry intestine, incoordination between the spleen and the stomach, various pains, etc. Besides, some of the sweet drugs have the effects of detoxication. Sour flavor: Drugs of sour flavor have the effects of inducing astringency and arresting discharge. Sour drugs are often used to treat sweating due to debility, chronic cough, chronic diarrhea, emission, spermatorrhea, enuresis, frequent micturition, chronic leukorrhagia, metrorrhagia or metrostaxis, etc. Bitter flavor: Drugs of bitter flavor have the effects of clearing heat, purging fire, sending down the adverse flow of qi to treat cough and vomiting, relaxing the bowels, eliminating dampness, etc. Such drugs are mostly used for syndromes of pathogenic fire, cough with dyspnea, vomiting, constipation due to heat of excess type, damp-heat syndrome, or cold-damp syndrome and other syndromes. Salty flavor: Drugs of this taste have the effects of relieving constipation by purgation, and softening and resolving hard mass. Salty drugs are mostly used in treating dry stool and constipation, scrofula, goiter, mass in the abdomen, and other problems. Tasteless flavor: Drugs of this flavor have the effects of excreting dampness and

inducing diuresis, and are commonly used for edema, dysuria and others. Astringent flavor: Drugs of this flavor have similar actions as those of sour flavor. Drugs of the same flavor generally have similar actions, and drugs of different tastes have quite different actions. Yet some drugs are the same in property but different in flavor, or the same in flavor but different in property, and, therefore, their effects are not all the same. Both coptis root and dried rehmannia root, for instance, have the same cold property, yet coptis root is bitter in flavor while dried rebmannia root sweet. The former has the effects of clearing heat and drying dampness and is used for damp-heat syndrome, while the latter has the effects of clearing heat and nourishing yin and is used for the condition of consumption of yin due to febrile diseases. Another example is the use of ephedra and peppermint, both of which have a pungent flavor. However, the property of ephedra is warm, whereas the property of peppermint is cool. The former has the effects of dispersing wind-cold pathogens and is used to treat exterior wind-cold syndrome, while the latter has the effects of dispersing pathogenic wind-heat and is used to treat exterior wind-heat syndrome. Therefore, the property and flavor of a drug should not be treated separately but should be taken into consideration as an integrated whole. Only in this way can drugs be understood and used correctly. 2. Actions of Lifting, Lowering, Floating and Sinking Actions of lifting, lowering, floating and sinking refer to the upward, downward, outward or inward directions in which drugs tend to act on the body. Lifting means going up or sending up while lowering means just the opposite. Floating means going outward or sending to the surface, whereas sinking means going inside or purging away. Lifting and floating drugs have upward and outward actions and are used for elevating yang, relieving exterior syndromes by means of diaphoresis, dispelling superficial wind and cold, inducing vomiting, causing resuscitation, etc. Lowering and sinking drugs have downward and inward actions and are used for clearing heat, purgation, promoting micturition, removing dampness, checking the exuberance of yang, sending down an adverse flow of qi to stop vomiting, relieving cough and asthma, improving digestion to remove stagnated food, tranquilizing the mind with heavy properties, etc. As the locations of diseases are different with some in the upper part of the body and some in the lower, some in the interior and some in the exterior, and as the tendencies of diseases are divided into upward (as with vomiting), downward (e. g. diarrhea, metrorrhagia, metrostaxis and proctoptosis), outward (e. g. spontaneous or night sweating) and inward (e. g. internal transmission of exterior syndrome), the lifting, lowering, floating and sinking actions of drugs are used in correspondence with the locations of diseases but in opposition to the tendencies of diseases. Generally speaking, for the diseases located in the upper part or the exterior, it is appropriate to use lifting and floating drugs instead of the lowering and sinking. For example, for the exterior syndromes, lifting and floating drugs should be chosen. On the contrary, for the diseases located in the lower part or the interior, such as dry stool or constipation, it is proper to use lowering and sinking drugs, not the opposite. For the diseases of which the manifestations tend upward, drugs of lowering actions should be given rather than that of lifting, just as in the treatment of headache and vertigo due to hyperactivity of the liver-yang, drugs of lowering and sinking actions should be used to calm the

liver and suppress hyperactivity of the liver-yang. On the contrary, for the diseases of which the manifestations tend downward, it is suitable to use lifting drugs instead of lowering drugs. For example, in the treatment of chronic diarrhea and proctoptosis due to sinking of qi of the middle-jiao, it is wise to choose lifting drugs to invigorate qi and lift yang. Tue lifting, lowering, floating and sinking actions of drugs have close relationship with their properties and flavors. Most drugs that are pungent or sweet in flavor and warm or hot in property have lifting and floating actions, whereas most drugs, bitter, sour, or salty in flavor and cold or cool in property have lowering and sinking actions. The lifting, lowering, floating and sinking actions also have some relationship with the textures of drugs. Generally speaking, most of the light substances have the actions of lifting and floating. In contrast, most of the heavy drugs have the actions of lowering and sinking. However, though some drugs are light, they have lowering and sinking actions; and conversely, some heavy drugs have lifting and floating actions. In addition, the lifting, lowering, floating and sinking actions can also be influenced or even altered through the processing and the joint use of drugs. For example, lowering and sinking drugs can have lifting and floating actions after processing with wine, while lifting and floating drugs can have lowering and sinking actions after preparation with salt solution. If lifting and floating drugs are dispensed together with a great amount of lowering and sinking drugs, they may also have lowering and sinking actions; and similarly, when lowering and sinking drugs are used together with a great amount of lifting and floating drugs, they may exhibit some lifting and floating character. 3. Channel Tropism Channel tropism refers to a drug's selective therapeutic effects on a certain part of the body. A drug may exert obvious or specific therapeutic action on the pathological changes in a certain channel (including some viscera thereof) or several channels, but with little effects on the others. For instances, among the heat-clearing drugs, some only clear the heat either in the lung channel or in the liver channel or in the heart channel, etc. Again, among the tonics, some strengthen the lung while others strengthen the spleen or the kidney. Channel tropism is based on the theory of viscera, the theory of channels and collaterals, and is summed up according to the curing particular diseases for which a drug is effective. The human body is an organic whole in which the channels and collaterals link up with the interior and exterior and all parts of the body. A pathological change in the exterior may affect the viscera while diseases in the viscera may, in turn, find expressions in the exterior of the body. For this reason, the symptoms and signs of diseases occurring in different parts of the body can be understood systematically according to the theory of channels and collaterals. For instance, the flaring up of stomach-fire may result in swollen gum; and whenever there is stagnation of liverqi, pain in the hypochondriac region will be present. Since the swelling and pain of the gum disappear when gypsum is administrated, and hypochondriac pain relieved with 'the use of bupleurum root, we may infer that gypsum acts on disorders of the stomach channel and bupleurum, the liver channel. The above examples show that the theory of channel tropism is summed up through clinical practice. The channel tropism theory should be associated with the theories of the four

properties and five flavors, and actions of lifting, lowering, floating and sinking of drugs. Different drugs acting on the same channel have different effects owing to their different properties, flavors and actions of lifting, lowering, floating and sinking. For example, scutellaria root, dried ginger, lily bulb, and lepidium seed all act on the lung channel, but scutellaria root can clear lung-heat, dried ginger can warm lung-cold, lily bulb can be used to make up for lung deficiency, and lepidium seed is used to soothe excess syndrome of the lung. Therefore, only when attention is paid to the different aspects of a drug, can its actions be comprehensively analyzed and the drug correctly employed. Besides, according to the theory that viscera as well as channels and collaterals are physiologically related to one another, and pathologically affect one another, when there is pathological change in one channel, drugs acting on other channels should be used in addition to the prescription for the diseased channel itself. For instance, for abnormalities in the lung channel, drugs for strengthening the spleen channel should be added, and in case of hyperactivity of the liver yang, drugs for nourishing the kidney-yin should be used at the same time. Extracted from "The Chinese Materia Medica"

Herbs should be processed before using or making into various forms. Because most Chinese herbs are used unprepared, besides general handling, quite a few should be specifically processed to meet demands for their clinical use. Preparation, a traditional Chinese pharmaceutical technology, was formed in a long history of practice with its complete theoretical system and strict technique. 1. Aims of Preparation High effects, low toxicity and convenience for use are the main aims of preparing Chinese herbs. 1.1. To enhance curative effects For example: corydalis tuber can obviously strengthen its analgesic effect by stirbaking with vinegar; ephedra can strengthen the effects of alleviating cough, and relieving asthma by stir-baking with honey; and eucommia bark can strengthen the effects of calming the liver and reducing blood pressure by stir-baking with salt. 1.2. To reduce toxic effects Some extremely toxic should not be used orally without preparation for reducing their toxicity. For example: defatted powder of croton seed, kansui root and knoxia root boiled with vinegar, Sichuan aconite root and wild aconite root boiled for a long time, and pinellia tuber and arisaema tuber decocted with ginger and alum can all reduce their toxic effects. 1.3. To change properties of herbs and expand their uses

Appropriate preparation can change cold or hot nature and augment effects of herbs. For example, dried rehmannia root, being cold in nature for removing heat from blood to stop bleeding, can be made into prepared rehmannia root for warming and tonifying essence and blood. Prepared arisaema being warm and dry in nature for resolving cold phlegm, expelling wind and alleviating spasm, can he made into biled arisaema with cool and moist nature for removing heat, resoling phlegm, expelling wind and arresting convulsion. Fleece-flower root with its main effects of treating malaria and loosing the bowels can be made into prepared fleece flower root with its special effects of tonifying the liver and kidney and nourishing essence and blood. In addition, through preparation, herbs become easy to use and store. Also, the abnormal flavor and some un-beneficial ingredients are removed. 2. Methods for Preparation Methods for preparation of Chinese herbs include purification, preparation with water, preparation with fire and preparation with both water and fire. Methods for preparation of Chinese herbs are closely related to their clinical usage; 2.1. Stir-baking Herbs are put into a pot over a fire, continually stir-baked to a certain extent and taken out. According to extent of heating, herbs can be stir-baked yellow in color, stir-baked charred or stir-baked carbonized. To be stir-baked yellow or stir-baked charred can moderate herbs' properties or strengthen the effect of invigorating the spleen; and to be stir-baked carbonized can strengthen the effects of stopping bleeding and arresting diarrhea. 2.2. Stir-baking with auxiliary fluid The common auxiliary fluid includes wine, vinegar, and honey, saline and ginger juice. Herbs stir-baked with auxiliary fluid can strengthen effects, reduce toxicity and remove abnormal flavor. For example: Chinese angelica root stir-baked with wine can strengthen the effects of promoting circulation of blood; corydalis tuber stir-baked with vinegar can strengthen its analgesic effect; and kansui root stirbaked with vinegar can reduce toxicity. In addition, herbs stir-baked with other auxiliary materials including sand and talc powder can make them crispy and en able their active ingredients to be easily decocted out, such as pangolin scales, stirbaked with sand and hedgehog skin stir-baked with talc powder. 2.3. Calcination Herbs are directly or indirectly calcined over a fierce fire to make them crispy for easily crushing or carbonized. Most of the solid and hard mineral herbs or shells are directly calcined, such as dragon's bone and oyster shell. Carbonize6 palm and carbonized hair are made by means of calcination in a sealed refractory vessel. 2.4. Roasting Wrapped in moistened paper or flour paste, herbs are heated in smoldering cinder or roasted in a oven until the coating becomes charred in order to remove oil from herbs or to moderate their properties, such as roasted aucklandia root roasted ginger and roasted nutmeg. 2.5. Steaming Herbs are steamed solely or with auxiliary materials to change their proper ties, strengthen their potency and reduce their toxic effects.

2.6. Boiling Herbs are boiled in water and auxiliary materials to reduce their toxicity, such as genkwa flower boiled with vinegar, and Sichuan aconite root boiled with bean curd. 2.7. Water-refining Mineral herbs insoluble in water are crushed, put in a mortar, ground with water into fine powder in suspension, then poured into a vessel for precipitation and dried, such as wet-refined cinnabar then and water-refined talc. In addition, there are fermentation, germination, frosting and many other methods for preparation, such as medicated leaven, germinated barley and defatted powder of croton seed.

RAINSTAR UNIVERSITY ISSUES RECOMMENDATIONS ABOUT HERB SAFETY March 9, 2000 SCOTTSDALE, AZ - If you want an opinion on the use of traditional oriental herbal remedies to treat what ails you, just ask Lloyd Wright, Licensed Acupuncturist, trained herbalist and Dean of RainStar University's College of Acupuncture and Oriental Medicine. With the introduction of raw herbs to RainStar University's on-campus medicinary on March 2, Dean Wright and RainStar University are making a combined effort to educate future Traditional Oriental Medicine practitioners and herb users about the benefits and misconceptions of herb use. While the rise in the use of herbs to combat illness is a signal that Americans are opening their minds to the benefits of Traditional Oriental Medicine, Dean Wright asserts that confusing marketing practices and the misconception that herbs can't hurt you can make for some potentially dangerous situations. "The FDA classifies Chinese herbs in the same way that dietary supplements are classified," says

Wright. "This has allowed vitamin and dietary supplement companies to market them as such, often fooling the public into the notion that herbs are not what they are - medicines that should be respected and prescribed by a trained herbalist." Wright points out that even doctors are not exempt from this warning, as one of the most famous cases of irresponsibly prescribed herbs illustrates. In the early 1990s a group of doctors in Belgium, none of whom were trained in Traditional Oriental Medicine, prescribed weight loss patients to take the herb, Stephania Tetrandra, in a powdered form for up to two years causing 105 cases of kidney damage and 18 cases of cancer. According to Dean Wright, the doctors were negligent in prescribing herbs that they knew nothing about. "Any trained herbalist knows that you never prescribe Stephania Tetrandra in a powdered form and you never prescribe it for more than one month maximum, usually only one to two weeks," says Wright. "My training has allowed me to use this herb to help several patients without any harmful side affects. This is an unfortunate example of how herbs in the hands of the untrained can threaten lives and do great harm to Traditional Oriental Medicine's acceptance in western countries." While sometimes dangerous in the hands of novices as witnessed in the Belgium case, Chinese herbs can be very effective treatments when a trained herbalist is consulted. With a full health assessment, the herbalist will be able to protect against herb-drug interaction or side-effects that may occur when using certain herbs when health conditions exist. "Korean Red Ginseng use by a person with high blood pressure can result in raised blood pressure and maybe even a stroke. Gingko, when taken in conjunction with prescribed blood thinners or even aspirin can also be dangerous," says Wright. "A trained herbalist knows these things. The herbs are not dangerous on their own. They only have the potential to be dangerous in the hands of the untrained or self-prescribers." In addition to finding a trained herbalist, Wright also recommends finding a reputable medicinary to purchase your herbs. Wright states that the best medicinaries will stock raw herbs and measure dosages according to an herbalist's prescription. Upon his appointment as Dean of the College of Acupuncture and Oriental Medicine at RainStar University, Wright ordered that RainStar's therapy center be stocked with raw herbs. "Using raw herbs, I can prescribe a specific recipe of herbs in specific combinations and ratios to suit an individual's needs," says Wright. "When raw herbs aren't available, tablet forms are acceptable in some cases, but people should be very careful that the tablets are made by a reputable manufacturer." Dean Wright's caution refers to a 1998 California Health Department study conducted by Richard Ko, Pharm.D., Ph.D. and Alice Au, Ph.D., that found dangerous levels of heavy metals, drugs and other chemicals in 260 imported traditional Chinese patent medicines. According to Wright, there are many American manufacturers who provide safe, reputable product lines, but when available, raw herbs are always best. RainStar University provides state-of-the-art education, training and service in the

art, science and business of holistic healthcare to its students and clients through constant and never-ending improvement in order to bring the holistic healthcare professional to the level of mainstream acceptance.

Toxicity and Interactions Issues in Chinese Herbal Medicine introduction: Several recorded incidents of adverse reactions have occurred to Chinese herbs over the past 12 years. In most cases, the incidents have involved multiple patients consuming the same or similar substance, rather than isolated case reports. This is significant because it allows an opportunity to evaluate the common factors in these cases. Before proceeding, it is important to review the unique aspects of Chinese medicine (in contradistinction to Western herbal medicine) which are of relevance to understanding these issues. general information: Chinese medicine largely relies on formulae of eight to sixteen herbs, rather than single herbs, nutrients or drugs, as in common in Naturopathic and conventional medicine. While the number of total active constituents can thus be very high, the amount of any individual constituent is generally low. This is generally thought to minimize both side-effects and interactions in correctly prescribed formulae. Chinese herbal formulae are prescribed as teas, powders, extracts and pills. Teas may have very large amounts of active ingredients, often beginning with raw material of more than 100 grams for a daily dose of decocted herbs in mainland China. Japanese Kampo practitioners often use much lower doses, with raw herb

equivalents ranging from 30-45 grams per day. Yet even these lower end dosages are relatively large compared to about 0.5-10 grams per day used in typical practice of Naturopathic medicine and medical herbalism. Thus, misprescribed formulae may have high potential for side effects, independent of the inherent safety of the herbs they contain. Chinese formulae of this size have been prescribed for 2000 years according to traditional Chinese parameters that match discrete symptom complexes or syndromes with specific herb combinations. The general rule of thumb is that an herb or formula will cause side effects if the disease is treated without consideration of the entire syndrome present. Syndromes are basically just the differences between patients in terms of appetite, energy level, sleep, physical fitness and other general parameters. Many of the herbs in a large formulae for chronic illness address such general parameters rather than the specific pathology as defined by conventional biomedicine. Most of these general herbs are completely nontoxic, such as mild tonics like Astragalus or digestives, like ginger. the written tradition: Because the Chinese had widespread distribution of medical books by 800 C.E. (A.D.), they have had at least 1,200 years to vigorously debate the effectiveness of various herbs and formulae, as well as the safety and clinical validity of their diagnostic methods. During the premodern era, the misuse of herbs was a constant concern to literate scholar physicians. Many important premodern medical texts have lengthy diatribes against prevailing medical malpractices. In most cases, these diatribes are directed at overall misdiagnosis or prescription without diagnosis. However, concerns have also been raised about toxic herbs like aconite or those that are easily abused, like tea, poppy and ginseng. cultivation: Many Chinese herbs are grown traditionally without pesticides and herbicides. About half of the standard materia medica are essentially weeds themselves. Another significant amount are wildcrafted. A smaller amount, especially the more valuable herbs, may be sprayed as necessary. Since Chinese herbs are exported to the U.S. as packaged food products, they are not directly fumigated at customs, though their packaging may be. However, contamination by such sources should remain a suspect in all future incidents, given China's apparent laxity at enforcing environmental and public safety regulations. A number of Chinese herbs were traditionally derived from what are now endangered species. The endangered animals are not actually used in any legitimate clinics of oriental medicine in America. However, they may be available in products in Chinatown herb shops. Herbal medicines made from endangered plants are all

sourced through cultivation; they are not taken from their wild habitat. patent medicines: Chinese herbs are frequently consumed in what are called patent or proprietary medicines. There are considerable legal, ethical and scientific problems with these prefabricated pill products and they should be avoided unless one is a fully trained professional in Chinese herbal medicine. In response to the apparent lack of quality control in Chinese patent medicines, several American manufacturers have set up production facilities in China which abide by strict quality control standards (GMP). toxicity: Most problems with Chinese herbs appear to arise from drug interactions, contamination or misidentification of herbal materials, drugs hidden in herbal products, heavy metal poisoning and acute allergic hypersensitivity. This suggests the greatest problem with Chinese herbs is lack of quality control and other regulations in production. All incidents, except for one, described in this Herb Group involve the prescribing of Chinese herbs by untrained individuals or self-prescribing by consumers. That one appears to be an allergic reaction to a particular herb, which was probably unavoidable. This suggests the lack of training in the proper use of Chinese herbs to be a significant factor in the occurrence of adverse effects. The fact that fully trained practitioners of TCM are rarely, if ever, responsible for serious adverse herb reactions in their patients, suggests that traditional prescribing methods should be further investigated for their contribution to the safe use of Chinese Herbs.

Traditional Chinese Medicine Introduction Traditional Chinese Medicine (TCM) is an ancient medical system that has been practiced for thousands of years and remains part of mainstream healthcare delivery in many Asian countries today. TCM promotes a holistic approach to health and aims to maintain physical, emotional, and spiritual balance in order to prevent and treat disease (Parker 2000; Ergil 1996). TCM modalities include acupuncture, moxibustion, herbal medicine, Chinese massage (known as tui na), movement combined with breathing exercises (such as tai chi and qi gong), nutrition, and lifestyle modification (Parker 2000). Cupping and bleeding are also employed (Ergil 1996). Historical Background The first written documentation of TCM is recorded in the Pharmacopoeia of the Heavenly Husbandman, a text dating back to 200 B.C. (Parker 2000). Herbal medicine and acupuncture, including theory, practice, diagnosis, and treatment, were recorded in classical Chinese texts and refined over many centuries (Ergil 1996). Although TCM has been practiced in the United States since the mid-19th century, it remained largely the province of immigrant Chinese communities until the general public became exposed to the practice following former President Nixon's trip to China in 1971. While covering Nixon's trip, New York Times reporter James Reston received acupuncture for post-operative pain following an emergency

appendectomy. He published accounts of his experience with TCM that fascinated the public and contributed to its mainstream emergence as an alternative modality (Ergil 1996). Today, TCM is practiced all over the world. A new term, Oriental medicine, has been coined to encompass both traditional and contemporary interpretations of TCM that are practiced throughout Asia (Ergil 1996). Scientific Principles According to an expert in the field, Dr. Kevin Ergil, TCM is based on three fundamental principles not easily understood from a Western cultural perspective. The first is the idea that qi (pronounced "chee"), described often in Western terminology as life energy, exists throughout the body and is responsible for maintaining normal physiological, psychological, and spiritual functions. There are five different types of qi with distinct associations: support and nourishment (construction qi); protection and warmth (defensive qi); flow of energy through channels, called meridians (channel qi); physiological activity of organs (organ qi); and ancestral qi, which controls circulation and respiration. Disease is caused by a disruption of qi and manifests as a unique collection of signs and symptoms depending on the origin of the disturbance. In an interesting analogy often used to explain its nature, qi is described as the wind in a sail; we do not see the wind directly but we are aware of its presence as it fills the sail (Ergil 1996). Qi also maintains the balance of yin and yang, the principle of complementary opposites that determines the world around us and is reflected within each of us; together, yin and yang represent a state of dynamic equilibrium that exists among all things in the universe. Thus, an individual cannot be understood outside the context of his or her environment. As Ergil writes, "The external landscape, or human environment, is understood to be in profound and dynamic relationship with the internal landscape, or human organism" (Ergil 1996). The third principle influencing health and illness in Oriental medicine is known as the five phases-earth, metal, water, wood, and fire-which may be thought of as metaphoric representations of the five patterns that characterize the dynamic interactions of natural phenomena (Ergil 1996); the concept again reflects the inability to separate the individual from the environment that is fundamental to the TCM philosophy and belief system. Two additional concepts are essential to the practice of TCM: mind and body are not distinct from one another, and moderation is required to achieve balance and health (Ergil 1996). Finally, TCM reflects an understanding of human anatomy that is different from that of conventional medicine. TCM views the internal organs not as individual structures, but as complex networks (Ergil 1996). In parallel with the five phases or elements mentioned above, there are five internal organs regulating the human body. These five organs-liver, heart, spleen, lung, and kidney-correspond to more than a specific bodily part. The kidney, for example, represents not only the kidney itself, but the entire urinary system and the adrenal glands as well. The heart represents both the heart and the brain (Cheng 2000). According to TCM, there are three major causes of disease: the external factors or environmental influences known as wind, cold, fire, dampness, heat, and dryness; the internal emotions of joy,

anger, worry, sorrow, and fear (Ergil 1996; Cheng 2000); and the constitutional factors relating to diet, sexual activity, lifestyle, work, and exercise (Parker 2000). Mechanism of Action Through the use of its therapeutic modalities, TCM stimulates the body's own healing mechanisms to regulate the flow of qi and the function of the organ systems, bringing the body back into a state of balance (Parker 2000). The main focus in TCM is to treat the underlying cause of disease as opposed to simply managing symptoms (Ergil 1996). The mechanistic action of acupuncture, in TCM terminology, is to access qi with the needle. The practitioner knows that qi has been accessed when a gentle grabbing of the needle is sensed in his or her hand and/or when the patient reports a feeling of itching, numbness, soreness, or change in temperature at the site of the needle (Ergil 1996). With respect to the use of herbs, TCM practitioners formulate herbal combinations to act synergistically in the body, and therefore typically prescribe combinations of herbs rather than a single herbal remedy (Ergil 1996). Moxibustion refers to burning the leaves of the herb Artemesia vulgaris on or near the skin; although used separately as well, it is often applied in conjunction with acupuncture to move qi appropriately. A safe and common way to apply this technique is with a cigar-shaped stick known as pole moxa held just above the skin to gently warm the acupuncture point (Ergil 1996). Tui na literally means "pushing and pulling" and refers to a process of massage that stimulates acupuncture points. Tui na can be used either as an adjunct to or instead of acupuncture, particularly for people such as children who may have a difficult time with needle insertion. The massage technique is used for many neurological and orthopedic conditions to increase the range of motion of joints; it can also be used for medical conditions not usually thought of as treatable via massage, such as asthma, gastritis, and dysmenorrhea (Ergil 1996). Cupping refers to a practice in which a cup with a vacuum seal is placed on the surface of the skin; the theory is that the local application of a vacuum to the skin increases lymph and blood circulation in the area under treatment. In TCM terminology, the intention is to draw out cold or damp elements from the patient that may be contributing to disease (Ergil 1996). Clinical Evaluation A clinical evaluation includes, in the following order: visual assessment of the patient's skin, hair, posture, affect, tongue, complexion, and eyes (Parker 2000; Ergil 1996); listening to the quality of the patient's breathing and speech; being aware of the patient's body odors; taking a medical history; diagnosing the pulse; and palpating the body along acupuncture points or meridian lines (Ergil 1996). Visualizing the overall appearance, complexion, and eyes, as well as assessing the quality of the patient's voice, enables the practitioner to observe the patient's shen (or spirit), which is critical for determining prognosis. Shen is the radiant aspect of human existence that encompasses consciousness and healthy mental and physical functioning (Ergil 1996). Following this assessment, the TCM practitioner makes recommendations for the modalities to be used (as described in the section on Mechanism of Action) and the

course of treatment; these decisions are based on "pattern identification" as determined by the TCM practitioner. Pattern identification is, again, a difficult concept to define in Western terminology; it is based on eight principles of yin and yang and, unlike the situation in Western medicine, the definition and particular diagnostic pattern does not depend solely on the disease. Rather, it depends on a complex interaction of the illness or set of signs and symptoms, the particular patient affected, and the environment at large. Therefore, one disease can have many different appropriate treatment approaches. Similarly, one treatment pattern can be appropriate for a wide variety of illnesses (Ergil 1996). These facts illustrate some of the difficulty in trying to understand TCM from the Western, biomedical perspective. Clinical Applications Despite the difficulty of applying contemporary research methodologies to evaluate outcomes of TCM, there have been some attempts with worthwhile results; the following paragraphs provide a few examples of traditional herbal remedies examined from the Western perspective. These examples are not meant to be an exhaustive reflection of the breadth of appropriate applications of TCM, a health system and approach that has been used for many diverse conditions for thousands of years. The intent of the following examples is to give some sense of the clinical benefits and limitations learned from studying aspects of TCM from a biomedical point of view. (Please see the Acupuncture monograph for more information on clinical applications of that modality specifically.) In a report published in JAMA, a randomized, double-blind, placebo-controlled trial of a Chinese herbal formulation was found to offer significant improvements for some patients with Irritable Bowel Syndrome (Bensoussan et al. 1998). Qian ceng ta, a Chinese herb used to treat age-related memory dysfunction and dementia, may show promise for possible adjunctive treatment of Alzheimer's disease. Of 103 Alzheimer's patients from seven different hospitals in Mainland China, 58% treated with huperzine A (the active ingredient of Qian ceng ta) chemically linked to tacrine (a medication commonly used for Alzheimer's) showed improvement in memory, cognition, and behavior (Carlier et al. 1999). Another small study in the elderly suggests that Cs-4, a fermentation product of Cordyceps sinesis (a popular supplement in China), increases maximum oxygen uptake and anaerobic threshold compared to placebo, thus improving exercise capacity and resistance to fatigue in this population (Xiao et al. 1999). The study, presented at the 46th annual meeting of the American College of Sports Medicine, included only 30 subjects, making it difficult to draw conclusions; however, the information is intriguing since Cordyceps sinesis has been used for similar purposes in TCM for many years. A combination of Chinese herbs known as "Slimax" reduced weight, waist and hip circumference, and body mass index significantly in an experimental group of 140 subjects participating in a randomized, placebo-controlled clinical trial (Ignjatovic et al. 2000). In TCM terms, diabetes and its complications are considered "wasting and thirsting" disorders; a common treatment for diabetes nourishes yin and tonifies qi (Luwen 2000). Patients with complications of diabetes, including elevated

cholesterol and triglycerides, poorly controlled blood sugar, and metabolic disturbances, are frequently diagnosed by a TCM practitioner as having "stagnant phlegm." According to researchers in China, Chinese herbs used to treat phlegm stagnation, such as Wen dan tang, also tend to lower lipid levels; there have been case reports of Wen dan tang improving additional diabetic complications such as retinopathy (Luwen 2000). Although a popular application in the lay community, the use of Chinese herbal remedies for eczema remains controversial. There is a paucity of data in the literature supporting the efficacy of oral Chinese herbs for this application (Armstrong and Ernst 1999); in addition, one study addressing the constituents of topical TCM remedies frequently used for eczema found that many of them actually contained illegal, unlabeled steroids. One concern here is that many patients taking such herbal preparations as an alternative to prescription medications are under the impression that they do not contain steroids, which may lead to excessive use, application to inappropriate sites, and unanticipated risks (Keane et al. 1999). All TCM modalities have traditionally been used for both male and female infertility. TCM treatment of male infertility from sperm anomalies, for example, generally involves replenishing kidney yin and/or kidney yang, fortifying the spleen, and nourishing the liver (Becker 2000). TCM treatment for infertility offers a viable opportunity for TCM to interface with Western medicine, since sperm count and quality can be followed easily, as can other contributing factors to male infertility such as chronic prostatitis and hyperprolactinemia (Becker 2000). Risks, Side Effects, Adverse Events Side effects from Chinese herbs are more likely to occur when a single agent or active ingredient is used, rather than the customary combination of herbs that are formulated to work harmoniously together and counterbalance side effects (Parker 2000). As is the case with Western pharmaceuticals, there are interactions among herbal medicines too numerous to mention here; trained and certified TCM practitioners know which herbs can be safely and effectively administered together (Parker 2000). Chinese herbs containing aristolochic acid, a compound present in plants of the family Aristolochiaceae, should be avoided, particularly in patients with underlying kidney disorders; the active ingredient has been identified as a carcinogen and nephrotoxin causing, by some reports, nearly 100 cases of kidney failure (Lewis and Alpert 2000) and even urothelial dysplasia and carcinoma in patients with end-stage nephropathy (Nortier et al. 2000). In addition, as mentioned above, some Chinese herbal creams used to treat skin conditions such as eczema contain unlabeled steroids (Keane et al. 1999). Although generally considered safe for autoimmune and rheumatological disorders, patients prescribed a remedy prepared from Tripterygium wilfordii Hook F (TwHF) occasionally report side effects of dry mouth, changes in skin pigmentation, rash, and loss of appetite; nausea, vomiting, diarrhea, abdominal pain, and secondary amenorrhea are even less common; leukopenia and thrombocytopenia may occur with this herbal anti-inflammatory. The use of properly prepared formulations of TwHF needs to be monitored, particularly for patients with impaired renal function. Long-term treatment may also result in reproductive tract damage (Tao and Lipsky 2000). These examples

point to the fact that all herbs need to be regulated for toxicity and monitored for side effects (Keane et al. 1999). Contraindications Great caution and, at times, avoidance of some of the herbs mentioned in the section entitled Risks, Side Effects, Adverse Events should be exercised; otherwise, there are no specific conditions for which TCM is contraindicated in its totality. There may be, however, specific conditions for which certain Chinese herbs should not be used, such as during pregnancy and/or lactation (Parker 2000). A trained and certified TCM practitioner knows under which clinical circumstances particular herbal remedies are contraindicated. Additional Clinical Outcomes TCM may also be a useful adjunctive or alternative treatment for addictions, allergies, sinusitis, asthma, respiratory infections, strep throat, amenorrhea, premenstrual syndrome, childbirth, postpartum care, arthritis (including rheumatoid arthritis), chronic or acute pain, bladder infection, candidal or other vaginal infections, benign prostatic hypertrophy, prostatic cancer, prostatitis, restless leg syndrome, sleep disorders, abdominal pain, stress, and tinnitus (Parker 2000). Although further research is needed, the Chinese herbal remedy Tripterygium wilfordii Hook F shows considerable promise for treating autoimmune and inflammatory diseases, including rheumatoid arthritis, systemic lupus erythematosus, ankylosing spondylitis, psoriasis, Behcet's disease, HenochSch�nlein purpura, IgA nephropathy, chronic nephrotic syndrome, nephritis, chronic lymphocytic thyroiditis, dermatitis, scleroderma, polymyositis, and kidney transplant rejection (Tao and Lipsky 2000). The Future The Ohio University College of Osteopathic Medicine and nine Chinese medical institutions recently formed the Sino-American Consortium to study applications for TCM in Western medicine (OU-COM. 2000). In 2001, the Ohio University College of Osteopathic Medicine plans to incorporate basic TCM principles into its curriculum (OU-COM. 2000). In addition, the University of Pittsburgh recently created the International TCM Center to coordinate research efforts with several TCM institutes in China. The result will be a large-scale, systematic, international effort to develop clinical standards for TCM (UPMC 2000). Future research studies and clinical trials on TCM are required to establish the efficacy, safety, cost-effectiveness, and mechanism of action of various TCM treatments and overcome the limitations of existing research studies (Armstrong and Ernst 1999). Training, Certification, and Licensing Requirements Currently, there are 35 Oriental medicine training programs in the United States. Programs range in duration from two to four years and include the study of herbs, acupuncture, and all other aspects of Oriental medicine (Parker 2000). To be certified, students must graduate from accredited institutions and pass the state board exam or the national certification commission exam. Licensure requirements vary in each state (Parker 2000). Resources

For more information, contact the American Association of Oriental Medicine in Catasauqua, Pennsylvania at 888-500-7999 or on the web at www.aaom.org; the National Acupuncture and Oriental Medicine Alliance in Olalla, Washington at 253851-6896 or on the web at www.acuall.org; the Institute of Traditional Medicine in Portland, Oregon at 503-233-4907 or on the web at www.itmonline.org; or the National Certification Commission for Acupuncture and Oriental Medicine in Alexandria, Virginia at 703-548-9004 or on the web at www.nccaom.org. References Armstrong NC, Ernst E. The treatment of eczema with Chinese herbs: a systematic review of randomized clinical trials. Br J Clin Pharmacol. 1999;48(2):262-264. Becker SA. Treatment by Chinese medicine: semen anomalies. J Chin Med. 2000;62:46-51. Bensoussan A, Talley NJ, Hing M, Menzies R, Guo A, Ngu M. Treatment of irritable bowel syndrome with Chinese herbal medicine. JAMA. 1998;280(18):15851589. Carlier PR, Du DM, Han Y, Liu J, Pang YP. Potent, easily synthesized huperzine Atacrine hybrid acetylcholinesterase inhibitors. Bioorg Med Chem Lett. 1999;9(16):2335-2338. Cheng JT. Review: drug therapy in Chinese traditional medicine. J Clin Pharmacol. 2000;40(5):445-450. Ergil KV. China's traditional medicine. In: Micozzi MS, ed. Fundamentals of Complementary and Alternative Medicine. New York, NY: Churchill Livingstone Inc.; 1996:185-223. Ignjatovic V, Ogru E, Heffernan M, Libnaki R, Lim Y, Ng F. Studies on the use of "Slimax," a Chinese herbal mixture, in the treatment of human obesity. Pharm Biol. 2000;38(1):30-35. Keane FM, Munn SE, du Vivier AW, Higgins EM. Analysis of Chinese herbal creams prescribed for dermatological conditions. BMJ. 1999;318(7183):563-564. Lewis CJ, Alpert S. Letter to Health Care Professionals on FDA Concerned about Botanical Products, Including Dietary Supplements, Containing Aristolochic Acid. Washington, DC: U.S. FDA Center for Food Safety and Applied Nutrition; May 31, 2000. Luwen G. Wen dan tang and diabetic retinal disease. J Chin Med. 2000;62:20-22. Nortier JL, Martinez MC, Schmeiser HH, et al. Urothelial carcinoma associated with the use of a Chinese herb. N Engl J Med. 2000;342(23):1686-1692. OU-COM. OU medical school teams with Chinese universities [press release]. Athens: Ohio University College of Osteopathic Medicine; April 29, 2000. Parker MJ. Traditional Chinese herbal medicine. In: Novey DW, ed. Clinician's Complete Reference to Complementary and Alternative Medicine. St. Louis, Mo: Mosby; 2000:203-218. Tao X, Lipsky PE. The Chinese anti-inflammatory and immunosuppressive herbal remedy Tripterygium wilfordii Hook F. Rheum Dis Clin North Am. 2000;26(1):2950. UPMC. Chinese government officials visit UPMC health system to establish ties with International Traditional Chinese Medicine Center [press release]. Pittsburgh: University of Pittsburgh Medical Center Health System; January 20, 2000.

Xiao Y, Huang XZ, Chen G, Wang MB, Zhu JS, Cooper CB. Increased aerobic capacity in healthy elderly humans given a fermentation product of Cordyceps Cs-4. Paper presented at: Annual Meeting of the American College of Sports Medicine; June 2-5, 1999; Seattle, Wash. Integrative Medicine Communications, Access 2.0; 2000.

Abnormal Menstruation Acute Cholecystitis Alopecia Areata Anal Fissure Aplastic Anemia Arterial Hypertension Arteriosclerosis obliterans of limbs Bell's facial paralysis Bronchial asthma Cancer Cerebral thrombosis Chronic bronchitis Chronic gastritis Chronic lumbar muscle strain Chronic nephritis Chronic pharyngitis Chronic rhinitis Chronic suppurative otitis media Coronary heart disease Diabetes mellitus Dysmenorrhea Eczema Endometriosis Enlarged prostate Epididymitis Epilepsy Glacucoma Habitual abortion Headache Hemorrhoids Hepatocirrhosis Hyperlipemia Hyperlipoproteinemia Hyperplasia of mammary glands Insomnia

Impotence Infection of biliary tract and gall stones Leukopenia Meniere Nephrotic syndrome Neurodermatitis Neurosis Peptic ulcer Proctoptosis Prolapse of lumbar intervertebral disc Prostatitis Pruritus Psoriasis Raynaud's Disease Rheumatic arthritis Rheumatic fever Sciatica Scleroderma Seminal emission Senile cataract Sterility Sudden deafness Thrombocytopenic purpura Thrombotic phlebitis Urinary calculus Urinary infection Urticaria Viral hepatitis Vitiligo http://www.purifymind.com/IC.htm

Diabetes mellitus is a heterogeneous primary disorder affecting the processing of carbohydrates with multiple etiologic factors that generally involve absolute or relative insulin deficiency, insulin resistance or both. All causes of diabetes ultimately lead to hyperglycemia, which is the hallmark of this disease. Diabetes is typically classified into Type I, or insulin dependent diabetes mellitus, in which patients have little or no endogenous insulin secretory capacity, and Type II, or non-insulin dependent diabetes mellitus, in which patients retain significant endogenous insulin secretory capacity. Diabetes mellitus is known in traditional Chinese medicine as depletion-thirst disease, characterized by polydipsia, polyphagia, polyuria, and emaciation. Pathomechanism and Pathogenesis Diabetes occurs in association with the following etiologic factors:

1. The spleen and stomach are damaged by overeating greasy food or by overconsuming alcohol, causing failure of the spleen in transporting and transforming which, in turn, causes interior-heat to accumulate and consume food and body fluids, finally resulting in diabetes. 2. Anxiety, anger, mental depression, etc. injure the liver, causing the liver qi to stagnate. Protractedly stagnated liver qi turns into evil heat which consumes body fluids body fluids and eventually leads to diabetes. 3. Deficiency in the kidneys caused by intemperance in sexual life or congenital essence defect causes the kidney qi to wane; as a result, the kidney qi fails to maintain the functioning of the bladder in restraining urine discharge, thus polyuria occurs. Differential Diagnosis of Syndromes Traditional Chinese medicine identifies three types of diabetes: the upper depletionthirst, the middle depletion-thirst, and the lower depletion-thirst. Differential diagnosis of syndromes is based upon these three types 1. Upper-warmer depletion-thirst diseases Pathogenic heat consumes the lung yin, thus affecting the upper-warmer. Primary manifestations: Severe thirst accompanied by dryness of the mouth and tongue, polyguria, reddened tip and margin of the tongue with thin, yellow coating, and full and rapid pulse. 2. Middle-warmer depletion-thirst disease Excessive fire of the stomach consumes the stomach yin fluids. Primary manifestations: Polyphagia, emaciation, constipation, reddened tongue with dry, yellow coating, and slippery and strong pulse. 3. Lower-warmer depletion-thirst disease a). Yin deficiency: A morbid state due to a defect in the kidney essence and consumption of the kidney yin. Primary manifestations: Polyguria, turbid urine, dry mouth, reddened tongue with little coating, and weak and rapid pulse. b). Deficiency of both yin and yang: A morbid state due to deficiency of the kidney yin and yang. Primary manifestations: Severe polyguria, turbid urine, lassitude, spontaneous sweating, shortness of breath, impotence, dark complexion, pale tongue with white coating, and deep and weak pulse. Treatment 1. Upper-warmer depletion-thirst disease Principle of treatment: Expel heat, purge fire, increase the production of the body fluids and relive thirst. Formula of choice: Asparagus and Ophiopogon Decoction with modifications; in this prescription, asparagus root (tian dong) and ophiopogon root (mai dong) nourish the yin of the lungs and stomach, and promote the production of the body fluids; scutellaria root (huang qin) and anemarrhena root (zhi mu) clear away heat from the lungs and stomach; ginseng (ren shen) strengthens the qi and produces the body fluids; for patients with extreme thirst accompanied by a dry and yellow tongue coating, gypsum (shi gao) can be prescribed to clear away the stomach fire. 2.Middle-warmer depletion-thirst disease

Principle of treatment: Clear away stomach heat and nourish the yin. Formula of choice: Jade Dew Decoction, in which gypsum and anemarrhena root (zhi mu) clear the stomach fire; fresh rehmannia root (sheng di) and ophiopogon root (mai dong) nourish the yin of the lungs and kidneys; and achyranthes root (niu xi) brings fire downward; for cases with yellow, greasy tongue coating, add coptis root (huang lian) and scutellaria root (huang qin) to expel dmap-heat from the stomach; for cases with constipation, add rhubarb (da huang), magnolia bark (hou po), and unripe bitter orange (zhi shi) to purge heat. 3.Lower-warmer depletion-thirst disease a). Yin deficiency: Principle of treatment: Nourish the kidney yin. Formula of choice: Six-Ingredient Rehmannia Pill; when this prescription is used to treat diabetes, use large dosages of cornus fruit (shan zhu yu), cooked rehmannia root (shou di), dioscorea root (shan yao) to nourish and retain the yin fluids of the liver and kidneys and to replenish the spleen yin in order to relive polyuria. b). Deficiency of the yin and yang: Principle of treatment: Replenish the qi and nourish the yin. Formula of choice: Six-Ingredient Rehmannia Pill and Pulse-Activating Powder; for patients with aversion to cold and clod limbs, add Kidney Qi Pill to invigorate the kidney yin and yang. Dr. Ming's TCM Medical Center, Hua Xi Xiao Yuan, Hutian Developing Area, Huaihua city, Hunan province China

Epilepsy is defined as paroxysmal and temporary disturbance of brain characterized by loss of consciousness and muscle tic or abnormal sensation, emotion and behavior. In TCM, this disease is categorized as "xian zheng" (epilepsy syndrome) and "dian xian" (epilepsy). Main Points of Diagnosis 1. The histories of family, epileptic attack and encephalopathia should be inquired

carefully. 2. Clinical manifestations of the disease vary greatly. There may be grand mal, petit mal, rolandic mal and infantile spasms. The grand mal is characterized by sudden loss of consciousness, general totanic spasm with apnea, cyanosis and foam in the mouth, which usually last for 1-5 minutes. The patients may then fall into sleep and become conscious a few hours later. The petit mal is characterized by sudden, short loss of consciousness without aurae and muscle tic, accompanied with interruptions of speech and action which usually persist for 2-10 seconds. The patient usually comes to consciousness rapidly. 3. Electroencephalogram examination and tomography may be useful for the diagnosis of epilepsy. Differentiation and Treatment of Common Syndromes 1. Epilepsy Induced by Terror Main Symptoms and Signs: Sudden panic resulting in confusion and loss of selfcontrol, sometimes fright and sometimes alarm and restlessness, crying with fear during sleep, tendency to remain in the mother's arms, alternative flush and pallow on the face, red tongue with white fur, taut and rapid or taut and slippery pulse. Therapeutic Principle: Tranquilizing the mind and resolving phlegm to arrest epilepsy. Recipe: Modified Polygala Bolus. polygala root codonopsis root poria grassleaved sweetflag rhizome dragon's teeth (To be decocted prior to others) curcuma root arisaema with pig's bile wile jujuba seed arborvitae seed cicada slough lucid asparagus All the above herbs are to be decocted in water for oral administration. 2. Epilepsy due to Accumulation of Phlegm Main Symptoms and Signs: Convulsion of extremities during a fit of epilepsy, unconsciousness or vertigo, headache and abdominal pain, accompanied with stridor produced by phlegm in the throat, salivation, yellow face, thick fur of the tongue, and slippery and rapid pulse. Therapeutic Principle: Removing phlegm and inducing resuscitation. Recipe: Modified Phlegm-Removing Decoction. pinellia tuber tangerine peel poria bamboo shavings bitter orange gastrodia tuber arisaema with bile

grassleaved sweetflag rhizome scorpion licorice root All the above herbs are to be decocted in water for oral administration. 3. Epilepsy due to Blood Stasis Main Symptoms and Signs: With a history of birth injury or trauma often manifested as paroxysmal localized headache, occasional vomiting, paroxysmal convulsion of the whole body or half body or local region upon attack, dark purple tongue with ecchymoses, thready and unsmooth pulse and dark purple superficial venule of the index finger. Therapeutic Principle: Promoting blood circulation to remove blood stasis, waking up the patient from unconscious ness and arresting epilepsy. Recipe: Modified Decoction for Activating Blood Circulation. ligusticum root red peony root peach kernel safflower bulb and root of Chinese green onion fresh ginger Chinese date red sage root musk (Ground into powder to be taken after being infused in the finished decoction) All the above ingredients except musk are to be decocted in water for oral administration. In case of deficiency of qi, add 30 grams of astragalus root and 12 grams of codonopsis root into the above mentioned recipe. Dr. Ming's TCM Medical Center, Hua Xi Xiao Yuan, Hutian Developing Area, Huaihua city, Hunan province China

Coronary heart disease, also know as ischemic heart disease, is commonly caused by atheromatous lesions of the coronary artery. Its major clinical manifestations are

angina pectoris and myocardial infarction. Although the terms angina pectoris and acute myocardial infarction were not used in ancient times, descriptions of the clinical manifestations of coronary heart disease are contained in the ancient texts of traditional Chinese medicine. Etiology and Pathogenesis Precordial pain is the most prominent feature of coronary heart disease. According to traditional medical theory, obstruction in the heart vessels usually causes this pain. The vessels may be blocked by phlegm accumulation in the chest, which obstructs the yang qi, and /or by blood stasis either due to qi deficiency or due to qi stagnation. Differential Diagnosis of Syndromes 1. Obstruction of yang qi in the chest due to accumulation of phlegm Primary manifestations: A feeling of oppression over the chest or chest pain radiating to the back, accompanied by shortness of breath, white, thick, greasy coating of the tongue and smooth pulse. (This condition is of the cold phlegm type; when the tongue coating turns yellow and greasy, it becomes a phlegm-heat type.) 2. Blood stasis caused by qi deficiency Primary manifestations: Fatigue, shortness of breath, palpitations accompanied by localized pain, dark purplish tongue with thin coating and uneven pulse. (In cases with cold extremities, intolerance of cold, pale and tender tongue and slow pulse, the blood stasis is due to yang deficiency; in cases with profuse sweating, deadly cold limbs, listlessness and fading pulse or even coma, the yang is exhausted and shock ensues. Some patients experience yin and qi deficiencies together, manifested by a hot sensation in the palms and soles, dry mouth, desire for cold drinks, reddened tongue with little or no coating and thin, rapid pulse.) 3.Blood stasis caused by qi stagnation Primary manifestations: A fullness sensation or pain in the chest, dark purplish tongue with thin coating, but no symptoms of qi deficiency, such as shortness of breath and fatigue. Treatment 1. Obstruction of yang-qi in the chest due to accumulation of phlegm Principle of treatment: Relieve the obstruction of the yang qi in the chest. Formula for choice: Trichosanthes, Chinese Chive, and White Liquor Decoction; in this prescription, trichosanthes fruit eliminates phlegm and reverse the adverse ascending of the qi; Chinese chive warms and activates the yang qi in the chest and relieves pain; and white liquor acts as a guide drug. 2. Blood stasis caused by qi deficiency Principle of treatment: Invigorate the qi and promote blood circulation. Formula of choice: Yang-Invigorating and Recuperation Decoction; in this recipe, astragalus root (huang qi) invigorates the qi to promote blood circulation and strengthens the effect of the other ingredients in removing blood stasis. Other ingredients are tangkuei (dang gui), red peony root (chi shao), earth worm (di long), ligusticum root (chuan xiong), peach kernel (tao ren), carthamus flower (hong hua). In cases with yang deficiency, add cuscuta seed (tu si zi), prepared lateral root of aconite (fu zi), and psoralea seed (bu gu zhi) to warm and replenish the yang qi. If there is collapse, use Ginseng and Aconite Decoction combining with Aconite

Decoction (including prepared lateral root of aconite, poria, ginseng, ovate atractylodes rhizome, white peony root); in these prescriptions, prepared lateral root of aconite and ginseng recuperate the depleted yang and replenish the qi. In cases of qi and yin deficiencies, add scrophularia root (xuan shen), ophiopogon root (mai dong), schisandra berry (wu wei zi), and fresh rehmannia root (sheng di ) to the above prescriptions. 3. Blood stasis caused by qi stagnation Principle of treatment: Activate qi and remove blood stasis. Formula of choice: Blood House Stasis-Expelling Decoction; in this recipe, bitter orange (zhi ke) and bupleurum root (chai hu) activate the stagnated qi; platycodon root (jie geng) acts as a guide drug; and the other ingredients promote blood circulation and remove blood stasis, including tangkuei (dang gui), fresh rehmannia root (sheng di huang), peach kernel (tao ren), carthamus flower (hong hua), red peony root (chi shao), licorice root (gan cao), ligusticum root (chuan xiong), achyranthes root (niu xi). Dr. Ming's TCM Medical Center, Hua Xi Xiao Yuan, Hutian Developing Area, Huaihua city, Hunan province China

Insomnia is a common complaint. Physical causes f insomnia are comparatively few. In most cases, insomnia is a psychophysiological disorder, resulting mainly from the self-stimulation engendered y anxiety, worry, or depression. Sleeping pills are routinely used for treating this disorder, but their continuous use in chronic cases may cause adverse side or toxic effects. Herbal medicines and acupuncture can be effectively used as alternative measures. Etiology and Pathogenesis Insomnia is often caused by emotional or psychic disturbances. Anxiety and anger make the Liver depressed, and the depressed Liver qi may be transformed into fire, which interferes with the normal functions of the Heart. Excessive anxiety may also impair the Heart (mind) and the Spleen, and insomnia occurs due to inadequate supply of nutrients and blood to the Heart. In the aged and the patients suffering from chronic diseases, qi and blood are insufficient to nourish the Heart, thus leading to palpitations and insomnia. Qi deficiency may also involve the Heart and the Gallbladder, impairing one's sleep and making one vulnerable to fright. Consumption of Kidney essence may break down the normal balance between the Heart and the Kidneys, and incoordination between the Heart and the Kidneys may also be manifested as insomnia. Syndrome Differentiation

According t the pathogenesis, insomnia can be classified into the following syndrome patterns: 1. Depressed Liver with exuberant fire: Insomnia accompanied by irritability, irascibility, thirst, yellow coating, and stringy, rapid pulse. 2. Incoordination of the Heart and the Kidneys: Insomnia accompanied by dizziness, tinnitus, dryness in the mouth, heat sensation in the palms and soles, palpitations, forgetfulness, lumbar aching, reddened tongue, and thready, rapid pulse. 3. Deficiency f both the Heart and the spleen: Dreamful sleep with early waking, palpitations, forgetfulness, dizziness, lassitude, lack of strength, anorexia, pallid complexion, and thready, weak pulse. 4. Deficiency of the Heart ad the Gallbladder: Dreamful sleep with wakefulness, susceptibility to fright, and stringy, thready pulse. Herbal Medication 1. Depressed Liver with exuberant fire Principle of treatment: To purge the Liver of fire. Formula of choice: Longdan Xiegan Tang (Decoction of Gentian to Purge the Liver). 2. Incoordination of the Heart and the Kidneys Principle of treatment: To coordinate the Heart and the Kidneys. Formula of choice: Liuwei Dihuang Wan (Pill of Six Ingredients with Rehmannia) plus Rhizoma Coptidis (goldthread rhizome) and Cortex Cinnamomi (cinnamon bark). 3. Deficiency of both the Heart and the Spleen Principle of treatment: to nourish the Heart and the Spleen. Formula of choice: Guipi Tang (Spleen-Invigorating Decoction). 4. Deficiency of the Heart and the Gallbladder Principle of treatment: To replenish qi and induce tranquilization Formula of choice: Anshen Wan (Tranquilizing Pill). Patent Medicines 1. Depresed Liver with exuberant fire: Longdan Xiegan Wan (Gentian Pill to Purge the Liver). 2. Incoordination of the Heart and the Kidneys: Tianwang Buxin Dan (Heavenly King's heart Tonic). 3. Deficiency of both the Heart and the Spleen: Renshen Guipi Wan (Spleeninvigorating Pill with Ginseng). 4. Deficiency of the Heart and the Gallbladder: Anshen Wan (Tranquilizing Pill). Dr. Ming's TCM Medical Center, Hua Xi Xiao Yuan, Hutian Developing Area, Huaihua city, Hunan province China

Prostatitis As to the middle-aged and young man, prostatitis is a commonly encountered disease, which is usually caused by urethritis, spermatocystitis, or epididymitis. In clinical practice, it is divided into the chronic type and acute type, or the inflammatory one and non-inflammatory one, or the specific one and non-specific one. Although the disease name of prostatitis does not exist in traditional Chinese medicine (TCM), it belongs to the categories of suspended yang-carbuncle, white turbidity, white evil, fatigue strangury, grease strangury, seminal turbidity, lumbar pains due to kidney deficient, etc. Acute Prostatitis Syndrome Identification and Treatment Determination: 1. Damp and Heat Inrushing Downward Major symptom: intermittent fevers and chills when occurring first, rapid progress, frequent micturation, urinary urgency with inhibited voidings, burring sensation and stinging pains in the urethra, or visible bloody urine, falling-like distension or pains of the perineum, dry mouth, a bitter taste in the sticky mouth, constipation, distension and pains in the lower abdomen, red tongue, yellow and slimy tongue coating, soggy and rapid pulse. Therapeutic Principle: clear heat and excrete damp . Formula and ingredients: Eight Corrections Variant Powder manshurian aristolochia stem (mu tong) 10g, plantago seed (che qian zi) 15g, rhubarb (da huang) 6g, knotgrass (bian xu) 10g, diathus (qu mai) 10g, phellodendron bark (huang bai) 10g, lonicera flower (jin yin hua) 15g, gardenia fruit (shan zhi) 10g, fresh rehmannia root (shen di huang) 15g, Yedo violet (zi hua di ding) 15g, licorice root (gan cao) 3g . Administration: A dosage per day, decocting with water, taking the decoction twice a day, 200-300ml of pure soup each time. 2. Intense Heat and Exuberant Toxin Major symptoms: Sudden onset, persistent high fever, vexation, unrest, thirst, liking drinks, reddening, swelling, heat and pains of the perineum, scanty urine, obstructed urination, or urine with visible pus and blood, burning sensation and pains in the urethra, constipation, red tongue, yellowish tongue coating, rapid and string-like pulse. Therapeutic principle: Discharge heat and resolve toxin. Formula and ingredients: Gentian Liver-Draining Variant Decoction gentian root (long dan cao) 10g, gardenia fruit (shan zhi) 10g, scutellaria root

(huang qin) 10g, phellodendron bark (huang bai) 10g, busy knotweed root (hu zhang) 10g, lonicera flower (jin yin hua) 15g, fresh rehmannia root (shen di huang) 15g, plantago seed (che qian zi) 15g, alisma tuber (ze xie) 10g, dandelion (pu gong ying) 15g, baijiang (bai jiang cao) 15g, licorice root (gan cao) 6g. ---------------Chronic Prostatitis Incomplete treatment of acute prostatitis may result in chronic prostatitis. However, most patients have no obviously acute stage. The etiology is clinically complex. In clinical practice, the following factors may bring on the occurrence of chronic prostatitis, including dysfunction of the immune system, frequent sexual activities, frequent masturbation, indulgence in drinking much wine, influence caused by inflammation of the upper-respiratory tract, urethra, seminal vesicle, rectum, epididymitis, perineum, and so forth. Syndrome Identification and Treatment Determination 1. Damp and Heat Inrushing Downward Major symptoms: short disease history, scanty and yellowish urine, frequent micturation, urinary urgency, painful urination, stinging pains or burning sensation in the urethra, distention and pains of the perineum and lower abdomen, intermittent white and profuse excretion from the mouth of the urethra, dry mouth, a bitter taste in the sticky mouth, yellow and slimy tongue coating, stinging and slippery and rapid pulse. Therapeutic principle: clear heat and excrete damp. Formula and components: Fish Poison Yam Clear-Turbid Separation Variant Beverage fish poison yam (bi xie) 10g, poria (fu ling) 15g, plantago seed (che qian zi) 15g, salvia root (dan shen) 10g, phellodendraon bark (huang bai) 10g, acorus root (shi chang pu) 10g, lonicera flower (jin yin hua ) 15g, alisma tuber (ze xie) 10g, magnolia bark (hou po) 6g, fangji root (fang ji) 10g, licorice root (gan cao) 3g. Administration: A dosage per day, decocting twice a day, taking 200-300ml of pure soup each time. 2. Qi-Stagnation and Blood Stasis Major symptoms: relatively long disease history, obvious pains radiating to the lower abdomen, testicle, and waist, white excreting from the urethra at the end of the urinating, strangury when urinating, or visible bloody urine, slight hardening of the prostate checked out by the doctor's finger insertion from the anus, or palpable nodules and tenderness, darkish tongue body, or stasis macules and speckles on the tongue, uneven pulse. Therapeutic principle: Move the qi, check pains, quicken blood circulation, transform stasis . Formula and ingredients: Origin-Restoring Blood- Quickening Variant Decoction tangkuei (dang gui) 6g, carthamus flower (hong hua) 10g, peach kernel (tao ren) 6g, rhubarb (da huang) 6g, red peony root (chi shao ) 15g, corydalis tuber (xuan hu suo) 15g, vaccaria seed (wang bu liu xing) 15g, salvia root (dan shen) 10g, trichosanthes root (gua lou gen ) 10g, pangolin scales (chuan shan jia) 10g. 3. Deficiency of the Kidney-Yin Major symptoms: The diseases lasts quite a long term without recovering. The

patient is enfeebled due to the chronic course, or he has once indulged in excessive sexual activities or masturbation. White or sticky excretion from the mouth of the urethra usually or at the end of the urination. Post-voidings dribble, aching pains of the loins, soft legs, feverish sensation in the soles and palms in the afternoon, dizziness, tinnitus, insomnia, profuse dreaming, seminal emission, premature ejaculation, hypofunction of the sexual ability, red tongue with few coating, thready and rapid pulse . Therapeutic principle: tonify kidneys, astringe essence, moisten the yin, and lower fire. Formula and ingredients: Anemarrhena, Phellodendron, and Rehmannia Variant Decoction anemarrhena (zhi mu) 10g, phellodendron bark (huang bai) 10g, fresh rehmannia root (shen di huang) 15g, dioscorea root (shan yao)15g, cornus fruit (shan yu you ) 10g, poria (fu ling) 15g, alisma tuber (ze xie) 10g, moutan bark (dan pi) 10g, plantago seed (che qian zi) 15g, vaccaria seed (wang bu liu xing) 10g, Cherokee rose fruit (jin ying zi) 10g. Dr. Ming's TCM Medical Center, Hua Xi Xiao Yuan, Hutian Developing Area, Huaihua city, Hunan province China

Urinary calculus is a common disease in the urinary system, including calculus of the kidneys, urethral calculus, vesical calculus and urethral calculus. This disease incidence appears obviously in certain areas. The disease belongs to the categories of "sha lin" (strangury form urolithiasis), "shi lin" (strangury caused by urinary calculus) and "xue lin" (strangury complicated by hematuria) in TCM. Main Points of Diagnosis 1.Symptoms 1) Calculus of the Kidneys: There is a dull pain in the lower loins of the affected side, when the stones in the kidney radiates along the ureter to the lower abdomen and the perineal region which is associated with different degrees of hematuria. If

the case turns into a complicated infection, the patient may have fever and pus cells in the urine. 2) Ureteral Calculus: In the lumbar region there is an acute pain which is often associated with hematuria. When the stones happen to be in the upper 1/3 part of the ureter, the pain will be in the costovertebral angle region and radiate to the part above iliac crest and external side of the abdomen. When the stones descend, the region of pain will also come down with the pain radiating to the thigh, testicle or vulva region. 3) Vesical Calculus: There is a pain in urination and the pain is often severest at the end of urination. This pain mainly occurs in the lower abdomen and may radiate to the perineum and balanus. Other symptoms are often difficulty of interruption in micturation and hematuria at the end of urination, urgent and frequent micturation. 4) Urethral Calculus: Pain in urination, thready urination, dribbling urination , or even retention of urine may appear. 2. Signs: The patients who have kidney calculus will have a percussion pain or a tenderness on the kidney area of the affected side. When there is an obstruction caused by kidney calculus and urethral calculus, sometimes, a swollen kidney will be felt. In vesical calculus and posterior urethral calculus, stones can be felt in rectal examination. In the case of anterior urethral calculus, a hard lump with tenderness may be felt in the local region. 3. Laboratory Examination: Through urine test the number of red blood cells is often found increased. When the function of kidney is suspected of being impaired, urea nitrogen and creatinine tests will be necessary. 4. X-ray Examination: The urogram will show the majority of the stones. Use excretion urography or retrograde urography to help you find out the positions of the stones and the functions of both kidneys. 5. Cystoscopy: "B" type ultrasonograpny and isotope renogram will be helpful for clinical diagnosis. Differentiation and Treatment of Common Syndromes The following therapies are good for those cases in which the transverse diameter of the stones in the kidney and ureter is less than 1 cm; the transverse diameter of the stones the urinary bladder is less than 2 cm and there is no serious obstruction and infection, and the function of kidney is in a good condition. 1. Internal Treatment 1) Qi-Stagnation Type Main Symptoms and Signs: In the waist and the lower abdomen there is distending pain, full ache or even paroxysmal colicky pain accompanied with nausea, vomiting and hematuria, tongue with white and greasy fur and tight and taut pulse. Therapeutic Principle: Promoting the circulation of qi, inducing diuresis, relieving strangury and removing the stones. Recipe: Modified Pyrrosia Decoction lysimachia pyrrosia leaf plantago seed (piece of cloth before it is decocted with other herbs ) cluster mallow fruit

oriental water plantain rhizome citron fruit vaccaria seed radish seed rhubarb all the above herbs are to be decocted in water for oral administration. 2) Damp-Heat Type Main Symptoms and Signs: There is a continuous pain in the waist or the lower abdomen accompanied with fever, frequent micturation, urgent urination, urodynia, cloudy or bloody urine, and pyuria, tongue with yellow and greasy fur and slippery rapid or taut rapid pulse. Therapeutic Principle: Clearing away pathogenic heat and dampness, relieving strangury and removing the stones. Recipe: Modified Eight Health Restoring Powder lysimachia prostrate knotweed Chinese pink herb talc phellodendron bark capejasmine fruit plantago seed (piece of cloth before it is decocted in water with other herbs ) rhubarb licorice root tip All the above herbs are to be decocted in water for oral administration. 3) Kidney-deficiency Type Main Symptoms and signs: The whole course of the illness lasts for a long period. Its symptoms are weakness and ache of the waist and limbs, fullness of abdomen, unsmoothness and feebleness of urination, pale tongue with thin and whitish fur, and deep and thready pulse. Therapeutic Principle: Supplementing qi, reinforcing the kidney, relieving stranguria and removing the stones. Recipe: Modified Kidney-Reinforcing Decoction prepared rehmannia root wolfberry fruit dogwood fruit achyranthes root bighead atractylodes rhizome eucommia bark cinnamon bark pilose asiabell root lysimachia climbing fern spore All the above herbs are to be decocted in water for oral administration. For those who are marked by acraturesis, add of 6 grams of ginseng instead of pilose asiabell root 30 grams of congongrass rhizome and 15 grams of milkvetch root, For those who have hematuria, add 20 grams each of Japanese thistle and field

thistle and 12 grams of sanguisorba root. 2. Acupuncture Therapy 1. Body Acupuncture Acupuncture Points: Shenshu (UB 23), Pangguangshu (UB 28), Zusanli (St 36), Guangyuan (Ren 4). Adjunct Acupuncture Points: Zhongji (Ren 3), Sanyingjiao(Sp 6), Yinlingquan (Sp 9), Shuidao (St 28). Manipulation: Choose 2 or 3 acupoints each time and use strong stimulation. Do this twice a day , retaining the needle for 20-30 minutes. 2) Electrotherapy Acupuncture Points: The therapeutic electrode (-)is connected with Shenshu (UB 23) or Pangguangshu (UB 28), while the (+) with Guanyuan (Ren 4) or Shuidao (St 28). Manipulation: Select the upper and the lower points of the affected side for needling. The intensity of the needling should be form weak to strong and it must be as strong as the patient could bear. Then, sustain the needling for 20-30 minutes, 1or 2 times a day. 3) Ear Needling Auricular Points: In the kidney and ureter's area or the tenderness area. Manipulation: Use strong stimulation, retaining the needle for 15-40 minutes. Dr. Ming's TCM Medical Center, Hua Xi Xiao Yuan, Hutian Developing Area, Huaihua city, Hunan province China

Urinary infection is the common name of pyelonephritis, cystitis and urethritis. The urinary infection is caused by bacteria, and it is common among females (especially among pregnant women). The main clinical symptoms are fever, lumbago, frequent micturition, urgent urination, urodynia, etc. According to the symptoms, urinary infection falls into two kinds: acute and chronic cases. Most of the acute infections may be cured, but a small number of the cases will become protracted and recurrent, which eventually develop into chronic state due to various causes. In the final state of the decease it can lead to a renal insufficiency. In Traditional Chinese Medicine (TCM) urinary infections are included in two categories: "strangury" and "lumbago." In the chronic urinary infections there are more complex pathogenesis and different clinical manifestations. The one with

remarkable symptoms due to deficiency such as edema, acratia and emaciation should be included in the syndromes of "edema" and "consumptive disease" of TCM. Etiology and Pathogenesis Because of eating too much food, which is pungent and sweet in flavour, and hot and fatty in nature; or because of excessive drinking [NOTE: this means usually alcoholic beverages; this can be stated also; or because of excessive drinking of water], damp-heat is led to flow downward into the urinary bladder. Because of the low orifices are unclean, dirty and turbid pathogens seize the opportunity to invade the urinary bladder; a damp-heat is formed; and because of damp-heat is accumulated in the lower-warmer, the qi of the urinary bladder fails to perform its function normally. In this case there will be urgent urination, frequent micturition and urodynia. If the disease is protracted, both the spleen and kidney will become weakened, and in turn, syndromes due to both deficiency and excess will be brought about. Type and Treatment 1. Type of Damp-Heat in the Urinary Bladder (usually seen in acute urinary infection) Symptoms: Fever, aversion to cold, frequent micturition , urgent urination, urodynia, distending pain in the low abdomen, lumbago, yellow greasy tongue coating, and slippery rapid pulse. Therapeutic Method: Clearing away heat, removing toxic material and inducing diuresis to treat strangury. Prescription: Shiwei Tonglin Fang (Pyrrosia Leaf Recipe for Treating Strangury). Ingredients: Shiwei Folium Pyrrosiae Bianxu Herbal polygoni Avicularis Qumai Herba Dian Thi Dahuang Radix et Rhizoma Rhei Danzhuye Herba Lophatheri Baimaogen Rhizoma Imperatae Cheqianzi Semen Plantaginis (decocted after being wrapped in a piece of cloth) Huashi Talcum Kuncao Herba Leonuri Gancao Radix Glycyrrhizae Administration: Decocted in water for oral use, 1 dose daily. Modification: In case of more severe chills and fever, bitter taste, nausea and vomiting, the drugs added are Chaihu Radix Bupleuri, Banxia Rhizoma Pinelliae and Huangqin Radix Scutellariae. If the number of pus cells fails to be reduced and the tongue coating is yellow and greasy, the herbs added are Pugongying Herbal Taraxaci, Tufuling Rhizoma Smilacis Glabrae. In case of hematuria, the herbs added are Xiaoji Herbal Cirii, Shendi Radix Rehmanniae and Oujie Nodus Nelumbinis Rhizoma. Simple Prescription 1

Pugongying Herba Taraxaci Decocted in water for oral use. Simple Prescription 2 Xianshuweigen Radix Pyrrosiae Cleaned, pounded and then decocted in water to get thick decoction for oral use. Proven Prescription 1 Ingredients: Diding Herba Violae Cheqianzi Semen Plantaginis Administration: Decocted in water for oral use. Proven Prescription 2 Ingredients Shuanghua Flos Lonicerae Maogen Rhizoma Imperatae Kuncao Herba Lonicerae Cheqiancao Herb Plantaginis Zhuye Herba Lophatheri Administration: Decocted in water for oral use. 2. Type of Retention of Damp-heat due to Insufficiency of the Kidney-Yin (usually seen in chronic urinary infection). Symptoms: Dizziness, tinnitus, soreness and weakness of the loins and knees, dry throat and lips, low fever, mild or severe frequent and urgent urination and urodynia, reddish tongue with thin coating, and taut thready rapid pulse. Therapeutic Method: Nourishing Yin, invigorating the kidney, clearing away heat and descending fire. Prescription: Modified Zhi Bai Dihuang. Tang (Decoction of Anemarrhena, Phellodendron and Rehmannia). Ingredients: Shengdi Radix Rehmanniae Shanyao Rhizoma Dioscroeae Shanyurou Fructus Corni Danpi Cortex Moutan Fuling Poria Zexie Rhizoma Alismatis Zhimu Rhizoma Anemarrhenae Huangbai Cortex Phellodendri Shiwei Herba Pyrrosiae Danzhuye Herba Lophatheri Administration: Decocted in water for oral use, 1 dose daily. 3. Type of Deficiency of Both the Spleen and Kidneys, and Weakened Body Resistance and Retention of Pathogens (usually seen in chronic pyelonephritis) Symptoms: Edema of the face and feet, listlessness, acratia, soreness and weakness of the loins and knees, dizziness, tinnitus, anorexia, distension of the abdomen, loose stools, frequent and dribbling urination, pale tongue with thin white coating, and deep thready weak pulse. Therapeutic Method: Strengthening the spleen, invigorating the kidney, clearing

way heat and inducing diuresis. Prescription: Wubi Shanyao Wan (Incomparable Pill of Chinese Yam). Ingredients: Shanyao Rhizoma Dioscoreae Fuling Poria Zexie Rhizoma Alismatis Shudi Radix Rehmanniae Preparata Shanyurou Fructus Corni Bajitian Radix Morindae Officinalis Tusizi Semen Cuscutae Duzhong Cortex Eucommiae Niuxi Radix Achyarn this Bidentatae Wuweizi Fructus Schisandrae Roucongrong Herba Cistanches Chishizhi Halloysitum Rubrum Administration: decocted in water for oral use, 1 dose daily. Dr. Ming's TCM Medical Center, Hua Xi Xiao Yuan, Hutian Developing Area, Huaihua city, Hunan province China

Viral hepatitis, caused by hepatitis viruses, can be usually divided into three types: Type A, Type B and Non-A Non-B hepatitis. People are susceptible to the disease. Clinically, the major symptoms are poor appetite, hepatalgia and fatigue. Fever and jaundice may occur. Liver function test shows various degrees of hepatic damage. In TCM, this disease belongs to the categories of "huang dan" (jaundice), "gan yu" (stagnation of liver-qi), "xie tong" (hypochondriac pain) and "zheng ji" (mass in the abdomen). Main Points of Diagnosis 1. Epidemiologic information: The epidemic condition and a history of close contact with a hepatitis patient, or a history of blood transfusion or receiving blood preparations or immunization injections should be noticed. 2. Clinical features (1) The onset of the disease in insidious and slow. The patients often complain of

fatigue and anorexia. Some have jaundice, but most of them belong of the type of non-icteric or mild hepatitis. Only ten percent of the patients have typical manifestations or jaundice. (2) patients with hepatitis A often manifest pyrexia, shorter course and rapid recovery; patients with hepatitis B usually have a chronic course and remain HB virus carriers for a long time. A few of them may progress to cirrhosis. The severity of the clinical features of Non-A Non-B hepatitis is between those of hepatitis A and hepatitis B. And its incubation period can be long or short. 3. Physical signs: The liver becomes enlarged, and tender on palpation and is painful on percussion. There is a mild change of liver texture. A small percentage of cases have splenomegaly. In the patients with icterohepatitis, jaundice may be found in the skin and sclera. Hepatic face, vascular spiders and liver palms may be present in chronic active hepatitis. A few patients suffering from fulminant hepatitis may have skin petcchiae, epistaxis and ascites, or even hepatic coma, indicating poor prognosis. 4. Laboratory examination (1) Liver function: In patients with acute hepatitis, the SGPT is marked elevated up to several hundreds units, even more than one thousand units. In icterohepatitis, the icterus index and the one-minute bilirubin fixed quantity are increased. In severe and chronic active hepatitis, metabolism of protein is disturbed resulting in the change of ratio of serum albumin to globulin. The albumin level lowered but the globulin level elevated, even the ratio may be inverted. Signs of clotting disorder may be present. (2) The detection of specific antigens and antibodies: It is available to detect the HAAg in filtrate of stools and the anti-HAV of the IgG and IgM class in the serum in the diagnosis of hepatitis A. Three antigen and antibody systems, that is HBsAg, HBcAg and HBeAg with their antibodies, can be detected, which is valuable in the diagnosis and in predicting the severity, infectivity and prognosis of the hepatitis B. Non-A Non-B hepatitis can only be diagnosed by using the exclusive method. (3) In chronic active hepatitis, tests for cellular immunity, humoral immunity and autoimmunity may be performed to evaluate the host immune mechanisms and severity of the disease so as to give a relevant treatment. Liver biopsy is only indicated for those whose cases defy diagnosis through clinical and laboratory examination. Differentiation and Treatment of Common Syndromes 1. Icterohepatitis (1) Yang Jaundice (Acute Icterohepatitis) Main Symptoms and Signs: Bright yellow coloration of the skin and sclera, fever, thirst, feeling of fullness and distension in the epigastrium, anorexia, fatigue, hypochondriac distension and pain, restlessness, nausea, scanty dark urine, dry stools, red tongue with yellow and greasy fur, taut and rapid pulse. Therapeutic Principle: Removing pathogenic heat and dampness. Recipe: Oriental Wormwood Decoction with additional ingredients. oriental wormwood capejasmine fruit rhubarb root

phellodendron bark honeysuckle flower forsythia fruit isatis root cogongrass rhizome All the above herbs are to be decocted in water for oral administration. Some other drugs are often employed for certain symptoms. In case of exhibiting more symptoms and signs of pathogenic heat, 30grams of isatis leaf and 30 grams of dandelion should be added. And in case of exhibiting more symptoms and signs of pathogenic damp, 10 grams of atractylodes rhizome , 10 grams of magnolia bark and 10 grams of alismatis rhizome may be added. Nausea and vomiting can be treated with the addition of pinellia tuber 10g and bamboo shavings 10g. While abdominal distension and anorexia can be treated with the addition of same dosage of 10 grams of parched hawthorn fruit parched malt and parched medicated leaven. To treat the cutaneous pruritus, 15 grams of dittany bark and 15 grams of broom cypress fruit are included. (2) Yin Jaundice (Chronic icterohepatitis) Main Symptoms and Signs: Dark yellow coloration of the skin and sclera just like smoky color, poor appetite, feeling of distension in the abdomen, loose stools, general debility, tastelessness in the mouth, whitish thick and greasy fur of the tongue, deep thready and weak pulse. Therapeutic principle: Activating the function of the spleen inducing diuresis and warming yang. Recipe: Modified Decoction of Oriental Wormwood and Bighead Atractylodes and Prepared Aconite. oriental wormwood bighead atractylodes rhizome codonopsis root poria coix seed prepared aconite root tangerine peel hawthorn fruit malt medicated leaven All the above herbs are to be decocted in water for oral administration. Apart from the ingredients in the above recipe, 10 grams of dried ginger should be prescribed for those who complain of aversion to cold and cold limbs; 15 grams of fresh-water turtle shell for those with hepatosplenomegaly; and 15 grams of shell of areca nut and 15 grams of plantain seed ( wrapped in a piece of cloth during decocting ) for those with ascites. 2. Anicteric Hepatitis (1) Dampness and Heat in the Liver and Gallbladder Main symptoms and Signs: Chest stuffiness, dysphoria with feverish sensation, pain in the hypochondrium, abdominal distension, lassitude and weakness, anorexia with aversion to greasy food, bitter taste and dry mouth, scanty dark urine, dry stools,

reddened tongue with yellow and greasy fur, taut and rapid or smooth and rapid pulse. Therapeutic Principle: Removing pathogenic heat and dampness. Recipe: Modified prescription of Oriental Wormwood Decoction combined with Decoction of Gentian for purging liver-fire. oriental wormwood capejasmine fruit scutellaria root gentian root isatis root patrinia curcuma root plantain seed (wrapped in a piece of cloth during decocting) red sage root poria magnolia bark All the above herbs are to be decocted in water for oral administration. In addition, 12 grams of Sichuan chinaberry and 10 grams of corydalis tuber are added for treating cases with prominent pain in the hypochondrium; 10 grams of amomum fruit and 10 grams of bitter orange are added for cases with obvious epigastric distension and stuffiness; 15 grams of hawthorn fruit and 10 grams of membrane of chicken's gizzard skin added for cases with poor appetite. (2) Stagnation of the Liver-qi with Deficiency of the Spleen hypochondrium, general debility, anorexia, loose stools, thin and whitish fur of the tongue, deep and taut pulse. Therapeutic Principle: Relieving the depressed liver-qi and reinforcing the function of the spleen. Recipe: Modified Ease Powder. bupleurum root Chinese angelica root white peony codonopsis root white atractylodes rhizome poria curcuma root tangerine peel red sage root Chinese yam hawthorn fruit medicated leaven, prepared licorice root All the above herbs are to be decocted in water for oral administration. If the disease is characterized by dryness of the eyes, dizziness, dull pain in the hypochondrium, hot sensation in palms and soles, soreness and weakness in the loins and knees, dry and red tongue coated with a little fur or no fur at all, taut and thready pulse, which is caused by deficiency of the liver-yin, nourishing the liver-yin

should dominates the treatment. The given recipe is Decoction for Nourishing the Liver and Kidney with additional ingredients: glehnia root ophiopogon root dried rehmannia root wolfberry fruit Chinese angelica Sichuan chinaberry fresh-water turtle shell curcuma root dendrobium (3) Stagnation of Qi and Blood Stasis Main Symptoms and Signs: Gloomy complexion, stabbing pain in the right hypochondrium, hepatomegaly or splenomegaly, abdominal distension, anorexia, some telangiectases in the skin of face and neck with vascular spiders, liver palms, dark purple tongue sometimes marked with ecchymoses, taut and uneven pulse. Therapeutic Principle: Promoting blood circulation, removing blood stasis and softening hard hepatiomegaly or splenomegaly. Recipe: Modified Decoction of Peach Kernel and Safflower with Other Four Ingredients. Chinese angelica white peony root ligusticum root peach kernel safflower red sage root fresh-water turtle shell pangolin scale zedoary spatholobus stem cyperus tuber finger citron prepared licorice root All the above herbs are to be decocted in water for oral administration. Apart from the above ingredients, codonopsis root and astragalus root are added for those with symptoms of lassitude and weakness. For all types of clinical manifestations mentioned above, if SGPT is higher than normal, powder of schisandra fruit may be taken at the same time, 3 grams are taken each time and 3 times a day; or additional intake of stringy stonecrop powder 50 mg are taken each time and three times a day; or choose any of the appropriate amount of the following ingredients for extra intake: bistort rhizome, giant knotweed rhizome and Japanese St. Johns wort. Dr. Ming's TCM Medical Center, Hua Xi Xiao Yuan, Hutian Developing Area, Huaihua city, Hunan province China

The prescriptions of traditional Chinese medicine (TCM) can be defined as a preparation which, on the basis of the differentiation of syndromes and the establishment of therapeutic methods, organically combines various drugs for the prevention and treatment of diseases in accordance with a certain principle of formulating a prescription. Pharmacology of traditional Chinese medicinal formulae is a science that studies and interprets the theories of prescriptions and their administrations. The formation and development of prescriptions have undergone a very long historical period. As far back as in the early period of slavery society, man began to use a single drug to prevent and treat diseases. In the Shang Dynasty, because of the increased variety of drugs and the enrichment of knowledge about diseases, more drugs were selected according to the different symptoms of illness to formulate compound prescriptions for clinical uses. People began to use compound drugs instead of a single one, thus greatly improving the curative effect. This is the embryonic form of prescriptions of TCM. A prescription book entitled "The Prescriptions for Fifty-two Kinds of Disease" was unearthed in 1979 from the No. 3 Han Tomb at Ma Wang Dui, Changsha, Hunan Province. It is the earliest extant medical formulary in China. With the development of traditional Chinese medicine, the prescription itself has also become perfected and enriched. Around the Warring States period and in the Qin and Han Dynasties, a classical writing of TCM entitled "The Yellow Emperor's Canon of Internal Medicine" came out. This is the earliest book dealing with the basic theories of the science of TCM formulae, such as the principle of formulating a prescription, incompatibility of drugs in a prescription, some dosage forms and their usages. The book consisting of 13 prescriptions has laid a solid foundation for the formation and the development of the science of TCM formulae. Zhang Zhongjing, an outstanding physician in the Eastern Han Dynasty, after diligently seeking the ancient experience and book knowledge and extensively collecting numerous prescriptions, compiled "Treatise on Febrile and Miscellaneous Diseases" which contains 269 prescriptions. This book gives interpretations in detail to the modification of the prescriptions and their administrations. The dosage forms are also quite excellent. Therefore, the book has been honored as the "forerunner of

prescription books" by all the later physicians. In the prosperous period of the Tang Dynasty, more voluminous prescription writing came out one after another and promoted the development of science of TCM formulae, such as "The Prescriptions Worth a Thousand Gold for Emergencies" and "A Supplement to the Essential Prescriptions Worth a Thousand Gold for Emergencies", compiled by Sun Simiao, and "The Medical Secrets of an Official" compiled by Wang Tao consisting of more than six thousand prescriptions. The three medical formularies representing the major achievements made before the Tang Dynasty collected famous earlier prescriptions in the previous historical periods and some foreign prescriptions used in the Tang Dynasty and preserved the materials on prescriptions. In the Song Dynasty, the government once organized outstanding physicians to compile "Peaceful Holy Benevolent Prescriptions" (with 16834 prescriptions), "General Collection for Holy Relief" (with approximately 20000 prescriptions), and "Prescription of Peaceful Benevolent Dispensary" (with 788 prescriptions). The last one was compiled on the basis of the revision and supplement to the formularies collected by the Official Pharmaceutical Bureau. It is one of the earliest formulary in the world compiled by the National Pharmaceutical Bureau. Each prescription gives interpretations in detail to its indications, ingredients and preparation of drugs. This prescription book--a "legal" formulary of Chinese patent medicines in the Song Dynasty and also the first pharmacopoeia of the Chinese patent medicines is a big step towards the standardization of prescription. 'Expounding on the Treatise on Febrile Diseases" compiled by Cheng Wuji, a physician in the Jin Dynasty, selected 20 prescriptions from the book "Treatise on Febrile Diseases" and analyzed them in detail, especially clearly described the different roles of the principal, assistant, adjuvant and guiding drugs. It is the first theoretical book on the interpretations of prescriptions and contributes a great deal to the development of theoretical prescription treatises of later periods. Dr. Zhu Su of the Ming Dynasty and others collected almost all the medical formularies having been used before the fifteenth century and compiled the most voluminous medical book "Prescriptions for Universal Relief" with as many as 61739 prescriptions in it. In the Qing Dynasty, with the emergence and development of the schools of epidemic febrile diseases came into being, enriching and perfecting the contents of pharmacology of TCM formulae. In addition, in the Ming and Qing Dynasties a lot of monographs on prescriptions were published such as "Textual Criticism on Prescriptions" and "Collection of Prescriptions with Notes," thus further promoting the development of the theoretical research of the science of TCM formulae. Since the founding of the People's Republic of China, a great number of prescription books have come out. Many ancient prescriptions, secret prescriptions, proved prescriptions have been collected, systematized, researched and widely applied to different clinical departments; their therapeutic mechanism researches. Meanwhile a lot of new effective prescriptions have been created and the reformation in the dosage forms of prescriptions have been carried out. As a result, a new prospect in the development of science of TCM formulae has been opened up. To sum up, the formation and development of pharmacology of TCM formulae have undergone a very long historical process from the elementary stage to the advanced

one, with forms simple to complex and has gradually become an independent science with a relatively perfect theoretical system.