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The Promise of Modern Phytotherapy.

Dan Kenner is licensed to practice Oriental medicine in Japan and the United States. He began practice in 1978, after graduation, hospital internships, and three years in a private practice clinic. He is author of Botanical Medicine: A European Professional Perspective and Kampo: A Clinical Fast-Reference Guide, as well as AHCC: A Superfood Nutrient From Japan. Kenner works in the Integrative Medical Clinic of the California Institute of Integrative Medicine (CIIM) in Santa Rosa, California, and is on the boards of CIIM and Meiji College of Oriental Medicine in Berkeley, California.

For what kinds of patients does phytotherapy work most reliably?

Botanical medicine, or phytotherapy, is the most widespread form of medical treatment in the world. The World Health Organization (WHO) estimates that 80 percent of the world's population relies principally on traditional medicines, in which phytotherapy plays a central role.1 Traditional Chinese Medicine (TCM), with its numerous variants, is the most pervasive form of medical therapy in East Asia. Even in Japan, 70 percent of physicians prescribe botanical formulas from Kampo, or Chinese medical tradition.2

In the industrialized West, the use of herbs and botanical extracts plays an increasing role in health care. In France alone, somewhere between 3,000 and 4,000 physicians use phytotherapy for primary care. Great Britain licenses "Medical Herbalists." German medical schools teach phytotherapy. In the U.S., the sale of herbs is undergoing significant growth. Sales of herbal medicines increased 59 percent in 1997 and are growing 20 percent a year, with the largest growth of sales in retail pharmacies.3 According to Landmark Health Care of Sacramento, California, herbal therapy has the highest utilization rate of all alternative health care in the U.S., at 17 percent. Among the people surveyed, 70 percent say that they are most likely to use herbal therapy.

Because of this renaissance of interest in phytotherapy in the industrialized West, there has been an increase in clinical research to determine which herbs "work" for which diseases. The issue of how to evaluate herbal efficacy raises larger issues of how patients are initially evaluated and how herbs are selected for prescription.

Traditional herbal methods individualize herbal prescriptions according to a "functional" nosology, organizing signs and symptoms in terms of physiological activities. For example, Chinese medicine uses the term "Spleen qi (energy)" to describe physiological activities like peristalsis, digestive absorption, and the circulation of lymph. Conventional allopathic ontological-localized nosology of disease names is not necessarily relevant to this "functional" diagnosis. The ontological-localized nosology classifies a disorder as a lesion or anomaly within a given anatomical system. A typical example is a gastric ulcer, consisting of a lesion (ulceration) in a locus (stomach). But Chinese practitioners would not be guided by this lesion/location diagnosis in their phytotherapy evaluation. The relevant Chinese functional nosological entities might be "Spleen dampness," "Spleen qi vacuity," or "Liver qi congestion."4

But each of these Chinese nosologies, like all functional classifications, is a disorder of the patient's entire physiology. "Spleen dampness" might indicate mucous membrane hypersecretion. A "Spleen vacuity," in Western terms, could mean an enzyme deficiency or immune system disorder. "Liver qi congestion" might indicate biliary dyskinesia or a psychogenic disorder. But each of these Chinese diagnostic categories can have a variety of manifestations. For example, spleen dampness can manifest as gastrointestinal disorders, arthritic disorders, bronchitis, or even epilepsy. From the Chinese viewpoint, what is at issue is not merely a lesion in the location where it happens to appear, but the redressing of a dangerous imbalance that might lead to other symptoms if balance is not reestablished. Diagnosis of these functional conditions in all cases requires a thorough history and physical examination. New research strategies in Japan and China have endeavored to compensate for this dissonance between holistic and reductionistic paradigms.

Prospective research

"Nobody likes to ask if a model is really correct, since if they did, most work would have come to a halt."

-Francis Crick, What Mad Pursuit, 1988

The double-blind placebo-controlled study is the gold standard for determining efficacy in the evaluation of drugs. In fact, double-blind paradigms are fraught with uncertainty.5 There are also questions about the scientific definition of a placebo.6 And although double-blind placebo-controlled studies supposedly determine pharmaceutical drugs to be safe and effective, the frequency at which they have been subjected to review (nearly 50 percent) and even taken off the market casts doubt on the scientific infallibility of this standard. It is likely, however, that the double-blind placebo-controlled study will maintain its status for the foreseeable future. Newer methods of evaluation such as outcome studies are acceptable to the academically oriented, but are less acceptable to more conservative government regulatory bodies.

Botanical medicines are not only marketed but also included in the National Health Insurance systems in Japan and France. Yet it has seemed economically unwise for herbal manufacturers to do controlled clinical trials of their products. Controlled studies that could yield negative results are avoided as unnecessary risks, since the game is rigged to their disadvantage. The conventional profession complains, "Why don't they want to test their medications? What have they got to hide?" But no single herb is effective for treating all patients, of different genetic types, different etiologies, and different physiological parameters. Because of the paucity of clinical trials, some National Health Insurance coverage has been reduced, but this has not stopped the Japanese or the French from being among the highest consumers of herbal products in the world.

China has integrated modern research methodology with holistic prescription systems. Chinese diagnostic criteria are identical to the WHO criteria for hypertension, a Western diagnostic entity. Then Chinese practice subdivides these patients into subcategories like: "Exuberance of liver fire," "Vacuity of yin with an exuberance of yang," "Vacuity of yin and yang," or "Accumulation of phlegm-dampness." Chinese hepatitis studies evaluate all patients with standard blood tests for liver enzymes and antibodies. Then clinical evaluation subdivides the population into groups of "Spleen vacuity with invasion of toxicity," "Damp-heat of liver and spleen," "Vacuity of yin with heat in the blood," and "Blood stagnation and obstruction in the liver channel." Cerebral vascular accident is subdivided into no less than nine different diagnostic categories.7 Each category of diagnosis indicates a different type of herbal prescription. As results are obtained, they are collated and evaluated collectively according to "Western" diagnoses.

In Japan, similar attempts to individualize treatment in research design were met with suspicion. Despite good initial media coverage, the medical community disparaged individualized treatment with different herbal formulas according to the patient's symptom-sign complex as lacking controls and rigorous research design. Despite such criticism, the Japanese results were good enough to get the attention of researchers who did further studies using more reductionistic research designs.

Unfortunately there have been some negative effects from using the same herb formula for all patients with hepatitis C or liver cirrhosis. For example, the herb bupleurum (Bupleurum falcatum) contains saikosaponins a, b, c and d. Saikosaponin b has been shown especially effective for treating intractable chronic hepatitis.9 Minor Bupleurum Combination contains ginseng (Panax ginseng), which contains saponins that protect liver cells from carbon tetrachloride-induced hepatotoxicity and accelerate regeneration of liver cells.11 Minor Bupleurum Combination also contains licorice (Glycyrrhiza glabra) which increases interferon production. Glycyrrhizin, an active compound of licorice, has been used intravenously for chronic hepatitis B and has caused complete recoveries on occasion.10 Another ingredient of Minor Bupleurum Combination is Scute, also called Chinese skullcap (Scutellaria baicalensis), which has been shown to stimulate the production of interleukins (IL-5, IL-6 and IL-10) in hepatitis C patients.12 So based on laboratory science criteria, Minor Bupleurum Combination seemed a good candidate for a "one-size-fits-all" hepatitis treatment.8

However, four patients taking Minor Bupleurum Combination for chronic hepatitis C developed interstitial pneumonitis, possibly caused by interferon or the combination of interferon with the formula. Interstitial pneumonitis is also induced by granulocyte colony- stimulating factors (G-CSF). It was subsequently found that Minor Bupleurum Combination stimulated G-CSF production in peripheral blood mononuclear cells.13

Numerous variations of bupleurum-based formulas treat a variety of symptom-sign complexes and types of patients. When immune system mechanisms go into action in the presence of hepatitis B virus, some people recover and others die, not only because of severity of the virus, but because of individual differences in disposing of it. The traditional-style herbalist would ask whether these negative results were caused by a failure to individualize treatment, that damaged the yin in susceptible patients, or by an immune system reaction to mobilizing too many necrotic liver cells at once.

Applying conventional research methodologies to phytotherapy research has created numerous other difficulties. Combinations display different properties than their component herbs, and single herbs behave differently from "active principles."14 Formulas' synergies depend not only on their combination of herbs but also on their method of preparation. Researchers found that saikosaponins a & d were not available in Minor Bupleurum Combination, but saikosaponin b was abundant.15 In other bupleurum combinations used to stabilize psychic and nervous system functions, saikosaponins a & d were available, but not b.15 The synergy of components in the formulas causing different chemical reactions was the explanation for the discrepancies. Researchers found that when they decocted licorice root with coptis root (Coptidis chinensis), new compounds were formed that were not present in either herb.

Such synergies of herbal formulas challenge paradigms based on active principles. Most formal attempts to validate herbal medications focus on which chemical components are active for certain symptoms or diseases. Researchers found that serum levels of the active principle of Ma Huang (Ephedra sinensis), ephedrine, were higher in patients that had been given Ma Huang and Apricot Seed Combination than in patients that were given pure ephedrine.16 Serum ephedrine levels were obtained when Ma Huang was decocted in the traditional formula Ma Huang and Gypsum Decoction with no new compounds formed from the decoction process.17 Licorice was found to potentiate the activity of the ephedra even though it decreased the plasma level of ephedrine.

So there is a need for methods of testing appropriate to botanical medication. Ignoring the details of personal history and physical examination will neither validate the traditional uses of herbs nor develop their therapeutic potential. When traditional formulas were reintegrated into the health care system in Japan in the early 1970s, the Japanese Medical Association took the position that conventional diagnostic methods were not sensitive enough to make prescriptions of traditional formulas. Prescription of herbal formulas depended on subjective evaluation of the symptoms and signs traditionally associated with the formulas. The use of traditional formulas was adopted without validation studies because it was believed that modern methods of laboratory evaluation could coexist with the traditional clinical observations.18 Yet the rewards of developmental research in phytotherapy may be rich.

Several botanical medications show promise in cancer treatment. Previous claims stated that Chinese herbal medicine only prolonged the lives of patients and protected their immune systems. Clinical trials indicated that their cancers were effectively treated with few side effects. The Chinese herbal combination known as PC-SPES proved effective in the treatment of prostate cancer.20 An intravenous herb drip and oral preparation of the herb Semen coicis has been used to induce remission of different types of cancer, especially digestive tract cancers.21 In Europe as well, intravenous Chelidonium majus,22 Helleborus niger,23 and Dionaea muscipula24 have demonstrated dramatic effects not only in strengthening the function of the immune system, but also in tumor reduction. Doctors in France using a whole-system model are able to individualize diagnosis and use botanical medications to regulate nervous system and endocrine function to a sophisticated degree, treating even disorders like diabetes and hypothyroidism without the use of hormones. They are able to treat even severe infections without antibiotics utilizing the powerful disinfectant properties of essential oils.19

Herbal extracts are used in Chinese hospitals for treating cardiovascular disease, autoimmune diseases, bacterial infections, kidney diseases and burns.25 These breakthroughs in herbal treatment are being made in countries conducting developmental research in treating chronic disease problems with non-toxic therapies.

Standards

In the U.S. today, much of the controversy over herbal products in the marketplace is about standards of quality. The 1994 Dietary Supplement Health and Education Act (DSHEA) classification of herbs, vitamins, minerals, etc. as nutritional or dietary supplements has been criticized for allowing these supplements to be marketed without testing for safety, efficacy, or quality. In fact, the safety definition for dietary supplements is actually stricter for supplements than it is for foods or drugs. Dietary supplements, including herbs, are considered unsafe if they "present a significant or unreasonable risk of illness or injury." By contrast, drugs are permitted to present "significant" risks, as long as risks are outweighed by benefits. By law, statements made about efficacy must be supported by scientific evidence.26 The U.S. Food and Drug Administration is required to prove a product unsafe before it can be taken off the market. Regulating agencies in Germany, France, the United Kingdom, Canada, and Japan also enforce standards of herbal product quality, as well as safety assessment of herbal product manufacturers.27 28

There remain several uncertainties with regard to standards. Potency of substances is also affected by growing conditions, storage, handling, as well as subsequent methods of preparation. Standards of potency are resolved by standardizing the quantity of an "active principle" of an herbal extract. Critics of standardization claim that destroying the integrity of an herb's natural chemical balance by adding other substances, sometimes synthetic, to standardize the product does not enhance quality.29

Another controversy arises over which component is the active one. Many herbs have numerous substances that could be deemed "active." We have already seen the problems of "active principle" isolation and interaction in the Bupleurum case above. France's solution confers pharmaceutical grade status on botanical extracts containing minimum levels of all constituents designated pharmacologically active.

Accurate plant identification is another important issue in standards of quality. Mistakes can be made when the wrong part of the plant is used, for the same plant may have parts with very different types of activity. Bogus echinacea has appeared on the market. There have also been cases of fraudulent ginseng labeling.32 Herbs have also been misidentified with dangerous results, as in the case where belladonna poisoning occurred among consumers of an herbal tea in New York City.30 In another case digitalis poisoning resulted from ingesting a mislabeled extract of plantain.31

Contamination of herbal raw materials can pose a problem. Crude plant substances in warehouses can be subjected to spraying with pesticides. Different countries have different standards regarding agricultural pest control. Pesticides banned in the U.S. are still widely used in other countries. Heavy metal residues in Chinese herbal patent medicines have been detected in the U.S., perhaps as a result of pesticide contamination.33 But it should be noted that many Chinese companies conform to international standards of quality and purity in their manufacturing practices.

France uses high performance liquid chromatography (HPLC) for analysis of components as well as in the detection of contaminants in products designated pharmaceutical grade. The Pharmaceutical Affairs Bureau of Japan's Ministry of Health and Welfare also regulates the quality of botanical formulas, monitoring specific plant constituents so that the herbal ingredients of each formula meet precise standards of quality.34

Medical education

The greatest concern to physicians in the U.S. today is herb-drug interactions; information is limited on the vast variety of herbal products on the market, but it is gradually becoming available. In the U.S., the likelihood of interactions between drugs and herbs is higher than elsewhere because doctors in the U.S. are more likely to prescribe a prescription drug than an herb, compared to Germany or Japan, where many doctors already use alternatives. National health care in Germany and Japan already covers herbal products prescribed by physicians. In the U.S., physicians are beginning to notice that over 60 million Americans use herbs; the number is even higher if other supplements are included. This number is expected to increase, especially in medical use, as insurance companies begin to cover herbal use. It is desirable that all health care providers have some basic knowledge of herbs, but it is also necessary for training to be available for those practitioners who wish to become specialists or experts in phytotherapy. The development of phytotherapy depends on the commitment of interested professionals to go beyond the "specific symptom" approach heavily promoted by manufacturers. This symptomatic approach simplifies the complexity of herbs and extracts into the image of a drug with a single type of application that allegedly benefits all potential users. This one-dimensional approach advocates St. John's Wort (Hypericum perforata) for depression, feverfew (Tanacetum parthenium) for migraines, or ginger (Zingiberis officinalis) for motion sickness.

The complex properties of herbs must be studied and applied within the context of more complex "functional" whole-system models of physiology. These systems are widely used even in official medicine in East Asia, and to a lesser extent in the U.S. and Europe. Whole-system models of clinical practice individualize treatment based on each patient's personal traits, body type, or "terrain," and the "balance" of physiological functions. If an exudative type of patient suffers from bronchitis, then herbs for hypersecretion should be used to dry up the condition. If the patient also suffers fatigue, is elderly, or has low adrenal function, an adrenal stimulant like black currant might be added. If the bronchitis patient has a spasmodic cough with bronchial constriction, a disinfectant substance might be recommended like essential oil of thyme, considered "vagolytic" by French phytotherapy doctors. If the bronchitis patient has a diabetic tendency, oil of eucalyptus, considered to be hypoglycemiant, might be chosen instead.35 As in French phytotherapy of the terrain, Ayurvedic and Chinese medical systems have long traditions of diagnosis that adjust treatment according to a complex interpretation of symptoms and signs.

It is important to understand these models of phytotherapy as being problem-solving methodologies, or clinical "software," and not merely cultural artifacts or metaphysical ideologies. Although Ayurveda and some systems of Chinese medicine may appear metaphysical, they also contain the elements of patient-centered practice. These systems are taught in China, Japan, India and in some western European nations. In the U.S., many acupuncture specialists study traditional-style Chinese phytotherapy. When successful, a whole-system approach will match the patient's pathophysiology correctly and preclude the possibility of side effects. In reality there are no "side effects" for any medication. There are only effects. The goal of whole-system treatment is to seek the correct combination of herbs to balance out unwanted effects or one- sided effects from individual herbs.

Teaching whole-system models for herbal prescription to practitioners of phytotherapy will gradually produce a population of clinical experts with capabilities beyond the "patent medicine" approach. Instruction in entry-level herbal medicine approaches should be made widely available to practitioners who do not intend to become specialists, but wish to offer the benefits of nontoxic treatment to their patients.

Public awareness

In the U.S. in recent years, articles have appeared in news media about the dangers of herbs. Alleged hazards are overstated even to the point of "fear propaganda," but the alleged dangers do not appear to represent a public health problem. According to the National Poison Control Center in Atlanta, the rate of occurrence of herbal poisonings is one out of every million. The most frequent causes of herbal poisoning are ingestion of house plants, usually by children, and mushroom poisoning. There have been no poisoning fatalities from commercial products, and fewer than "a half-dozen cases in five years."36

By contrast, the fourth leading cause of death in the U.S. is fatalities from prescribed drugs; the number of such deaths exceeds 100,000 a year. Every year, prescription drugs cause 1 million injuries so severe that they require hospitalization; another 2 million drug-related injuries occur during hospital care.37 Dr. Brian Strom, Associate Director of Medicine and Pharmacology at the University of Pennsylvania School of Medicine, estimated that drug side effects result in the hospitalization of 1.6 million people at a cost of more than US $20 billion each year.50 In a review of one ten-year period by the Government Accounting Office, more than half of newly-approved drugs were recalled due to unexpected side effects-problems that had not yet surfaced during the long and expensive research conducted for the FDA approval process.38

These numbers, while horrifying, do not negate the importance of physicians' concerns over herbal safety. Estimated sales of herbal medicine in the U.S. reached $1.2 billion in 1996.40 According to a survey by Applied Biometrics of North Palm Beach, Florida, 62 percent of American consumers take herbs for disease prevention, 54 percent to increase energy, 40 percent to improve fitness, 31 percent to increase alertness, and 27 percent to reduce stress.41 Many patients in the U.S. and Europe seek nontoxic "soft" therapy first and use dangerous substances as a backup or last resort. In France, Germany, Japan, and China, physicians have adapted to this strategy. In Japan in the 1960s there was a public uprising, now referred to as the "Kampo Boom," when public demand rehabilitated the traditional herbal medicine against the excessive use of pharmaceuticals. Even though this has not solved the problem with the overuse of drugs, it now offers an alternative within the mainstream.39

The chief danger of herb use is in additive interactive effects with prescription drugs the patient already is using. Consumers would be well advised to consult with experienced phytotherapy practitioners regarding the long-term use of any botanical substance or combination. Consumers using prescription drugs should obtain medical advice regarding potential problems resulting from herb-drug interactions. Women should exercise special caution if pregnant or lactating. Consumers who are self-medicating using packaged products should shop for those that label the expiration date, lot number, botanical name of the herb, strength of the recommended dose, and the name and address of the manufacturer. No reasonable person would oppose efforts to develop standards, or a grading system for botanical products with respect to their proper identification, potency, safe handling, proper storage, and their influences on pathophysiology. All efforts to do so are salutory, beneficial for the public and for the health care professions.

Cost-effectiveness

Formal cost-effectiveness studies are rare even in East Asia where the economic impact of herbs in the medical marketplace is greatest. One reason that 10 percent of Americans self-medicate is that herbs are much less expensive than prescription drugs.42 In Third World nations, drugs are prohibitively expensive for an even larger portion of the population. When an herb can be shown to be as effective as a pharmaceutical drug for a medical disorder, it can be a significant cost reduction factor. In Germany, Bayer Corporation markets St. John's Wort as an antidepressant. In Canada, Nytol maker, the Block Drug Company, sells valerian as a sleep aid, and Johnson & Johnson sells feverfew for migraine treatment. Studies have shown saw palmetto (Serenoa repens) berry extract as effective as finisteride for benign prostatic hyperplasia.43 Herbal medications are potentially effective for withdrawing patients from benzodiazepine drugs, at a significant savings in cost as well as in quality of life.44 Herbs have also been tested for a variety of other complaints including nausea,45 hyperglycemia,47 circulation problems,48 hypercholesterolemia,49 and hormone regulation for disorders of climacteric.46 Thus there is tremendous potential to reduce health care costs by using herbs and herbal extracts.

The use of nontoxic therapies can also be contrasted with the cost- effectiveness of a system based primarily on pharmaceutical drugs. As one counts the miracle drugs that have appeared and disappeared over the history of pharmaceutical companies' producing dangerous products that are later quietly removed from the market, one gets the impression of a serious failure to provide safe, inexpensive care. If we include quality of life issues, the problem is less quantifiable, but no less significant. Drug side effects such as impotence, depression, rashes, dizziness, confusion, and even shortened life span underscore the need to develop an accounting of risks versus benefits that is not just quantitative. These dangers are a significant reason that $11 billion has been spent by one-third of Americans on alternative health care.51

Education about phytotherapy should include the laboratory-based approach to symptoms and diseases, but should also make use of whole- system clinical models. Efforts to educate the public, the health care professions, and public policy-makers about the integration of botanical medicines into the health care arena should objectively evaluate the costs and benefits of existing pharmaceutical-based medical systems and its acceptability to consumers.

The future development of phytotherapy in world medicine will require new levels of research addressing treatment of cancer, AIDS, cardiovascular diseases, chronic pain, and similar health care problems that most burden public health provider systems. In order to integrate phytotherapy into national health care delivery systems, we face an urgent need to solve problems of quality control standards, efficacy, and third-party payment. Future developments in phytotherapy should include research into cross-cultural comparison of how phytotherapy is integrated into health care systems in different nations.

Notes

1. Saleh, A.A., "La plante medicinale de la tradition a la science." First International Congress of Clinical Phytotherapy. Paris: Jacques Grancher, 1997.

2. Ross, C. "New life for old medicine." Lancet. 1992, 342: 486-487.

3. Drug Store News. "The right stuff: Drug Store News picks the categories taking off in '94." 1994, 16: 15.

4. Ellis, Wiseman and Boss. Fundamentals of Chinese Medicine. Brookline, MA: Paradigm, 1988.

5. Fisher, S., Greenberg, R., "Second opinion: rethinking the claims of biological psychiatry." The Limits of Biological treatments for Psychological Distress. Hillsboro, NJ: Laurence Erlbaum, 1989.

6. Parfitt, Andrew. "Placebo treatments." Proceedings of the First Symposium of the Society for Acupuncture Research. Rockville, MD, 1993.

7. Xinyao Shenpi Banfa (Provisions for New Drug Approval). Beijing: The Ministry of Public Health, 1985 (In Chinese and English).

8. Abe, H., Arichi, S., et al. Yakugaku Zasshi [Journal of Pharmacology] 1980, 100(6): 602-610.

9. Li, W., and Lien, E., "A survey of Chinese herbs: Bupleurum chinense," Bulletin of the Oriental Healing Arts Institute. 1984, 9 (5): 237-245.

10. Sato, H. et al., "Therapeutic basis of glucyrrhizin on chronic hepatitis B."Antiviral Research (Toyama Medical and Pharmaceutical University, Japan), May, 1996, 30 (2-3): 171-177.

11. Jeong, T. C., et al., "Protective effects of ginseng saponins against carbon tetrachloride-induced hepatotoxicity in Sprague Dawley rats." (Toxicology Research Center, Korea Research Institute of Chemical Technology, Taejon.) Planta Med. April 1997, 63 (2): 136-140.

12. Yamashiki, M. et al., "Effects of Japanese herbal medicine Sho- saiko-to (TJ-9) on in vitro interleukin-10 production by peripheral blood mononuclear cells of patients with chronic hepatitis C." Hepatology , June 1997, 25 (6): 1390-1397.

13. Ishizaki, T. et al., "Pneumonitis during interferon and/or herbal drug therapy in patients with chronic active hepatitis." European Respiratory Journal. Dec. 1996, 9 (12): 2691-2696.

14. Kenner, Dan, & Requena, Yves. Botanical Medicine: A European Professional Perspective. Brookline, MA: Paradigm, 1996, p. 18.

15. Kubo, Michinori, Kampo Iyakugaku. Tokyo: Kogawa shoten, 1985, pp. 83-86.

16. Kubo Michinori, Kampo no Rinsho Yakugaku. Osaka: Kaigai Pub. 1978, p. 37.

17. Hasegawa, M., ed. Herbal Medicine: Kampo Past and Present. Tokyo: Tsumura Juntendo, 1985, pp. 52-66.

18. Yakazu, D., "Takemi Kaicho ga Kampo Seizai wo Yakka Kijun ni Tosai no Ketsui wo surumade no Haikei [Background of the decision of inclusion of Kampo drugs in the National Health Insurance by Dr. Takemi, President of the Japanese Medical Association." Kampo no Rinsho, 1987, 34 (7): 442-447.

19. Kenner, Dan, & Requena, Yves, as in note 14.

20. Study at Sloan Kettering Memorial cited in The New Yorker, October 26, 1998. No completed studies published yet, but studies are under way at the Cancer Research Institute, New York Medical College, Robert Wood Johnson Medical School, and the University of California at San Francisco Cancer Center. Early findings consistently reported PSA levels lowered by 50% and clearance in major metastatic sites.

21. Ye, J. Q., et al., Jiangsu Zhongyi [Jiangsu Journal of Traditional Chinese Medicine]. 1962, (1): 29, reports that Zhejiang College of Traditional Chinese Medicine developed "Kang Lai Te," patented in China, Russia, the Philippines, and the U.S. for cancer treatment.

22. Nowicky, J. W., et al., "Sensitization for specific lysis in target-effector-systemwith derivatives of Chelidonium majus L. alkaloids." Proceedings of the 16th International Congress of Chemotherapy, Ukraine, June 1989, p. 852.

23. Trials underway in Germany.

24. Todorov, D.K. et al., "Antitumor activity of Dionaea muscipula E. preparation Carnivora new in vitro and in vivo, on animal and human tumors sensitive and resistant to antitumor drugs," (National Center of Oncology, Sofia, Bulgaria,) Biotech. & Biotechnol. Eq., 1998, 12: 2.

25. Li, C. P. Chinese Herbal Medicine, U.S. Dept. HEW, NIH (1974).

26. McCaleb, R. Herbal Research Foundation's response to the New England Journal of Medicine editorial of September 17, 1998: www.herbs.org.

27. Tyler, V. E., Herbs of Choice: The Therapeutic Use of Phytomedicinals. Binghamton, NY: Pharmaceuticals Products Press, 1994.

28. Newall, C. A., Anderson, L. A., and Phillipson, J. D., Herbal Medicine: A Guide for Health Care Professionals. London: Pharmaceutical Press, 1996.

29. Awang, D., "Feverfew trials: The promise of - and problem with - standardized botanical extracts." Herbalgram, 1997, (41): 16-17.

30. "Herbal roulette." Consumer Reports. November 1995: 698-705.

31. The Denver Post. June 13, 1997.

32. Siegel, R. "Kola, ginseng, and mislabeled herbs." Journal of the American Medical Association, 1978, 237: 24.

33. Ko, R. "Adulterants in Asian patent medicines," New England Journal of Medicine, 1998, 339 (12).

34. Tsutani, K. "Dentoteki Iyakuhin ni tai suru Senshinkoku no Seifu, Seiyakusangyo no yakuwari [Role of the government and the drug industry on traditional drugs in developed countries]." Rinsho Igaku, 1988, 4: 855-860

35. Duraffourd, C., Lapraz, J. C., Valnet, J., ABC de la Phytotherapie dans les maladies infectieuses. Paris: Jacques Grancher, 1998.

36. Atlanta Poison Control Center.

37. Moore, T., "Prescription for Safety," Natural Health, October, 1998, pp. 52-55.

38. General Accounting Office, April, 1990.

39. Fukushima, M. "Overdose of drugs in Japan." Nature, 1989, 342: 850- 851.

40. Tyler, V. E., "What pharmacists should know about herbal remedies." Journal of the American Pharmacological Association, 1996, 36: 29-37.

41. The Business of Herbs, March/April, 1996, p. 29.

42. Duke, J. "Why people take supplements," Nature's Herbs, 1(2).

43. Bach, D., Schmitt, M., and Ebeling, L. "Phytopharmaceutical and synthetic agents in the treatment of benign prostatic hyperplasia (BPH)." Phytomedicine, 1997, 3 (4): 309-313.

44. Rasmussen, P. "A role for phytotherapy in the treatment of benzodiazepine and opiate drug withdrawal (part 1)." The European Journal of Herbal Medicine, 1997, 3 (1): 11-21.

45. Bone, M. E., et al., "Ginger root: a new antiemetic: the effect of ginger root on postoperative nausea and vomiting after major gynecological surgery." Anesthesia, 1990, 45: 669-671.

46. Zava, D. et al., "Estrogen and progestin bioactivity of foods, herbs and spices." PSEBM, 1998, 217: 369-378.

47. Yokozawa, T. et al., "Studies on the mechanism of the hypoglycemic activity of ginsenoside-Rb2 in streptozotocin-diabetic rats." Chem Pharm Bull. 1985, 14: 255-259.

48. Bauer, U. "Six-month double-blind randomized clinical trial of Ginkgo biloba extract versus placebo in two parallel groups in patients suffering from peripheral arterial insufficiency." Arzneim Forsch Drug Res. 1984, 34 (1): 716-720.

49. Aue, W. et al., "Hypertension and hyperlipidemia: garlic helps in mild cases." Brit. J Clin Pract. 1990, 69: 3-6.

50. Strom, B., "As prescription drugs cure, some side effects harm," Philadelphia Inquirer, June 24, 1990.

51. Natural Pharmacy, Oct/Nov 1996, 1 (1).

From Time for Healing: Integrating Traditional Therapies With Scientific Medical Practice, ed. Carl Becker (St. Paul: Paragon House). (c) 2003 by International Conference on the Unity of the Sciences
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