The World Health Organization recently estimated that Japan consumes more botanical medicines and other natural products per capita than any other country on Earth. The island nation is a veritable wellspring of natural medicines, some of which are based on centuries-old traditional medicines and foods. Botanicals and natural products are commonly used by Japanese MDs, and their manufacture is regulated according to pharmaceutical standards by the government. Recently, a number of these products have been introduced into the US market. In this and upcoming issues of Holistic Primary Care, we will explore some of the most innovative products to emerge from across the Pacific.
Practitioners of Kampo, Japan's botanical medicine tradition, are enthusiastic about the opportunity to have one of their standardized herbal formulas undergo a formal clinical trial here in the U.S., following a long period of extensive clinical study in Japan.
The first trial of a botanical formula from Japan's Kampo tradition is at the patient-enrollment stage at Memorial Sloan-Kettering Cancer Center (MSKCC) in New York City. Researchers Andrew Vickers, Ph.D., and surgeon Yuman Fong, M.D., will explore the potential benefit of Sho-Saiko-to (Xiao-Chai-Hu-Tang in Chinese herbal medicine)—a traditional formula for liver disease—in non-resectable liver cancer patients treated with ablation therapy.
MSKCC investigators are in the process of enrolling 80 subjects who are expected to receive a 7.5 grams per day dose of Sho-Saiko-to over a two-year period. The formula contains bupleurum root, pinellia tuber, ginger, scutellaria root, jujube, ginseng, and licorice, many of which have already shown therapeutic effects on hepatic cells.
The one-year follow-up would include a historical cohort comparison, analyzing liver function, alpha-fetoprotein, and 15-month median survival time that remained intervention-free. (Those interested in participating are encouraged to explore the clinical trial website listing at www.mskcc.org.)
The version of Sho-Saiko-to (also known as H09) to be used in the MSKCC trial is distributed by Tempe, Arizona–based Honso USA, a subsidiary of Japan's Honso Pharmaceutical Co., which makes the formula using seven herbs first utilized in traditional Chinese medicine. Honso is the first company to bring Kampo formulas to the US. In addition to Sho-Saiko-to "Liver Kampo," the line includes formulations for women's health, weight loss, digestion, cold and flu defense, nasal congestion, migraines, healthy prostate, and energy enhancement.
Dan Wen, MD, President of Honso USA, is a licensed acupuncturist who gives lectures nationwide to medical groups about Kampo. He told Holistic Primary Care that Sho-Saiko-to has been shown to have hepatoprotective, immunostimulant and antiproliferative properties in several previous in vitro trials.
"What we'd really like to study is the compound's activity against hepatitis C. I believe that will be most promising based on earlier reports," said Dr. Wen. Sho-Saiko-to is widely administered in Japan to patients with chronic hepatitis and cirrhosis. MSKCC approached Dr. Wen about inclusion of the formula in the hepatic carcinoma study, which is funded by the cancer center itself.
Sho-Saiko-to is one of the most well researched botanical formulas for liver function with over 50 investigations to date. In a prospective study at the Tokushima University School of Medicine, it showed a chemopreventive role in the development of hepatocellular carcinoma in patients with cirrhosis.
The exact mechanisms by which Sho-Saiko-to protects against hepatic carcinoma remains a mystery, although animal studies suggest it has anti-carcinogenic properties. Herbs within the formula act as biological response modifiers and suppress proliferation of hepatoma cells by inducing apoptosis. Clinical trials in the U.S. may offer more insight about the action of specific chemical compounds.
|Japanese medical prints courtesy of the Clendening History of Medicine Library, University of Kansas Medical Center.
Traditional botanical medicine doesn't really adhere to national boundaries. We may refer to a healing tradition as Chinese, Tibetan, or Japanese. But remedies have always migrated across cultures and lands. Blending at the borders, reshaped and altered by local botanical usage and regional preferences, traditional medicine has always been much more dynamic than many modern practitioners realize.
The Japanese have a reputation for improving the efficiency of whatever comes their way. Whether or not it's true is another matter, but that reputation merits some credibility in the evolution of Kampo, which migrated from China to Japan by way of Korea, somewhere between 500 and 1,000 AD. The name itself—Kampo—literally means "Chinese method."
For centuries Kampo existed as an oral tradition. The tendency to simplify, standardize and develop consistent quality formulas began with its first arrival in Japan. Legend has it that early Buddhist monks adopted several hundred Chinese herbal recipes as first-aid measures but resisted the longer apprenticeships of pulse and tongue diagnosis. Having a ready-to-go pharmacopoeia tailored to a precise set of symptoms was a bold move toward efficiency and represented a sort of democratization of herbal therapies.
As the centuries went on, though, the sciences of highly individualized diagnosis typical of Chinese tradition resurfaced in Japan. Skills in abdominal palpation, tongue and pulse diagnosis, and an elaborate method of sign and symptom matching through a sophisticated scoring system, were integrated into Japanese Kampo. Until the mid-19th Century, this constituted the official medical system of Japan.
Today, the Kampo "barefoot doctors" of the past have been virtually obliterated in modern Japan, with its insistence on formalization and standardization. Japan embraced Western-styled medicine as early as 1866 at the start of the Meiji era, and under the government-initiated modernization reforms traditional healers were forced "underground." Still, Kampo is practiced in modern Japan, primarily by MDs or pharmacists licensed to work with about 150 standard Kampo formulas approved by the Ministry of Health and Welfare (the Japanese equivalent of the FDA). Over 210 formulas exist, most unaltered from the original formulations centuries ago.
The herbal tradition is decidedly popular with modern Japanese. According to the World Health Organization, Japan has the world's highest per capita consumption of botanicals. In 1972, when the Japanese government instituted a licensing practice that recognized doctors only if they practiced Western-style medicine, the usually acquiescent Japanese public voiced a notable outcry. The demand was unmistakable: "Make Kampo available and accessible."
Since the '70s, its popularity skyrocketed. By 1990, the Health Sciences Institute reported that Japanese consumers were buying 1.5 billion bottles of Kampo annually. Currently, over 70% of MDs use it in their practice; about 95% of pharmacies carry the formulations, which are available through prescription only. And—US health plan executives take note—the Japanese national medical insurance covers Kampo formulas on the government-approved list.
Kampo in Modern Clinical Practice
The way to learn Kampo is through a mentored, clinical apprenticeship. Hands-on training is emphasized rather than learning through written materials.
Finding a Kampo practitioner in the U.S. takes some digging since the herbal therapy is not as well known as Western botanical medicine or traditional Chinese medicine. But that picture may change, according to Kampo expert Dan Kenner, Ph.D., L.Ac., of Santa Rosa, Calif. He predicts that the quickly delivered, easily assessed clinical application of Kampo will find a loyal following among time-pressed primary care physicians.
Recognizing that Kampo herbal formulations work synergistically and holistically in the body, Dr. Kenner believes they are much better suited to health service research settings which embrace a whole-systems orientation rather than laboratory or basic science investigations, which are by nature reductionistic and emphasize ruling out variables.
According to Dr. Kenner, Kampo is a much older herbal tradition than what we now know as TCM, which is actually a hybridization of traditional techniques developed by the Chinese government 50 years ago. Kampo formulas are time-tested with human usage over thousands of years. "The synergy of the formulas is rather remarkable," he said. "Changing just one herb in these well-honed preparations can create a completely different physiologic effect, as well as buffer or cancel out various constituent properties."
When asked why he prefers Kampo to TCM, Dr. Kenner said, "It's fast and incredibly effective, if done right. When you dispense a Chinese herb concoction, you have less compliance among patients. Think about it. They have to boil a foul-tasting herbal concoction for an hour or longer, perhaps add other herbs to the brew in the next few hours, then add a series of aromatic herbs at a steeping stage. It's a complicated procedure, even for practitioners, let alone people who are feeling too sick to stand over a stove." With Kampo, compliance is greater because the formulas come in easy-to-swallow tablets or granules made in accordance with pharmaceutical manufacturing practices.
Kenner's appreciation for the quick-delivery capacity of Kampo, as well the attention to sign/symptom recognition, was inspired by his observation of Kampo masters in Japan, where he trained. "Here (in the US), the doctor is expected to ask a lot of questions—to show interest and flush out the details. In Japan, patients have more confidence in their doctors if they can remain silent, while a skilled physician silently looks at physical signs—tongue, abdomen, pulse, physique. Then the patient asks, "What's wrong with me?" and the doctor announces the finding."
Modern Kampo practice shares much with modern TCM. It features its own descriptive diagnostic vocabulary, and a multi-layered scoring system including analysis of the state of a patient's Ki, (Japanese word for chi or life-force energy), determination of Ki-Blood Fluids, Five Yin Organs, Six Stages and Eight Parameters. The basic analysis broadens into a complex system of patterns and subpatterns. Botanical formulas are selected according to these patterns rather than "chief complaints."
For instance, in a patient with hepatic problems, the presence of a "white, furry" tongue, "wiry pulse," and medium build might call for a prescription of Sho-Saiko-to, the liver formula being studied at MSKCC. But another patient with the same symptoms but a frail or heavy build might require a different liver formula, with a different herbal composition. Once administered, the white furry tongue, indicating excess of "phlegm," might change to a "dry mucus" condition, and a completely different formula would advance the patient to the next stage of healing. This close observation of shifting signs and symptoms is what distinguishes a true "sensei" (Master) Kampo practitioner.
While extensive training helps, one can still make good clinical use of modern Kampo formulations by simply following the government-approved clinical algorithms. However, because Kampo formulations affect the entire body and not just a few symptoms, they can affect the metabolism of conventional medications. Dr. Kenner is currently translating not only the officially recommended Japanese guidelines for use of Kampo formulas, but also data on potential drug-herb interactions for each formula.
In its attention to clusters of symptoms or signs rather than disease labels, Kampo parallels the practice of classical homeopathy. And like other forms of holistic alternative therapy, the aim of Kampo is to enhance the body's self-healing strengths and restore the body's homeostasis. Side effects are minimal, if any, throughout the Kampo scientific literature.
The emergence of Honso's Kampo line in the US is not the only sign that this venerable herbal tradition may soon become part of American medicine. The Kampo Institute in River Forest, IL, now offers training in the Kampo tradition. Tsumura, another large Japanese producer of Kampo formulas also has plans to launch a line of formulas in the US.
To Learn More about Kampo
Kampo Institute, 7773 Lake Street, River Forest, IL 60305.
Hands-on training seminars with visual aids, offered by Miki Shima, OMD. Contact for information: (415) 924-2910.
Honso USA, Inc. Contact President Dan Wen. (A division of Honso Pharmaceutical Co Ltd., in Japan). www.honso.com. Distributors include Emerson Ecologics (800-654-4432) and Natural Partners (800-633-7620)
Kampo Today, an online magazine about Japan's herbal tradition published by Tsumura, Inc., can be found at: www.tsumura.co.jp/english/kthp/today.htm.
Information on the history of Kampo and the primary, secondary, and tertiary herbs used in common Kampo formulations can be found at: www.kindaikampo.net.
Robert Rister's Japanese Herbal Medicine: The Healing Art of Kampo (Avery, 1999) is one of the few English language titles on this subject.
Yoshihara Shibata MD and Jean Wu's Kampo Treatment for Climacteric Disorders (Paradigm, 1998) is a thorough treatise on traditional Japanese botanical therapy for menopausal conditions.
Key Papers on Kampo Herbal Formulas
Borchers AT, Sakai S, Henderson GL, et al. Sho-Saiko-to and other Kampo medicines: a review of their immunomodulatory activities. J Ethnopharmacol 2000; 73(1–2): 1–13.
Shimizu I. Sho-Saiko-to: Japanese herbal medicine for protection against hepatic fibrosis and carcinoma. (Review) (85 refs). J Gastroenterol & Hepatol 2000; 15(Suppl): D84–90.
West Meets East: Looking for the Interphase of Western Medicine and Traditional Oriental Medicine in Future. Japan J Clin Pathol 2000; 48(8).