ince its establishment
in 1950, the Japan Society for Oriental Medicine has played an important
role in helping Kampo medicine achieve its high status in present-day Japanese
healthcare. |
| Participants from around the world gathered in Tokyo International Forum for the 10th International Congress of Oriental Medicine and 50th Annual Congress of the Japan Society for Oriental Medicine in May of this year (1999). |
At the session on "The Current Status of Herbal Medicine in Europe, the U.S. and the Western Pacific Region," Dr. James G. Farrelly of the U.S. Food and Drug Administration, Dr. Peter C. Scriba of the University of Munich, Dr. Chen Ken of the World Health Organization (paper presented by Dr. Chieko Ikeda of the WHO), and Dr. Akira Ishibashi, vice chairman of the Japan Society for Oriental Medicine, reported on herbal therapies and traditional medicine in their respective regions. We summarize their presentations on the following pages.:
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Panel on "The Current Status of Herbal Medicine in Europe, the U.S., and the Western Pacific Region" highlighted the growing popularity of herbal therapies as well as divergent approaches to regulation. |
"The Present Situation and Future Vision for the Medicinal Use of Plants in the U.S.A."
Dr. James G. Farrelly, U.S. FDA Center for Drug Evaluation and Research
In
accordance with the Dietary Supplements Health and Education Act (DSHEA)
of 1994, vitamins, minerals and herbs, etc. are recognized in the U.S. as
dietary supplements (DS) that play a role in promoting health. According
to a survey carried out by the FDA in 1994, 51% of those interviewed used
some type of DS, and 16% used herbal products. The DS market in the U.S.
is growing rapidly, with sales totaling $12 billion in 1998. Of this, vitamin
products accounted for 50% and herbal products about 30%. Herbal products
can legally be marketed as either foods or DS; however, it is forbidden
to sell them as medicines for the treatment, diagnosis or prevention of
medical conditions. In order to market an herbal product as a medicine,
an NDA is required, and efficacy and safety must be shown. As far as clinical
studies of herbal products are concerned, the FDA has received 50 applications
for INDs, of which 34 have been approved. The FDA recommends that producers
of herbal products apply for INDs and conduct clinical studies. However,
the approval process for the FDA's proposed guidelines on development of
herbal products as medicines has not yet reached the public comment stage."The Present Situation and Future Vision for Medical Use of Plants in Germany"
Dr. Peter C. Scriba, Medizinische Klinik, Klinikum Innenstadt, University of Munich
In
Europe, particularly Germany, herbal medicine is based on a tradition going
back to ancient Greece and Rome. Of the EU's $5.6 billion herbal healthcare
market, Germany accounts for 44%, France 28% and Italy 11%. In Germany,
herbal medicines represent about 10% of the market for drugs and nearly
30% of the OTC market. Herbal medicines are categorized as medical products
in Germany, not as food supplements as in the U.S. A special committee of
experts from various fields called Commission E, which was established in
1978, prepares monographs determining the ingredients, dosage, and applicability
of herbal medicines. Since the 1970's, evaluation of herbal therapy has
been steadily growing more positive. There are three reasons for this. First,
as society ages, the structure of the medical care population is shifting
from acute to chronic patients. Second, herbal medicines, which have been
used for thousands of years and are derived from natural products, are generally
regarded as safe and gentle. And third, convincing scientific data from
clinical studies has validated successful experiences using herbal therapy
to treat various conditions. The phenomena reflected in these three points
also apply to the U.S., Japan and other advanced countries."Overview of Situation of Traditional Medicine in Western Pacific Region
Dr. Chen Ken, World Health Organization, Regional Office for the Western Pacific (Presented by Dr. Chieko Ikeda, WHO)
The
World Health Organization has, at present, about 50 programs, covering such
fields as malaria, AIDS, mother and child welfare, etc. A program dealing
with traditional medicine was established in 1976. The following year, at
the 30th World Health Assembly (WHA), the WHO adopted a proposal (WHA30
- 49) to promote education and research on traditional medicine, thereby
formally recognizing traditional medicine as a full-fledged program of WHO.
In the Western Pacific region, a well-established system exists based on
the Chinese medical classics, utilizing acupuncture and herbal therapy,
principally with complex combinations of herbs. Chinese traditional medicine
has its own theoretical systems, which reflect thousands of years of accumulated
experience and knowledge, and an enormous number of texts have been passed
down to the present. In countries such as Viet Nam, Malaysia, Singapore,
Korea and Japan, traditional medicine which originated in China has been
adapted to local conditions and needs. Thus, for economic reasons, folk
medicine -- which is deeply rooted in traditional communities, is often
not organized, and in many instances includes occult or magical elements
-- is playing an important primary healthcare role among those unable to
receive modern medical care. This folk medicine makes wide use of herbal
therapies. Against this backdrop, WHO is working to build cooperative relationships
with the various governments in the region in order to help revitalize research
on traditional medicine.The Present Situation of Kampo Medicine in Japan
Dr. Akira Ishibashi, Vice Chairman, the Japan Society for Oriental Medicine
The
establishment of the Japan Society for Oriental Medicine by physicians engaged
in studying Kampo marked the real beginning of scientific investigation
of the effectiveness and safety of Kampo. The society has now grown nearly
100-fold from the original 98 founding members to 9,165, of whom 7,416 are
medical doctors. The fact that those treating patients with Kampo are required
by Japan's medical system to be qualified as physicians explains why nearly
80% of the members of the society are doctors. It also explains why Kampo
therapy has become such a rapidly growing part of healthcare in Japan today.The development of extract forms of Kampo prescriptions in the 1950's greatly simplified the use of Kampo medicine and made it more adapted to modern life. Then, in 1967, four Kampo prescriptions were, for the first time, approved for reimbursement under Japan's national health insurance. An additional 42 prescriptions were added to the approved list in 1976, and the number expanded thereafter to reach today's 148. Valued at 9.5 billion yen in 1976, Kampo medicine production has grown to reach 1.2 trillion yen (about $1 billion) today.
Beginning in 1991, Japan's Ministry of Health and Welfare initiated a program of reevaluating Kampo prescriptions, and a series of double-blind studies is being undertaken to corroborate their effectiveness. Three prescriptions have already been verified as effective for the indications specified: Daio-kanzo-to (constipation), Sho-seiryu-to (allergic rhinitis) and Sho-saiko-to (chronic hepatitis).
Kampo prescriptions have proved particularly valuable for treating the multiple illnesses and complaints of the elderly, and have the additional attraction of playing a role in health maintenance. Thus, Kampo can be expected to play an increasingly important role in advancing health care for older people in Japan, where the population is aging faster than in any other country.
Some of the main points of the discussion that followed the presentations are summarized below:
1) It is evident that social trends and forces are quite similar in such advanced countries as the U.S., Germany and Japan. They share, for example, changes in the structure of medical needs based on the advent of an aging society and a reaction against the over-specialization of today's medical care. There is also a growing concern about the strong side effects of synthesized drugs and hence a greater appreciation and higher demand for herbal therapies. On the other hand, it is a lack of availability of modern medicine that has caused the WHO to recommend herbal and traditional therapies for developing countries.
2) Because of historical differences, herbal medicines have been regulated differently in the various advanced industrial nations. Thus, in the U.S., they are considered dietary supplements along with vitamins and minerals. In Germany, on the other hand, they are considered another category of either prescription or OTC drugs, with standards drawn up in monographs for each of the recognized single herbs. Japan's Kampo medicines are also considered drugs, with 80% of these complex herbal formulas dispensed by physician prescription.
3) In spite of all of the differences mentioned, it was agreed that the continued growth in the importance of herbal medicines in all countries would depend upon obtaining scientific evidence, such as clinical studies, that demonstrated their efficacy.
The presentations from the U.S., Germany, the WHO and Japan helped to make clear the present status of herbal therapy and traditional medicine and identified common features, such as growing popularity, and differences, such as divergent approaches to regulation. The symposium served to stimulate exchanges of ideas about traditional medicine that, it is hoped, will continue in the future among clinicians, researchers and regulators around the world.