Herbs & Botanicals
Excerpts from "The Complete German Commission E
Monographs
Therapeutic Guide to Herbal Medicines
FOREWORD
"The therapeutic use of herbs and phytomedicines has always been very popular in
Germany. About 600 - 700 different plant drugs are currently sold there, singly and
combination, in Apotheken (pharmacies), Drogerien (drugstores), Reformhauser (health food
stores), and Markte (markets). In addition to the self-selection of herbal products by
consumers, about 70 percent of the physicians in general practice prescribe the thousands
of registered herbal remedies, and a significant portion of the $1.7 billion annual sales
(a conservative estimate) is paid for by government health insurance. In 1988, 5.4 Million
prescriptions were written for a single phytomedicine, ginkgo biloba extract, a figure
that does not include the substantial over-the-counter sales of the product
In view of this significant role which phytomedicines play in Germany, it is only
natural that the government there would develop a mechanism to assure users of their
safety and efficacy. The process is unique. For various reasons, other advanced nations
have not yet chosen to emulate it. But it is worthy of imitation, and it is probably only
a matter of time before consumers in other countries are able to benefit from the German
experience.
This experience began in 1976 when the Federal Republic of Germany defined herbal
remedies in the same manner as other drugs -specifically as plants, parts of plants, or
preparations of plants, either in the processed or crude state-intended to cure,
alleviate, or prevent disease, suffering, physical injury, or symptoms of illness, or to
influence the nature, state, or function of the body or mental health conditions.
Interestingly, herbal remedies are considered as a single active constituent, even though
they may contain many different chemical constituents. Isolated constituents of plant
origin- morphine, quinine, digitoxin, etc. - are not legally considered to be herbal
remedies.
Then, in 1978, the Bundesgesundheitsamt (Federal Health Agency), now called the Federal
Institute for Drugs and Medical Devices, established an expert committee on herbal
remedies, composed principally of members proposed by associations of the health
professions, to evaluate the safety and efficacy of phytomedicines. This so-called
"Commission E" included physicians, pharmacists, pharmacologists, toxicologists,
representatives of the pharmaceutical industry, and lay persons. Its assessment is
independent of the Federal Health Agency, which handles only the organizational details.
Unlike the United States Food and Drug Administration which evaluates drugs only in a
passive manner based on data supplied by the manufacturer, Commission E actively checks
so-called bibliographic data independently. Such data include information obtained from
clinical trials, field studies, collections of single cases, scientific literature
including facts published in the standard reference works, and expertise of medical
associations. If controlled clinical data are lacking, safety and efficacy can still be
determine on the basis of information in the literature, the presence of supplemental data
supporting clinical results, and significant experimental studies supporting traditional
use.
Application of this kind of evaluation process results in the establishment of
"reasonable certainty" of the safety and efficacy of the herb being evaluated.
It is not the full equivalent of the "absolute certainty" required by the USFDA
for all drugs. However, it is much less costly than the $350 million expenditure required
to prove the safety and efficacy of a new chemical entity in the United States. This is an
important point. Expenditures of that magnitude will never be made for classic herbal
remedies because patent protection is not ordinarily available for them and these
exorbitant research costs cannot be recovered. Besides, the German experience has
definitely shown that reasonable certainty of safety and efficacy is adequate for
long-used remedies.
After Commission E has completed its evaluation, a draft monograph is prepared with a
positive or negative assessment regarding suitability for medicinal use, and after
allowing a suitable period for comments and their consideration, a monograph is published
in the Bundesanzeiger (Federal Gazette). Such monographs normally include nomenclature,
part used, constituents, range of application, contraindications, side effects,
incompatibilities with other medications, dosage, use, and action of the herb.
By 1993, about 300 such monographs had been prepared. Approximately two-thirds of them
are positive assessments covering herbs that have been found to be safe and effective; the
remainder are negative, usually because use of the drug presents an unsatisfactory
risk-benefit ratio. Although critical scientists and clinicians might quibble with a few
of the findings in some of the monographs-I do so myself-it is necessary to remember that,
taken as a whole, they represent the most accurate information available in the
entire world on the safety and efficacy of herbs and phytomedicines. As such, they are
worthy of careful study by anyone interested in any type of drug therapy. Ignorance of the
Commission E monographs is ignorance of a substantial segment of modern medicine.
Consequently, it is a pleasure to note that the American Botanical Council has
sponsored the translation into English and the publication of these significant studies.
The information contained in them is now made readily available in the common language of
science to a vast audience worldwide. Without question, their ready availability will
benefit all of us, consumers and healthcare practitioners alike. "
Varro E. TYLER, PH.D., Sc.D.
Dean and Distinguished
Professor of Pharmacognosy Emeritus
School of Pharmacy and Pharmacal Sciences
Purdue University
