Rational Phytotherapy: A Physicians’ Guide to Herbal Medicine

396 Pages·2001·25.4 MB·English

by  Prof. Dr. med. Volker Schulz, Prof. Dr. rer. nat. Rudolf Hänsel, Prof. em. Varro E. Tyler Ph. D., Sc. D. (auth.)

V. Schulz R. Kinsel V.E. Tyler
Rational Phytotherapy
A Physicians' Guide to Herbal Medicine
Springer
Berlin
Heidelberg
New York
Barcelona
Hong Kong
London
Milan
Paris
Singapore
Tokyo
Volker Schulz Rudolf Hansel Varro E. Tyler
Rational
Phytotherapy
A Physicians' Guide to Herbal Medicine
Fourth edition, fully revised and expanded
With 90 figures and 50 tables
Springer
Prof. Dr. med. Volker Schulz
Oranienburger Chaussee 25
13465 Berlin, Germany
Prof. Dr. rer. nat. Rudolf Hansel
formerly Institut fur Pharmakognosie und
Phytochernie der Freien Universitat Berlin
Private address:
WestpreuBenstraBe 71
81927 Munchen, Germany
Prof. em. Varro E. Tyler, Ph. D., Sc. D.
Purdue University
Present address:
P.O. Box 2566
West Lafayette, Indiana 47996, USA
Translator:
Terry C. Telger
6112 Waco Way
Fort Worth, TX 76133, USA
ISBN-13: 978-3-642-98095-4 e-ISBN -13: 978-3-642-98093-0
DOT: 10.1007/978-3-642-98093-0
Library of Congress Cataloging-in-Publication Data
Schulz. Volker, Prof. Dr. med. [Rationale Phytotherapie. Englishl Rational phytotherapy : a
physician's guide to herbal medicine / Volker Schulz, Rudolf Hansel, Vano E. Tyler. - 4th ed.,
fully rev. and expanded. p. cm. Includes bibliographical references and index.
1. Herbs-Therapeutic use.!. Rudolf, Hiinsel, 1920-. II. Tyler, Vano E. III. Title. RM666.H33 S3813
2000 615.321-dc21
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Preface
to the Fourth German Edition
Rational Phytotherapy continues to add a truly significant dimen
sion to the practice of evidence-based herbal medicine. Prepara
tion of a new edition, so short a time after publication of the pre
vious English version, was necessitated by the rapid increase in
the number of scientific and clinical studies attesting to the safe
ty and utility of phytomedicines. The results of these recent inves
tigations are now incorporated in the revised text of this volume.
Comprehensive, updated information on scientific studies and
clinical trials of the therapeutically useful botanical drugs is now
placed before interested readers worldwide.
Even the most CurS01Y acquaintance with phytotherapy, herbal
treatment, botanical medicine - whatever you choose to call it -
causes one to recognize that throughout most of the world, and
especially in the United States and the United Kingdom, the prac
tice is at best still an imperfect art. In Germany, the use of plant
drugs is a science. There are many reasons for this. Tradition can
certainly not be discounted. However, the principal reason is,
without question, the enlightened system of laws and regulations
governing the sale and use of such products in that country.
Basically, the regulations in Germany permit phytomedicines
to be sold either as self-selected or prescription drugs provided
there is absolute proof of their safety and reasonable certainty of
their efficacy. The words "reasonable certainty" are extremely
important here. They require that some scientific and clinical evi
dence be provided prior to approval, but the requirements are not
the same as would be necessary for a new chemical entity.
Because patent protection is not ordinarily available for these
ancient drugs, pharmaceutical companies are generally unwilling
to invest the hundreds of millions of dollars required to prove
them effective by the same standards applied to totally new, syn
thetic drugs. They are, however, willing to invest more modest
amounts in the scientific and clinical testing needed to establish
reasonable certainty of efficacy.
That has been and continues to be done in Germany. Data
regarding safety and efficacy submitted to a special scientific body
designated Commission E of the German Federal Health Agency
(now the Federal Institute for Drugs and Medical Devices) have
resulted in judgments validating the utility of several hundred dif
ferent phytomedicines. The brief summaries of these Commission
v
E findings, as well as its conclusions on about 100 different botan
icals that were not approved, were originally published in Ger
man in the Bundesanzeiger, the counterpart of the u.s. Federal Reg
ister, but they have now been published in English translation by
the American Botanical Council in Austin, Texas. The Commission
E monographs are based, in part, on proprietary information so,
unfortunately, they are not referenced. If one wants to review the
detailed information which they summarize - or to examine addi
tional studies conducted since their publication - one must seek
elsewhere. Presentation and comprehensive analysis of such data,
resulting from pharmacological studies in animals and, especially,
from clinical trials in humans, is the unique dimension provided
by this book.
Much of the knowledge contained in Rational Phytotherapy is
not available in other English language publications. Summaries
of the numerous clinical trials on some of the popular phy
tomedicines will astonish many readers who were not only
unaware of the results but in many cases were unaware that such
studies had even been conducted. There is, of course, a reason
for this lack of awareness. Studies on the botanical, chemical, and
pharmacological aspects of plant drugs are often published in
English, even in journals originating in non-English speaking
nations. Those that do appear in other languages are rapidly
made available in summary form through such publications as
Chemical Abstracts. German medical literature, on the other hand,
is much less available to English-only readers. Yet it is in just this
literature where many of the clinical studies on phytomedicines
are published. In the United States, even those who can read Ger
man have considerable difficulty in locating the journals, many of
which are often unavailable in major libraries. Relatively few of
the pertinent articles are currently indexed on MEDLINE. Person
ally, I have always found it much easier to request photocopies
of such medical studies from colleagues in Germany rather than
to attempt to acquire them here in the United States.
Of the hundreds of medicinal plants used therapeutically
today, a relatively small number account for a very large percent
age of the total sales. Just 10 of them account for some 55% of
the sales in the United States. Interestingly, those enjoying the
greatest popularity are those which, by and large, have been most
thoroughly investigated. These are the ones that are discussed in
detail in this book. The tables in the Appendix provide details on
the popularity of both individual and combination phytomedi
cines in Germany.
Members of the conventional medical community who are
skeptical about the utility of phytomedicines often base their
skepticism on the lack of human clinical trials for such products
or, more precisely, on their lack of knowledge of those trials that
have been conducted. Now, by turning to the pages of this book,
VI Preface to the Fourth English Edition
they can letrn just exactly how many therapeutic trials have been
carried iout with capsules or tablets of, for example, garlic pow
der, the total number of patients involved, the dosage used,
whether the studies were controlled, double-blinded, and the
results compared with those obtained from using placebos. In
short, all of the necessary clinical data, with references, are pro
vided here in addition to sound scientific information on the
botany, chemistry, and pharmacology of the herb itself.
All of the numerous books on herbs written previously lack
one or more of these essential components. English-language vol
umes usually are deficient in clinical information on the herbs
considered. The few which do present some clinical details neg
lect other necessary aspects of botanicals. In the truest sense of
the word, the first English edition of Rational Phytotherapywas the
world's first qualitatively complete, science-based herbal in the
English language. That distinction continues with this revision.
It is my belief that the information presented in this volume
will continue to have a considerable impact on the therapeutic
use of botanicals in the English-speaking world. Physicians, phar
macists, lawmakers, regulators, scientists, and interested lay per
sons will no longer be able to disregard the scientific and clinical
evidence supporting herbal utility simply by claiming ignorance
of data available previously only in a foreign language. The evi
dence recorded on these pages strongly supports the safety and
efficacy of a substantial number of herbs and should facilitate
their increased use as desirable conventional drugs for the pre
vention and treatment of a variety of conditions, syndromes, and
illnesses.
For far too long, the use of botanicals in English-speaking
countries has depended largely on folklore, hearsay, and even
gossip. Now the broad spectrum of scientific and clinical evidence
supporting the use of may such products has been collected,
summarized, presented, referenced, and updated in a concise,
intelligible form. Rational Phytotherapy will, without questions,
continue to be a significant landmark, a milestone of achieve
ment, in the development of phytomedical science and its appli
cation to human health.
West Lafayette, Indiana, U.S.A. Varro E. Tyler
Preface to the Fourth English Edition VII
Preface
to the Fourth English Edition
In 1997, phytomedicines comprised approximately 5% of all pre
scription drugs covered by health insurance plans in Germany,
with total sales of over $2 billion. Two-thirds of the prescriptions
were for single-herb products, i.e., products that contained only
one medicinal herb. Just five herbs accounted for 60% of these
prescriptions, and 27 herbs accounted for more than 90%. This is
surprising when we consider that Commission E of the former
German Federal Health Agency evaluated the therapeutic use of
some 400 medicinal herbs from 1982 to 1994 and recommended
approximately 300 of them. Clearly, the prescriptions written by
present-day physicians no longer reflect the rich historical diver
sity of herbal remedies. Of course, family doctors also counsel
their patients with regard to self-medication, and this more than
doubles the yearly consumption of the leading phytomedicines.
Nevertheless, the total number of medicinal herbs that are still
used to a significant degree in modern medicine are but a frac
tion of the traditional botanicals that have been presented and
described in classic textbooks of herbal medicine.
Despite its characterization as an "alternative therapy" in a
1976 German drug law, phytotherapy is in fact a scientifically
tested and proven treatment modality in which modern phar
macotherapy has its roots. As with any medication, our knowl
edge of the safety and efficacy of a phytomedicine improves as
the medicine is used more frequently. In preparing this fourth
edition, therefore, we again focused our attention on the herbal
constituents and products whose safety and efficacy are based
not just on tradition but also on modern scientific testing. We
have added considerable material since the 1994 edition, includ
ing new results on clinical pharmacology and toxicology, espe
cially for products made from ginkgo leaves, St. John's wort,
kava rhizome, valerian root, garlic, ivy leaves, artichoke leaves,
peppermint oil, saw palmetto berries, devil's claw root, and
echinacea. Chapter 8 has been reorganized under the title "Skin,
Trauma, Rheumatism, and Pain" and includes new information
on the therapeutic use of evening primrose oil, peppermint oil,
devil's claw root extract, and capsicum (paprika) extract. At the
same time, products that are rarely used or whose safety and
efficacy are not adequately documented have been given briefer
mention or omitted entirely.
IX
Combination products consisting of several medicinal herbs
are particularly difficult to evaluate from a scientific perspective.
Most of these products are derived from traditional herbal medi
cine. With few exceptions, we cannot draw conclusions on the
additive or potentiating effects of their individual constituents
based on comparative clinical studies. Nevertheless, we gave due
regard to practical physician experience with these multi-herb
products and included those products that are among the 100
most commonly prescribed herbal medications listed in Table A3
of the Appendix.
We express our sincere thanks to Mrs. Monika Schmidt, who
oversaw the technical organization of the book from the comput
er manuscript to the page proofs, and to our wives, who served
as patient "copyreaders" during the course of our work.
Berlin and Munich, July 2000 V. Schulz
R. Hansel
X Preface to the Fourth German Edition
Table of Contents
1 Medicinal Plants, Phytomedicines,
and Phytotherapy . . . . . . . . . . . . . . . . . . . . . . 1
1.1 Common Roots of Pharmacotherapy 1
1.2 Making Medicines Safer by Isolating
and Modifying Plant Constituents . . . . . . . . . . . 2
1.3 Pharmaceutical Preparation of Phytomedicines .. 4
1.3.1 What are Extracts? ..................... . 5
1.3.2 Standardization of Extracts ............... . 5
1.3.2.1 Quality of the Herbal material . . . . . . . . . . . . . . 6
1.3.2.2 Production Methods . . . . . . . . . . . . . . . . . . 6. . .
1.3.2.3 Adjustment of Quality . . . . . . . . . . . . . . . . . . . . 7
1.3.2.4 Analytical Quality Control . . . . . . . . . . . . . . . . . 8
1.4 Phytomedicines .... . . . . . . . . . . . . . . . . . . . . 9
1.4.1 Liquid Dosage Forms ................... . 9
1.4.1.1 Tinctures, Glycerites, and Related Products . . . . . 9
1.4.1.2 Syrups ............................. . 10
1.4.1.3 Medicinal Oils . . . . . . . . . . . . . . . . . . . . . . . . . 10
1.4.1.4 Medicinal Spirits ...................... . 11
1.4.1.5 Plant Juices . . . . . . . . . . , . . . . . . . . . . 1. 1. . . . .
1.4.2 Solid Dosage Forms .................... . 11
1.4.2.1 Granules ............................ . 12
1.4.2.2 Uncoated Tablets ...................... . 12
1.4.2.3 Coated Tablets . . . . . . . . . . . . . . . . . . . . . . . . . 12
1.4.2.4 Capsules ............................ . 12
1.4.2.5 Lozenges ............................ . 13
1.4.3 Packaging ........................... . 13
1.4.4 Herbal Combination Products ........... . . . 14
1.5 Phytotherapy .................. . ...... . 16
1.5.1 Pharmacologic Characteristics ............. . 16
1.5.1.1 Therapeutic Range ..................... . 16
1.5.1.2 Onset of Action . . . . . . . . . . . . . . . . . . . . . . . . 16
1.5.2 Pharmacologic and Clinical Research ... . . . . . . 17
1.5.3 Indications for the Use of Phytomedicines ..... 19
1.5.4 What Physicians Require from Phytomedicines .. 20
1.5.5 Hopes and Expectations of the Patients ...... . 22
1.5.6 Benefits and Risks of Phytomedicines
Compared with Other Therapies ........... . 23
XI