V. Schulz R. Hansel v. E. Tyler. Rational Phytotherapy A Physicians' Guide to Herbal Medicine

Transcription

1 V. Schulz R. Hansel v. E. Tyler Rational Phytotherapy A Physicians' Guide to Herbal Medicine

2 Springer Berlin Heidelberg New York Barcelona Budapest Hong Kong London Milan Paris Santa Clara Singapore Tokyo

3 Volker Schulz Rudolf Hansel Varro E. Tyler Rational Phytotherapy A Physicians' Guide to Herbal Medicine Third edition, fully revised and expanded With 81 figures and 42 tables Springer

4 Prof. Dr. med. Volker Schulz Oranienburger Chaussee Berlin Germany Prof. Dr. rer. nat. Rudolf Hansel formerly Institut fur Pharmakognosie und Phytochemie der Freien Universitat Berlin Private address: Westpreu6enstra6e Miinchen Germany Prof. em. Varro E. Tyler, Ph. D., Sc. D. Purdue University Present address: P. O. Box 2566 West Lafayette, Indiana USA Translator: Terry C. Telger 6112 Waco Way Fort Worth, TX 76133, USA ISBN-13: e-isbn-13: DOl: / Library of Congress Cataloging-in-Publication Data Schulz, Volker, Prof. Dr. med. [Rationale Phytotherapie. English] Rational phytotherapy : a physician's guide to herbal medicine 1 Volker Schulz, Rudolf Hansel, Varro E. Tyler. - 3rd ed., fully rev. and expanded. p. cm. Includes bibliographical references and index. ISBN-13: Herbs-Therapeutic use. I. Rudolf, Hansel, II. Tyler, Varro E. Ill. Title. RM666.H33S dc21 This work is subject to copyright. All rights are reserved, whether the whole or part of the material is concerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfilms or in any other way, and storage in data banks. Duplication of this publication or parts thereof is permitted only under the provisions of the German Copyright Law of September 9, 1965, in its current version, and permission for use must always be obtained from Springer-Verlag. Violations are liable for prosecution under the German Copyright Law. Springer-Verlag Berlin Heidelberg 1998 Softcover reprint of the hardcover 3rd edition 1998 The use of general descriptive names, registered names, trademarks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. Product liability: The publishers cannot guarantee the accuracy of any information about dosage and application contained in this book. In every individual case the user must check such information by consulting the relevant literature. Typesetting: Appl, Wemding SPIN: / Printed on acid-free paper

5 Preface to the English Edition Rational Phytotherapy adds a truly significant dimension to the practice of science-based herbal medicine. Detailed examination of the original German edition led to the conclusion that the book simply had to be translated into English to make the valuable information it contained available to a broader audience. That desire has now been realized, and the results of scientific studies and clinical trials of therapeutically useful botanical drugs are now placed before interested readers in the universallanguage of science. Even the most cursory 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 practice is at best 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 evidence be provided prior to approval, but the requirements are not the same as would be necessary for a new chemical entity. Because patent protection it 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, synthetic 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 different phytomedicines. The brief summaries of these Commission E findings, as well as its conclusions on about 100 different botanicals that were not approved, were

6 VI Preface to the English Edition originally published in German in the Bundesanzeiger, the counterpart of the U. S. Federal Register, 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 additional 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 new dimension provided by this book. Much of the knowledge contained in Rational Phytotherapy has never before been made available in the English language. Summaries of the numerous clinical trials on some of the popular phytomedicines 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 medial 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 German have considerable difficulty in locating the journals, many of which are often unavailable in major medical libraries. Relatively few of the pertinent articles are currently indexed on MEDLINE. Personally, 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 in Europe today, a relatively small number account for a very large percentage of the total sales. 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 phytomedicines 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, they can learn just exactly how many therapeutic trials have been conducted with capsules or tablets of, for example, garlic powder, 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 provided

7 Preface to the English Edition VII 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 volumes have usually been deficient in clinical information on the herbs considered. The few which do present some clinical details neglect other necessary aspects of botanicals. In the truest sense of the world, Rational Phytotherapy may be called the world's first qualitatively complete, sciencebased herbal in the English language. It is my belief that the information presented in this volume will have a considerable impact on the therapeutic use of botanicals in the English-speaking world. Physicians, pharmacists, lawmakers, regulators, scientists, and interested lay persons 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 evidence 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 prevention 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, for the first time, the broad spectrum of scientific and clinical evidence supporting the use of many such products has been collected, summarized, presented and referenced in a concise, intelligible form. Publication of Rational Phytotherapy will, without question, become a significant landmark, a milestone of achievement, in the development of phytomedical science and its application to human health. Varro E. Tyler West Lafayette, Indiana, U. S. A.

8 Preface to the Third Edition In 1995, phytomedicines accounted for approximately 7% of all prescription medications covered by public health insurance in Germany, with total sales of about 2 billion DM. Two-thirds of the prescriptions were for single-herb products, i. e., products whose active ingredients derive from only one medicinal plant. Just 5 herbs account for approximately 60 % of these prescriptions, and 28 herbs account for more than 90 %. But when Commission E of the former German Health Agency reviewed the efficacy of 363 different medicinal plants from 1982 to 1994, it gave a positive rating to about 250 of them. A comparison of these figures shows that the historical diversity of herbal remedies in Germany is no longer reflected in the present-day practice of prescribing medications. Of course, many family doctors advise their patients on self-medication, and this could easily double the figures on sales and use of the leading plant drugs. Nevertheless, the total number of medicinal plants that are important in medical practice is still only a fraction of those that are listed and described in historical textbooks of herbal medicine. Despite its special treatment in the 1976 German Drug Law, phytotherapy is not an "alternative medicine" but a scientifically tested and proven treatment modality that is at the very root of modern pharmacotherapy. It is true with herbal medicines as with other drugs that as a remedy becomes more widely used, better information is needed regarding its safety and efficacy. Thus, a basic goal of this third edition of Rational Phytotherapy is to take a focused, systematic look at the most important groups of indications in phytotherapy and at herbal products that have been proven safe and effective by scientific standards. Little or no attention is given to preparations that are rarely used or whose safety and efficacy have not been well documented. The evaluation of combination products that contain several medicinal herbs is a particularly difficult task. Most of these products are derived from traditional herbal practices, and very few have been subjected to comparative clinical studies to evaluate the additive or synergistic effects of their individual components. Nevertheless, 49 of the 100 most commonly prescribed herbal medications in 1995 were combination products. Theoretical considerations aside, we believed it important to recognize the authority of medical experience; therefore we included combination herbal products under the Drug Products heading that concludes each

9 x Preface to the Third Edition of the indication-oriented chapters, considering only those products that are among the 100 most commonly prescribed herbal drugs (see Appendix, Table A3). The findings of Commission E of the former German Health Agency were very helpful in evaluating the products. References to Commission E findings later in the text are based on the monographs published by the Commission in the Bundesanzeiger (a publication comparable to the Federal Register in the U. s.). We are deeply indebted to Mrs. Gabriele Voigt, who managed all aspects of technical organization from the initial text entry to the page proofs. We are also grateful to our wives for patiently helping with our work as "assistant instructors." Berlin and Munich July 1996

10 Table of Contents 1 Medicinal Plants, Phytomedicines, and Phytotherapy Common Roots of Pharmacotherapy Making Medicines Safer by Isolating and Modifying Plant Constituents Extracts as Pharmacologically Active Components of Phytomedicines What are Extracts? Standardization of Extracts Quality of the Herbal Material Production Methods Adjustment of Quality Analytical Quality Control Phytomedicines Liquid Dosage Forms Tinctures, Glycerites, and Related Products Syrups Medicinal Oils Medicinal Spirits Plant Juices Solid Dosage Forms Granules Uncoated Tablets Coated Tablets Capsules Lozenges Packaging Herbal Combination Products Phytotherapy Pharmacologic Characteristics Therapeutic Range Onset of Action Pharmacologic and Clinical Research Indications for the Use of Phytomedicines

11 XII Table of Contents What Physicians Require from Phytomedicines Hopes and Expectations of the Patients Benefits and Risks of Phytomedicines Compared with Other Therapies Medicinal Teas Today Origin of the Word Tea. Medicinal and Nonmedicinal Teas Medicinal Teas and Their Actions Various Forms of Medicinal Teas 28 Mixtures of Cut and Dried Herbs Tea-bag Teas Soluble Teas Standard Approval for Tea Mixtures Teas Compounded as Prescribed by a Physician Guidelines for Tea Preparation Teas for Infants and Children Adverse Effects and Risks Central Nervous System Ginkgo in the Treatment of Cognitive Deficiency..... Introduction Botanical Description Crude Drug and Extract Key Constituents, Analysis, Pharmacokinetics.... Pharmacology and Toxicology Clinical Efficacy in Patients with Cognitive Deficiency.. Indications, Dosages, Risks, and Contraindications.... Therapeutic Significance Drug Products St. John's Wort as an Antidepressant Introduction Botanical Description Crude Drug and Extract Key Constituents, Analysis, Pharmacokinetics..... Pharmacology Toxicology Clinical Efficacy in Depressed Patients Indications, Dosages, Risks, and Contraindications.... Therapeutic Significance Drug Products Kava as an Anxiolytic Introduction Botanical Description

12 Table of Contents XIII Crude Drug and Extract Key Constituents, Analysis, Pharmacokinetics Pharmacology and Toxicology Clinical Efficacy Side Effects and Risks Indications and Dosages Therapeutic Significance Restlessness and Sleep Disturbances Valerian Medicinal Plant Crude Drug and Extract Key Constituents, Analysis, Pharmacokinetics.... Pharmacology and Toxicology.... Pharmacologic Effects in Humans and Clinical Efficacy in Patients.... Indications, Dosages, Risks, and Contraindications.... Therapeutic Significance Hops, Lemon Balm, Passion Flower, and Lavender Hop Strobiles and Hop Glands.... Balm Leaves Passion Flower Lavender Sedative Teas Drug Products Cardiovascular System Heart Failure and Coronary Insufficiency.... Hawthorn Introduction Medicinal Plant Crude Drug and Extract Key Constituents, Analysis, Pharmacokinetics Pharmacology Toxicology Clinical Efficacy Indications, Dosages, Risks, and Contraindications.... Therapeutic Significance Drug Products Herbs Containing Digitaloids.... False Hellabore Lily-of-the-Valley Squill Powder..... Oleander Leaves Other Cardioactive Plant Drugs

13 XIV Table of Contents Hypotension and Hypertension.... Phytotherapy of Hypotension.... Caffeine-Containing Herbs and Beverages.... Essential Oils.... Phytotherapy of Hypertension P Atherosclerosis and Arterial Occlusive Disease.... Garlic.... Historical Background.... Botanical Description.... Crude Drug.... Key Constituents, Analysis, Pharmacokinetics.... Experimental Pharmacology.... Effects on Atherogenesis and Lipid Metabolism Effects on Vascular Resistance, Fibrinolysis, and Platelet Aggregation Antimicrobial Properties Other Actions Toxicology Clinical Studies.... Effects on Blood Lipids.... Blood Pressure Reduction.... Antiatherosclerotic Effects in Humans Further Clinical Studies.... Side Effects and Garlic Odor.... Indications, Dosages, Risks, and Contraindications.... Therapeutic Significance.... Drug Products Gingko Special Extract for Peripheral Arterial Occlusive Disease Other Herbs with Antiatherosclerotic Properties.... Chronic Venous Insufficiency.... Horse Chestnut Seed Extract Introduction Crude Drug and Extract Chemistry and Pharmacokinetics of Aescin Pharmacology Toxicology Actions and Efficacy in Subjects and Patients Studies in Healthy Subjects Therapeutic Studies in Patients Indications, Dosages, Risks, and Contraindications Therapeutic Significance Topical Venous Remedies Drug Products

14 Table of Contents XV Respiratory System.... Cold Syndrome (Flulike Infection).... Risk Factors Viruses and Host Defenses General Phytotherapeutic Measures.... Teas for Cold Relief.... Elder Flowers Linden Flowers Meadowsweet Flowers.... Willow Bark and Salicylates..... Tea Formulas Essential Oils.... Nasal Ointments and Nosedrops Inhalation Therapy Lozenges, Troches and Gargles Herbal Cough Remedies.... Mucilaginous Herbs in Antitussive Teas.... Essential Oils in Cough Remedies Ephedra ) Herbal Expectorants.... Mechanisms of Action Reduction of Mucus Viscosity by Water.... Neural Mechanism Based on the Gastropulmonary Reflex Liquefaction of Secretions by Direct Action on the Bronchial Glands.... Saponin-Containing Herbs.... Essential Oils as Expectorants Dosage Forms.... Cineole (Eucalyptol).... Myrtol.... Anise Oil and Anethole.... Licorice Root.... Suggested Formulations.... Phytotherapy of Sinusitis Drug Products Digestive System Anorexia and Dyspepsia.... Introduction Bitter Herbs (Bitters).... Wormwood (Absinth).... Other Bitter Herbs......

15 XVI Table of Contents Biliary Remedies (Cholagogues).... Some Specific Herbs.... Digestive Enzymes Suggested Formulations.... Drug Products.... Bloating and Flatulence.... Definition and Actions of Carminatives.... Typical Carminative Herbs.... Suggested Formulations.... Gastritis and Ulcer Disease Chamomile.... Licorice Root.... Drug Products Irritable Bowel Syndrome Symptoms and Approaches to Treatment.... Peppermint Crude Drug and Constituents.... Peppermint Oil.... Pharmacokinetics Pharmacology Therapeutic Efficacy.... Risks and Side Effects Indications, Dosages, and Contraindications.... Acute Diarrhea.... Tannin-Containing Herbs.... Green and Black Tea.... Other Tannin-Containing Herbs.... Tannic Acid and Albumin Tannate.... Pectins.... Live Dried Yeast.... Pharmacology and Toxicology Therapeutic Efficacy.... Indications, Dosages, Risks, and Contraindications.... Other Herbal Antidiarrheals Suggested Formulations.... Constipation Symptoms, Causes, General Measures Bulk-Forming Agents.... Mechanism of Action.... Linseed.... Wheat Bran.... Psyllium Seed and Husk.... Agar and Karaya Gum.... Osmotic Agents

16 Table of Contents XVII Anthranoid-Containing Herbs Rhubarb Root Buckthorn Bark Senna Pods and Leaves Aloe Castor Oil Suggested Formulations Liver Diseases Milk Thistle Fruits, Silymarin Medicinal Plant and Crude Drug Components and Active Constituents Pharmacokinetics Pharmacology and Toxicology Therapeutic Efficacy in Chronic Liver Diseases Use in Mushroom Poisoning Indications, Dosages, Risks, and Contraindications.... Soybean Phospholipids Drug Products Urinary Tract Inflammatory Diseases of the Urinary Tract Uva Ursi Leaves Petasite Rnizome Benign Prostatic Hyperplasia Saw Palmetto Berries Nettle Root Pumpkin Seeds Grass Pollens Phytosterols from Hypoxis rooperi Pygeum Therapeutic Significance Drug Products Other than Teas Bladder and Kidney Teas Gynecologic Indications for Herbal Remedies Chasteberry Black Cohosh Other Herbs Therapeutic Significance Drug Products

17 XVIII Table of Contents Skin and Connective Tissues Dosage Forms and Preparations Inflammations and Injuries of the Skin Chamomile Flowers Crude Drug, Constituents, and Preparations Pharmacology and Toxicology Therapeutic Efficacy Indications, Dosages, Side Effects, and Risks Witch Hazel and Other Tannin-Containing Herbs..... Evening Primrose Oil, Hypericum Oil, Podophyllin, Medicinal Yeast Calendula, Flarers, Echinacea, Dulcamara, Lemon Balm......, Post-traumatic and Postoperative Conditions Arnica Comfrey Bromelain Inflammatory and Degenerative Joint Diseases Devil's Claw Aspen, Ash, Willow TransdermaI Pain Relief Formulations Drug Products Agents that Increase Resistance to Diseases Adaptogens Ginseng Plant, Crude Drug, and Constituents Pharmacology and Toxicology Clinical Studies in Humans Indications, Dosages, Risks, and Contraindications Eleutherococcus Root Immune Stimulants Coneflower (Echinacea) Plant, Crude Drug, and Constituents Pharmacology and Toxicology Studies on Therapeutic Efficacy Indications, Dosages, and Risks European Mistletoe Plant, Constituents, and Actions

18 Table of Contents XIX Clinical Efficacy Studies Indications, Dosages, and Risks Medicinal Yeasts Therapeutic Significance Botanical Antioxidants (Grape seed, Green Tea, Pinebark) Pharmacology and Toxicology Clinical Studies Indications and Dosage Appendix The 100 most commonly prescribed Herbal Medications in Germany Subject Index

19 List of Figures All figures were taken from "HanseI/Holzl, Lehrbuch der Pharmazeutischen Biologie", 1996, Springer-Verlag Heidelberg, unless indicated otherwise. Figure Name Origin 2 7 St. John's wort Herbert E. Maas 2.20 Lavender Lichtwer Pharma GmbH 3 1 Hawthorn Herbert E. Maas 3 8 Garlic Lichtwer Pharma GmbH 3 9 All garlic for commercial use is Lichtwer Pharma GmbH cultivated 5 6 Flowering tops of the licorice plant Lichtwer Pharma GmbH 5 8 Tea shrub Lichtwer Pharma GmbH 5 11 Medicinal rhubarb Herbert E. Maas 5 13 Milk thistle Herbert E. Maas 6 3 Saw palmetto Lichtwer Pharma GmbH 7 1 Chasteberry plant Lichtwer Pharma GmbH 7-4 Black cohosh Lichtwer Pharma GmbH 8 4 Witch hazel Herbert E. Maas 9 5 European mistletoe Herbert E. Maas