An Evidence-Based Guide to Herbal Medicinal Products
Author: Sarah E. Edwards
Publisher: John Wiley & Sons
Healthcare professionals, including doctors, pharmacists and nurses, are often confronted with patients who use over-the-counter (OTC) herbal medicinal products and food supplements. While taking responsibility for one’s own health and treatment options is encouraged, many patients use these products based on limited (and sometimes inaccurate) information from non-scientific sources, such as the popular press and internet. There is a clear need to offer balanced, well-informed advice to patients, yet a number of studies have shown that, generally, conventionally trained health practitioners consider their knowledge about herbal medicinal products and supplements to be weak. Phytopharmacy fills this knowledge gap, and is intended for use by the busy pharmacist, nurse, or doctor, as well as the ‘expert patient’ and students of pharmacy and herbal medicine. It presents clear, practical and concise monographs on over a hundred popular herbal medicines and plant-based food supplements. Information provided in each monograph includes: • Indications • Summary and appraisal of clinical and pre-clinical evidence • Potential interactions • Contraindications • Possible adverse effects An overview of the current regulatory framework is also outlined, notably the EU Traditional Herbal Medicinal Products Directive. This stipulates that only licensed products or registered traditional herbal medicinal products (THRs), which have assured quality and safety, can now legally be sold OTC. Monographs are included of most of the major herbal ingredients found in THRs, and also some plant-based food supplements, which while not strictly medicines, may also have the potential to exert a physiological effect.
Ethnopharmacology is one of the world’s fastest-growing scientific disciplines encompassing a diverse range of subjects. It links natural sciences research on medicinal, aromatic and toxic plants with socio-cultural studies and has often been associated with the development of new drugs. The Editors of Ethnopharmacology have assembled an international team of renowned contributors to provide a critical synthesis of the substantial body of new knowledge and evidence on the subject that has emerged over the past decade. Divided into three parts, the book begins with an overview of the subject including a brief history, ethnopharmacological methods, the role of intellectual property protection, key analytical approaches, the role of ethnopharmacology in primary/secondary education and links to biodiversity and ecological research. Part two looks at ethnopharmacological contributions to modern therapeutics across a range of conditions including CNS disorders, cancer, bone and joint health and parasitic diseases. The final part is devoted to regional perspectives covering all continents, providing a state-of-the –art assessment of the status of ethnopharmacological research globally. A comprehensive, critical synthesis of the latest developments in ethnopharmacology. Includes a section devoted to ethnopharmacological contributions to modern therapeutics across a range of conditions. Contributions are from leading international experts in the field. This timely book will prove invaluable for researchers and students across a range of subjects including ethnopharmacology, ethnobotany, medicinal plant research and natural products research. Ethnopharmacology- A Reader is part of the ULLA Series in Pharmaceutical Sciences www.ullapharmsci.org
There is an herbal remedy for most ailments - and you will find the most important ones in this concise pocket guide. Co-authored by Karin Kraft, one of the members of the German Commission E, and Christopher Hobbs, a renowned North-American herbalist, this handy pocket guide gives you the decisive facts about important medicinal herbs, taking into consideration both major European monographs (Commission E and ESCOP) and up-to-date clinical trials. The book goes on to inform the reader on the usage of herbal remedies for a number of common indications.The book gives first-hand, easy to access information on the administration of herbal remedies for the medical practitioner and herbal therapist alike. Profit from the wealth of German tradition, extended by North American experience in the usage of herbal medicines.
A landmark guide to naturopathic practice in Australia – ideal for naturopaths, naturopathy students and Allied Health and medical practitioners Clinical Naturopathy: An evidence-based guide to practice details key treatment protocols and evidence-based complementary medicine interventions for use in naturopathic practice. This valuable naturopathy resource is authored by leading practitioners in the field. Its unique perspective combines clinical experience with evidence-based substantiation from rigorous medical research. Clinical Naturopathy explores key naturopathic treatments – including herbal treatments, nutritional and dietary treatments and lifestyle treatments – for common medical symptoms and conditions encountered in modern practice. Clinical Naturopathy: An evidence-based guide to practice outlines an introduction to case-taking methodology and naturopathic diagnostic techniques. It then details treatment protocols and naturopathic prescriptions to treat major health conditions within individual body systems. The textbook also offers special sections on naturopathic treatment throughout the life cycle, including paediatrics, pregnancy and aging, as well as complex health conditions like HIV, cancer and pain management. Comprehensive appendices provide additional clinically important material, such as reference levels for laboratory medical tests, nutrient food values and traditional Chinese medical diagnosis. This one-of-a-kind naturopathic reference makes essential reading for practitioners wishing to enhance practical application of their skills in a clinical setting, and advance their knowledge of evidence-based complementary medicine interventions. • addresses pre-clinical and clinical naturopathy subjects (from third year naturopathy to post-graduate level) • focuses on major medical conditions, and outlines naturopathic and integrative medical treatments • features case studies to contextualise theory into relevant clinical application • includes user-friendly clinical decision trees, tables and figures • is rigorously researched with over 4000 references
The ABC Clinical Guide to Herbs is a unique reference book and nationally accredited continuing education course for physicians, pharmacists, nurses, dietitians and other healthcare professionals, and will be of great interest to herbalists and consumers. This book contains extensive information on 29 of the most popular herbs sold in the U.S. market today, including which products have shown safe and effective activity in published clinical trials. Each chapter contains a well-referenced, comprehensive therapeutic Monograph, a 2-page Clinical Overview for quick reference, and a 1-page Patient Information Sheet for the health professional to photocopy and give to patients. The ABC Clinical Guide to Herbs also reviews 13 proprietary products used in clinical studies.
A must-have health companion for herbalists, naturopaths, complementary medicine practitioners and students Herbs and Natural Supplements, 3rd Edition: An evidence-based guide presents evidence-based information on the 130 most popular herbs, nutrients and food supplements used across Australia and New Zealand. This exhaustive textbook is organised alphabetically by each herb or nutrient’s common name. Herbs and nutrients are then accompanied by critical information such as daily intake, main actions and indications, adverse reactions, contraindications and precautions, safety in pregnancy and more. This new edition of Herbs and Natural Supplements has been expanded with new chapters on pregnancy and wellness. It also features 10 new monographs for Arginine, Dunaliella, Elde, Goji, Pelargonium, Prebiotics, Red Yeast Rice, Rhodioloa, Shatavari and Taurine. • provides current, evidence-based information on herbal, nutritional and food supplements used in Australia and New Zealand • is user-friendly and easily organised by easy-to-find A-Z herbal monographs • appendices offering important additional information for the safe use of herbal and nutritional supplements, including a list of poison information centres, associations, manufacturers and more • offers clear, comprehensive tables including herb/natural supplement - drug interactions • lists the pharmacological actions of all herbs and natural supplements • a glossary of terms relevant to herbs and natural supplements • two comprehensive new chapters: Herbs and Natural Supplements in Pregnancy and Introduction to Wellness • all chapters completely updated and expanded • ten new monographs taking the total to 130 • now also available as an eBook! A code inside Herbs and Natural Supplements, 3rd Edition: An evidence-based guide enables a full text download, allowing you to browse and search electronically, make notes and bookmarks in the electronic files and highlight material
Author: Pharmaceutical Press-Royal Pharmaceutical Society (RPS)Publishing
Preface to the Third Edition This third edition of Herbal Medicines: A guide for healthcare professionals comes a little over ten years after publication of the first edition, and reflects continuing public, professional, research, commercial and other interests in medicinal plants. At the same time, there have been ongoing concerns surrounding the quality, safety and efficacy of herbal medicinal products, and heightened awareness of the need to protect the public against poor-quality and unsafe products. Pharmacists, doctors, nurses, herbalmedicine practitioners and other healthcare providers should be knowledgeable about these issues and should be able to advise patients and the public on the safe, effective and appropriate use of herbal preparations; this book aims to provide pharmacists and other healthcare professionals with summarised, yet sufficiently detailed, scientific information to enable them to do so. Herbal medicines continue to be a popular healthcare choice with the general public not only for health maintenance and wellbeing, minor ailments (e.g. coughs and colds), chronic conditions (e.g. back pain) and serious chronic diseases (e.g. asthma, cancer, depression, diabetes), but also for 'enhancement' of functions or processes, such as the use of Ginkgo biloba products for memory enhancement. The general public receives information on herbal medicines through various sources, including popular magazines and newspaper articles, as well as television, internet and other sources of advertising literature provided by manufacturers. Much of this information is presented uncritically, and targeted to the consumer along with details of substantial price reductions on products, including continuous sales promotions, that often are the main recommendations for the products. There is an increasing number of products that respond to the public demand for so-called 'lifestyle' medicines, and manufacturers market, for example, herbal alternatives to Viagra (sildenafil), 'slimming/ weight-loss' preparations, 'hangover' cures, and breast-enlargement products. Typically, these types of products are sold over the internet without any assurance of their quality, safety and efficacy. The last decade has seen several important developments with respect to herbal medicines. The most significant of these has been the introduction of a new regulatory framework for traditional herbal medicines in the UK and the 27 other member states of the European Union (EU) following the implementation in 2005 of the EU Directive on Traditional Herbal Medicinal Products. Several other countries worldwide have introduced new legislation to regulate herbal medicinal products: Australia and Canada, for example, have been particularly active in this respect. That the regulatory landscape for herbal medicines has changed substantially has required a full revision of the 'Introduction to the Monographs', which in this edition can be found under 'How to Use Herbal Medicines'; this now includes details of new legislation in Europe and a summary of regulations for herbal medicines in several other countries. Although there are new regulations, in Europe there is a transitional period until 2011 to allow manufacturers time to comply with the new requirements, so issues relating to the quality, safety and efficacy of herbal medicines are likely to continue, even beyond the next edition of this book! Therefore, with respect to quality, consumers and healthcare professionals should be aware that the labels of unlicensed (unregulated) herbal medicines may not reflect their actual contents, and that the precise constituents of herbal medicines containing the same herbal ingredient(s) but produced by different manufacturers are likely to differ. The quality of herbal medicines (i.e. uniformity of dose) is important for their efficacy: clinical trial results for a particular herbal medicinal product cannot necessarily be extrapolated to other products containing the same ingredient, since their precise contents may differ. Details of herbal medicinal products tested in clinical trials are provided in individual monographs in this book. There is an increasing amount of research comprising qualitative (i.e. the profile of chemical constituents) and quantitative (quantity of chemical constituents) analysis of herbal medicines and showing variations in the contents of different manufacturers' products. For those herbal ingredients for which there is substantial information, and for commonly encountered herbal ingredients, we have summarised the findings of these analyses in a new section in some monographs on Quality of plant material and commercial products (for examples, see the monographs on St John's wort and Echinacea). The quality of herbal medicines is also important as regards their safety, and safety concerns with herbal medicines, including intrinsic toxicity as well as problems due to adulteration and contamination, continue to arise. This edition includes new monographs on kava (Piper methysticum) and greater celandine (Chelidonium majus) and a fully revised monograph on black cohosh (Cimicifuga racemosa), all of which have been associated with hepatotoxic reactions. The concurrent use of herbal and other medicines remains a major concern for healthcare professionals because of the potential for important drug interactions. Evidence of pharmacokinetic and pharmacodynamic interactions between St John's wort (Hypericum perforatum) and 'conventional' medicines emerged in the year 2000 and, since then, reports have been made of interactions between other herbal medicines and conventional medicines, typically those with a low therapeutic index. At present though, there has been little formal clinical research into interactions between herbal and other medicines, and information relies mainly on spontaneous reports and, to some extent, findings of in-vitro studies of the effects of certain herbal medicines on cytochrome P450 drug-metabolising enzymes. Information on known and potential interactions is summarised in the Appendices to this book, and further information and detail is provided in the individual monographs. Continual vigilance and reporting of adverse effects, including interactions and problems related to poor quality, associated with herbal medicines is essential in order to detect safety issues as soon as possible. In the UK, pharmacists and other stateregistered healthcare providers and, since 2005, patients and consumers, can report suspected adverse drug reactions (ADRs) associated with herbal medicines directly to the Medicines and Healthcare products Regulatory Agency (MHRA) using 'yellow card' report forms. These forms are included in the British National Formulary and available on-line (see www.mhra.gov.uk), and for the first time several are included in this book so that they may be more readily at hand to healthcare professionals using this book for information on adverse effects experienced and reported viii to them by consumers and patients. Many other countries have an ADR reporting scheme similar to that of the UK and encourage reporting of suspected herbal ADRs, at least by healthcare professionals. The World Health Organization's Uppsala Monitoring Centre in Sweden receives such reports from over 70 countries, including Australia, Canada, France, Germany, New Zealand, UK and the USA, and we have summarised this information for a number of herbal medicines for which there have been important safety concerns (see individual monographs). The effects of herbal medicines are, of course, brought about by their chemical constituents. It may not be fully recognised by some individuals that while, for example, aspirin tablets contain a measured quantity (within narrow limits) of a single active chemical compound, tablets (and indeed other dosage forms) of a herbal medicine typically contain a complex mixture of many (hundreds or more) chemical compounds. In order to appreciate the quality control and quality assurance procedures that are essential for herbal medicinal products and to understand their pharmacological and toxicological effects, it is necessary to be aware of the different types of chemical constituents, e.g. alkaloids, glycosides, flavonoids, etc, that may be present, as well as the individual constituents in specific herbal medicines. This edition includes two new features which provide this information: chemical structural formulae are included with virtually every monograph to supplement the textual information on constituents, and a new chapter 'Chemical Constituents of Plants Used as Herbal Medicines' has been added, which summarises the different groups of natural product compounds (e.g. alkaloids, glycosides, flavonoids, terpenes) that are present in medicinal plants. The first edition of this book provided information on herbal medicines available in pharmacies in the UK, whereas we have expanded the scope of this third edition to include new monographs on herbal medicines that may not necessarily be found in UK pharmacies but which are of public or professional interest. Hence, this edition includes new monographs on butterbur (Petasites hybridus), greater celandine (Chelidonium majus), kava (Piper methysticum) and rhodiola (Rhodiola rosea). Kava has been prohibited in the UK since 2002 because of its association with hepatotoxic reactions; we include a monograph here as it is possible that consumers and patients in the UK may obtain supplies from overseas. At least 10 existing monographs on popular herbal medicines have been completely revised, substantial updates and revisions have been made to over 20 other monographs, and minor amendments have been made to all remaining monographs. In addition, in response to comments from practising pharmacists, academics and other users of this book, this edition includes photographs of the crude herbal drugs which feature in the monographs as well as, for many monographs, the plants from which they originate. Also for the first time the individual monographs contain information from several countries on marketed products containing the respective herbal ingredients. We hope that these new features will be both useful and pleasing to the eye! As always, keeping a book up to date is a never-ending task, and the explosion in the scientific literature on herbal medicines makes this ever more difficult. In the last five years, there have been over 500 scientific papers published on St John's wort alone, and it is impossible and undesirable to describe each of them. The need for a book that reviews and summarises all this information has, perhaps, never been greater and we hope that this edition will provide healthcare professionals with the information they need to be able to advise their patients, competently and confidently, on the safe, effective and appropriate use of herbal medicines. Constructive criticism of the contents of Herbal Medicines is welcome and may be used to assist in the preparation of any future editions. The reader is asked to send any comments to the publisher by post or email ([email protected]). Joanne Barnes, Linda Anderson, David Phillipson Auckland and London May 2007 Acknowledgements We are grateful to the following Pharmaceutical Press staff for their active help and encouragement with this book: Tamsin Cousins, Simon Dunton, Louise McIndoe, Karl Parsons, Linda Paulus, Paul Weller and John Wilson. We also thank Marion Edsall for her proofreading work, and Lida Teng, PhD student at the School of Pharmacy, University of London, for administrative assistance. Photographs are included with kind permission of Thomas Brendler (www.plantaphile.com, Germany). Some of the photographs were supplied to Plantaphile by Larry Allain, Pierre Cabalion, Alvin Diamond, Ulrich Feiter, Trish Flaster, Nigel Gericke, Michael Guiry, MJ Hatfield, Gary Kauffman, Diane Robertson, Joachim Schmitz, Stan Shebs and Michael Wink. In addition, the photograph of blue flag is reproduced with kind permission of Brian Mathew, Royal Botanic Gardens, Kew, UK, Honorary Research Associate, and the photograph of nettle with kind permission of Dr Tom Cope, Royal Botanic Gardens, Kew, UK. Most of the herbal plant photographs were taken in major European botanical gardens. Photographs of the drug material were taken from materials supplied by reputable German herbal medicinal product suppliers. We are also very grateful to Dr Christine Leon (Royal Botanic Gardens, Kew, UK), who provided helpful advice and suggestions on appropriate botanical names and synonyms to include. Dr Leon was able to call on the specialist advice of the following colleagues, whom we thank. Staff at the Royal Botanic Gardens, Kew, UK: Dr Tom Cope, Dr Aaron Davis, Dr Nicholas Hind, Dr Sven Landrein, Dr Gwilym Lewis, Eve Lucas, Dr Alan Paton, Dr Nigel Taylor. Kew Honorary Research Associates: Jill Cowley, Dr Phillip Cribb, Dr David Frodin, Brian Mathew. Dr Leon and colleagues also provided helpful comments on the photographs. We thank all of the above individuals for their support with this publication. If there are any errors or omissions in the content of this book, then they are our responsibility. Preface to the Third Edition ix About the Authors Dr Joanne Barnes BPharm, PhD, MRPharmS, RegPharmNZ, MPSNZ, FLS Joanne Barnes obtained a degree in Pharmacy from the University of Nottingham in 1988, a postgraduate Certificate in Pharmacovigilance and Pharmacoepidemiology from the London School of Hygiene and Tropical Medicine in 1999, and a PhD in Pharmacy from the School of Pharmacy, University of London in 2001. She has been registered as a pharmacist with the Royal Pharmaceutical Society of Great Britain since 1989, was made a Fellow of the Linnean Society of London in 2003 and achieved registration as a pharmacist in New Zealand in 2007. She was Research Fellow in Complementary Medicines in the Department of Complementary Medicine, University of Exeter (1996–1999), Research Fellow (1999–2002) and Lecturer in Phytopharmacy (2002–2005) in the Centre for Pharmacognosy and Phytotherapy, School of Pharmacy, University of London, UK and, since 2005, has been Associate Professor in Herbal Medicines, School of Pharmacy, Faculty of Medical and Health Sciences, University of Auckland, New Zealand. Her research focuses on the utilisation, efficacy and safety of herbal medicines, particularly in exploring issues related to pharmacovigilance. Before embarking on an academic career, she practised as a hospital clinical pharmacist, as a medical information pharmacist in the pharmaceutical industry and worked in pharmaceutical publishing. She was Editor (1996–1999) and a co-founder of the journal Focus on Alternative and Complementary Therapies (FACT), Coeditor (2003–2005) of Complementary Therapies in Medicine and is an Associate Editor of Phytochemistry Letters and a member of the editorial boards of Phytotherapy Research, Drug Safety and the International Journal of Pharmacy Practice. She is a member of the Health Canada Natural Health Product Directorate's Expert Resource Group, the RPSGB's complementary medicine working group, and was a member of the UK Medicines and Healthcare products Regulatory Agency's Independent Review Panel for the Classification of Borderline Products (2000–2005). Dr Linda A Anderson BPharm, PhD, FRPharmS Linda Anderson obtained her first degree in Pharmacy and her PhD in Pharmacognosy at the Welsh School of Pharmacy in Cardiff. She was a postdoctoral research and teaching fellow at the School of Pharmacy, University of London from 1981 to 1987. Dr Anderson joined the Medicines and Healthcare products Regulatory Agency (MHRA, Department of Health, UK; formerly Medicines Control Agency) in 1987. Within the MHRA, she was initially involved in the assessment of new chemical entities and is now mainly involved with abridged applications and has specific responsibility for herbal products. She is Principal Assessor to the Committee on Safety of Medicine's (CSM) Expert Advisory Group on Chemistry, Pharmacy and Standards (CPS) and is UK delegate to the European Committee on Human Medicinal Products (CHMP) Quality Working Party. Dr Anderson is also UK Delegate to the European Medicines Agency (EMEA) Committee on Herbal Medicinal Products (HMPC), a member of the Herbal Medicines Advisory Committee (HMAC) of the MHRA, and is Vice-Chair of the British Pharmacopoeia Expert Advisory Group on Herbals and Complementary Medicines. She is a member of the Royal Pharmaceutical Society's Science Committee's working group on complementary/alternative medicine. Linda Anderson has been awarded a Fellowship of the Royal Pharmaceutical Society of Great Britain (2001). Professor J David Phillipson BSc(Pharm), MSc, PhD, DSc, FRPharmS, FLS David Phillipson graduated BSc in Pharmacy (1956), MSc (1959), and DSc (1979) from the University of Manchester, and PhD (1965) from the University of London. Hewas Lecturer in Pharmacognosy (1961–1972) at the Department of Pharmacy, Chelsea College, London, and Senior Lecturer (1973–1979), Reader in Phytochemistry (1979–1981), and Professor and Head of the Department of Pharmacognosy (1981–1994) at the School of Pharmacy, University of London. On retirement he became Emeritus Professor of Pharmacognosy. In 1995 he was appointed as Wilson T S Wang Distinguished International Visiting Professor at the Chinese University of Hong Kong from January to June. His research included investigations of the chemistry and biological activities of natural products from higher plants with special interests in indole and isoquinoline alkaloids, and plants used in traditional medicines for the treatment of malaria and other protozoal diseases. Collaboration with the pharmaceutical industry included the application of radioligand–receptor binding assays in the search for natural products with activity in the central nervous system. David Phillipson has received awards from the Phytochemical Society of Europe including the Tate and Lyle Award (1982), Medal (1994), and the Pergamon Prize for Creativity in Plant Biochemistry (1996). He was awarded the Korber Foundation Prize for Achievement in European Science (1989) in collaboration with Professor MH Zenk of the University of Munich and four other European colleagues, was presented with the Harrison Memorial Medal of the Royal Pharmaceutical Society of Great Britain (1999), and with the Sir Hans Sloane Medal of the Faculty of the History and Philosophy of Medicine and Pharmacy, Society of Apothecaries (2001). In 1985 he was Science Chairman of the British Pharmaceutical Conference and has been Secretary (1977–1982), Vice-Chairman (1982–1984, 1986–1988) and Chairman (1984– 1986) of the Phytochemical Society of Europe. He has been awarded Fellowships of the Royal Pharmaceutical Society of Great Britain (1980) and of the School of Pharmacy, University of London (1998). He has supervised 33 PhD students and 11 postdoctoral researchers, publishing some 222 full research papers, 150 short communications, 42 review articles, and has edited six books on natural products. Collaborative research was established with scientists in many countries world-wide and in 1989 he was appointed Honorary Professor of the Chinese Academy of Medical Sciences at the Institute of Medicinal Plant Research and Development, Beijing, China. For 19 years he was a member of the Natural Products Group of the International Foundation for Science, Sweden, helping to award research grants to individual young scientists in developing countries. He has been a member of a number of national and international committees, including the Herbal Medicines Advisory Committee (HMAC) of the MHRA. x How to Use Herbal Medicines Purpose and Scope Herbal Medicines is intended to serve as a reference work for pharmacists, doctors, nurses and other healthcare professionals, assisting in their provision of advice on the use of herbal medicines to members of the public. Herbal Medicines is not intended to represent a guide to self-diagnosis and self-treatment with herbal medicines, and should not be used as such. The term 'herbal medicine' or 'herbal medicinal product' (or, less frequently, 'herbal remedy') is used to describe a marketed product, whereas 'herbal ingredient' refers to an individual herb that is present in a herbal medicine. 'Herbal constituent' is used to describe a specific chemical constituent of a herbal ingredient. Thus, as examples, Valerian Tablets are a herbal product, valerian root is a herbal ingredient, and valtrate is a herbal constituent of valerian. The main criterion for inclusion of a herbal ingredient in the text is its presence in herbal medicines that are used in the UK, particularly those which are sold through pharmacies. In addition, herbs that have recently been the subject of media or scientific interest have been included. The aim of Herbal Medicines is to draw the attention of the reader to the reputed actions and uses of herbal ingredients, and to whether or not these have been substantiated by evidence from preclinical and/or clinical studies. In addition, any known or potential toxicities of herbal ingredients, and how these may influence the suitability for inclusion in herbal medicines or for use with conventional medicines, are also discussed. Introduction to the Monographs The introductory section to the 152 monographs on the individual herbal ingredients contained in Herbal Medicines discusses the legal aspects of herbal medicines including licensed medicines and non-licensed products in the UK and within the European Union (EU). All medicines are assessed for their quality, safety and efficacy and, in the context of herbal medicines, there are often specific criteria which are not encountered in the assessment of other medicines. As a first line in ensuring the safety and efficacy of herbal medicines there is a series of guidelines for quality assessment and this is briefly discussed. In terms of safety, it is a popular conception that because herbs are 'natural' then they must also be safe. This is a misconception, and it is emphasised that some herbal ingredients have the capability to cause adverse effects, whilst some are decidedly toxic. Within the context of the 152 monographs on herbal ingredients, most have documented adverse effects, or the potential to interact with other medication, and few can be recommended for use during pregnancy. Tables in the Introduction and appendices at the end of the monographs summarise the safety aspects of these herbal ingredients and give information on biologically active herbal ingredients and their active principles. Clinical efficacy has not been established for the majority of the herbal ingredients described in this handbook and, in some instances, there is a lack of documentation for chemical constituents and for pharmacological actions. The Herbal Monographs Some 152 monographs on individual herbal ingredients found in herbal products are included, the title used for the monograph being their preferred common name. A data sheet-type format was chosen for the monographs because it was felt important to arrange the relevant information in a format familiar to pharmacists, doctors, nurses and other healthcare professionals. Although conventional data sheets are written for products, it was decided to draw up the data sheets for herbal ingredients and not for specific products, although where possible details are provided of the specific products assessed in the studies discussed. The headings used in the herbal monographs are listed below with a brief explanation of the information provided under them. Monograph title Common name for the herbal ingredient; if more than one common name exists, this is the chosen preferred name. Summary and Pharmaceutical Comment This section is designed to give the reader an overall summary of the monograph contents, indicating the extent of phytochemical, pharmacological and clinical data available for the herbal ingredient, whether or not proposed herbal uses are justified, concerns over safety and, based on this information, whether or not the herbal ingredient is considered suitable for use as a herbal medicine Species (Family) Preferred botanical name with authority, together with the plant family. Synonym(s) Other common or botanical names. Part(s) Used Plant part(s) traditionally used in herbal medicine. Pharmacopoeial and Other Monographs Key pharmacopoeial monographs and texts on herbal medicines. UK Legal Category Legal category of the herb with respect to licensed products. For the majority of herbal ingredients this will be the General Sales List (GSL). Constituents Main documented chemical constituents grouped into categories such as alkaloids (type specified), flavonoids, iridoid glycosides, saponins, tannins, triterpenes, volatile oil and other constituents for miscellaneous and minor chemical components. table continues 1 Chemical structural formulae Chemical structural formulae are included for key constituents of herbal ingredients for virtually every monograph. This information supplements the textual information on constituents. Quality of plant material and commercial products This section has been included for several herbal ingredients commonly encountered in commercial products. It describes studies examining the variation in phytochemical content of crude plant material and marketed products and other aspects relating to product quality, such as differences between actual and labelled content of commercial products. Food Use Provides an indication as to whether the herbal ingredient is used in foods. The Council of Europe (COE) category, which reflects the opinion of the COE on the suitability of the herbal ingredient for use as a food flavouring, is quoted where applicable. Herbal Use States the reputed actions and uses of the herbal ingredients, based on information from several sources. In some instances, current investigations of particular interest are included. Photographs Provided for most of the monographs for the crude drug substance and the plant from which it originates. As we do not provide botanical, macroscopical or microscopical descriptions, these photographs are for illustrative purposes only and are not intended to be used for identification purposes. Dosage States the traditional dose of the herbal ingredient, mainly from the British Herbal Pharmacopoeia (BHP), German Commission E and European Scientific Cooperative on Phytotherapy (ESCOP) monographs, giving doses for plant part used (e.g. herb, rhizome, leaf), liquid extract and infusion. Where possible, dosages typically used in clinical trials are included. Pharmacological Actions Describes any documented pharmacological actions for the herbal ingredient. This is further divided into a section on In vitro and animal studies and a Clinical studies section, which describes studies involving humans. Side-effects, Toxicity Details documented side-effects to the herbal ingredient and toxicological studies. If side-effects or toxicity are generally associated with any of the constituents in the herbal ingredient, or with its plant family, then these are mentioned here. See also Table 1 and Table 2 in the Introduction. Contra-indications, Warnings Describes potential contra-indications and potential side-effects, and individuals who may be more susceptible to a particular side-effect. This section should be used in conjunction with Appendices 1–3. Comments on Pregnancy and lactation are included; a summary is provided in Table 3 of the Introduction. Preparations Describes product information from over 35 countries. Arranged in two sections, the first section lists by country the proprietary names (product names) of preparations containing the single herbal ingredient described in the monograph. The second section lists by country products that contain multiple ingredients including the herbal ingredient described in the monograph. Specific suppliers of preparations are shown in Appendix 4 along with the supplier contact information in Appendix 5. References References are included at the end of the text on each monograph. There is considerable literature on herbal plants and general references have been selected for use with the handbook. These General References, referred to as G1 to G88, are listed after the Introduction. For some well-known herbal ingredients only general references are cited. The majority of the monographs also contain specific references which are cited at the end of each monograph. 2 How to Use Herbal Medicines