WHO monographs on selected medicinal plants Volume 3

WHO monographs on selected medicinal plants Volume WHO monographs on selected medicinal plants VOLUME SMPvol3 layout.indd i 10.8.2007 12:09:48 WHO Library Cataloguing-in-Publication Data WHO monographs on selected medicinal plants Vol Plants, Medicinal Angiosperms Medicine, Traditional I WHO Consultation on Selected Medicinal Plants (3rd: 2001: Ottawa, Ont.) II World Health Organization ISBN 978 92 154702 (NLM classification: QV 766) © World Health Organization 2007 All rights reserved Publications of the World Health Organization can be obtained from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: bookorders@who.int) Requests for permission to reproduce or translate WHO publications — whether for sale or for noncommercial distribution — should be addressed to WHO Press, at the above address (fax: +41 22 791 4806; e-mail: permissions@who.int) The designations employed and the presentation of the material in this publication not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries Dotted lines on maps represent approximate border lines for which there may not yet be full agreement The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication However, the published material is being distributed without warranty of any kind, either expressed or implied The responsibility for the interpretation and use of the material lies with the reader In no event shall the World Health Organization be liable for damages arising from its use Printed in Spain SMPvol3 layout.indd ii 10.8.2007 12:09:49 Contents Acknowledgements Introduction General technical notices v Monographs (in alphabetical order of plant name) Fructus Ammi Majoris Fructus Ammi Visnagae Fructus Anethi Aetheroleum Anisi Fructus Anisi Semen Armenicae Flos Arnicae Folium Azadirachti Oleum Azadirachti Flos Carthami Stigma Croci Fructus Foeniculi Radix Gentianae Luteae Radix Gentianae Scabrae Gummi Gugguli Radix Harpagophyti Rhizoma Hydrastis Radix Ipecacuanhae Aetheroleum Lavandulae Flos Lavandulae Strobilus Lupuli Gummi Myrrha Herba Passiflorae Testa Plantiginis Radix Rehmanniae 23 33 42 53 64 77 88 102 114 126 136 150 160 169 182 194 204 219 229 236 247 257 268 283 iii SMPvol3 layout.indd iii 10.8.2007 12:09:50 Contents Fructus Schisandrae Radix Scutellariae Radix cum Herba Taraxaci Semen Trigonellae Foenugraeci Cortex Uncariae Fructus Zizyphi 296 314 328 338 349 359 Annex Participants in the Third WHO Consultation on Selected Medicinal Plants, The Governmental Conference Centre, Ottawa, Canada, 16–19 July, 2001 370 Annex Cumulative index (in alphabetical order of plant name) 373 Annex Cumulative index (in alphabetical order of plant material of interest) 375 iv SMPvol3 layout.indd iv 10.8.2007 12:09:50 Acknowledgements Special acknowledgement is due to Professors Norman R Farnsworth, Harry H.S Fong, and Gail B Mahady of the WHO Collaborating Centre for Traditional Medicine, College of Pharmacy, University of Illinois at Chicago, Chicago, IL, USA, for drafting and revising the monographs Similarly, special acknowledgement is due to Dr Raymond BoudetDalbin of the Laboratoire de Chimie Thérapeutique, University of René Descartes, Paris, France, for drawing the chemical structures The photograph for the front cover was kindly provided by Professor Yoshiteru Ida of the School of Pharmaceutical Sciences, Showa University, Tokyo, Japan WHO also acknowledges with thanks the valuable work of the approximately 170 experts in more than 65 countries who provided comments and advice on the draft texts; those who submitted comments through the World Self-Medication Industry (a nongovernmental organization in official relations with WHO); and those who participated in the Third WHO Consultation on Selected Medicinal Plants held in Ottawa, Canada, in July 2001 to review the monographs (see Annex 1) Sincere appreciation is extended to Health Canada, who hosted the above-mentioned WHO Consultation with its financial support, and to the Regional Government of Lombardy, Italy, which provided funds for the editing and printing of this volume Finally, WHO wishes to express thanks to Mr Raymond Tsai, Boston, USA, and Dr Hermann Garden, Düsseldorf, Germany, for their indispensable assistance in finalizing and editing the manuscripts v SMPvol3 layout.indd v 10.8.2007 12:09:50 SMPvol3 layout.indd vi 10.8.2007 12:09:50 Introduction Increasing role of the WHO monographs on selected medicinal plants Since 1999, WHO has published two volumes of the WHO monographs on selected medicinal plants Volume includes 28 monographs and volume contains an additional 30 monographs Both of these volumes are now available on the WHO web site http://www.who.int/medicines/ organization/trm/orgtrmstrat.htm) Despite the increasing use of herbal medicines, there is still a significant lack of research data in this field, so that the WHO monographs are playing an increasingly important role For example, in the recent WHO global survey on national policy and regulation of herbal medicines, of the 34 countries reporting that they not have their own national monographs and use other monographs, 13 use the WHO monographs as an authoritative reference Moreover, the format of the WHO monographs continues to be commonly used for developing national monographs In the same survey, of the 46 countries that have already developed national monographs on herbal medicines, several countries, such as Armenia, Bhutan, Brazil, Malaysia, and Myanmar, reported having used the WHO format as a basis In May 2002, WHO launched its Traditional Medicine Strategy covering the period 2002–2005 In 2003, the World Health Assembly adopted resolution WHA56.31 on traditional medicine, which requests WHO to seek, together with WHO collaborating centres, evidence-based information on the quality, safety and cost-effectiveness of traditional therapies The objective is to provide guidance to Member States on the definition of products to be included in national directives and proposals on traditional-medicine policy implemented in national health systems The continued development of the WHO monographs on selected medicinal plants is one of the important activities being undertaken to meet the demands from Member States and in the implementation of the WHO Traditional Medicine Strategy Preparation of monographs for volume During the preparation of volume 3, more than 170 experts were involved, in addition to members of WHO’s Expert Advisory Panel on Traditional SMPvol3 layout.indd 10.8.2007 12:09:50 Introduction Medicine, a significant expansion in comparison to the numbers involved in the first two volumes National drug regulatory authorities in 65 countries participated in the process, again a greater number than for the previous volumes This global network of active players facilitated wider access to the available scientific references and information, in terms of both quality and quantity This considerable level of support contributed greatly to the efficiency of the preparation process The Third WHO Consultation on Selected Medicinal Plants was held in Ottawa, Canada, in July 2001 to review and finalize the draft monographs Thirty-two experts and drug regulatory authorities from WHO Member States participated (Annex 1) Following extensive discussion, 31 of the 33 draft monographs were adopted for inclusion At the subsequent tenth International Conference of Drug Regulatory Authorities held in China, Hong Kong Special Administrative Region in June 2002, the 31 draft monographs adopted for volume of the WHO monographs on selected medicinal plants were presented In its recommendations, the Conference requested WHO to publish them as soon as possible Selection of medicinal plants The selection of medicinal plants for inclusion in the WHO monographs is based on worldwide use The medicinal plants selected must meet two major criteria: (1) they must be in common use in at least two WHO Regions; and (2) there must be sufficient scientific data available to satisfy the requirements of the various sections in the monograph format The Third WHO Consultation on Selected Medicinal Plants discussed the selection criteria and made recommendations that will be applied starting with the preparation of volume of the WHO monographs Changes in format in volume Following intensive discussion at the Ottawa Consultation the title and context of the three categories included in the section Medicinal uses has been changed The changes are described in the in the General technical notices It was also decided at the Ottawa Consultation that the section on Adverse reactions should be moved to follow immediately after the section on Pharmacology, to provide a more logical progression for the subsequent sections on Contraindications, Warnings and Precautions A description of selected sections of the monographs is given in the General technical notices, which reflect the above-mentioned format changes For easy reference, two cumulative indexes are provided as an2 SMPvol3 layout.indd 10.8.2007 12:09:50 ... two volumes of the WHO monographs on selected medicinal plants Volume includes 28 monographs and volume contains an additional 30 monographs Both of these volumes are now available on the WHO. .. WHO monographs on selected medicinal plants VOLUME SMPvol3 layout.indd i 10.8.2007 12:09:48 WHO Library Cataloguing-in-Publication Data WHO monographs on selected medicinal plants Vol Plants, ... Semen Trigonellae Foenugraeci Cortex Uncariae Fructus Zizyphi 296 31 4 32 8 33 8 34 9 35 9 Annex Participants in the Third WHO Consultation on Selected Medicinal Plants, The Governmental Conference