Hamamelidis foliumHamamelis Leaf

MonographsThe Scientific Foundation for Herbal Medicinal Products

2012

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The Scientific Foundation for Herbal Medicinal Products

HAMAMELIDIS FOLIUMHamamelis Leaf

2012

ESCOP Monographs were first published in loose-leaf form progressively from 1996 to 1999 as Fascicules 1-6, each of 10 monographs

© ESCOP 1996, 1997, 1999

Second Edition, completely revised and expanded© ESCOP 2003

Second Edition, Supplement 2009© ESCOP 2009

ONLINE SERIESISBN 978-1-901964-02-8

Hamamelidis folium - Hamamelis Leaf

© ESCOP 2012

Published by the European Scientific Cooperative on Phytotherapy (ESCOP)Notaries House, Chapel Street, Exeter EX1 1EZ, United Kingdom

www.escop.com

All rights reservedExcept for the purposes of private study, research, criticism or review no part of this text

may be reproduced, stored in a retrieval system or transmitted, in any form or by any means, without the written permission of the publisher.

Important Note: Medical knowledge is ever-changing. As new research and clinical experience broaden our knowledge, changes in treatment may be required. In their efforts to provide information on the efficacy and safety of herbal drugs and herbal preparations, presented as a substantial overview together with summaries of relevant data, the authors of the material herein have consulted comprehensive sources believed to be reliable. However, in view of the possibility of human error by the authors or publisher of the work herein, or changes in medical knowledge, neither the authors nor the publisher, nor any other party involved in the preparation of this work, warrants that the information contained herein is in every respect accurate or complete, and they are not responsible for any errors or omissions or for results obtained by the use of such information. Readers are advised to check the product information included in the package of each medicinal preparation they intend to use, to be certain that the information contained in this publication is accurate and that changes have not been made in the recommended dose or in the contraindications for administration.

Edited by Simon Mills and Roberta HutchinsCover photograph by Simon Mills (Hamamelis virginiana)

Cover and text design by Martin WilloughbyTypeset in Optima by Roberta Hutchins

Plant illustrated on the cover: Hamamelis virginiana

FOREWORD

It is a great pleasure for me to introduce the online era of ESCOP Monographs. Interest in herbal medicinal products continues to stimulate research on herbal substances and the body of knowledge in this field is steadily growing. ESCOP takes account of this by preparing new monographs and - as the only organisation in the field at the moment - particularly through regular revision of our published monographs. In order to provide readers and authorities with balanced compilations of scientific data as rapidly as possible, ESCOP Monographs will be published online from now on. This contemporary way of publishing adds further momentum to ESCOP’s endeavours in the harmonization of European standards for herbal medicinal products.

The Board of ESCOP wishes to express its sincere gratitude to the members of the Scientific Committee, external experts and supervising editors, and to Peter Bradley, the final editor of every monograph published up to March 2011. All have voluntarily contributed their time and scientific expertise to ensure the high standard of the monographs.

Liselotte KrennChair of the Board of ESCOP

PREFACE

Over the 15 years since ESCOP published its first monographs, initially as loose-leaf documents then as two hardback books, ESCOP Monographs have achieved a reputation for well-researched, comprehensive yet concise summaries of available scientific data pertaining to the efficacy and safety of herbal medicinal products. The Second Edition, published in 2003 with a Supplement in 2009, covered a total of 107 herbal substances.

The monograph texts are prepared in the demanding format of the Summary of Product Characteristics (SPC), a standard document required in every application to market a medicinal product for human use within the European Union and ultimately providing information for prescribers and users of individual products.

As a change in style, literature references are now denoted by the name of the first author and year of publication instead of reference numbers; consequently, citations at the end of a monograph are now in alphabetical order. This is intended to give the reader a little more information and perspective when reading the text.

Detailed work in studying the pertinent scientific literature and compiling draft monographs relies to a large extent on the knowledge, skills and dedication of individual project leaders within ESCOP Scientific Committee, as well as invited experts. After discussion and provisional acceptance by the Committee, draft monographs are appraised by an eminent Board of Supervising Editors and all comments are taken into account before final editing and approval. In this way a wide degree of consensus is achieved, but it is a time-consuming process.

To accelerate the publication of new and revised monographs ESCOP has therefore decided to publish them as an online series only, commencing in 2011. We trust that rapid online access will prove helpful and convenient to all users of ESCOP Monographs.

As always, ESCOP is indebted to the many contributors involved in the preparation of monographs, as well as to those who provide administrative assistance and hospitality to keep the enterprise running smoothly; our grateful thanks to them all.

NOTES FOR THE READER

From 2011 new and revised ESCOP Monographs are published as an online series only. Earlier monographs are available in two books, ESCOP Monographs Second Edition (2003) and the Second Edition Supplement 2009, but are not available online for copyright reasons.

After purchase of a single monograph, the specific items to be downloaded are:

Front cover Title page Verso Foreword and Preface Notes for the Reader Abbreviations The monograph text Back cover

Information on the member organizations and people involved in ESCOP’s activities can be found on the website (www.escop.com): Members of ESCOP Board of Supervising Editors ESCOP Scientific Committee Board of Directors of ESCOP

ABBREVIATIONS used in ESCOP monographs

AA arachidonic acidABTS 2,2’-azino-bis(3-ethylbenzthiazoline-6-sulphonic acid)ACE angiotensin converting enzymeADP adenosine diphosphateALAT or ALT alanine aminotransferase (= SGPT or GPT)ALP alkaline phosphataseanti-IgE anti-immunoglobulin EASA acetylsalicylic acidASAT or AST aspartate aminotransferase (= SGOT or GOT)ATP adenosine triphosphateAUC area under the concentration-time curveBMI body mass indexBPH benign prostatic hyperplasiab.w. body weightcAMP cyclic adenosine monophosphateCI confidence intervalCmax maximum concentration of a substance in serumCNS central nervous systemCoA coenzyme ACOX cyclooxygenaseCSF colony stimulating factorCVI chronic venous insufficiencyCYP cytochrome P450d dayDER drug-to-extract ratioDHT dihydrotestosteroneDNA deoxyribonucleic acidDPPH diphenylpicrylhydrazylDSM Diagnostic and Statistical Manual of Mental Disorders (American Psychiatric Association)ECG electrocardiogramED50 effective dose in 50% of casesEDTA ethylenediamine tetraacetateEEG electroencephalogramEMA European Medicines AgencyENT ear, nose and throatER oestrogen receptorERE oestrogen-responsive elementFSH follicle-stimulating hormoneGABA gamma-aminobutyric acidGal galactoseGFR glomerular filtration rateGGTP gamma-glutamyl transpeptidaseGOT glutamate oxalacetate transaminase (= SGOT)GPT glutamate pyruvate transaminase (= SGPT)GSH glutathione (reduced)GSSG glutathione (oxidised)HAMA Hamilton Anxiety Scale12-HETE 12-hydroxy-5,8,10,14-eicosatetraenoic acidHDL high density lipoproteinHIV human immunodeficiency virusHMPC Committee on Herbal Medicinal Products (of the EMA)HPLC high-performance liquid chromatography 5-HT 5-hydroxytryptamine (= serotonin)IC50 concentration leading to 50% inhibitionICD-10 International Statistical Classification of Diseases and Related Health Problems, Tenth RevisionICH The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human UseICSD International Classification of Sleep DisordersIFN interferonIL interleukini.m. intramusculariNOS inducible nitric oxide synthaseINR International Normalized Ratio, a measure of blood coagulation (clotting) tendency

i.p. intraperitonealIPSS International Prostate Symptom Scorei.v. intravenouskD kiloDaltonKM Index Kuppermann Menopausal IndexkPa kiloPascalLC-MS liquid chromatography-mass spectrometryLD50 the dose lethal to 50% of animals tested LDH lactate dehydrogenaseLDL low density lipoproteinLH luteinizing hormone5-LOX 5-lipoxygenaseLPS lipopolysaccharideLTB4 leukotriene B4M molar (concentration)MAO monoamine oxidaseMBC minimum bactericidal concentrationMDA malondialdehydeMFC minimum fungicidal concentrationMIC minimum inhibitory concentrationMr molecularMRS Menopause Rating ScaleMRSA methicillin-resistant Staphylococcus aureusMTD maximum tolerated doseMTT 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromideMW molecular weightNBT nitro blue tetrazoliumNF-kB necrosis factor kappa-BNO nitric oxide NOS nitric oxide synthasen.s. not significantNSAID non-steroidal anti-inflammatory drugovx ovariectomy or ovariectomizedORAC oxygen radical absorbance capacityPA pyrrolizidine alkaloidPAF platelet activating factorPCR polymerase chain reactionPEG polyethylene glycolPGE prostaglandin EPHA phythaemagglutininp.o. per osPOMS profile of mood statesPVPP polyvinylpolypyrrolidoneRANKL receptor activator of nuclear factor kappa-B ligandRNA ribonucleic acidRT-PCR reverse transcription polymerase chain reactions.c. subcutaneousSCI spinal cord injury SERM selective oestrogen receptor modulatorSGOT or GOT serum glutamate oxalacetate transaminase (= ASAT or AST)SGPT or GPT serum glutamate pyruvate transaminase (= ALAT or ALT)SHBG sex hormone binding globulinSOD superoxide dismutaseSSRI selective serotonin reuptake inhibitorSTAI state-trait anxiety inventoryt1/2 elimination half-lifeTBARS thiobarbituric acid reactive substancesTGF-b transforming growth factor-betaTNF tumour necrosis factorTPA 12-O-tetradecanoylphorbol-13-acetateURT upper respiratory tractURTI upper respiratory tract infectionUTI urinary tract infectionVAS visual analogue scaleVLDL very low density lipoprotein

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HAMAMELIDIS FOLIUM 2012

Hamamelis Leaf

DEFINITION

Hamamelis leaf consists of the whole or cut, dried leaf of Hamamelis virginiana L. It contains not less than 3 per cent of tannins, expressed as pyrogallol (C6H6O3; Mr 126.1) and calculated with reference to the dried drug.

The material complies with the monograph of the European Pharmacopoeia [Hamamelis Leaf].

CONSTITUENTS

The main characteristic constituents are tannins (5-10%) [Egerer 2005; Bradley 2006; Hiller 2009], including condensed tannins (mainly proanthocyanidin oligomers with catechin and/or gallocatechin units) and hydrolysable gallo-tannins, notably a small amount of hamamelitannin [Vennat 1988, 1992; Scholz 1994; Wang 2003; Bradley 2006; Hiller 2009, Duckstein 2011]. (+)-Catechin, (+)-gallocatechin, (-)-epicatechingallate and (-)-epigallocatechingallate are also present [Friedrich 1974; Bradley 2006, Duckstein 2011].

Other constituents include flavonoids such as kaempferol, quercetin, quercitrin, isoquercitrin and myricetin; phenolic acids such as caffeic acid and gallic acid [Bernard 1977; Vennat 1992; Hoffmann-Bohm 1993; Laux 1993; Bradley 2006; Hiller 2009, Duckstein 2011]; and a volatile fraction, 0.04-0.14% [Messerschmidt 1971; Bradley 2006; Hiller 2009], containing aliphatic hydrocarbons (63%), mono- and sesquiterpenes (11%) and aldehydes and ketones (4.6%) among over 170 compounds detected [Engel 1998; Bradley 2006].

CLINICAL PARTICULARS

Therapeutic indications

Internal useSymptomatic treatment of complaints related to varicose veins, such as painful and heavy legs, and of haemorrhoids [Bernard 1977; Van Hellemont 1988; Hoffmann-Bohm 1993; Laux 1993; Hörmann 1994; MacKay 2001; Egerer 2005; Hiller 2009; Schilcher 2010].

External useBruises, sprains and minor injuries of the skin [Hoffmann-Bohm 1993; Laux 1993; Bradley 2006; Bühring 2008; Hiller 2009].Local inflammations of the skin and mucosa [Bernard 1977; Hoffmann-Bohm 1993; Laux 1993; Millikan 2003; Bradley 2006; Bühring 2008; Hiller 2009; Schilcher 2010].Haemorrhoids [Hoffmann-Bohm 1993; Laux 1993; Hamamelis Leaf (BHP) 1983; Bradley 2006; Hiller 2009; Schilcher 2010].Relief of the symptoms of neurodermitis atopica [Wokalek 1993; Bradley 2006] and feeling of heavy legs [Hoffmann-Bohm 1993].

Efficacy in these indications is plausible on the basis of human experience and long-standing use.

Posology and method of administration

Dosage

Internal useAdults: 2-3 g of drug as infusion [Hoffmann-Bohm 1993; Bradley 2006; Hiller 2009] or 2-4 ml of liquid extract (1:1, 45% ethanol), three times daily [Hamamelis Leaf (BHP) 1983; Bradley 2006].

External useExtracts in semisolid or liquid preparations, containing 5-10% of drug [Hoffmann-Bohm 1993; Bradley 2006; Schilcher 2010].

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HAMAMELIDIS FOLIUM

Decoctions, 5-10 g of drug per 250 ml water for compresses or washes [Hoffmann-Bohm 1993; Bradley 2006; Hiller 2009; Schilcher 2010].Suppositories containing 200 mg of dried extract, 1-2 per day [Bradley 2006; Schilcher 2010]. Ointment containing 10% of liquid extract [Bradley 2006; Schilcher 2010]. The use of the decoction (e.g. for compresses or bathes) is also recommended in children [Bühring 2008]

Method of administration For oral administration and topical application.

Duration of administrationIf symptoms persist or worsen, medical advice should be sought.

ContraindicationsNone known.

Special warnings and special precautions for useNone required.

Interaction with other medicaments and other forms of interactionNone reported.

Pregnancy and lactationNo data available. In accordance with general medical practice, the drug should not be used internally during pregnancy without medical advice.

Effects on ability to drive and use machinesNone known.

Undesirable effectsIn sensitive patients there is a possibility of stomach upsets after taking hamamelis leaf preparations [Hoffmann-Bohm 1993]. Chamomile-sensitive persons might also react to hamamelis preparations after topical application [Paulsen 2008].

OverdoseNo toxic effects reported.

PHARMACOLOGICAL PROPERTIES

Pharmacodynamic properties

In vitro experimentsA lyophilized 10% decoction and a methanolic dry extract of Hamamelis leaf both exerted antibacterial activity on various periodonthopathic bacteria such as Eikenella corrodens, Actinomyces odontolyticus, Porphyromonas gingivalis and Prevotella spp.; the methanolic extract being more potent with MICs from 32 µg/mL onwards [Iauk 2003].

An extract from Hamamelis leaf and bark (ethanol 60%) showed antioxidant activity in the ABTS assay in a dilution of 1:10000 with an activity equivalent to 40 µM of trolox [Pereira da Silva A 2000].

In vivo experimentsVenotonic activity was demonstrated in experiments where the dried residue (300 mg) from aqueous or various hydroethanolic extracts of hamamelis leaf was added to one litre of an isotonic dextran/water (60 g/litre) solution. This was perfused at constant pressure into the arteries of the hind quarters of rabbits (45-100 drops/min). Venoconstriction, measured in terms of output on the venous side, was reduced by up to 60-70% depending on

the type of extract [Bernard 1972].

A dry 70%-ethanolic extract of hamamelis leaf, administered orally to rats at 200 mg/kg daily for 19 days, significantly inhibited paw swelling (p<0.05) in the chronic phase of adjuvant-induced arthritis but was not active against the acute phase of oedema [Duwiejua 1994].

Pharmacological studies in humansIn a study conducted on 30 human volunteers, topical applic-ation of a hydroglycolic extract of hamamelis leaf produced a significant reduction in skin temperature (p<0.001 after 5 min; p<0.03 after 60 min), which was interpreted as a vasoconstrictor effect [Diemunsch 1987].

Clinical studiesIn a pilot study involving cases of neurodermitis atopica, a cream containing hamamelis leaf extract was applied twice daily for 2 weeks in six groups of patients:- Group I consisted of 7 children aged from 6 to 14 years with atopic neurodermitis on the feet (chilblains). After treatment the condition had considerably improved in all the patients.- Group II consisted of 5 children with eczema in the flexure of the joints in subacute and chronic forms. After treatment 3 children were completely cured; in 2 children a considerable reduction of the inflamed condition and a clear reduction of the itch was noted.- In Group III, which consisted of 10 adults with eczema in the flexure of the joints, 7 cases showed a good response and in three cases there was reasonable improvement. - Group IV consisted of 5 adults with eczema of the neck and throat. 3 cases were completely cured and a remarkable reduction in symptoms was noted in the remaining 2 cases.- Group V consisted of 3 adults with atopic eczema of the trunk. In one patient there was extensive healing and in the others a noticeable reduction of symptoms. - Group VI consisted of 2 cases of atopic xerodermia. Following twice daily application of the cream, there was an improvement of the skin barrier situation and a clear diminution of desquamating pruritus in both cases [Wokalek 1993].

Pharmacokinetic propertiesNo data available.

Preclinical safety data

CarcinogenicityNIH black rats (15 male and 15 female) were injected sub-cutaneously with a lyophilised aqueous leaf extract at a dosage of 10 mg (dissolved in 0.5 ml of saline solution) weekly for a period of 78 weeks; 30 animals were injected with saline solution only. The animals were observed for a period of 90 weeks. After about 73 weeks, three of the male rats developed malignant mesenchymoma, while in the control animals no tumours developed. The tumour rate was not considered to be significant [Hoffmann-Bohm 1993].

REFERENCES

Bernard P, Balansard P, Balansard G, Bovis A. Valeur pharmaco-dynamique toniveineuse des préparations galéniques à base de feuilles d'hamamélis. J Pharm Belg 1972;27:505-12.

Bernard P. Les feuilles d’hamamélis. Plantes Méd Phytothér 1977;11 (Spécial):184-8.

Bradley P. Hamamelis Bark. In: British Herbal Compendium - A hand-book of scientific information on widely used plant drugs, Volume 2. Bournemouth: British Herbal Medicine Association, 2006:189-91.

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HAMAMELIDIS FOLIUM

Bühring U, Ell-Beiser H, Girsch M. Heilpflanzen in der Kinderheil-kunde. Stuttgart:Sonntag, 2008:77-8.

Diemunsch A-M, Mathis C. Effet vasoconstricteur de l'hamamélis en application externe. STP Pharma 1987;3:111-4.

Duckstein SM, Stintzing FC. Investigation on the phenolic constituents in Hamamelis virginiana leaves by HPLC-DAD and LC-MS/MS. Anal Bioanal Chem. 2011 Aug;401(2):677-88. Epub 2011 May 31. http://dx.doi.org/10.1007/s00216-011-5111-3

Duwiejua M, Zeitlin IJ, Waterman PG, Gray AI. Anti-inflammatory activity of Polygonum bistorta, Guaiacum officinale and Hamamelis virginiana in rats. J Pharm Pharmacol 1994;46:286-90. http://dx.doi.org/10.1111/j.2042-7158.1994.tb03795.x

Egerer HP. Hamamelisblätter – Hamamelidis folium. In: Bracher F, Heisig P, Langguth P, Mutschler E, Rücker G, Scriba G et al., editors. Kommentar zum Europäïschen Arzneibuch. Stuttgart, Eschborn: Wissenschaftliche Verlagsgesellschaft, Govi-Verlag 2005 (19. Lfg):H 4.00/0909.

Engel R, Gutmann M, Hartisch C, Kolodziej H, Nahrstedt A. Study on the composition of the volatile fraction of Hamamelis virginiana. Planta Med 1998;64:251-8. http://dx.doi.org/10.1055/s-2006-957420

Friedrich H, Krüger N. Neue Untersuchungen über den Hamamelis-Gerbstoff. II. Der Gerbstoff der Blätter von H. virginiana. Planta Med 1974;26:327-32. http://dx.doi.org/10.1055/s-0028-1099395

Hamamelis Leaf - Hamamelidis folium. European Pharmacopoeia, Council of Europe.

Hamamelis Leaf. In: British Herbal Pharmacopoeia 1983. Bournemouth: British Herbal Medicine Association, 1983:110.

Hiller K, Loew D. Hamamelidis folium. Hamamelisblätter. In: Wichtl M, editor. Teedrogen und Phytopharmaka, 5th ed. Stuttgart: Wissenschaftliche Verlagsgesellschaft, 2009:321-3.

Hoffmann-Bohm K, Ferstl W, Aye R-D. Hamamelis. In: Hänsel R, Keller K, Rimpler H, Schneider G, editors. Hamamelis. Hagers Handbuch der Pharmazeutischen Praxis, 5th ed. Volume 5: Drogen E-O. Berlin-Heidelberg: Springer-Verlag, 1993:367-84.

Hörmann HP, Korting HC. Evidence for the efficacy and safety of topical herbal drugs in dermatology: Part 1: Anti-inflammatory agents. Phytomedicine 1994;1:161-71. http://dx.doi.org/10.1016/S0944-7113(11)80036-X

Iauk L, Lo Bue AM, Milazzo I, Rapisarda A, Blandino G. Antibacterial activity of medicinal plant extracts against periodontopathic bacteria.

Phytother Res 2003;17:599-604. http://dx.doi.org/10.1002/ptr.1188

Laux P, Oschmann R. Die Zaubernuß - Hamamelis virginiana L. Z Phytotherapie 1993;14:155-66.

MacKay D. Hemorrhoids and varicose veins: a review of treatment options. Alternative Medicine Review 2001;6:126-40.

Messerschmidt W. Zur Kenntnis des Wasserdampfdestillats der Blätter von Hamamelis virginiana L. 4. Mitteilung: Charakterisierung von Blattdroge und Destillat. Dtsch Apoth Ztg 1971;111:299-301.

Millikan LE. Alternative therapy in pruritus. Dermatol Ther 2003;16: 175-80. http://dx.doi.org/10.1046/j.1529-8019.2003.01626.x

Paulsen E, Christensen LP, Andersen KE. Cosmetics and herbal remedies with Compositae plant extracts - are they tolerated by Compositae-allergic patients? Contact Dermatitis 2008;58:15-23.

Pereira da Silva A, Rocha R, Silva CML, Mira L, Duarte MF, Florêncio MH. Antioxidants in medicinal plant extracts. A research study of the antioxidant capacity of Crataegus, Hamamelis and Hydrastis. Phytother Res 2000;14:612-6. http://dx.doi.org/10.1002/1099-1573 (200012)14:8<612::AID-PTR677>3.0.CO;2-T

Schilcher H, Kammerer S, Wegener T. Leitfaden Phytotherapie. 4th edition. München, Elsevier: 2010, 353-5.

Scholz E. Pflanzliche Gerbstoffe. Pharmakologie und Toxikologie. Dtsch Apoth Ztg 1994;134:3167-79.

Van Hellemont J. Hamamelis virginiana L. In: Fytotherapeutisch compendium, 2nd ed. Houten, Netherlands: Bohn Stafleu Van Loghum, 1988:284-6.

Vennat B, Pourrat H, Pouget MP, Gross D, Pourrat A. Tannins from Hamamelis virginiana: Identification of proanthocyanidins and hamamelitannin quantification in leaf, bark and stem extracts. Planta Med 1988;54:454-6. http://dx.doi.org/10.1055/s-2006-962499

Vennat B, Gross D, Pourrat A, Pourrat H. Hamamelis virginiana: Identification and assay of proanthocyanidins, phenolic acids and flavonoids in leaf extracts. Pharm Acta Helv 1992;67:11-4.

Wang H, Provan GJ, Helliweill K. Determination of hamamelitannin, catechins and gallic acid in witch hazel bark, twig and leaf by HPLC. J Pharm Biomed Anal 2003;33:539-44. http://dx.doi.org/10.1016/S0731-7085(03)00303-0

Wokalek H. Zur Bedeutung epidermaler Lipide und des Arachidon-säurestoffwechsels bei Neurodermitis atopica. Deutsche Dermatologe 1993;5:498-506.

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The second edition of ESCOP Monographs, published as a hardback book in 2003 with a Supplement in 2009, has been widely acclaimed for its authoritative information on the therapeutic uses of herbal medicines. Monographs covering a total of 107 herbal substances include extensive summaries of pharmacological, clinical and toxicological data, and copious references to scientific literature form an important part of each text.

Although publication in the form of books was convenient in the past, ESCOP recognizes that online publication now offers a number of advantages, not least in facilitating rapid publication of individual monographs as soon as all stages of preparation have been completed. Commencing from 2011, therefore, new and revised monographs will be published online only.

The European legislative framework for herbal medicines has advanced considerably over the past decade. Directive 2004/24/EC introduced a simplified registration procedure for traditional herbal medicinal products in EU member states and imposed a 2011 deadline for the registration of certain products on the market. The Committee on Herbal Medicinal Products (HMPC), established in 2004 as part of the European Medicines Agency, has made substantial progress in the preparation of Community Herbal Monographs and associated documentation to provide a more harmonized approach to the scientific assessment of herbal medicinal products throughout the European Community

Whether the evaluation of a herbal medicine is based on evidence of clinical efficacy (well-established use) or on experience and historical use of that product (traditional use) those involved at all levels of the regulatory process need access to detailed, reliable and structured summaries of the available efficacy and safety data. ESCOP monographs meet that requirement and offer an invaluable source of scientific information on herbal medicines to regulators, manufacturers, academics, researchers, health professionals and numerous others.

MonographsThe Scientific Foundation for Herbal Medicinal Products

www.escop.com ISBN 978-1-901964-02-8

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