MyrrhaMyrrh

MonographsThe Scientific Foundation for Herbal Medicinal Products

2014

www.escop.com

onlineseries

The Scientific Foundation for Herbal Medicinal Products

MYRRHAMyrrh

2014

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 978-1-901964-22-6

Myrrha - Myrrh

© ESCOP 2014

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 © Alsterdrache CC-BY-SA-3.0 (Commiphora molmol)

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

Plant illustrated on the cover: Commiphora molmol

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

1

MYRRHA 2014

Myrrh

DEFINITION

Myrrh consists of a gum-resin, hardened in air, obtained by incision or produced by spontaneous exudation from the stem and branches of Commiphora molmol Engler and/or other species of Commiphora.

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

Species other than Commiphora molmol Engler [synonym: C. myrrha (Nees) Engler var. molmol] which may be acceptable sources of medicinal myrrh include Commiphora abyssinica (Berg) Engler and C. schimperi (Berg) Engler [Wichtl 1999].

CONSTITUENTS

Myrrh contains three major groups of compounds: volatile oil (2-10%), resin (25-40%) and gum (30-60%) [Wiendl 1994].

The main constituents of the volatile oil are furanosesquiterpenes of various structural types including furanoeudesma-1,3-diene (principal component), furanoeudesma-1,4-diene-6-one, lindestrene, curzerenone, furanodiene, 2-methoxyfuranodiene and 4,5-dihydrofuranodiene-6-one, together with sesquiterpenes such as a-copaene, elemene and bourbonene [Brieskorn 1982, Brieskorn 1983, Martinetz 1988, Hänsel 1992].

Characteristic constituents of the resin are a-, b- and g-commiphoric acids, a- and b-heerabomyrrhols, heeraboresene and burseracin [7, 8]; also various terpenes [Mincione 1972;Zhu 2001;Shen 2009;Su 2009;Xu 2011a; Xu 2011b] and a sesquiterpene lactone, commiferin [Mincione 1972].

The water soluble gum is composed of a heterodisperse mixture of proteo-glycans in which chains of alternating galactose and 4-O-methylglucuronic acid, and separate chains of arabinose, are attached to the protein moieties via hydroxyproline linkages [Wiendl 1994, Hough 1952, Jones 1955].

CLINICAL PARTICULARS

Therapeutic indications

Topical treatment of gingivitis, stomatitis (aphthous ulcers), minor skin inflam-mations, minor wounds and abrasions; supportive treatment for pharyngitis, tonsillitis [Moeck 2007, Martinetz 1989, Bradley 1992, Hiller 2009, Sweetman 2011, Barnes 2007].

Posology and method of administration

Dosage

Adults: As a gargle or mouthwash, 1-5 ml of tincture (1:5, ethanol 90% V/V) in a glass of water several times daily [Hager, Bradley 1992, Barnes 2007]. For use on skin, dab 2-3 times daily with diluted or undiluted tincture (1:5, ethanol 90% V/V) [Moeck 2007, Bradley 1992, Hiller 2009, Sweetman 2011, Martinetz 1989].

Elderly: as for adults.

Children: as for adults except using only diluted tincture on skin.

Method of administrationFor topical application.

Duration of useNo restriction.

2

MYRRHA

Contra-indicationsNone known.

Special warnings and special precautions for useNone required.

Because of the alcohol content, a transient burning sensation on the skin may be experienced depending on the level of dilution of the tincture.

Interaction with other medicaments and other forms of interactionNone reported.

Pregnancy and lactationNo data available. In accordance with general medical practice the product should not be used during pregnancy or lactation without medical advice.

Effects on ability to drive and use machinesNone known.

Undesirable effectsVery rare cases of allergic contact dermatitis have been reported [Gallo 1999, Al-Suwaidan 1997].

OverdoseNo toxic effects reported.

PHARMACOLOGICAL PROPERTIES

Pharmacodynamic properties

In vitro experiments

Antibacterial and antifungal effectsVarious sesquiterpene-containing fractions from myrrh inhibited Pseudomonas aeruginosa, Staphylococcus aureus, Escherichia coli and Candida albicans with minimum inhibitory concentrations of 0.18-2.8 µg/mL [Dolara 2000].

Essential oil from myrrh inhibited the growth of a variety of Gram-positive and Gram- negative bacteria with MIC values from 0.1-0.4 % [Wanner 2010].

Antiproliferative effectAn aqueous dry extract (7.5 g herbal drug/125 mL water) showed an antiproliferative activity in eight different murine and human cancer cell lines with IC50 values of 208-419 µg/mL [Shoemaker 2005].

Myrrh showed an effect on cell viability in a murine neuro-blastoma cell line with LC50 of 0.158 mg/mL [Mazzio 2009].

Aromatase inhibiting effectDiterpenes isolated from myrrh showed aromatase inhibiting activity with IC50 values of 0.21 µM and 0.32 µM, and significant (p<0.01) inhibition of human umbilical vein endothelial cell (HUVEC) growth [Su 2009].

In vivo experiments

Anti-inflammatory effectsIn carrageenan-induced paw oedema in rats, a petroleum ether dry extract of myrrh, at an oral dose of 500 mg/kg b.w. given 1h before carrageenan injection, exerted anti-inflammatory activity comparable to the effect of the anti-inflammatory agent oxyphenbutazone 100mg/kg b.w. In the cotton pellet granuloma

test the same extract, at an oral daily dose of 500mg/kg b.w. for four consecutive days, demonstrated a 26.49% inhibition of the resulting increase in pellet weight compared to control (saline) [Tariq 1985].

An ethanolic dry extract of myrrh (approximately 6:1), admin-istered intraperitoneally to mice, exerted a significant anti-inflammatory effect (p<0.05) at 400 mg/kg b.w. in the xylene-induced ear swelling model. The same extract significantly inhibited cotton pellet granuloma (p<0.05) in rats at an oral dose of 400 mg/kg [Atta 1998].

An ethanolic (85%) dry extract and a petroleum ether fraction from the extract at doses of 100 mg/kg b.w. given orally to mice significantly (p<0.05) inhibited formalin-induced paw swelling [Su 2011].

Antipyretic effect Mice with hyperpyrexia induced by administration of a 20% aqueous suspension of brewer’s yeast were then administered either an ethanolic (95%) dry extract or a petroleum ether extract (25:1) of myrrh at a dose of 500 mg/kg b.w. A significant antipyretic effect (p<0.001 to 0.05) was demonstrated [Mohsin 1989, Tariq 1985].

Stimulation of phagocytosisMale mice (19±1g) inoculated with Escherichia coli were treated intraperitoneally with either a dried ethanolic extract or the unsaponifiable fraction of myrrh, as solutions in aqueous ethanol (10% V/V) at 50 mg/kg b.w. Both treatments stimulated phagocytosis in 80% of the mice compared to controls [Delaveau 1980].

Analgesic effectsIn the hot plate test in mice a significant analgesic effect (p<0.01) was demonstrated after oral administration of myrrh at 1 mg/kg b.w. [Dolara 1996].

Furanoeudesma-1,3-diene isolated from myrrh showed significant analgesic properties in mice when administered by intracerebroventricular injection at 1.25 mg/kg b.w.(p<0.01) or orally at 50 mg/kg in the hot plate test, and also at 50 mg/kg in the writhing test. The analgesic effects were reversed by naloxone at 1 mg/kg, indicating an interaction with brain opioid receptors. Furanoeudesma-1,3-diene concentration-dependently displaced the specific binding of [3H]diprenorphine to rat brain membrane in vitro [Dolara 1996].

A fraction from myrrh composed of furanodiene-6-one and methoxyfuranoguaia-9-ene-8-one, administered as eye drops at a concentration of 280 µg/mL into the conjunctival sac of rabbits, had a strong local anaesthetic effect (p<0.01 compared to the vehicle as control) of about half that of procaine at 100 µg/mL [Dolara 2000].

An ethanolic dry extract of myrrh (approximately 6:1), admin-istered orally to mice, exerted a significant and dose-dependent analgesic effect in the acetic acid-induced writhing test at 200 mg/kg (p<0.05) and 400 mg/kg (p<0.01) [Atta 1998].

Cytoprotective effectOral administration of myrrh to male Wistar albino rats (aged 7-8 weeks) at 250, 500 and 1000 mg/kg b.w. provided significant and dose-dependent protection to the gastric mucosa against the ulcerogenic effects of various necrotizing agents: 80% ethanol, 25% sodium chloride, 0.2 M sodium hydroxide, indometacin 30 mg/kg and combined ethanol 80%-indometacin 2.5 mg/kg (p<0.05 to p<0.001, depending on the dose). The same suspension significantly and dose-dependently protected against

3

MYRRHA

ethanol-induced depletion of gastric wall mucus (p<0.05 at 500 mg/kg; p<0.001 at 1000 mg/kg) [Al-Harbi 1997].

Antitumour and cytotoxic effectsAfter oral treatment of Ehrlich solid tumour (EST)-bearing mice with an aqueous suspension of myrrh at daily doses of 250 or 500 mg/kg b.w., the higher dose produced significant decreases (p<0.05) after 25 days and 50 days, in tumour weight, in the viability of EST cells and in levels of DNA, RNA and protein in EST cells. The antitumour potential of myrrh was found to be comparable to that of the cytotoxic drug cyclophosphamide 10mg/kg b.w. [Al-Harbi 1994].

The antitumour activity of an aqueous suspension of myrrh, equivalent to that of cyclophosphamide, has also been demonstrated in Ehrlich ascites carcinoma (EAC) cell-bearing mice. At an oral dose of 500 mg/kg, significant reductions in the DNA (p<0.05), RNA (p<0.01) and protein (p<0.01) contents of EAC cells, and in their viability (p<0.05), were observed together with an increased survival rate of the animals (25.1 days) compared to negative control (16.7 days)[Qureshi 1993].

Oral administration of an extract of myrrh (not further specified) demonstrated no anti-tumour activity against Ehrlich ascites carcinoma in mice when given at doses of 100 mg/kg b.w. daily for 6 days or 250 mg/kg b.w. every other day for 6 days, as evaluated by total ascetic volume. The treatment caused a 5 day increase in the median survival time compared to control [El-Naggar 2011].

Hypoglycaemic effectsIntragastric treatment of normal and streptozotocin-induced diabetic rats with a 5% m/V aqueous extract of myrrh (prepared with boiling water and filtration) daily for one week at 10 ml/kg b.w. significantly lowered fasting blood glucose levels (p<0.05 for both groups) and, in the oral glucose tolerance test, significantly increased glucose tolerance in both normal (p<0.02) and diabetic animals (p<0.05) [Al-Awadi 1987].

Oral administration of two fractions (200-250 mg/kg b.w.) and two pure furanosesquiterpenes (150-175 mg/kg) from myrrh (C. myrrha) to obese diabetic mice produced significant reductions in blood glucose at 27 hours post-dose (p<0.005 in all cases). One active fraction at 200 mg/kg reduced blood glucose by 50% (p<0.0001), compared to a 41% reduction with the oral antidiabetic metformin at 250 mg/kg [Ubillas 1999].

Anthelmintic effectsMice infected with Schistosoma mansoni were treated intra-gastrically with 10 mg/kg b.w. per day of an extract of myrrh for three successive days 6 weeks after infection. Three weeks after treatment, the serum antischistosomal antibody level was significantly decreased (p<0.0001). The result was comparable to praziquantel at 250 mg/kg b.w. per day. The level of IL-2 was decreased significantly (p<0.01); the level of gamma interferon was not affected [Abdel-Aziz 2006].

Mice infected with 60 cercariae of Schistosoma mansoni were orally treated with an undefined myrrh extract (250 mg or 500 mg/kg b.w.), praziquantel as a positive control (250 mg/kg b.w.) or vehicle only, twice a day for three consecutive days. The treatment with the extract and praziquantel caused a significant (p<0.001) reduction in the worm burden of the mice, it induced the separation of male-female coupled worms and shifted female worms from their normal habitat to the liver [Badria 2001].

Antischistosomal activity of different myrrh preparations were tested at dosages from 180-10000 mg/kg b.w. in mice and

hamsters infected with Schistosoma mansoni strains of different geographical origin. No signs of antibilharzial activity were observed [Botros 2004].

Other effectsPowdered myrrh, administered orally at 100 mg/kg b.w., pro-vided 86% protection against experimental thrombosis in mice (p<0.05), comparable to the effect of acetylsalicylic acid at 20 mg/kg [Olajide 1999].

To assess the effect of myrrh on the genotoxic effects and liver oxidising effects of lead acetate, male albino mice (4 months old) received either normal diet (negative control), normal diet with 0.5% lead acetate (positive control) or normal diet with 1% myrrh powder and 0.5% lead acetate for 8 weeks (n=30/group). Addition of myrrh to the diet significantly (p<0.05) decreased the level of GSH, increased the activity of GSH-transferase and reduced lipid peroxidation determined in liver homogenate compared to negative control. It significantly (p<0.05) reduced genotoxicity of lead acetate, the number of aberrant cells as well as the increased frequency of chromosomal aberrations [El-Ashmawy 2006].

Clinical studies

Anthelmintic effectsOral treatment of 204 patients suffering from schistosomiasis with myrrh at 10 mg/kg b.w. per day for 3 days in an open study produced a cure rate of 91.7%. Non-responding patients treated for 6 further days with the same dose gave a cure rate of 76.5%, increasing the overall rate to 98%. 20 patients provided biopsy specimens 6 months after treatment and none of them showed living ova [Opdyke1976].

In an open study, 65 patients infected with Schistosoma mansoni (n=26) or S. haematobium (n=39) were treated with two capsules (600 mg) of a myrrh preparation (not further specified) for six consecutive days. The cure rates after three months were 96.2% and 97.4% respectively [Abo-Madyan 2004].

In an open study, 104 patients with schistosomiasis were treated with 600 mg of an undefined myrrh extract or praziquantel (positive control) at 40 mg/kg b.w. for 3 consecutive days. The treatments were given twice with a 3 week interval. After the first treatment phase the cure rate for the extract was 15.6% compared to 73.7% for praziquantel. After the second treatment phase the rates were 8.9% and 76.3% respectively [Baracat 2005].

Note: The studies above all point to clinical evidence that myrrh is effective against schistosomiasis; however in all cases the administered preparations are not sufficiently characterized.

In a preliminary open study 7 patients with fascioliasis (infection with parasitic liver flukes) were treated orally with a preparation consisting of 8 parts of myrrh resin and 3.5 parts of myrrh volatile oil at 12 mg/kg b.w./day for 6 days. The therapy proved to be effective, with pronounced improvement in the general condition of the patients and amelioration of all symptoms and signs. By the end of treatment a dramatic drop in the egg count was observed and eggs were no longer detectable in the faeces after 3 weeks or after a follow-up period of 3 months. High eosinophilic counts, elevated liver enzymes and Fasciola antibody titres returned to nearly normal [Rao 2001].

In an open study, 18 patients infected with Dicrocoelium dendriticum (a liver fluke) were given two capsules (600mg) of an unspecified myrrh extract for six successive days. Sixteen of the eighteen patients were followed up for two months and showed clinical and parasitological cure [Al-Mathal 2004].

4

MYRRHA

Antimicrobial effectsIn an open study, 13 patients infected with metronidazole- and tinidazole-resistant Trichomonas vaginalis were treated with 600 mg of an unspecified myrrh preparation for six to eight successive days. 11 of the 13 patients were reported to be cured by the treatment [El-Sharbini 2009].

Pharmacokinetic propertiesNo data available.

Preclinical safety dataThe acute oral LD50 for rats of myrrh oil has been determined as 1.65 g/kg b.w. [Opdyke1976].

The LD50 for rats of an extract from myrrh given intragastrically was determined to be 2 g/kg b.w. [Badria 2001].

LD50 in mice for an undefined myrrh extract were 3139 mg/kg b.w. given by gastric intubation and 1740 mg/kg b.w. given orally [Botros 2004, El-Naggar 2011].

In the open mouse ear assay, the essential oil, a chloroform dry extract and some isolated constituents from myrrh exhibited irritant potential [Saeed 2004].

Myrrh and the volatile oil of myrrh are reported to be non-irritating, non-sensitizing and non-phototoxic when applied to animal or human skin [Martinetz 1989,Al-Harbi 1994].

Oral toxicity studies of myrrh were carried out in mice using acute doses of 0.5, 1.0 and 3.0 g/kg b.w. and chronic doses of 100 mg/kg/day for 90 days. Compared to controls, no significant differences in mortality, weight gain or biochemical parameters were observed after acute or chronic treatment. After chronic treatment there were significant increases in weight of testes and seminal vesicles (p<0.05) and of caudae epididymis (p<0.01), and a significant increase in red blood cell count and haemoglobin (p<0.05). The toxicity studies supported the safe medicinal use of myrrh [Rao 2001].

Genotoxicity and cytotoxicityMyrrh administered orally to normal mice for 7 days at 125-500 mg/kg b.w. per day as an aqueous suspension showed no mutagenicity in the micronucleus test. It caused a significant, dose-dependent reduction in the RNA content of hepatic cells (p<0.01 at 250 mg/kg), but not the DNA or protein content, and a highly significant, dose-dependent, mitosis-depressant effect in femoral cells (p<0.001) [Qureshi 1993, Al-Harbi 1994].

Clinical safety dataMyrrh was well tolerated with only mild and transient side effects when administered orally to 204 patients with schistosomiasis at 10 mg/kg b.w./day for 3-9 days [Sheir 2001].

No signs of toxicity or adverse effects were observed from treatment of 7 patients with fascioliasis with myrrh resin/volatile oil at 12 mg/kg b.w. for 6 days [Massoud 2001].

Ethnopharmacological evidence suggests that myrrh has been extensively used both internally and externally without serious adverse effects [Martinetz 1989].

No side effects were reported in an open study involving 18 dicrocoeliasis patients treated for six days with a dose of 600 mg of an unspecified myrrh extract [Al-Mathal 2004].

REFERENCES

Abdel-Aziz MM, Abbas AT, ElbakryKA, Toson EA, El-Sherbiny M.

Immune response on mice infected with Schistosoma mansoni and treated with myrrha. J Med Sci 2006;6:858-61. http://dx.doi.org/10.3923/jms.2006.858.861

Abo-Madyan AA, Morsy TA, Motawea SM. Efficacy of myrrh in the treatment of Schistosomiasis (haematobium and mansoni) in Ezbet El-Bakly, Tamyia center, El-Fayoum governorate, Egypt. J Egypt Soc Parasitol 2004;34:423-46.

Al-Awadi FM, Gumaa KA. Studies on the activity of individual plants of an antidiabetic plant mixture. Acta Diabetol 1987;24:37-41. http://dx.doi.org/10.1007/BF02732051

Al-Harbi MM, Qureshi S, Ahmed MM, Rafatullah S, Shah AH. Effect of Commiphora molmol (oleo-gum-resin) on the cytological and biochemical changes induced by cyclophosphamide in mice. Am J Chin Med 1994;22:77-82. http://dx.doi.org/10.1142/S0192415X94000103

Al-Harbi MM, Qureshi S, Raza M, Ahmed MM, Afzal M, Shah AH. Gastric antiulcer and cytoprotective effect of Commiphora molmol in rats. J Ethnopharmacol 1997;55:141-50. http://dx.doi.org/10.1016/S0378-8741(96)01488-2

Al-Harbi MM, Qureshi S, Raza M, Ahmed MM, Giangreco AB, Shah AH. Anticarcinogenic effect of Commiphora molmol on solid tumors induced by Ehrlich carcinoma cells in mice. Chemotherapy 1994;40:337-47. http://dx.doi.org/10.1159/000239216

Al-Mathal EM, Fouad MAH. Myrrh (Commiphora molmol) in treatment of human and sheep Dendrocoeliasis dendriticum in Saudi Arabia. J Egypt Soc Parasitol 2004;34:713-20.

Al-Suwaidan SN, Gad el Rab MO, Al-Fakhiry S, Al Hoqail IA, Al-Maziad A, Sherif A-B. Allergic contact dermatitis from myrrh, a topical herbal medicine used to promote healing. Contact Dermatitis 1997;39:137.http://dx.doi.org/10.1111/j.1600-0536.1998.tb05867.x

Asif Saeed M, Sabir AW. Irritant potential of some constituents from oleo-gum-resin of Commiphora myrrha. Fitoterapia 2004;75:81-4.http://dx.doi.org/10.1016/j.fitote.2003.08.010

Atta AH, Alkofahi A. Anti-nociceptive and anti-inflammatory effect of some Jordanian medicinal plant extracts. J Ethnopharmacol 1998;60:117-24. http://dx.doi.org/10.1016/S0378-8741(97)00137-2

Badria F, Abou-Mohamed G, El-Mowafy A, Masoud A, Salama O. Mirazid: A new Schistisomicidal drug. Pharm Biol 2001;39:127-31.http://dx.doi.org/10.1076/phbi.39.2.127.6253

Barakat R, Elmorshedy H, Fenwick A. Efficacy of myrrh in the treatment of human Schistosomiasis mansoni. Am J Trop Med Hyg 2005;73:365-7.

Barnes J, Anderson LA and Phillipson JD. Myrrh. In: Herbal Medicines - A guide for healthcare professionals, 3 ed. London-Chicago: Pharmaceutical Press, 2007:449-51.

Botros S William S, Ebeid F, Cioli D, Katz N, Day TA, Bennett JL. Lack of evidence for an antischistosomal activity of myrrh in experimental animals. Am J Trop Med Hyg 2004;71:206-10.

Bradley PR, editor. Myrrh. In: British Herbal Compendium, Volume 1. Bournemouth: British Herbal Medicine Association, 1992:163-5.

Brieskorn CH, Noble P. Furanosesquiterpenes from the essential oil of myrrh. Phytochemistry 1983;22:1207-11. http://dx.doi.org/10.1016/0031-9422(83)80223-4

Brieskorn CH, Noble P. Inhaltsstoffe des etherischen Öls der Myrrhe. II: Sesquiterpene und Furanosesquiterpene. Planta Med 1982;44:87-90. http://dx.doi.org/10.1055/s-2007-971408

Brieskorn CH, Noble P. Two furanoeudesmanes from the essential oil

5

MYRRHA

of myrrh. Phytochemistry 1983;22:187-9. http://dx.doi.org/10.1016/S0031-9422(00)80085-0

Delaveau P, Lallouette P, Tessier AM. Drogues végétales stimulant l’activité phagocytaire du système réticulo-endothélial. Planta Med 1980;40:49-54. http://dx.doi.org/10.1055/s-2008-1074941

Dolara P, Luceri C, Ghelardini C, Monserrat C, Aiolli S, Luceri F et al. Analgesic effects of myrrh. Nature 1996;379:29. http://dx.doi.org/10.1038/379029a0

Dolara P, Corte B, Ghelardini C, Pugliese AM, Cerbai E, Menichetti S, Lo Nostro A. Local anaesthetic, antibacterial and antifungal properties of sesquiterpenes from myrrh. Planta Med 2000;66:356-8. http://dx.doi.org/10.1055/s-2000-8532

Dolara P, Moneti G, Pieraccini G, Romanelli N. Characterization of the action on central opioid receptors of furanoeudesma-1,3-diene, a sesquiterpene extracted from myrrh. Phytotherapy Res 1996;10(Suppl 1):S81-3.

El-Ashmawy IM, Ashry KM, El_Nahas AF, Salama OM. Protection by turmeric and myrrh against liver oxidative damage and genotoxicity by lead acetate in mice. Basic & clinical pharmacology & toxicology 2006;98:32-7. http://dx.doi.org/10.1111/j.1742-7843.2006.pto_228.x

El-Naggar SA. Lack of the beneficial effects of Mirazid (Commiphora molmol) when administered with chemotherapeutic agents on Erlich ascetic carcinoma bearing mice. Adv Biol Res 2011;5:193-9.

El-Sherbini GTM, El-Gozamy BR, Abdel-Hady NM, Morsy TA. Efficacy of two plant extracts against vaginal trichomoniasis. J Egypt Soc Parasitol 2009;39:47-58.

Gallo R, Rivara G, Cattarini G, Cozzani E, Guarrera M. Allergic contact dermatitis from myrrh. Contact Dermatitis 1999;41:230-1. http://dx.doi.org/10.1111/j.1600-0536.1999.tb06143.x

Hiller K, Loew D. Myrrha. in:Teedrogen und Phytopharmaka - Ein Handbuch für die Praxis auf wissenschaftlicher Grundlage, 5th ed. Stuttgart: Wissenschaftliche Verlagsgesellschaft, 2009:453-5

Hough L, Jones JKN, Wadman WH. Some observations on the constitution of gum myrrh. J Chem Soc 1952:796-800. http://dx.doi.org/10.1039/jr9520000796

Jones JKN, Nunn JR. The constitution of gum myrrh. Part II. J Chem Soc 1955:3001-4. http://dx.doi.org/10.1039/jr9550003001

Martinetz D, Lohs K, Janzen J. Myrrhe als Arzneimittel. In: Weihrauch und Myrrhe. Kulturgeschichte und wirtschaftliche Bedeutung: Botanik, Chemie, Medizin. Stuttgart: Wissenschaftliche Verlagsgesellschaft, 1989:141-51.

Martinetz D, Lohs K, Janzen J. Zur Chemie der Myrrhe. In: Weihrauch und Myrrhe. Kulturgeschichte und wirtschaftliche Bedeutung: Botanik, Chemie, Medizin. Stuttgart: Wissenschaftliche Verlagsgesellschaft, 1988:169-80.

Massoud A, El Sisi S, Salama O, Massoud A. Preliminary study of therapeutic efficacy of a new fasciolicidal drug derived from Commiphora molmol (myrrh). Am J Trop Med Hyg 2001;65:96-9.

Mazzio EA, Soliman KFA. In vitro screening for the tumoricidal properties of international medicinal drugs. Phytother Res 2009;23:385-98. http://dx.doi.org/10.1002/ptr.2636

Mincione E, Iavarone C. Terpeni dalla Commifera mirra arabica. Nota I. Chim Ind 1972;54:424-5.

Mincione E, Iavarone C. Terpeni dalla Commifera mirra arabica. Nota II. Chim Ind 1972;54:525-7.

Moeck S. Commiphora. In: Blaschek W, Ebel S, Hackenthal E, Holzgrabe U, Keller K, Reichling J, Schulz V, editors. Hagers Enzyklopädie der Arzneistoffe und Drogen, 6th ed. Volume 14. Berlin-Heidelberg-New York-London: Springer-Verlag, 2007:106-17

Mohsin A, Shah AH, Al-Yahya MA, Tariq M, Tanira MOM, Ageel AM. Analgesic, antipyretic activity and phytochemical screening of some plants used in traditional Arab system of medicine. Fitoterapia 1989;60:174-7.

Myrrh - Myrrha. European Pharmacopoeia, Council of Europe.

Olajide OA. Investigation of the effects of selected medicinal plants on experimental thrombosis. Phytotherapy Res 1999;13:231-2. http://dx.doi.org/10.1002/(SICI)1099-1573(199905)13:3<231::AID-PTR414>3.0.CO;2-2

Opdyke DLJ. Monographs on fragrance raw materials: Myrrh oil. Food Cosmet Toxicol 1976;14:621. http://dx.doi.org/10.1016/S0015-6264(76)80025-9

Qureshi S, Al-Harbi MM, Ahmed MM, Raza M, Giangreco AB, Shah AH. Evaluation of the genotoxic, cytotoxic and antitumor properties of Commiphora molmol using normal and Ehrlich ascites carcinoma cell-bearing Swiss albino mice. Cancer Chemother Pharmacol 1993:33:130-8. http://dx.doi.org/10.1007/BF00685330

Rao RM, Khan ZA, Shah AH. Toxicity studies in mice of Commiphora molmol oleo-gum-resin. J Ethnopharmacol. 2001;76:151-4. http://dx.doi.org/10.1016/S0378-8741(01)00189-1

Sweetman SC, editor. Myrrh. In: Martindale , the complete drug reference, 37 ed. London: Pharmaceutical press, 2011:2578.

Sheir Z, Nasr AA, Massoud A, Salama O, Badra GA, El-Shennawy H et al. A safe, effective, herbal antischistosomal therapy derived from myrrh. Am J Trop Med Hyg 2001;65:700-4.

Shen T, Lou H-X. Bioactive constituents of myrrh and frankincense, two simultaneously prescribed gum resins in Chinese traditional medicine. Chemistry & biodiversity 2008;5;540-55. http://dx.doi.org/10.1002/cbdv.200890051

Shen T, Wan W-Z, Wang X-N, Yuan HQ, Ji M, Lou HX. A triterpenoid and sesquiterpenoids from the resinous exudates of Commiphora myrrha.Helv chim acta 2009;92:645-52. http://dx.doi.org/10.1002/hlca.200800347

Shoemaker M, Hamilton B, Dairkee SH, Cohen I, Campbell MJ. In vitro anticancer activity of twelve Chinese medicinal herbs. Phytother Res 2005;19:649-51. http://dx.doi.org/10.1002/ptr.1702

Su S, Wang T, Duan J-A, Zhou W, Hua Y-Q, Tang Y-P, Yu L, Qian D-W. Anti-inflammatory and analgesic activity of different extracts of Commiphora myrrha.J Ethnopharmacol 2011;134:251-8. http://dx.doi.org/10.1016/j.jep.2010.12.003

Su S-L, Duan J-A, Tang Y-P, Zhang X, Yu L, Jiang F-R, Luo D, Ding A-W. Isolation and biological activities of neomyrrhaol and other terpenes from the resin of Commiphora myrrha. Planta Med 2009;75:351-5. http://dx.doi.org/10.1055/s-0028-1112214

Tariq M, Ageel AM, Al-Yahya MA, Mossa JS, Al-Said MS, Parmar NS. Anti-inflammatory activity of Commiphora molmol. Agents Actions 1985;17:381-2. http://dx.doi.org/10.1007/BF01982655

Ubillas RP, Mendez CD, Jolad SD, Luo J, King SR, Carlson TJ, Fort DM. Antihyperglycemic furanosesquiterpenes from Commiphora myrrha. Planta Med 1999;65:778-9. http://dx.doi.org/10.1055/s-2006-960870

Wanner J, Scmidt E, Bail S, Jirovetz L, Buchbauer G, Gochev V, Girova T, Atanasova T, Stoyanova A. Chemical composition and antibacterial

activity of selected essential oils and some of their main components. Natural product communications 2010;5:1359-64.

Wichtl M, Neubeck M. Myrrhe. In: Hartke K, Hartke H, Mutschler E, Rücker G, Wichtl M, editors. Kommentar zur Europäischen Arzneibuch. Stuttgart: Wissenschaftliche Verlagsgesellschaft, 1999 (12. Lfg.):M 87.

Wiendl RM, Franz G. Myrrhe - Neue Chemie einer alten Droge. Dtsch Apoth Ztg 1994;134:25-30.

Xu J, Guo Y, Li Y, Zhao P, Liu C, Ma Y, Gao J, Hou W, Zhang T.

Sesquiterpenoids fron resinous exudates of Commiphora myrrha and their neuroprotective effects. Planta medica 2011;

Xu J, Guo Y, Zhao P, Xie C, Jin D-Q, Hou W, Zhang T. Neuroprotective cadinane sesquiterpenes from the resinous exudates of Commiphora myrrha.Fitoterapia 2011;

Zhu N, Kikuzaki H, Sheng S, Sang S, Rafi MM, Wang M, Nakatani N, DiPaola RS, Rosen RT, HO C-T. Furanosesquiterpenoids of Commiphora myrrha. J Nat Prod 2001;64:1460-2. http://dx.doi.org/10.1021/np010072j

MOST RECENT VERSIONS

Title Common name Publication

ABSINTHII HERBA Wormwood Second Edition, 2003AGNI CASTI FRUCTUS Agnus Castus Second Edition, 2003AGRIMONIAE HERBA Agrimony Supplement 2009ALCHEMILLAE HERBA Lady's Mantle Online Series, 2013ALLII SATIVI BULBUS Garlic Second Edition, 2003ALOE BARBADENSIS Barbados Aloes Supplement 2009ALOE CAPENSIS Cape Aloes Second Edition, 2003ALTHAEAE RADIX Marshmallow Root Second Edition, 2003ANGELICAE RADIX Angelica Root Supplement 2009ANISI FRUCTUS Aniseed Second Edition, 2003ARNICAE FLOS Arnica Flower Second Edition, 2003BALLOTAE NIGRAE HERBA Black Horehound Supplement 2009BETULAE FOLIUM Birch Leaf Second Edition, 2003BOLDI FOLIUM Boldo Leaf Second Edition, 2003CALENDULAE FLOS Calendula Flower Second Edition, 2003CAPSICI FRUCTUS Capsicum Supplement 2009CARVI FRUCTUS Caraway Fruit Second Edition, 2003CARYOPHYLLI AETHEROLEUM Clove Oil Online Series, 2014CENTAURII HERBA Centaury Second Edition, 2003CENTELLAE ASIATICAE HERBA Centella Supplement 2009CHELIDONII HERBA Greater Celandine Second Edition, 2003CIMICIFUGAE RHIZOMA Black Cohosh Online Series, 2011CINNAMOMI CORTEX Cinnamon Second Edition, 2003CRATAEGI FOLIUM CUM FLORE Hawthorn Leaf and Flower Second Edition, 2003CRATAEGI FRUCTUS Hawthorn Berries Supplement 2009CUCURBITAE SEMEN Pumpkin Seed Supplement 2009CURCUMAE LONGAE RHIZOMA Turmeric Second Edition, 2003CURCUMAE XANTHORRHIZAE RHIZOMA Javanese Turmeric Supplement 2009CYNARAE FOLIUM Artichoke Leaf Supplement 2009ECHINACEAE ANGUSTIFOLIAE RADIX Narrow-leaved Coneflower Root Supplement 2009ECHINACEAE PALLIDAE RADIX Pale Coneflower Root Supplement 2009ECHINACEAE PURPUREAE HERBA Purple Coneflower Herb Supplement 2009ECHINACEAE PURPUREAE RADIX Purple Coneflower Root Supplement 2009ELEUTHEROCOCCI RADIX Eleutherococcus Supplement 2009EUCALYPTI AETHEROLEUM Eucalyptus Oil Second Edition, 2003FILIPENDULAE ULMARIAE HERBA Meadowsweet Second Edition, 2003FOENICULI FRUCTUS Fennel Second Edition, 2003FRANGULAE CORTEX Frangula Bark Second Edition, 2003FUMARIAE HERBA Fumitory Supplement 2009GENTIANAE RADIX Gentian Root Online Series, 2014GINKGO FOLIUM Ginkgo Leaf Second Edition, 2003GINSENG RADIX Ginseng Second Edition, 2003GRAMINIS RHIZOMA Couch Grass Rhizome Supplement 2009GRINDELIAE HERBA Grindelia Supplement 2009HAMAMELIDIS AQUA Hamamelis Water Online Series, 2012HAMAMELIDIS CORTEX Hamamelis Bark Online Series, 2012HAMAMELIDIS FOLIUM Hamamelis Leaf Online Series, 2012HARPAGOPHYTI RADIX Devil’s Claw Root Supplement 2009HEDERAE HELICIS FOLIUM Ivy Leaf Second Edition, 2003HIPPOCASTANI SEMEN Horse-chestnut Seed Second Edition, 2003HYDRASTIS RHIZOMA Goldenseal rhizome Online Series, 2013HYPERICI HERBA St. John’s Wort Second Edition, 2003JUNIPERI PSEUDO-FRUCTUS Juniper Second Edition, 2003LAVANDULAE FLOS/AETHEROLEUM Lavender Flower/Oil Supplement 2009LICHEN ISLANDICUS Iceland Moss Second Edition, 2003LINI SEMEN Linseed Second Edition, 2003LIQUIRITIAE RADIX Liquorice Root Second Edition, 2003

LUPULI FLOS Hop Strobile Second Edition, 2003MALVAE FLOS Mallow Flower Supplement 2009MARRUBII HERBA White horehound Online Series, 2013MATRICARIAE FLOS Matricaria Flower Second Edition, 2003MELALEUCAE AETHEROLEUM Tea Tree Oil Supplement 2009MELILOTI HERBA Melilot Second Edition, 2003MELISSAE FOLIUM Melissa Leaf Online Series, 2013MENTHAE PIPERITAE AETHEROLEUM Peppermint Oil Second Edition, 2003MENTHAE PIPERITAE FOLIUM Peppermint Leaf Second Edition, 2003MENYANTHIDIS TRIFOLIATAE FOLIUM Bogbean Leaf Online Series, 2013MILLEFOLII HERBA Yarrow Supplement 2009MYRRHA Myrrh Online Series, 2014MYRTILLI FRUCTUS Bilberry Fruit Online Series, 2014OLIBANUM INDICUM Indian Frankincense Supplement 2009ONONIDIS RADIX Restharrow Root Second Edition, 2003ORTHOSIPHONIS FOLIUM Java Tea Online Series, 2014PASSIFLORAE HERBA Passion Flower Second Edition, 2003PAULLINIAE SEMEN Guarana Seed Supplement 2009PIPERIS METHYSTICI RHIZOMA Kava-Kava Second Edition, 2003PLANTAGINIS LANCEOLATAE FOLIUM/HERBA Ribwort Plantain Leaf/Herb Online Series, 2013PLANTAGINIS OVATAE SEMEN Ispaghula Seed Second Edition, 2003PLANTAGINIS OVATAE TESTA Ispaghula Husk Second Edition, 2003POLYGALAE RADIX Senega Root Second Edition, 2003PRIMULAE RADIX Primula Root Second Edition, 2003PRUNI AFRICANAE CORTEX Pygeum Bark Supplement 2009PSYLLII SEMEN Psyllium Seed Second Edition, 2003RATANHIAE RADIX Rhatany Root Supplement 2009RHAMNI PURSHIANI CORTEX Cascara Second Edition, 2003RHEI RADIX Rhubarb Second Edition, 2003RIBIS NIGRI FOLIUM Blackcurrant Leaf Second Edition, 2003ROSAE PSEUDO-FRUCTUS Dog Rose Hip Supplement 2009ROSMARINI FOLIUM Rosemary Leaf Second Edition, 2003RUSCI RHIZOMA Butcher’s Broom Second Edition, 2003SALICIS CORTEX Willow Bark Second Edition, 2003SAMBUCI FLOS Elder flower Online Series, 2013SALVIAE OFFICINALIS FOLIUM Sage Leaf Second Edition, 2003SALVIA TRILOBAE FOLIUM Sage Leaf, Three-lobed Online Series, 2014SENNAE FOLIUM Senna Leaf Second Edition, 2003SENNAE FRUCTUS ACUTIFOLIAE Alexandrian Senna Pods Second Edition, 2003SENNAE FRUCTUS ANGUSTIFOLIAE Tinnevelly Senna Pods Second Edition, 2003SERENOAE REPENTIS FRUCTUS (SABAL FRUCTUS) Saw Palmetto Fruit Second Edition, 2003SERPYLLI HERBA Wild Thyme Online Series, 2014SOLIDAGINIS VIRGAUREAE HERBA European Golden Rod Second Edition, 2003SILYBI MARIANI FRUCTUS Milk Thistle Fruit Supplement 2009SYMPHYTI RADIX Comfrey Root Online Series, 2012TANACETI PARTHENII HERBA Feverfew Online Series, 2014TARAXACI FOLIUM Dandelion Leaf Second Edition, 2003TARAXACI RADIX Dandelion Root Second Edition, 2003THYMI HERBA Thyme Second Edition, 2003TORMENTILLAE RHIZOMA Tormentil Online Series, 2013TRIGONELLAE FOENUGRAECI SEMEN Fenugreek Second Edition, 2003URTICAE FOLIUM/HERBA Nettle Leaf/Herb Second Edition, 2003URTICAE RADIX Nettle Root Second Edition, 2003UVAE URSI FOLIUM Bearberry Leaf Online Series, 2012VACCINII MACROCARPI FRUCTUS Cranberry Supplement 2009VALERIANAE RADIX Valerian Root Supplement 2009VIOLAE HERBA CUM FLORE Wild Pansy Supplement 2009VITIS VINIFERAE FOLIUM Red Vine Leaf Supplement 2009ZINGIBERIS RHIZOMA Ginger Supplement 2009

9

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 978-1-901964-22-6

onlineseries