E/S/C/O/P Monographs: The Scientific Foundation for Herbal Medicinal Products, 2nd ed. Published by ESCOP, the European Scientific Cooperative on Phytotherapy: Exeter, UK, in collaboration with Georg Thieme Verlag, Stuttgart, Germany, and Thieme New York. 2003. 556 pp. ISBN 1-901964-07-8 (ESCOP), ISBN 3-13-129421-3 (GTV), and ISBN 1-58890-233-1 (TNY). $139.00. ABC catalog #B524.

The European Scientific Cooperative on Phytotherapy (ESCOP) was established in 1989, and the first ESCOP monographs were published in March 1996 as the first of 6 fascicules (installments of 10 monographs each, in loose-leaf, ring binder format) with the final fascicule published in October 1999. The second edition, a hard-back book, contains 60 fully revised and expanded therapeutic monographs from the first edition in addition to 20 completely new monographs. The monographs are arranged alphabetically according to their pharmacopeial names, and the corresponding common names used by ESCOP, in many cases, do not match the Standardized Common Names¹ collected and promoted by the American Herbal Products Association that are accepted in North America. For example, ESCOP uses Hamamelis Bark instead of Witch Hazel Bark (Hamamelis virginiana) and Pale Coneflower Root instead of Echinacea Pallida Root (Echinacea pallida).

ESCOP is a consortium of many of the most respected and knowledgeable phytomedicine experts in Europe. Accordingly, the ESCOP monographs are considered to be an authoritative source of scientific evidence for phytomedicines and in fact are being utilized by the Committee for Herbal Medicinal Products (CHMP) of the European Medicines Evaluation Agency (EMEA) as a basis for establishing core data on leading European herbal medicinal products. Such core data is referenced by product manufacturers for their product license applications in order to obtain pre-marketing authorization for phytomedicinal products in the European Union (EU).

The ESCOP monographs are intended to be a contribution to the harmonization of therapeutic guidelines and standards for herbal medicines in the EU. The ESCOP monographs do not contain data on identity, quality control, analytical methods, etc., as are found in the European Pharmacopoeia (PhEur) and other national pharmacopeias, and to some extent in the monographs produced by the World Health Organization (WHO). However, each ESCOP monograph specifies the quality standard with which the botanical raw material must comply. For example, Ginkgo Leaf must comply with the monograph of the PhEur and Standardized Ginkgo Dry Extract must comply with the monograph of the German Pharmacopeia (DAB).

It is of particular interest for this American writer that 12 of the 80 monographs (15%) are native American herbs that have been introduced into European phytomedicine over the last couple of hundred years, another 3 monographs are Pacific Island herbs (eucalyptus [Eucalyptus globulus], Java tea [Orthosiphon stamineus], kava-kava [Piper methysticum]), and at least 15 of the 80 monographs cover herbs of Asian origin, stemming from traditional use in the Indian and/or Chinese systems of medicine, among other Asian systems. These include Asian ginseng (Panax ginseng), cinnamon (Cinnamomum zeylanicum), eleuthero (Eleutherococcus senticosus), garlic (Allium sativum), ginger (Zingiber officinale), ginkgo (Ginkgo biloba), Tinnevelly senna (Cassia angustifolia), and turmeric (Curcuma longa), among others. Table 1 lists ESCOP monographs of Native American herbs. Table 2 shows ESCOP Monographs appearing for the first time in the second edition.

Table 1. ESCOP Monographs of Native American Herbs

Table 2. ESCOP Monographs Introduced in Second Edition

Each monograph includes the following elements: definition, constituents, clinical particulars (therapeutic indications, dosage, method of administration, duration of administration, contraindications, special warnings and precautions, interactions, pregnancy and lactation, effects on ability to drive, undesirable effects, overdose), pharmacological properties (pharmacodynamic properties, in vitro experiments, in vivo experiments, pharmacological studies in humans, clinical studies, pharmacokinetic properties, preclinical safety data), and references. In some cases there are also a number of tables provided. For example, in the Ginkgo folium monograph there are five tables: (1) Critical reviews and meta-analysis of clinical studies; (2) Clinical studies in dementia; (3) Clinical studies in cerebral insufficiency; (4) Clinical studies in neurosensory disturbances; and (5) Clinical studies in peripheral arterial occlusive disease. Aside from the 80 monographs, the book has only a subject index that includes the botanical names, common names, and pharmacopeial names. No constituents, actions, indications, or other terms are indexed.

As an example of the extent of revision and expansion, the ESCOP 1996 Zingiberis Rhizoma (Ginger) monograph referenced 47 citations, mostly from the 1980s with a few up through 1994. The ESCOP 2003 Zingiberis Rhizoma monograph has 58 citations, mainly from the 1980s, 1990s, and up through 2002. The 1996 monograph stated that the quality of the raw material must comply with the monograph of the British Pharmacopoeia (BP), which had no quantitative standard for essential oil content, while the 2003 monograph requires the material to comply with the monograph of the PhEur, containing not less than 15 ml/kg of essential oil.* The 1996 ESCOP Ginger monograph provided summaries of 10 human studies while the 2003 revision includes summaries of 15 human studies (6 under the heading of Pharmacological studies in humans and 9 under the heading of Clinical studies) as well as a summary of 1 systematic review of clinical studies. The 2003 Ginger monograph has an additional Clinical safety data section that provides a summary of adverse events extrapolated from the already summarized clinical studies.

* Following harmonization of national pharmacopeial monographs between EU Member States, once a monograph becomes official in the PhEur, it is then retired from each of the individual national pharmacopeias (e.g., BP, DAB, French Pharmacopoeia) in their next edition.

Due to the rapid proliferation of research findings on medicinal herbs and herbal products over the past decade, a completely revised edition of the ESCOP monographs is a timely and welcome contribution. Additionally, the second edition of the ESCOP monographs is an essential compendium, at least for the 80 herbs that it covers, to be used in conjunction with other authoritative sources of evidence (e.g., German Commission E monographs, WHO monographs) to help satisfy the levels of evidence requirements and the acceptable sources of safety and efficacy evidence that are required under various regulatory frameworks for the marketing of phytomedicinal products. Such useful documentation applications include substantiation of structure/function claims listed in herbal dietary supplement notification letters to the U.S. Food and Drug Administration (FDA), product license applications/pre-marketing authorizations of natural health products with the Health Canada Natural Health Products Directorate (NHPD), or traditional herbal medicinal product license applications under the new European Union (EU) Directive, among other frameworks. The ESCOP monographs are useful not only for industry substantiation purposes to fulfill their legal evidence requirements in the licensing, notification, and/or re-registration of herbal products, but also as an authoritative reference by healthcare providers, researchers, and journalists.

Josef Brinckmann Vice President of Research and Development Traditional Medicinals, Inc. Sebastopol, CA.

Reference

1. McGuffin M, Kartesz JT, Leung AY, Tucker AO, eds. American Herbal Products Associations Herbs of Commerce, 2^nd ed. Silver Spring, MD: American Herbal Products Association; 2000.