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eCAM Advance Access published online on February 20, 2008
eCAM, doi:10.1093/ecam/nen009
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© 2008 The Author(s).
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/2.0/uk/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Black Cohosh Hepatic Safety: Follow-up of 107 Patients Consuming a Special Cimicifuga racemosa rhizome Herbal Extract and Review of Literature

Fabio Firenzuoli1, Luigi Gori1 and Paolo Roberti di Sarsina2

1Clinical Center of Natural Medicine, S. Giuseppe Hospital, Empoli and 2Department of Mental Health, AUSL Bologna, Italy

European Medicines Agency (EMEA) and the Committee on Herbal Medicinal Products (HMPC) on July 2006 have released an alert to get European sanitary authorities aware of 42 cases of suspected hepatotoxic reactions in patients consuming Cimicifuga racemosa rhizome. In the public statement EMEA itself considered reliable as hepatotoxic reactions only four cases, on the base of RUCAM score: two were considered possible and two probable. Lacking in almost all of them a precise description of cases, especially a botanical–chemical analysis of the suspected substance, we think there is no real proof of supposed C. racemosa rhizome hepatotoxicity. In our department we administer from about 10 years C. racemosa as special herbal dry extract as single substance or mixed with other medicinal plants at the dose of 500–1000 mg daily, for treatment of menopause related disorders without any reported adverse effect. After EMEA's official signal we have contacted all our patients using a C. racemosa rhizome herbal extract continuously from more than 12 months to verify possible hepatotoxic effects. We followed-up 107 women, and asked them by telephone (33/107) and/or after anamnesis and clinical examination (74/107) to undergo a blood sample examination. In all the patients there was no sign of hepatic disease, or worsening of already altered but stable parameters. We think on the base of these data and current literature C. racemosa rhizome extract should not be considered a potential hepatotoxic substance.

Keywords: Cimicifuga racemosa rhizome – hepatotoxicity – herbal extract – menopause

For reprints and all correspondence: Fabio Firenzuoli, Centro di Medicina Naturale, S.Giuseppe Hospital, Az USL 11. Via Paladini 1, 50053, Empoli, Italy. Tel: +39-0571-702661; Fax: +39-0571-702639; E-mail: f.firenzuoli{at}usl11.toscana.it

Received February 12, 2007; accepted July 3, 2007


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