Black Cohosh Hepatic Safety: Follow-Up of 107 Patients Consuming a Special Cimicifuga racemosa rhizome Herbal Extract and Review of LiteratureReport as inadecuate




Black Cohosh Hepatic Safety: Follow-Up of 107 Patients Consuming a Special Cimicifuga racemosa rhizome Herbal Extract and Review of Literature - Download this document for free, or read online. Document in PDF available to download.

Evidence-Based Complementary and Alternative MedicineVolume 2011 2011, Article ID 821392, 7 pages

Original Article

Clinical Center of Natural Medicine, S. Giuseppe Hospital, Empoli, Italy

Italian High Council of Health, Ministry of Health, Rome, Italy

Received 12 February 2007; Accepted 3 July 2007

Copyright © 2011 Fabio Firenzuoli et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

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.





Author: Fabio Firenzuoli, Luigi Gori, and Paolo Roberti di Sarsina

Source: https://www.hindawi.com/



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