title: Herb induced liver injury presumably caused by black cohosh: a survey of initially purported cases and herbal quality specifications.
abstract: Herb induced liver injury (HILI) is a particular challenge that also applies to purported cases presumably caused by black cohosh (BC), an herb commonly used to treat menopausal symptoms. We analyzed and reviewed all published case reports and spontaneous reports of initially alleged BC hepatotoxicity regarding quality of case details and causality assessments. Shortcomings of data quality were more evident in spontaneous reports of regulatory agencies compared to published case reports, but assessments with the scale of CIOMS (Council for the International Organizations of Sciences) or its updated version revealed lack of causality for BC in all cases. The applied causality methods are structured, quantitative, and liver specific with clear preference over an ad hoc causality method or the liver unspecific Naranjo scale. Reviewing the case data and the reports dealing with quality specifications of herbal BC products, there is general lack of analysis with respect to authentication of BC in the BC products used by the patients. However, in one single regulatory study, there was a problem of BC authentication in the analysed BC products, and other reports addressed the question of impurities and adulterants in a few BC products. It is concluded that the use of BC may not exert an overt hepatotoxicity risk, but quality problems in a few BC products were evident that require additional regulatory quality specifications.
authors.affiliation: Department of Internal Medicine II, Division of Gastroenterology and Hepatology, Klinikum Hanau, Teaching Hospital of the Goethe University, Frankfurt/Main, Germany. rolf.teschke@gmx.de
authors.forename: Rolf
authors.initials: R
authors.lastname: Teschke
authors.forename: Alexander
authors.initials: A
authors.lastname: Schwarzenboeck
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Schmidt-Taenzer
authors.forename: Albrecht
authors.initials: A
authors.lastname: Wolff
authors.forename: Karl-Heinz
authors.initials: KH
authors.lastname: Hennermann
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000592:standards*; D056486:Chemical and Drug Induced Liver Injury / Q000175:diagnosis / Q000453:epidemiology* / Q000209:etiology; D031885:Cimicifuga / Q000009:adverse effects*; D005260:Female; D006306:Health Surveys; D006801:Humans; D008593:Menopause / Q000187:drug effects; D008517:Phytotherapy / Q000009:adverse effects* / Q000592:standards; D010936:Plant Extracts / Q000009:adverse effects / Q000494:pharmacology; D015995:Prevalence; D011787:Quality of Health Care
chemical_list: D010936:Plant Extracts