Tuesday, March 31, 2009

Assessment of Liver Toxicity Cases Associated with Black Cohosh Concludes Lack of Causality

In the past several years, there have been numerous reports of possible liver toxicity associated with the use of various preparations made from black cohosh (Actaea racemosa, Ranunculaceae, syn. Cimicifuga racemosa), popular for treating symptoms associated with menopause.

Although some regulatory agencies and related bodies have reviewed these cases and have announced some preliminary cautions (for example the European Medicines Agency [EMEA]), critical analyses have questioned the causality of such cases.

Pharmacoepidemiological experts from the Teaching Hospital of the Johann Wolfgang Goethe University of Frankfurt/Main, Hanau, Germany, analyzed case reports which regulators have previously considered "possible" or "probable" in causality with black cohosh.

After analyzing 4 cases:

The clinical analysis and structured causality assessment reveal that in one patient there was no valid evaluation possible due to lack of basic information and the remaining 3 cases had no convincing evidence that the liver diseases were caused by black cohosh. These 3 patients were all treated with steroids for acute drug-induced hepatocellular jaundice and fulminant liver failure. The authors note that there is no evidence of steroids’ benefiting this condition, and that since early antiviral therapy is necessary for herpetic liver disease, steroid therapy should not be considered unless all viral causes have been safely excluded. It is fascinating that the reanalysis of the data showed that the EMEA drew inaccurate conclusions. Vigorous causality assessments using a diagnostic algorithm are essential to determine causality for any severe adverse event.

Click Here to download the complete article review from HerbClip, the American Botanical Council.

2009 Teschke R, Schwarzenboeck A. Suspected hepatotoxicity by Cimicifugae racemosae Phytomed. rhizome (black cohosh, root): Critical analysis and structured causality assessment. 2009;16: 72-84: http://cms.herbalgram.org/herbclip/372/review020591-372.html

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