No Causality Found Between Black Cohosh and Liver Problems
Results of a Randomized Study Presented at ACOG 2009 Annual Meeting Confirming Teschke’s Re-evaluation of Spontaneous Reports
“Teschke’s re-evaluation of the four ‘remaining’ cases considered by the European Medicines Agency (EMEA) as having a ‘possible’ or ‘probable’ causality, concluded that there was in fact no evidence for a causal relationship between treatment with black cohosh and the observed liver problems,” explained Dr. Naser, Head of Drug Safety at Schaper & Brummer GmbH & Co. KG. This re-evaluation of case reports applied the latest qualitative and quantitative causality assessment and diagnostic algorithm of the Council for International Organizations of Medical Sciences (CIOMS).
“Due to incomplete data, the case of one patient was not assessable. In the remaining three cases, one patient diagnosed with autoimmune hepatitis had a favorable course under continued steroid therapy. The two other patients, who required liver transplants, received a final diagnosis of herpetic hepatitis. In none of these four was there any causality between treatment with black cohosh and liver disease,” concluded Dr. Teschke.
“This analysis confirms our conclusion that these cases were, in general, insufficiently documented. More significantly, even the so-called ‘well-documented cases’ were debatable and little, if any, evidence remains that black cohosh (Cimicifugae racemosae rhizoma) can cause liver toxicity,” said Dr. Naser.
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