Results of a Randomized Study Presented at ACOG 2009 Annual Meeting Confirming Teschke's Re-evaluation of Spontaneous Reports
CHICAGO, May 5 /PRNewswire/ -- Black cohosh has been widely used in Europe and also in North America to treat menopausal symptoms including hot flashes, night sweats, occasional irritability and mood swings. While extensive research has been published on this botanical, the question of liver safety has arisen in a few isolated cases. Now, with the recent publication of Rolf Teschke, MD's re-evaluation of the four remaining cases held in question by the European Medicines Agency (EMEA), the suspicion of liver problems connected to black cohosh should be laid to rest.
This week, Belal Naser, MD, presented at the American College of Obstetricians and Gynecologists Annual Clinical Meeting in Chicago results of a placebo-controlled, double blind study. He concluded that the isopropanolic black cohosh extract (Remifemin(R)) has no effects on liver function. These findings are in agreement with Teschke's study published in Phytomedicine (2009; 16:72-84).
"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.
Remifemin(R), manufactured by Schaper & Brummer GmbH & Co. KG in Germany is the most extensively researched form of black cohosh in the market--with 90 scientific papers and over 15 published studies establishing safety and efficacy. The present controlled study confirmed the safety of this botanical for the liver.
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