No Liver Toxicity from Black Cohosh Confirmed in New Meta-Analysis

GREEN BAY, Wis., Sept. 26, 2011 /PRNewswire/ -- A new meta-analysis on black cohosh for the treatment of menopausal symptoms underscored the safety of the natural ingredient and showed no liver toxicity.  The meta-analysis was conducted and co-authored by Dr. Belal Naser, Head of Drug Safety, Schaper & Brummer, Salzgitter, Germany.  Dr. Naser presented these findings at the North American Menopause Society's (NAMS) annual conference in Washington, D.C. on September 22, 2011.

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Black cohosh has been used as a natural and safe treatment in the management of menopausal symptoms for years.  Substantial clinical research and long-term use has underscored its safety, yet there have been some reports of suspected liver toxicity that have gained attention recently.  These reports were in clear contrast to results from randomized clinical trials (RCTs), where no signs of liver toxicity risk had been observed to date. Dr. Belal Naser, along with co-authors; Susana Garcia de Arriba, PhD, Klaus-Ulrich Nolte, PhD, Jorg Schnitker, PhD, Mary Jane Minkin, MD and Rudiger Osmers, MD, joined together to evaluate this discrepancy.  The resounding positive results of the study emphasize the safety and efficacy of black cohosh.

The meta-analysis reviewed liver function tests and in a second step, the data was analyzed in light of evaluations of cases from other sources, including literature case studies and events from the spontaneous reporting.  The results show that black cohosh is indeed a safe and effective alternative to Hormone Replacement Therapy (HRT) for the treatment of menopausal symptoms.* The study co-sponsors included Schaper & Brummer, GmbH & Co. KG, IAS, Institute for Applied Statistics, and Hildesheim General Hospital.

Schaper & Brummer is the manufacturer of a special isopropanolic black cohosh extract, called Remifemin®, which is the type of extract used in the RCTs.  Enzymatic Therapy®, a division of Schwabe North America, distributes Remifemin to physicians, pharmacies and natural product retailers in the U.S.

Dr. Mary Jane Minkin, a board-certified obstetrician/gynecologist and co-author of the black cohosh meta-analysis, has recommended Remifemin black cohosh for relief of hot flashes, night sweats and mood swings to her menopausal and perimenopausal patients for many years.*  According to Dr. Minkin, "There have been some reports over the past few years about suspected liver toxicity associated with the use of black cohosh.  However, in this meta-analysis of all the prospective randomized clinical trials of Remifemin, which are the gold-standard type trials of medical research, no risk of liver toxicity was shown.  This was very reassuring to me as a physician, and I know it will also be reassuring to my patients."

Remifemin® provides effective relief for menopausal symptoms, including a 70% reduction of hot flashes, night sweats, irritability, mood swings and occasional sleeplessness.*

*This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

SOURCE Schwabe North America