Critical evaluation of the safety of Cimicifuga racemosa in menopause symptom relief.

OBJECTIVE This comprehensive review examines the safety of Cimicifuga racemosa for the treatment of menopause symptoms, particularly in populations in which conventional menopause treatment regimens, including estrogen replacement, are contraindicated. DESIGN An extensive database of information on Cimicifuga, which included all published literature pertaining to preclinical and clinical safety of various forms of Cimicifuga, the FDA and World Health Organization adverse-event reporting systems, monographs, compendia, internal unpublished data from a major manufacturer, foreign literature, and historical anecdotal reports, was reviewed, and findings pertaining to the safety of Cimicifuga use for menopause treatment were reported. RESULTS Uncontrolled reports, postmarketing surveillance, and human clinical trials of more than 2,800 patients demonstrate a low incidence of adverse events (5.4%). Of the reported adverse events, 97% were minor and did not result in discontinuation of therapy, and the only severe events were not attributed to Cimicifuga treatment. CONCLUSIONS Although the effects of Cimicifuga may be dependent on the specific extract preparation, this review clearly supports the safety of specific Cimicifuga extracts, particularly isopropanolic preparations, for use in women experiencing menopausal symptoms and as a safe alternative for women in whom estrogen therapy is contraindicated.