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

Objective: This comprehensive review examines the safety of Cimicifuga racemosa for the treat-ment of menopause symptoms, particularly in populations in which conventional menopause treat-ment regimens, including estrogen replacement, are contraindicated. Design: An extensive database of information on Cimicifuga, which included all published lit-erature 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of Cimicifuga, the FDA and World Health Organization adverse-event reporting systems, monographs, compendia, internal unpublished data from a major manufacturer, foreign literature, and historical anecdotal reports, was reviewed, and findings pertaining to the safety of Cimicifuga use for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 extrac