Cimicifuga racemosa dried ethanolic extract in menopausal disorders:: a double-blind placebo-controlled clinical trial

Objectives: To compare the efficacy and safety of the black cohosh root extract Cr 99 with placebo in women with climacteric complaints. Methods: A multicenter, randomized, placebo-controlled, double-blind, parallel group study was conducted in 122 menopausal women (intention-to-treat population) with >= 3 hot flashes a day, treated over 12 weeks. Two main efficacy measures - weekly weighted score of hot flashes and Kupperman Index - and secondary efficacy variables, e.g. Menopause Rating Scale, were defined. Routine safety laboratory parameters and adverse events were documented. Results: The primary efficacy analysis showed no superiority of the tested black cohosh extract compared to placebo. However, in the subgroup of patients with a Kupperman Index >= 20 a significant superiority regarding this index could be demonstrated (P < 0.018). A decrease of 47% and 21 % was observed in the black cohosh and placebo group, respectively. The weekly weighted scores of hot flashes (P < 0.052) and the Menopause Rating Scale (P < 0.009) showed similar results. Prevalence and intensity of the adverse events did not differ in the two treatment groups. Conclusions: The results indicate a superiority of the tested Cimicifuga racemosa extract compared to placebo in patients with menopausal disorders of at least moderate intensity according to a Kupperman Index >= 20, but not in the intention-to-treat population as a whole. (c) 2004 Elsevier Ireland Ltd. All rights reserved.