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In Brief Objective: To investigate the effects of a novel dietary supplement containing soy isoflavones and Actaea racemosa Linnaeus (formerly called Cimicifuga racemosa L.) on climacteric symptoms in healthy perimenopausal women. Design: In a multicenter, randomized, placebo-controlled, double-blind study, 124 women experiencing at least five vasomotor symptoms every 24 hours were randomized to receive daily either a phytoestrogen-containing supplement (n = 60) or placebo (n = 64) for 12 weeks. The modified Kupperman Index and Greene Climacteric Scale, a visual analogue scale designed to measure quality of life and the daily number and severity of hot flushes, was used in the screening period and in weeks 6 and 12. Changes in these scores from baseline were calculated. Results: At weeks 6 and 12, all scores in both groups had improved compared with baseline, though the overall difference in scores between the groups was not statistically significant. Conclusion: The supplement containing soy isoflavones and A racemosa L. had no statistically significant effect on climacteric symptoms in perimenopausal women experiencing at least five vasomotor symptoms per day. In this multicenter, randomized, placebo-controlled, double-blind study of 12 weeks, daily supplementation with a phytoestrogen-containing supplement was not superior compared with placebo in reducing climacteric symptoms in 124 healthy postmenopausal women suffering from at least five vasomotor symptoms per day.
Verhoeven et al. (Fri,) studied this question.