The effect of synthetic genistein on menopause symptom management in healthy postmenopausal women: A multi-center, randomized, placebo-controlled study

Objective: To evaluate the efficacy of synthetic genistein for reducing the frequency and severity of hot flushes. Study design: A 12 week randomized double-blind, placebo-controlled study in which 84 postmenopausal women received placebo or a single 30 mg dose of synthetic genistein. Outcome measures primary: percentage change in the number of daily hot flushes from pre-treatment to week 12. Secondary: duration and severity of daily hot flushes, Greene Climacteric Scale score, serum follicle stimulating hormone (FSH), 17 beta-estradiol and endometrial thickness. Results: Genistein supplemented subjects completing at least 4 weeks on trial (n=40) demonstrated a 51% reduction (9.4-4.7/day) in the number of hot flushes by week 12 compared to a 27% reduction in the placebo group (9.9-7.1/day) (p=0.026). Subjects in the genistein group also reported significantly fewer hot flushes per day (p=0.010) and a decrease in total duration of hot flushes per day (p=0.009) at week 12 versus placebo. Subjects on genistein (n=32) completing 12 weeks on trial demonstrated a 51% reduction (9.7-4.7/day) in the number of hot flushes by week 12 (p=0.049) compared to 30% reduction in the placebo group (9.8-7.0/day) and had fewer hot flushes per day and a decrease in total duration of hot flushes per day at week 12 compared to placebo (p=0.020 and p=0.017, respectively). There were no differences between groups in Greene Climacteric Scale, FSH, 17 beta-estradiol, endometrial thickness or adverse events. Conclusions: The current study provides the first evidence that a single daily dose of 30 mg of synthetic genistein reduces hot flush frequency and duration. (C) 2010 Elsevier Ireland Ltd. All rights reserved.