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

Abstract

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), 17β-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, 17β-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.