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.

ObjectiveTo evaluate the effectiveness of a safe, high‐purity, non‐plant derived, non‐allergenic, patent‐protected, proprietary genistein (geniVida) in alleviating hot flashes in peri/post menopausal women.Methods84 peri/post menopausal women (minimum 7 hot flashes/day or 40/week) were enrolled in a randomized, placebo‐controlled, parallel, multi‐center ICH/GCP trial and given a 30 mg capsule of geniVida or a 30 mg placebo capsule daily with breakfast for 12 weeks. Measurements included daily hot flashes, FSH, 17 beta‐estradiol, endometrial thickness and adverse events.ResultsWomen on geniVida had fewer hot flashes/day from baseline to 8 and 12 weeks vs. women on the placebo (p=0.045 and p=0.015, respectively). 61.5% of women on geniVida had 50% or greater reduction in daily hot flashes vs. 25.9% of women on placebo. 88.5% of women on geniVida had 25% or greater reduction in duration of daily hot flashes vs. 59.3% of women on placebo. Severity of hot flashes was not different between groups. There were no differences between the groups for FSH, 17 beta‐estradiol, endometrial thickness and adverse events.ConclusionsgeniVida genistein was demonstrated to have a significant benefit in reducing the number and duration of daily hot flashes in peri/post menopausal women and may be used to manage menopausal symptoms without hormone replacement. Supported by DSM Nutritional Products, Inc.