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Genistein reduces the number and duration of hot flashes in peri/post menopausal women in a randomized, double‐blind, placebo‐controlled, multi‐center trial
Author(s) -
Elliott James Gary,
Evans Mal,
Sharma Prachi,
Berman Robert,
Guthrie Najla
Publication year - 2009
Publication title -
the faseb journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.709
H-Index - 277
eISSN - 1530-6860
pISSN - 0892-6638
DOI - 10.1096/fasebj.23.1_supplement.lb471
Subject(s) - placebo , medicine , adverse effect , peri , menopause , randomized controlled trial , hot flash , hormone replacement therapy (female to male) , breast cancer , cancer , alternative medicine , pathology , testosterone (patch)
Objective To 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. Methods 84 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. Results Women 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. Conclusions geniVida 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.