Effects of genistein on hot flushes in early postmenopausal women: a randomized, double-blind EPT- and placebo-controlled study.
Menopause. 2004 Jul-Aug;11(4):400-4. PMID: 15243277
Department of Clinical and Experimental Medicine and Pharmacology, School of Medicine, University of Messina, Via C.Valeria, 98125 Gazzi, Messina, Italy.
OBJECTIVE: We evaluated and compared the effects of the phytoestrogen genistein, estrogen-progestogen therapy (EPT), and placebo on hot flushes and endometrial thickness in postmenopausal women.
DESIGN: Ninety healthy, postmenopausal women, 47 to 57 years of age, were randomly assigned to receive for 1 year continuous EPT (n = 30; 1 mg 17beta-estradiol combined with 0.5 mg norethisterone acetate), the phytoestrogen genistein (n = 30; 54 mg/day), or placebo (n = 30). Endometrial safety was evaluated by intravaginal ultrasounds at baseline, 6 and 12 months.
RESULTS: By comparison with placebo, daily flushes reduced significantly by a mean of 22% (95% CI: -38 to -6.2; P<0.01) after 3 months, by a mean of 29% (95% CI: -45 to -13; P<0.001) after 6 months, and by a mean of 24% (95% CI: -43 to -5; P<0.01) after 12 months of genistein treatment. Flush score decreased by a mean of 53% (95% CI: -79 to -26; P<0.001) after 3 months, by a mean of 56% (95% CI: -83 to -28; P<0.001) after 6 months, and by a mean of 54% (95% CI: -74 to -33; P<0.001) after 12 months of EPT, as compared with placebo. No side effect was observed on the uterus of the participants.
CONCLUSIONS: The present study confirms that genistein might have positive effects on hot flushes without a negative impact on endometrial thickness and suggests a future role of this phytoestrogen as a strategically therapeutic alternative in the management of postmenopausal symptoms.