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Effects of genistein on hot flushes in early postmenopausal women: a randomized, double-blind EPT- and placebo-controlled study.

Crisafulli, Alessandra MD1,5; Marini, Herbert MD1; Bitto, Alessandra MD1; Altavilla, Domenica PhD1; Squadrito, Giovanni MD2; Romeo, Adolfo MD2; Adamo, Elena B. MD4; Marini, Rolando PhD4; D'Anna, Rosario MD3; Corrado, Francesco MD3; Bartolone, Sebastiano MD2; Frisina, Nicola MD2; Squadrito, Francesco MD1

doi: 10.1097/01.GME.0000109314.11228.E5
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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 17β-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.

Healthy, postmenopausal women were randomly assigned to receive for 1 year continuous estrogen-progestin therapy, the phytoestrogen genistein, or placebo. By comparison with placebo, daily flushes reduced significantly by a mean of 22% after 3 months, by a mean of 29% after 6 months, and by a mean of 24% after 12 months of genistein treatment. No side effect was observed on the uterus of the participants. The study confirms that genistein has positive effects on hot flushes without a negative impact on endometrial thickness.

From the 1Department of Clinical and Experimental Medicine and Pharmacology, 2Department of Internal Medicine, 3Department of Obstetrical and Gynaecological Sciences, and 4Department of Biochemical Physiological and Nutritional Sciences, School of Medicine, University of Messina, Italy; and 5Department of Biomedical Sciences, Section of Pharmacology, University of Modena and Reggio Emilia, Italy.

Received June 24, 2003; revised and accepted October 15, 2003.

Address correspondence to: Francesco Squadrito, MD, Department of Clinical and Experimental Medicine and Pharmacology, Section of Pharmacology, School of Medicine, University of Messina, Azienda Ospedaliera Universitaria, “G. Martino,” Torre Biologica 5° Piano, Via C. Valeria 98125, Gazzi Messina, Italy. E-mail: francesco.squadrito@unime.it.

©2004The North American Menopause Society