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Effects of the phytoestrogen genistein on hot flushes, endometrium, and vaginal epithelium in postmenopausal women: a 1-year randomized, double-blind, placebo-controlled study

D'Anna, Rosario MD1; Cannata, Maria Letizia MD1; Atteritano, Marco MD2; Cancellieri, Francesco MD1; Corrado, Francesco MD1; Baviera, Giovanni PhD1; Triolo, Onofrio MD1; Antico, Francesco MD1; Gaudio, Agostino MD2; Frisina, Nicola MD2; Bitto, Alessandra MD3; Polito, Francesca PhD3; Minutoli, Letteria MD3; Altavilla, Domenica PhD3; Marini, Herbert MD4; Squadrito, Francesco MD3

doi: 10.1097/01.gme.0000248708.60698.98
Articles

Objective: To evaluate in a 12-month, prospective, randomized, double-blind, placebo-controlled study whether pure administration of the phytoestrogen genistein (54 mg/d) might reduce the number and severity of hot flushes in postmenopausal women with no adverse effect on the endometrium.

Design: A total of 389 participants met the main study criteria and were randomly assigned to receive the phytoestrogen genistein (n = 198) or placebo (n = 191). About 40% of participants in both groups did not suffer from hot flushes, and the evaluation was performed in a subgroup of 247 participants (genistein, n = 125; placebo, n = 122). Reductions from baseline in the frequency and severity of hot flushes were the principal criteria of efficacy. Endometrial thickness was evaluated by ultrasonography. The maturation value was also used to determine hormonal action on the vaginal cells.

Results: There were no significant differences in age, time since menopause, body mass index, and vasomotor symptoms between groups at baseline (4.4 ± 0.33 hot flushes per day in the genistein group and 4.2 ± 0.35 hot flushes per day in the control group). The effect was already evident in the first month and reached its peak after 12 months of genistein therapy (−56.4% reduction in the mean number of hot flushes). Furthermore, there was a significant difference between the two groups at each evaluation time (1, 3, 6, and 12 months). No significant difference was found in mean endometrial thickness and maturation value score between the two groups, either at baseline or after 12 months.

Conclusions: The phytoestrogen genistein has been shown to be effective on vasomotor symptoms without an adverse effect on endometrium.

In a 12-month, prospective, randomized, double-blind, placebo-controlled study, the phytoestrogen genistein has been shown to be effective on vasomotor symptoms without adverse effects on endometrium.

From the 1Department of Obstetrical and Gynaecological Sciences, 2Department of Internal Medicine, 3Department of Clinical and Experimental Medicine and Pharmacology, Section of Pharmacology, and 4Department of Biochemical, Physiological and Nutritional Sciences, Section of Physiology and Human Nutrition, University of Messina, Messina, Italy.

Received July 28, 2006; revised and accepted October 6, 2006.

Funding/support: This study was entirely funded by the Italian Ministry of Scientific Research and Technology and by the University of Messina, Italy.

Financial disclosure: None reported.

Address correspondence to: Prof. Francesco Squadrito, Department of Experimental and Clinical Medicine and Pharmacology, Section of Pharmacology, Torre Biologica 5th floor, A.O.U. Policlinico "G. Martino" Via C. Valeria, 98125 Messina, Italy. E-mail: Francesco.Squadrito@unime.it.

©2007The North American Menopause Society