Effects of a soy-based dietary supplement compared with low-dose hormone therapy on the urogenital system: a randomized, double-blind, controlled clinical trial

Autor(es)

Carmignani, Lucio O. ^[1] ; Pedro, Adriana Orcesi ^[1] ; Montemor, Eliana B. ^[1] ; Arias, Victor A. ^[2] ; Costa-Paiva, Lucia H. ^[1] ; Pinto-Neto, Aarao M. ^[1]

Afiliação do(s) autor(es)

^[1] Univ Estadual Campinas, Dept Obstet & Gynecol, Sao Paulo - Brazil

^[2] Univ Fed Sao Paulo, Dept Pathol, Sao Paulo, SP - Brazil

• Tipo de documento: Artigo Científico
• Fonte: MENOPAUSE-THE JOURNAL OF THE NORTH AMERICAN MENOPAUSE SOCIETY; v. 22, n. 7, p. 741-749, JUL 2015.
• Citações Web of Science: 7

Resumo

Objective This study aims to compare the effects of a soy-based dietary supplement, low-dose hormone therapy (HT), and placebo on the urogenital system in postmenopausal women. Methods In this double-blind, randomized, placebo-controlled trial, 60 healthy postmenopausal women aged 40 to 60 years (mean time since menopause, 4.1 y) were randomized into three groups: a soy dietary supplement group (90 mg of isoflavone), a low-dose HT group (1 mg of estradiol plus 0.5 mg of norethisterone), and a placebo group. Urinary, vaginal, and sexual complaints were evaluated using the urogenital subscale of the Menopause Rating Scale. Vaginal maturation value was calculated. Transvaginal sonography was performed to evaluate endometrial thickness. Genital bleeding pattern was assessed. Statistical analysis was performed using chi(2) test, Fisher's exact test, paired Student's t test, Kruskal-Wallis test, Kruskal-Wallis nonparametric test, and analysis of variance. For intergroup comparisons, Kruskal-Wallis nonparametric test (followed by Mann-Whitney U test) was used. Results Vaginal dryness improved significantly in the soy and HT groups (P = 0.04). Urinary and sexual symptoms did not change with treatment in the three groups. After 16 weeks of treatment, there was a significant increase in maturation value only in the HT group (P < 0.01). Vaginal pH decreased only in this group (P < 0.01). There were no statistically significant differences in endometrial thickness between the three groups, and the adverse effects evaluated were similar. Conclusions This study shows that a soy-based dietary supplement used for 16 weeks fails to exert estrogenic action on the urogenital tract but improves vaginal dryness. (AU)

• Processo FAPESP: 03/04464-0 - Fitoestrogenos como alimento funcional no controle da sindrome climaterica: ensaio clinico randomizado.
• Beneficiário: Adriana Orcesi Pedro
• Modalidade de apoio: Auxílio à Pesquisa - Regular