No abstract

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.

The trial is registered at the Brazilian Clinical Trials Registry (Registro Brasileiro de Ensaios Clínicos - ReBEC), number RBR-76mm75.

No abstract

Objectives: To compare the effects of a soy-based dietary supplement, low-dose hormone therapy (HT) and placebo on climacteric symptoms and on quality of life (QOL) of symptomatic postmenopausal women, and to evaluate the correlation between the improvement in menopausal symptoms and QOL according to treatment type, and also assess the effects of each intervention on the urogenital system in postmenopausal women. Methods: This was a double-blind, randomized and placebo-controlled clinical trial. Sixty healthy postmenopausal women, aged 40-60, were recruited and randomly assigned to three groups: a soy dietary supplement group (isoflavone 90mg/day), a low-dose HT group (estradiol 1mg plus noretisterone acetate 0.5mg) and a placebo group. Menopausal symptoms changes were evaluated through Menopause Rating Scale (MRS). QOL was measured by the abbreviated version of the World Health Organization's Quality of Life instrument (WHOQOL-BREF). These instruments were applied at baseline and after 16 weeks of treatment. Urinary, vaginal and sexual complaints were evaluated by using the urogenital subscale of the MRS. Evaluation of therapeutic effects on urogenital system was performed by vaginal pH measurement and maturation value calculation. Transvaginal sonography was performed to evaluate endometrial thickness. Statistical analysis were performed using the chi-square test, Fisher's exact test, paired Student's t-test, Kruskal-Wallis xii test, Kruskal-Wallis nonparametric test, and analysis of variance (ANOVA). For MRS and QOL scores intergroup analysis were used ANOVA, Kruskal-Wallis test, and Kruskal-Wallis followed Mann-Whitney test. Correlation analysis was performed using the Correlation Spearman Coefficient. For Intergroup comparisons related to MRS urogenital subscale, the Kruskal-Wallis nonparametric test was used, followed by the Mann-Whitney test. Results: The mean age of the patients was 52.4 (±3.9) years, with 4.1 (±3.1) years mean time since menopause. QOL scores increased significantly in the physical health domain of QOL in the users of HT and in a much lesser extent in the soy group (233.1% x 39.7%; p=0.02). It was observed that only in the HT group there was a statistically significant correlation between the improvement of symptoms of total MRS and improvement in the QOL physical (p=0.01) and psychological (p=0.01) domains and also on general health assessment (p<0.01). Urogenital system evaluation showed a significantly improvement in vaginal dryness in the soy group and HT group (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: Hormone therapy was effective in improving the physical health domain of QOL, it was also observed with the use of is...