Fitoestrogênios como alimento funcional no tratamento da síndrome climatérica: Ensaio clínico randomizado duplo-cego e controlado

Abstract

Objectives: To compare the effects of daily intake of a dietary supplement based on soy, hormone therapy (HT) low dose and placebo on the psychological symptoms, somatic and urogenital climacteric in women after menopause and assess the effects on key markers of cardiovascular risk. Methods: A randomized, double-blind, controlled involving 60 symptomatic women with a mean time since menopause of 4.1 years, aged between 40 and 60 years. Were selected and randomized into three groups: one group received a dietary supplement derived from soya (isoflavones 90 mg/day) another group received hormone therapy with low dose (1 mg estradiol and norethindrone acetate 0.5 mg) and a control group who received placebo for a period of 16 weeks. We used the Menopause Rating Scale (MRS) to assess changes in climacteric symptoms at baseline and after 16 weeks of treatment. Statistical analysis was performed using the test of χ, Fisher's exact test, analysis of covariance, nonparametric Kruskal-Wallis test, t Student test, paired Wilcoxon test and testeANOVA. RESULTS: The results showed a decrease in score MRS total, compared to the beginning and end of treatment in all groups, no statistical difference between them. There a significant improvement of somatic symptoms (hot flushes and complaints joint/muscle) and urogenital (vaginal dryness) in groups who used HRT and add soy. For psychological symptoms, there was no difference between groups studied: all had a similar improvement. After 16 weeks of intervention, total cholesterol decreased by 11.3% and LDL-cholesterol decreased by 18.6% only in the group using TH. The triglicérides, HDL-cholesterol, glicemia, rate of corporal mass, blood pressure and waist-hip ratio did not change during treatment in three groups. Conclusions: This study suggests treatment with dietary supplement soy can be an effective alternative therapy for somatic symptoms and urogenital related to menopause. The dietary supplement soy showed significantly favorable effect on the markers of cardiovascular risk when compared to the use of HRT.