Department of Obstetrics and Gynecology, State University of Campinas, Campinas, SP, Brazil.
Maturitas. 2010 Nov;67(3):262-9. doi: 10.1016/j.maturitas.2010.07.007. Epub 2010 Sep 15.
To compare the effects of daily ingestion of dietary soy supplementation, low-dose hormone therapy (HT) and placebo on psychological, somatic and urogenital symptoms in postmenopausal women.
A double-blind, randomized, controlled trial. Sixty healthy, symptomatic, postmenopausal women of 40-60 years of age were allocated to use dietary soy supplementation (containing 90 mg of isoflavone) or HT (1mg estradiol and 0.5mg norethisterone acetate) or placebo.
the Menopause Rating Scale (MRS) was used to assess menopausal symptoms at baseline and after 16 weeks of treatment. Intention-to-treat analyses were performed using the chi-square test, Fisher's exact test, the Kruskal-Wallis non-parametric test and analysis of variance (ANOVA).
No statistically significant differences were found between the groups with respect to baseline clinical and sociodemographic characteristics. The psychological, somatic and urogenital symptoms analyzed in the MRS improved during treatment in all the groups, except for urogenital symptoms in the placebo group in which no significant changes were detected. Comparison between groups revealed a statistically significant improvement in somatic symptoms (hot flashes and muscle pain) in the users of HT (-45.6%) and dietary soy supplementation (-49.8%). Urogenital symptoms (vaginal dryness) improved significantly in HT users (-38.6%) and in users of the dietary soy supplementation (-31.2%). There was no statistically significant difference between the groups with respect to overall MRS score or to scores obtained in the psychological symptoms subscale.
Dietary soy supplementation may constitute an effective alternative therapy for somatic and urogenital symptoms of the menopause.
比较每日摄入饮食大豆补充剂、低剂量激素治疗（HT）和安慰剂对绝经后妇女心理、躯体和泌尿生殖系统症状的影响。
双盲、随机、对照试验。将 60 名健康、有症状、年龄在 40-60 岁的绝经后妇女随机分配，使用饮食大豆补充剂（含有 90 毫克异黄酮）或 HT（1 毫克雌二醇和 0.5 毫克醋酸炔诺酮）或安慰剂。
采用绝经评定量表（MRS）评估基线和治疗 16 周后的绝经症状。采用卡方检验、Fisher 确切检验、Kruskal-Wallis 非参数检验和方差分析（ANOVA）进行意向治疗分析。
各组间基线临床和社会人口学特征无统计学差异。MRS 分析的心理、躯体和泌尿生殖系统症状在所有组中均在治疗期间得到改善，但安慰剂组的泌尿生殖系统症状未发现显著变化。组间比较显示，HT 使用者（-45.6%）和饮食大豆补充剂使用者（-49.8%）的躯体症状（热潮红和肌肉疼痛）显著改善，而 HT 使用者（-38.6%）和饮食大豆补充剂使用者（-31.2%）的泌尿生殖系统症状（阴道干燥）显著改善。在总体 MRS 评分或心理症状亚量表评分方面，各组间无统计学差异。
饮食大豆补充剂可能是治疗绝经后躯体和泌尿生殖系统症状的有效替代疗法。
