Effects of soy-derived isoflavone on hot flushes and endometrial thickness: a randomized, double-blind controlled trial - Revista Brasileira de Ginecologia e Obstetrícia
PURPOSE: to determine the effects of soy-derived isoflavone on hot flashes, menopausal symptoms, and endometrial thickness in postmenopausal women. METHODS: this double-blind, placebo-controlled, randomized study involved 90 postmenopausal patients aged 45-60 years old attended at the Outpatient Menopause Clinic. All patients had been experiencing hot flashes accompanied or not by other hypo-estrogenic symptoms. Patients were randomized to receive either two soy capsules containing 50 mg of soy-derived isoflavone or two identical placebo capsules, twice a day for 12 weeks in a double-blind fashion. Each patient was observed for 12 weeks, with two evaluations being made, one at baseline and the other at the end of the study. At each time point, the patients were given a diary to record the severity of the climacteric symptoms experienced, assessed with a modified Kupperman index, using a 100 mm Visual Analogue Scale (VAS). The intensity of hot flashes was also assessed separately. The patients were also submitted to a transvaginal echography for the measurement of endometrial thickness. Yates chi2, ANOVA or t de Student and Mann-Whitney were used for statistical analysis. RESULTS: no significant difference was detected in the Kupperman index (64 versus 82, p>0,05) or in the hot flashes (20 versus 20, p>0,05) between the isoflavone and placebo groups. No significant difference was either detected concerning the Kupperman index and hot flashes before and after treatment, when the two groups were analyzed separately. No difference was detected in the endometrial thickness either in the isoflavone or the placebo group (0.28 versus 0.26 mm, respectively, p>0.05). CONCLUSIONS: our results indicate that 100 mg of isoflavone are not more effective than placebo in reducing hot flashes and hypo-estrogenic symptoms in postmenopausal women and present no effect on the endometrium thickness.
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PURPOSE: to determine the effects of soy-derived isoflavone on hot flashes, menopausal symptoms, and endometrial thickness in postmenopausal women. METHODS: this double-blind, placebo-controlled, randomized study involved 90 postmenopausal patients aged 45-60 years old attended at the Outpatient Menopause Clinic. All patients had been experiencing hot flashes accompanied or not by other hypo-estrogenic symptoms. Patients were randomized to receive either two soy capsules containing 50 mg of soy-derived isoflavone or two identical placebo capsules, twice a day for 12 weeks in a double-blind fashion. Each patient was observed for 12 weeks, with two evaluations being made, one at baseline and the other at the end of the study. At each time point, the patients were given a diary to record the severity of the climacteric symptoms experienced, assessed with a modified Kupperman index, using a 100 mm Visual Analogue Scale (VAS). The intensity of hot flashes was also assessed separately. The patients were also submitted to a transvaginal echography for the measurement of endometrial thickness. Yates chi2, ANOVA or t de Student and Mann-Whitney were used for statistical analysis. RESULTS: no significant difference was detected in the Kupperman index (64 versus 82, p>0,05) or in the hot flashes (20 versus 20, p>0,05) between the isoflavone and placebo groups. No significant difference was either detected concerning the Kupperman index and hot flashes before and after treatment, when the two groups were analyzed separately. No difference was detected in the endometrial thickness either in the isoflavone or the placebo group (0.28 versus 0.26 mm, respectively, p>0.05). CONCLUSIONS: our results indicate that 100 mg of isoflavone are not more effective than placebo in reducing hot flashes and hypo-estrogenic symptoms in postmenopausal women and present no effect on the endometrium thickness.
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