Comparison of the symptomatic response in Indian menopausal women with different estrogen preparations for the treatment of menopausal symptoms: a randomized controlled trial.

Abstract

To compare symptomatic response in Indian women using different estrogen preparations for treatment of menopausal symptoms. A randomized, single blind, four arm, parallel assignment study was conducted in VMMC and SJH, New Delhi, India. 200 Indian menopausal women were recruited and assigned into four treatment groups viz., estradiol valerate (E2V), conjugated equine estrogen (CEE), isoflavones and Placebo group. The statistical significance of categorical variables was determined by Chi-square, Fisher's exact test. In case of quantitative variable parametric test Student's t test was used. In case of quantitative variables where data are not normally distributed, Kruskal-wallis test and Wilcoxon Mann-Whitney test were used. Symptomatic response in vasomotor/vaginal symptoms was assessed in all groups. Both E2V and CEE groups were effective in reducing severity and frequency of hot flashes. 91.9% decrease was observed in mean hot flash score in the E2V group after 24weeks of treatment, 89.2% in the CEE group, 60.42% decrease in the isoflavones group. While placebo led to 47.9% decrease in mean hot flash score. After 24weeks of therapy there was significant increase in vaginal health index in the E2V and CEE and the isoflavones group. No serious side effect was reported in any of the groups. Low doses of both CEE and E2V were equally effective for management of vasomotor/vaginal symptoms when administered over 24weeks. However, it seems more reasonable to replenish with less costly and bio-identical hormone, i.e. micronized estradiol valerate which is equally effective. The trial was registered under Clinical trial registry of India prospectively (number: CTRI/2012/04/002566).