OBJECTIVES: To compare the effect of micro-dose transdermal estradiol and placebo on the incidence and severity of menopausal symptoms and well-being in postmenopausal Asian women with vasomotor symptoms. DESIGN: Multicenter, double-blind, randomized, placebo-controlled study. RESULTS: Of 165 subjects randomized toestradiol 0.014 mg/day or placebo for 12 weeks, 80 per group were included in the analysis. Groups were comparable at baseline, although time since menopause was slightly shorter in the estradiol group. There was a greater reduction in mean weekly hot flushes at week 12 in the estradiol group (55%) than the placebo group (40%; p < 0.01), which was evident by week 4. A similar pattern was seen for moderate and severe hot flushes (-58% vs. -39%, respectively). Reductions were statistically significant at weeks 4, 8, and 12. Vaginal pH fell significantly in the estradiol group by week 4 and then remained stable throughout the treatment period, but there were no significant changes in the placebo group. Vaginal maturation value increased more in the estradiol than the placebo group (p < 0.001). Few subjects had vaginal bleeding or spotting. Quality of life improved similarly in both groups. Urogenital symptoms improved considerably from baseline in both treatment groups, with no significant differences. Eight subjects experienced treatment-related adverse events (seven in the estradiol group). CONCLUSIONS: In Asian women, micro-dose estradiol was significantly superior to placebo in improving vasomotor symptoms. The bleeding profile was comparable with that of placebo. Micro-dose estradiol was safe and well tolerated in Asian women.
RCT Entities:
OBJECTIVES: To compare the effect of micro-dose transdermal estradiol and placebo on the incidence and severity of menopausal symptoms and well-being in postmenopausal Asian women with vasomotor symptoms. DESIGN: Multicenter, double-blind, randomized, placebo-controlled study. RESULTS: Of 165 subjects randomized to estradiol 0.014 mg/day or placebo for 12 weeks, 80 per group were included in the analysis. Groups were comparable at baseline, although time since menopause was slightly shorter in the estradiol group. There was a greater reduction in mean weekly hot flushes at week 12 in the estradiol group (55%) than the placebo group (40%; p < 0.01), which was evident by week 4. A similar pattern was seen for moderate and severe hot flushes (-58% vs. -39%, respectively). Reductions were statistically significant at weeks 4, 8, and 12. Vaginal pH fell significantly in the estradiol group by week 4 and then remained stable throughout the treatment period, but there were no significant changes in the placebo group. Vaginal maturation value increased more in the estradiol than the placebo group (p < 0.001). Few subjects had vaginal bleeding or spotting. Quality of life improved similarly in both groups. Urogenital symptoms improved considerably from baseline in both treatment groups, with no significant differences. Eight subjects experienced treatment-related adverse events (seven in the estradiol group). CONCLUSIONS: In Asian women, micro-dose estradiol was significantly superior to placebo in improving vasomotor symptoms. The bleeding profile was comparable with that of placebo. Micro-dose estradiol was safe and well tolerated in Asian women.
Authors: Ana Marcia I S Gaudard; Sulani Silva de Souza; Maria E S Puga; Jane Marjoribanks; Edina M K da Silva; Maria R Torloni Journal: Cochrane Database Syst Rev Date: 2016-08-01
Authors: Susan D Reed; Caroline M Mitchell; Hadine Joffe; Lee Cohen; Jan L Shifren; Katherine M Newton; Ellen W Freeman; Joseph C Larson; JoAnn E Manson; Andrea Z LaCroix; Katherine A Guthrie Journal: Obstet Gynecol Date: 2014-08 Impact factor: 7.623