Abstract
OBJECTIVE: To estimate the effect of escitalopram (10-20 mg/d) versus placebo for reducing hot flash interference in daily life and understand correlates and predictors of reductions in hot flash interference, a key measure of quality of life. DESIGN: Multisite, randomized, double-blind, placebo-controlled clinical trial. SETTING: MsFLASH clinical sites in Boston, Indianapolis, Oakland, and Philadelphia. PATIENT(S): A total of 205 midlife women (46% African-American) who met criteria participated. INTERVENTION(S): After baseline, women were randomized to one pill of escitalopram 10 mg/d (n = 104) or placebo (n = 101) with follow-up at 4 and 8 weeks. At week 4, those not achieving 50% fewer hot flashes were increased to two pills daily (20 mg/d or 2 placebo pills). MAIN OUTCOME MEASURE(S): The Hot Flash Related Daily Interference Scale; correlates were variables from hot flash diaries; predictors were baseline demographics, clinical variables, depression, anxiety, sleep quality, and hot flashes. RESULT(S): Compared to placebo, escitalopram significantly reduced hot flash interference by 6.0 points at week 4 and 3.4 points at week 8 more than placebo. Reductions in hot flash interference correlated with changes in hot flash diary variables. However, baseline variables did not significantly predict reductions in hot flash interference. CONCLUSION(S): Escitalopram (10-20 mg/d) for 8 weeks improves women's quality of life and this benefit did not vary by demographic, clinical, mood, sleep, or hot flash variables. CLINICAL TRIAL REGISTRATION NUMBER: NCT00894543.