Effect of escitalopram on hot flash interference: a randomized, controlled trial.

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.