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.
Bibliographical noteFunding Information:
Supported by the National Institute of Aging, in collaboration with the Eunice Kennedy Shriver National Institute of Child Health and Development, the National Center for Complementary and Alternative Medicine, the Office of Research and Women's Health , and grants U01AG032656, U01AG032659, U01AG032669, U01AG032682, U01AG032699, and U01AG032700 . At Indiana, the project was supported by the Indiana Clinical and Translational Sciences Institute ( UL1 RR025761 ) from the National Center for Research Resources, Clinical and Translational Sciences Award .
- hot flashes
- night sweats
- selective serotonin reuptake inhibitor