Concerns for the risks of hormone therapy have resulted in its decline and a demand for non-hormonal treatments with demonstrated efficacy for hot flashes.
Determine the efficacy and tolerability of 10–20 mg/day escitalopram, a selective serotonin reuptake inhibitor, in alleviating the frequency, severity and bother of menopausal hot flashes.
Design, Setting and Patients
Randomized, double-blind, placebo-controlled, parallel arm trial for 8 weeks in a sample stratified by race (African American n=95; white n=102) and conducted at 4 MsFlash network sites between July 2009 and June 2010. Of 205 women randomized, 194 (95%) completed week 8 (intervention endpoint), and 183 completed post-treatment follow-up.
Main Outcome Measures
Primary outcomes were the frequency and severity of hot flashes assessed by prospective daily diaries. Secondary outcomes were hot flash "bother" recorded on daily diaries and clinical improvement (hot flash frequency >=50% decrease from baseline).
Hot flash frequency was 9.78/day (SD 5.60) at baseline. At week 8, reduction in hot flash frequency was greater in the escitalopram group versus placebo (−4.60, SD 4.28 and −3.20, SD 4.76, respectively, P=0.004). Fifty-five percent of the escitalopram group (versus 36% of the placebo group) reported >=50% decreases in hot flash frequency (P=0.009). Differences in decreases in the severity and bother of hot flashes were significant (P=0.003 and P=0.013, respectively), paralleling the decreases in hot flash frequency. Three weeks after treatment ended, hot flash frequency increased in the escitalopram group to the level of the placebo group, which remained stable in the follow-up interval (P=0.020). Overall discontinuation due to side effects was 4% (7 drug, 2 placebo).
Escitalopram 10–20 mg/day provides non-hormonal off-label treatment for menopausal hot flashes that is effective and well-tolerated in healthy women.