Efficacy of escitalopram for hot flashes in healthy menopausal women: a randomized controlled trial.
BACKGROUND
Concerns regarding the risks associated with estrogen and progesterone to manage menopausal symptoms have resulted in its declining use and increased interest in nonhormonal treatments with demonstrated efficacy for hot flashes.


OBJECTIVE
To determine the efficacy and tolerability of 10 to 20 mg/d escitalopram, a selective serotonin reuptake inhibitor, in alleviating the frequency, severity, and bother of menopausal hot flashes.


METHODS
A multicenter, 8-week, randomized, double-blind, placebo-controlled, parallel group trial that enrolled 205 women (95 African American; 102 white; 8 other) between July 2009 and June 2010.


METHODS
Women received 10 to 20 mg/d of escitalopram or a matching placebo for 8 weeks.


METHODS
Primary outcomes were the frequency and severity of hot flashes assessed by prospective daily diaries at weeks 4 and 8. Secondary outcomes were hot flash bother, recorded on daily diaries, and clinical improvement (defined as hot flash frequency ≥50% decrease from baseline).


RESULTS
Mean (SD) daily hot flash frequency was 9.78 (5.60) at baseline. In a modified intent-to-treat analysis that included all randomized participants who provided hot flash diary data, the mean difference in hot flash frequency reduction was 1.41 (95% CI, 0.13-2.69) fewer hot flashes per day at week 8 among women taking escitalopram (P < .001), with mean reductions of 4.60 (95% CI, 3.74-5.47) and 3.20 (95% CI, 2.24-4.15) hot flashes per day in the escitalopram and placebo groups, respectively. Fifty-five percent of women in the escitalopram group vs 36% in the placebo group reported a decrease of at least 50% in hot flash frequency (P = .009) at the 8-week follow-up. Reductions in hot flash severity scores were significantly greater in the escitalopram group (-0.52; 95% CI, -0.64 to -0.40 vs -0.30; 95% CI, -0.42 to -0.17 for placebo; P < .001). Race did not significantly modify the treatment effect (P = .62). Overall discontinuation due to adverse events was 4% (7 in the active group, 2 in the placebo group). Three weeks after treatment ended, women in the escitalopram group reported a mean 1.59 (95% CI, 0.55-2.63; P = .02) more hot flashes per day than women in the placebo group.


CONCLUSIONS
Among healthy women, the use of escitalopram (10-20 mg/d) compared with placebo resulted in fewer and less severe menopausal hot flashes at 8 weeks of follow-up.


BACKGROUND
clinicaltrials.gov Identifier: NCT00894543.
Department of Obstetrics/Gynecology, University of Pennsylvania School of Medicine, Philadelphia, USA. freemane@mail.med.upenn.edu
Ellen W
EW
Freeman
Katherine A
KA
Guthrie
Bette
B
Caan
Barbara
B
Sternfeld
Lee S
LS
Cohen
Hadine
H
Joffe
Janet S
JS
Carpenter
Garnet L
GL
Anderson
Joseph C
JC
Larson
Kristine E
KE
Ensrud
Susan D
SD
Reed
Katherine M
KM
Newton
Sheryl
S
Sherman
Mary D
MD
Sammel
Andrea Z
AZ
LaCroix
D001741:Black or African American; D015283:Citalopram / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D019584:Hot Flashes / Q000188:drug therapy*; D006801:Humans; D008593:Menopause; D008875:Middle Aged; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D012720:Severity of Illness Index; D016896:Treatment Outcome; D044465:White People
D015283:Citalopram; D017367:Selective Serotonin Reuptake Inhibitors
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