Efficacy of escitalopram for hot flashes in healthy menopausal women: A randomized controlled trial

Ellen W. Freeman, Katherine A. Guthrie, Bette Caan, Barbara Sternfeld, Lee S. Cohen, Hadine Joffe, Janet Carpenter, Garnet L. Anderson, Joseph C. Larson, Kristine E. Ensrud, Susan D. Reed, Katherine M. Newton, Sheryl Sherman, Mary D. Sammel, Andrea Z. LaCroix

Research output: Contribution to journalArticle

135 Citations (Scopus)

Abstract

Context: 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. Design, Setting, and Patients: 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. Intervention: Women received 10 to 20 mg/d of escitalopram or a matching placebo for 8 weeks. Main Outcome Measures: 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. Conclusion: 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. Trial Registration: clinicaltrials.gov Identifier: NCT00894543.

Original languageEnglish
Pages (from-to)267-274
Number of pages8
JournalJournal of the American Medical Association
Volume305
Issue number3
DOIs
StatePublished - Jan 19 2011

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Hot Flashes
Citalopram
Randomized Controlled Trials
Placebos
Serotonin Uptake Inhibitors

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Freeman, E. W., Guthrie, K. A., Caan, B., Sternfeld, B., Cohen, L. S., Joffe, H., ... LaCroix, A. Z. (2011). Efficacy of escitalopram for hot flashes in healthy menopausal women: A randomized controlled trial. Journal of the American Medical Association, 305(3), 267-274. https://doi.org/10.1001/jama.2010.2016

Efficacy of escitalopram for hot flashes in healthy menopausal women : A randomized controlled trial. / Freeman, Ellen W.; Guthrie, Katherine A.; Caan, Bette; Sternfeld, Barbara; Cohen, Lee S.; Joffe, Hadine; Carpenter, Janet; Anderson, Garnet L.; Larson, Joseph C.; Ensrud, Kristine E.; Reed, Susan D.; Newton, Katherine M.; Sherman, Sheryl; Sammel, Mary D.; LaCroix, Andrea Z.

In: Journal of the American Medical Association, Vol. 305, No. 3, 19.01.2011, p. 267-274.

Research output: Contribution to journalArticle

Freeman, EW, Guthrie, KA, Caan, B, Sternfeld, B, Cohen, LS, Joffe, H, Carpenter, J, Anderson, GL, Larson, JC, Ensrud, KE, Reed, SD, Newton, KM, Sherman, S, Sammel, MD & LaCroix, AZ 2011, 'Efficacy of escitalopram for hot flashes in healthy menopausal women: A randomized controlled trial', Journal of the American Medical Association, vol. 305, no. 3, pp. 267-274. https://doi.org/10.1001/jama.2010.2016
Freeman, Ellen W. ; Guthrie, Katherine A. ; Caan, Bette ; Sternfeld, Barbara ; Cohen, Lee S. ; Joffe, Hadine ; Carpenter, Janet ; Anderson, Garnet L. ; Larson, Joseph C. ; Ensrud, Kristine E. ; Reed, Susan D. ; Newton, Katherine M. ; Sherman, Sheryl ; Sammel, Mary D. ; LaCroix, Andrea Z. / Efficacy of escitalopram for hot flashes in healthy menopausal women : A randomized controlled trial. In: Journal of the American Medical Association. 2011 ; Vol. 305, No. 3. pp. 267-274.
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T1 - Efficacy of escitalopram for hot flashes in healthy menopausal women

T2 - A randomized controlled trial

AU - Freeman, Ellen W.

AU - Guthrie, Katherine A.

AU - Caan, Bette

AU - Sternfeld, Barbara

AU - Cohen, Lee S.

AU - Joffe, Hadine

AU - Carpenter, Janet

AU - Anderson, Garnet L.

AU - Larson, Joseph C.

AU - Ensrud, Kristine E.

AU - Reed, Susan D.

AU - Newton, Katherine M.

AU - Sherman, Sheryl

AU - Sammel, Mary D.

AU - LaCroix, Andrea Z.

PY - 2011/1/19

Y1 - 2011/1/19

N2 - Context: 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. Design, Setting, and Patients: 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. Intervention: Women received 10 to 20 mg/d of escitalopram or a matching placebo for 8 weeks. Main Outcome Measures: 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. Conclusion: 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. Trial Registration: clinicaltrials.gov Identifier: NCT00894543.

AB - Context: 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. Design, Setting, and Patients: 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. Intervention: Women received 10 to 20 mg/d of escitalopram or a matching placebo for 8 weeks. Main Outcome Measures: 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. Conclusion: 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. Trial Registration: clinicaltrials.gov Identifier: NCT00894543.

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