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Efficacy of escitalopram for hot flashes in healthy menopausal women: a randomized controlled trial.
JAMA. 2011 Jan 19; 305(3):267-74.JAMA

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.

Authors+Show Affiliations

Department of Obstetrics/Gynecology, University of Pennsylvania School of Medicine, Philadelphia, USA. freemane@mail.med.upenn.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

21245182

Citation

Freeman, Ellen W., et al. "Efficacy of Escitalopram for Hot Flashes in Healthy Menopausal Women: a Randomized Controlled Trial." JAMA, vol. 305, no. 3, 2011, pp. 267-74.
Freeman EW, Guthrie KA, Caan B, et al. Efficacy of escitalopram for hot flashes in healthy menopausal women: a randomized controlled trial. JAMA. 2011;305(3):267-74.
Freeman, E. W., Guthrie, K. A., Caan, B., Sternfeld, B., Cohen, L. S., Joffe, H., Carpenter, J. S., Anderson, G. L., Larson, J. C., Ensrud, K. E., Reed, S. D., Newton, K. M., Sherman, S., Sammel, M. D., & LaCroix, A. Z. (2011). Efficacy of escitalopram for hot flashes in healthy menopausal women: a randomized controlled trial. JAMA, 305(3), 267-74. https://doi.org/10.1001/jama.2010.2016
Freeman EW, et al. Efficacy of Escitalopram for Hot Flashes in Healthy Menopausal Women: a Randomized Controlled Trial. JAMA. 2011 Jan 19;305(3):267-74. PubMed PMID: 21245182.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy of escitalopram for hot flashes in healthy menopausal women: 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 S, 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 - 2011/1/20/entrez PY - 2011/1/20/pubmed PY - 2011/1/25/medline SP - 267 EP - 74 JF - JAMA JO - JAMA VL - 305 IS - 3 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. SN - 1538-3598 UR - https://www.unboundmedicine.com/medline/citation/21245182/Efficacy_of_escitalopram_for_hot_flashes_in_healthy_menopausal_women:_a_randomized_controlled_trial_ L2 - https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2010.2016 DB - PRIME DP - Unbound Medicine ER -