A drug commonly prescribed to treat clinical depression in men and women has been found to be effective in a decidedly female concern — hot flashes in menopause.
New research out of the University of Pennsylvania School of Medicine suggests that women who take escitalopram (Lexapro) experience a reduction in both the frequency and severity of menopausal hot flashes compared to women who took placebo (a sugar pill).
Hormonal treatments had been the predominantÂ therapy for menopausal hot flashes, but their use decreased substantially after the Women’s Health Initiative Estrogen plus Progestin study found that the benefits did not necessarily outweight the risks associated with serious side effects.
Ellen W. Freeman, Ph.D., and colleagues evaluated the efficacy of escitalopram vs. placebo to reduce the frequency and severity of hot flashes in healthy women, and examined whether race, menopausal status, depressed mood, and anxiety were important modifiers of any observed effect.
The multicenter, eight-week, randomized trial enrolled 205 women (95 African American; 102 white; eight other) between July 2009 and June 2010.
Women received 10 to 20 mg/d of escitalopram or a matching placebo for 8 weeks. The primary outcomes measured included frequency and severity of hot flashes assessed by prospective daily diaries at weeks 4 and 8.
The average frequency of hot flashes at the beginning of the study was 9.8 per day. Escitalopram was associated with a significant reduction in the frequency of hot flashes relative to placebo, adjusted for race, site, and baseline hot flash frequency. In the escitalopram group, average hot flash frequency at week 8 decreased to 5.26 hot flashes per day.
This was a significant 47 percent decrease — or an average of 4.6 fewer hot flashes per day — than at the beginning of the study.
In the placebo group, hot flash frequency decreased to 6.43 hot flashes per day (33 percent decrease or an average of 3.2 fewer hot flashes per day).
Clinical improvement at week 8 (decrease of 50 percent or more from baseline in hot flash frequency) was significantly greater in the escitalopram group than in the placebo group (55 percent vs. 36 percent). Also, use of escitalopram significantly reduced hot flash severity compared with placebo, adjusted for race, site, and baseline severity.
Race did not significantly modify the treatment effect. Overall discontinuation due to adverse events was 4 percent (7 in the active group, 2 in the placebo group).
“The 3-week postintervention follow-up demonstrated that hot flashes increased after cessation of escitalopram but not after cessation of placebo, providing further evidence of escitalopram’s effects,” the authors write.
The researchers note that although the decreases in hot flash frequency and severity appear modest, the study participants perceived these improvements as meaningful, as indicated by their reported satisfaction with treatment and desire to continue the treatment.
“Our findings suggest that among healthy women, 10 to 20 mg/d of escitalopram provides a nonhormonal, off-label option that is effective and well-tolerated in the management of menopausal hot flashes.
“Further studies are needed to directly compare the relative efficacy of SSRIs and SNRIs with hormone therapy in the treatment of menopause-related hot flashes.”
No other treatments have U.S. Food and Drug Administration approval for menopausal hot flashes, and the efficacy of alternative pharmacologic and nonpharmacologic agents is inconclusive, according to the article. Selective serotonin and serotonin norepinephrine reuptake inhibitors (SSRIs and SNRIs) have been investigated for hot flash treatment with mixed results. The SSRI escitalopram reduced hot flashes with minimal toxicities in two earlier pilot investigations, but conclusions were limited by the small samples and other factors.
The study is published in the January 19 issue of JAMA.
Source: JAMA and Archives Journals