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Antidepressant eyed to reduce hot flashes
[Editor's note: This story discusses off-label use of the antidepressant medication escitalopram (Lexapro, Forest Laboratories, New York City).]
For women with hot flashes associated with menopause, clinicians have long looked to hormonal agents as the predominant treatment option. Use of hormone therapy has greatly decreased since the Women's Health Initiative (WHI) estrogen plus progestin randomized trial combination hormon therapy highlighted risks associated with combination hormone therapy. No other treatments for menopausal hot flashes have Food and Drug Administration (FDA) approval.1,2
Scientists are looking at safe, effective options for menopausal therapy. News is just in from a scientific initiative of alternative treatments funded by the National Institutes of Health's National Institute of Aging, with the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Center for Complementary and Alternative Medicine, and the Office of Research on Women's Health. In a study that looked at use of the antidepressant medication escitalopram (Lexapro, Forest Laboratories, New York City), results suggest women who were in the transition to menopause or postmenopausal experienced reduced frequency and severity of menopausal hot flashes with the drug, compared to women who received placebo.3 Use of the drug for hot flash treatment is considered off-label by the FDA.
"Our findings suggest that among healthy women who were not depressed or anxious, a 10 to 20 mg dose of escitalopram, which is well below the dosage level for psychiatric use, provides a nonhormonal, off-label option that is effective and well-tolerated in the management of menopausal hot flashes," says Ellen Freeman, PhD, principal investigator of the national, multi-site study and research professor of obstetrics and gynecology at the University of Pennsylvania School of Medicine in Philadelphia.
Investigators enrolled 205 women between July 2009 and June 2010 to conduct the eight-week trial. Women were randomized to receive 10 mg per day of escitalopram or a matching placebo pill for eight weeks.
If women did not report a reduction in hot flash frequency of at least 50% or a decrease in hot flash severity after four treatment weeks, the study medication dose was increased to 20 mg per day (or matched placebo) without unblinding the randomization. Primary outcomes included frequency and severity of hot flashes assessed by prospective daily diaries at weeks four and eight.
Researchers report the average frequency of hot flashes at the beginning of the study at 9.8 per day. Use of the study drug was associated with a 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 eight decreased to 5.26 hot flashes per day, a 47% decrease. A three-week study participant follow-up also showed that hot flashes increased after cessation of escitalopram but not after cessation of placebo, further indicating the effectiveness of the drug.3 Symptom relief with the escitalopram treatment is substantially less than that which is achieved with hormone therapy; results of hormone therapy trials show 80-90% symptom relief.4,5
Options now in review
The report is the first published research from the National Institutes of Health's Menopause Strategies: Finding Lasting Answers for Symptoms and Health (MsFLASH), a network of research studies looking at treatments for common symptoms of menopause.
The network is conducting several randomized clinical trials to test a variety of approaches for treating menopausal symptoms, including use of anti-depressant medications, yoga, omega-3 supplementation, exercise, and low dose estrogen gel. Participants in the studies are women ages 40-62 who live in Boston, Indianapolis, Oakland, Philadelphia, and Seattle.
Scientists are enrolling women into a second study. The second study will examine the effectiveness of yoga, exercise, or omega-3 supplementation for relieving menopausal symptoms. Centers at the Indiana University School of Medicine in Indianapolis, Kaiser Permanente, Northern California in Oakland and the Group Health Center for Health Studies and the University of Washington School of Medicine, both in Seattle, are participating. The intervention period is 12 weeks, says Sherry Sherman, PhD, program director of Clinical Aging and Reproductive Hormone Research at the National Institute on Aging. "For decades, estrogen with or without progesterone has been the treatment of choice for relieving menopause-related symptoms because of the lack of alternative therapies of comparable proven efficacy," said Sherman. "The collaborative, multidisciplinary, multicenter approach of MsFLASH will enable researchers to test other options, including behavioral and complementary and alternative medicine approaches, to determine whether they are also effective against hot flashes."