Objective: To evaluate the effects of escitalopram 10-20 mg/day on menopause-related quality of life and pain in healthy menopausal women with hot flashes. Study design: A double-blind, placebo-controlled randomized trial of escitalopram 10-20 mg/day vs. identical placebo was conducted among 205 women ages 40-62 years with an average of ≥4 daily hot flashes recruited at 4 clinical sites from July 2009 to June 2010. Main outcome measures: The primary trial outcomes, reported previously, were the frequency and severity of vasomotor symptoms at 8 weeks. Here, we report on the pre-specified secondary endpoints of total and domain scores from the Menopause-Specific Quality of Life Questionnaire (MENQOL) and the pain intensity and interference scale (PEG). Results: Outcome data were collected on 97% of randomized women and 87% of women took at least 70% of their study medication. Treatment with escitalopram resulted in significantly greater improvement in total MENQOL scores (mean difference at 8 weeks of -0.41; 95% confidence interval (CI) -0.71 to -0.11; p < 0.001), as well as Vasomotor, Psychosocial, and Physical domain scores with the largest difference seen in the Vasomotor domain (mean difference -0.75; 95% CI -1.28 to -0.22; p = 0.02). There was no significant treatment group difference for the Sexual Function domain. Escitalopram treatment resulted in statistically significant improvements in PEG scores compared to placebo (mean treatment group difference at 8 weeks of -0.33; 95% CI -0.81 to 0.15; p = 0.045). Conclusions: Treatment with escitalopram 10-20 mg/day in healthy women with vasomotor symptoms significantly improved menopause-related quality of life and pain.
Bibliographical noteFunding Information:
Dr. LaCroix reported serving on scientific advisory boards for Pfizer, Sanofi-Adventis and Amgen. Dr. Freeman reported research support from Forest Laboratories, Inc., Wyeth, Pfizer, and Xanodyne Pharmaceuticals; honoraria for consulting and presentations from Wyeth, Forest Laboratories, Inc., Pherin Pharmaceuticals, and Bayer Health Care. Dr. Cohen reported research support from National Alliance for Research on Schizophrenia and Depression, Astra-Zeneca Pharmaceuticals, Sepracor, Inc., Bayer HealthCare, Bristol-Myers, Stanley Foundation, Ortho-McNeill Jansen, Pfizer, Inc.; Advisory/consulting: Eli Lilly, GlaxoSmithKline, JDS/Noven Pharmaceuticals, Wyeth-Ayerst Pharmaceuticals; Honoraria: Eli Lilly, Forest Laboratories, Inc., GlaxosmithKline, Pfizer, Inc., and Wyeth-Ayerst Pharmaceuticals. Dr. Joffe reported research support from Cephalon/Teva; Advisory/ Consulting, Noven and Sunovion. No other authors reported having a financial conflict of interest.
The study was supported by a cooperative agreement issued by the National Institute of Aging (NIA) , in collaboration with the Eunice Kennedy Shriver National Institute of Child Health and Development (NICHD) , the National Center for Complementary and Alternative Medicine (NCCAM) and the Office of Research and Women's Health (ORWH) , and grants U01 AG032656, U01AG032659, U01AG032669, U01AG032682, U01AG032699, U01AG032700 from the NIA . At the Indiana University site, the project was funded in part with support from the Indiana Clinical and Translational Sciences Institute, funded in part by grant UL1 RR025761 from the National Institutes of Health, National Center for Research Resources, Clinical and Translational Sciences Award. Escitalopram and matching placebo pills were provided by Forest Research Institute. Trial registration clinicaltrials.gov Identifier: NCT00894543
- Menopausal quality of life
- Randomized controlled trial
- Vasomotor symptoms