Study Objectives: The Menopause Strategies: Finding Lasting Answers for Symptoms and Health network conducted three randomized clinical trials (RCTs) testing six interventions treating vasomotor symptoms (VMS), and also collected self-reported sleep outcomes. A fourth RCT assessed an intervention for insomnia symptoms among women with VMS. We describe these seven interventions’ effects relative to control in women with comparably severe insomnia symptoms and VMS. Methods: We analyzed pooled individual-level data from 546 peri- and postmenopausal women with Insomnia Severity Index (ISI) ? 12, and ?14 bothersome VMS/week across the four RCTs. Interventions included the following: escitalopram 10–20 mg/day; yoga; aerobic exercise; 1.8 g/day omega-3 fatty acids; oral 17-beta-estradiol 0.5-mg/day; venlafaxine XR 75-mg/day; and cognitive behavioral therapy for insomnia (CBT-I). Outcome measures were ISI and Pittsburgh Sleep Quality Index (PSQI) over 8–12 weeks of treatment. Results: CBT-I produced the greatest reduction in ISI from baseline relative to control at ?5.2 points (95% CI ?7.0 to ?3.4). Effects on ISI were similar for exercise at ?2.1 and venlafaxine at ?2.3 points. Comparably small decreases in ISI were observed with escitalopram, yoga, and estradiol. The largest reduction in PSQI from baseline was with CBT-I at ?2.7 points (?3.9 to ?1.5), although PSQI decreases of 1.2 to 1.6 points were significantly better than control with escitalopram, exercise, yoga, estradiol, and venlafaxine. Omega-3 supplements did not improve insomnia symptoms. Conclusions: This study’s findings support current recommendations for CBT-I as a first line treatment in healthy midlife women with insomnia symptoms and moderately bothersome VMS.
Bibliographical noteFunding Information:
The MsFLASH studies were 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 NIA grants U01AG032659, U01AG032669, U01AG032682, U01AG032699, and U01AG032700. In Indiana, the project was supported by 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 for the MsFLASH 01 trial were provided by Forest Research Institute. Omega-3 supplements and matching placebo pills for the MsFLASH 02 trial were provided by Nordic Naturals, Watsonville, CA.
HJ has received grant funding from NIH, Merck, and SAGE and has been a consultant for NeRRe, Merck, SAGE, and Mitsubishi Tanabe. SDR has received research funding from Bayer Pharmaceuticals. CMM has received fees for consultancy from Merck and Cereve.
- Vasomotor symptoms