Table 1.
Summary of MsFLASH RCT Study Designs
Trial | Sample Size | Design | Primary Outcome | Intervention Length | Primary Results References |
---|---|---|---|---|---|
01 | 205 | 2-arm: Escitalopram vs. placebo tablet | Frequency and severity of hot flashes | 8 weeks | Freeman EW, Guthrie KA, et al. Efficacy of escitalopram for hot flashes in healthy menopausal women: a randomized controlled trial. JAMA 2011;305(3):267–274. |
02 | 355 | 3×2 factorial: Aerobic exercise and yoga vs. usual activity, plus omega-3 supplementation vs. placebo capsule | Frequency and bother of hot flashes | 12 weeks | Sternfeld BS, Guthrie KA, Ensrud KE, et al. Efficacy of exercise for menopausal symptoms: a randomized controlled trial. Menopause 2014;21(4):330–338. Cohen LS, Joffe H, Guthrie KA, et al. Efficacy of Omega-3 treatment for vasomotor symptoms: a randomized controlled trial. Menopause 2014;21(4):347–354. Newton KM, Reed SD, Guthrie KA, et al. Efficacy of yoga for vasomotor symptoms: a randomized controlled trial. Menopause 2014;21(4):339–346. |
03 | 339 | 3-arm: Low dose oral estradiol and venlafaxine vs. placebo, all in identical capsules | Frequency of hot flashes | 8 weeks | Joffe H, Guthrie KA, LaCroix AZ, et al. Low-dose estradiol and the serotonin-norepinephrine reuptake inhibitor venlafaxine for vasomotor symptoms: a randomized clinical trial. JAMA Int Med 2014;174(7):1058–1066. |
04 | 106 | 2-arm: Telephone cognitive behavior therapy for insomnia vs. menopause education control | Insomnia Severity Index | 8 weeks | McCurry S, Guthrie KA, Morin DM, et al. Telephone-based cognitive behavioral therapy for insomnia in perimenopausal and postmenopausal women with vasomotor symptoms: a MsFLASH randomized clinical trial. JAMA Intern Med 2016;176(7):913–920. |
05 | 302 | 3-arm: Vaginal estradiol+placebo gel and vaginal moisturizer+placebo tablet, vs. placebo gel+placebo tablet | Severity of most bothersome vulvovaginal symptom | 8 weeks | Mitchell CM, Reed SD, Diem S, et al. Efficacy of vaginal estradiol or vaginal moisturizer vs placebo for treating postmenopausal vulvovaginal symptoms. JAMA Intern Med 2018;178(5):681–690. |