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. Author manuscript; available in PMC: 2021 Apr 1.
Published in final edited form as: Menopause. 2020 Apr;27(4):473–484. doi: 10.1097/GME.0000000000001461

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.