Objective: The Menopause Strategies: Finding Lasting Answers for Symptoms and Health clinical trials network was funded by the National Institutes of Health to find new ways to alleviate the most common, bothersome menopausal symptoms by designing and conducting multiple concurrent clinical intervention studies, accommodating a wide scope of populations and intervention strategies.
Methods: Trials were conducted in Boston, Indianapolis, Minneapolis, Oakland, Philadelphia, and Seattle, with the Data Coordinating Center in Seattle, and were designed with standardized eligibility criteria and endpoints. Primary outcomes focused on vasomotor symptoms, sleep quality and insomnia symptoms, and vaginal symptoms. Secondary outcomes included quality of life, sexual function, and mood.
Results: We completed five randomized clinical trials and three ancillary studies, testing nine interventions in over 1,300 women and collecting nearly 16,000 bio-specimens. Escitalopram, venlafaxine hydrochloride extended release, and low-dose estradiol diminished hot flashes by approximately 50% as compared with a 30% decrease by placebo. No benefits on vasomotor symptoms were observed with yoga or exercise compared with usual activity, nor with omega-3 supplementation compared with placebo. Cognitive behavioral therapy for insomnia reduced self-reported insomnia symptoms and improved overall sleep quality compared with menopause education control. We did not find significant benefit from a vaginal estradiol tablet or a vaginal moisturizer compared with placebo tablet and gel in diminishing the severity of vaginal symptoms.
Conclusions: The MsFLASH trials contributed substantially to our understanding of bothersome menopausal symptom treatment. It is important that clinicians counseling women about available treatment options consider all therapies-both nonhormonal and hormonal.
Effects of Pharmacologic and Nonpharmacologic Interventions on Insomnia Symptoms and Self-reported Sleep Quality in Women With Hot Flashes: A Pooled Analysis of Individual Participant Data From Four MsFLASH Trials.Sleep. 2018 Jan 1;41(1):zsx190. doi: 10.1093/sleep/zsx190. Sleep. 2018. PMID: 29165623 Free PMC article. Clinical Trial.
Methods for the design of vasomotor symptom trials: the menopausal strategies: finding lasting answers to symptoms and health network.Menopause. 2014 Jan;21(1):45-58. doi: 10.1097/GME.0b013e31829337a4. Menopause. 2014. PMID: 23760428 Free PMC article.
Pooled Analysis of Six Pharmacologic and Nonpharmacologic Interventions for Vasomotor Symptoms.Obstet Gynecol. 2015 Aug;126(2):413-22. doi: 10.1097/AOG.0000000000000927. Obstet Gynecol. 2015. PMID: 26241433 Free PMC article. Clinical Trial.
Hormone Therapy and Other Treatments for Symptoms of Menopause.Am Fam Physician. 2016 Dec 1;94(11):884-889. Am Fam Physician. 2016. PMID: 27929271 Review.
Bioidentical hormones for women with vasomotor symptoms.Cochrane Database Syst Rev. 2016 Aug 1;(8):CD010407. doi: 10.1002/14651858.CD010407.pub2. Cochrane Database Syst Rev. 2016. PMID: 27479272 Review.