Susan D Reed1, Andrea Z LaCroix2, Garnet L Anderson3, Kristine E Ensrud4, Bette Caan5, Janet S Carpenter6, Lee Cohen7, Susan J Diem4, Ellen W Freeman8, Hadine Joffe9, Joseph C Larson3, Susan M McCurry10, Caroline M Mitchell11, Katherine M Newton12, Barbara Sternfeld5, Katherine A Guthrie3. 1. Obstetrics and Gynecology/Epidemiology, University of Washington, Seattle, WA. 2. Epidemiology/Family and Preventive Medicine, University of California at San Diego, La Jolla, CA. 3. Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA. 4. Epidemiology/Medicine, University of Minnesota, Minneapolis, MN. 5. Department of Research, Kaiser Permanente, Oakland, CA. 6. School of Nursing, Indiana University, Indianapolis, IN. 7. Reproductive Psychiatry Resource & Information Center, Massachusetts General Hospital/Harvard Medical School, Boston, MA. 8. Obstretrics and Gynecology, and Psychiatry, Perlman School of Medicine, University of Pennsylvania, Philadelphia, PA. 9. Psychiatry Research, Brigham and Women's Hospital, Boston, MA. 10. Psychosocial and Community Health, University of Washington, Seattle, WA. 11. Obstetrics & Gynecology, Massachusetts General Hospital, Boston, MA. 12. Department of Research, Kaiser Permanente Washington Health Research Institute, Seattle, WA.
Abstract
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.
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.
Authors: Caroline M Mitchell; Sujatha Srinivasan; Anna Plantinga; Michael C Wu; Susan D Reed; Katherine A Guthrie; Andrea Z LaCroix; Tina Fiedler; Matthew Munch; Congzhou Liu; Noah G Hoffman; Ian A Blair; Katherine Newton; Ellen W Freeman; Hadine Joffe; Lee Cohen; David N Fredricks Journal: Menopause Date: 2018-05 Impact factor: 2.953
Authors: Ellen W Freeman; Kristine E Ensrud; Joseph C Larson; Katherine A Guthrie; Janet S Carpenter; Hadine Joffe; Katherine M Newton; Barbara Sternfeld; Andrea Z LaCroix Journal: Psychosom Med Date: 2015 Feb-Mar Impact factor: 3.864
Authors: Amy E Oakley; Robert A Steiner; Charles Chavkin; Donald K Clifton; Laura K Ferrara; Susan D Reed Journal: Menopause Date: 2015-12 Impact factor: 3.310
Authors: Caroline M Mitchell; Sujatha Srinivasan; Xiang Zhan; Michael C Wu; Susan D Reed; Katherine A Guthrie; Andrea Z LaCroix; Tina Fiedler; Matthew Munch; Congzhou Liu; Noah G Hoffman; Ian A Blair; Katherine Newton; Ellen W Freeman; Hadine Joffe; Lee Cohen; David N Fredricks Journal: Menopause Date: 2017-10 Impact factor: 3.310
Authors: Janet S Carpenter; Katherine A Guthrie; Joseph C Larson; Ellen W Freeman; Hadine Joffe; Susan D Reed; Kristine E Ensrud; Andrea Z LaCroix Journal: Fertil Steril Date: 2012-04-03 Impact factor: 7.490
Authors: Ellen W Freeman; Katherine A Guthrie; Bette Caan; Barbara Sternfeld; Lee S Cohen; Hadine Joffe; Janet S Carpenter; Garnet L Anderson; Joseph C Larson; Kristine E Ensrud; Susan D Reed; Katherine M Newton; Sheryl Sherman; Mary D Sammel; Andrea Z LaCroix Journal: JAMA Date: 2011-01-19 Impact factor: 157.335
Authors: Katherine M Newton; Susan D Reed; Katherine A Guthrie; Karen J Sherman; Cathryn Booth-LaForce; Bette Caan; Barbara Sternfeld; Janet S Carpenter; Lee A Learman; Ellen W Freeman; Lee S Cohen; Hadine Joffe; Garnet L Anderson; Joseph C Larson; Julie R Hunt; Kristine E Ensrud; Andrea Z LaCroix Journal: Menopause Date: 2014-04 Impact factor: 3.310
Authors: Kristine E Ensrud; Joseph C Larson; Katherine A Guthrie; Carolyn J Crandall; Andrea Z LaCroix; Susan D Reed; Shalender Bhasin; Caroline M Mitchell; Hadine Joffe Journal: Menopause Date: 2022-08-16 Impact factor: 3.310
Authors: Carolyn J Crandall; Joseph C Larson; Kristine E Ensrud; Andrea Z LaCroix; Katherine A Guthrie; Susan D Reed; Shalender Bhasin; Susan Diem Journal: Maturitas Date: 2022-04-25 Impact factor: 5.110
Authors: Janet S Carpenter; James E Tisdale; Chen X Chen; Richard Kovacs; Joseph C Larson; Katherine A Guthrie; Kristine E Ensrud; Katherine M Newton; Andrea Z LaCroix Journal: J Womens Health (Larchmt) Date: 2020-11-20 Impact factor: 3.017