Katherine A Guthrie1, Andrea Z LaCroix, Kristine E Ensrud, Hadine Joffe, Katherine M Newton, Susan D Reed, Bette Caan, Janet S Carpenter, Lee S Cohen, Ellen W Freeman, Joseph C Larson, JoAnn E Manson, Kathy Rexrode, Todd C Skaar, Barbara Sternfeld, Garnet L Anderson. 1. MsFLASH Data Coordinating Center, Fred Hutchinson Cancer Research Center, the Group Health Research Institute, and the University of Washington School of Medicine, Seattle, Washington; the Department of Family and Preventive Medicine, University of California, San Diego, San Diego, and the Division of Research, Kaiser Permanente, Oakland, California; the VA Medical Center/University of Minnesota, Minneapolis, Minnesota; Brigham and Women's Hospital, Dana Farber Cancer Institute, and Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts; the School of Nursing and the Department of Medicine, Division of Clinical Pharmacology, Indiana University, Indianapolis, Indiana; and the Departments of Obstetrics and Gynecology and Psychiatry, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania.
Abstract
OBJECTIVE: To describe the effects of six interventions for menopausal vasomotor symptoms relative to control in a pooled analysis, facilitating translation of the results for clinicians and symptomatic women. The Menopause Strategies: Finding Lasting Answers for Symptoms and Health network tested these interventions in three randomized clinical trials. METHODS: An analysis of pooled individual-level data from three randomized clinical trials is presented. Participants were 899 perimenopausal and postmenopausal women with at least 14 bothersome vasomotor symptoms per week. Interventions included 10-20 mg escitalopram per day, nonaerobic yoga, aerobic exercise, 1.8 g per day omega-3 fatty acid supplementation, 0.5 mg low-dose oral 17-beta-estradiol (E2) per day, and 75 mg low-dose venlafaxine XR per day. The main outcome measures were changes from baseline in mean daily vasomotor symptom frequency and bother during 8-12 weeks of treatment. Linear regression models estimated differences in outcomes between each intervention and corresponding control group adjusted for baseline characteristics. Models included trial-specific intercepts, effects of the baseline outcome measure, and time. RESULTS: The 8-week reduction in vasomotor symptom frequency from baseline relative to placebo was similar for escitalopram at -1.4 per day (95% confidence interval [CI] -2.7 to -0.2), low-dose E2 at -2.4 (95% CI -3.4 to -1.3), and venlafaxine at -1.8 (95% CI -2.8 to -0.8); vasomotor symptom bother reduction was minimal and did not vary across these three pharmacologic interventions (mean -0.2 to -0.3 relative to placebo). No effects on vasomotor symptom frequency or bother were seen with aerobic exercise, yoga, or omega-3 supplements. CONCLUSION: These analyses suggest that escitalopram, low-dose E2, and venlafaxine provide comparable, modest reductions in vasomotor symptom frequency and bother among women with moderate hot flushes. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00894543 (MsFLASH 01), NCT01178892 (MsFLASH 02), and NCT01418209 (MsFLASH 03).
OBJECTIVE: To describe the effects of six interventions for menopausal vasomotor symptoms relative to control in a pooled analysis, facilitating translation of the results for clinicians and symptomatic women. The Menopause Strategies: Finding Lasting Answers for Symptoms and Health network tested these interventions in three randomized clinical trials. METHODS: An analysis of pooled individual-level data from three randomized clinical trials is presented. Participants were 899 perimenopausal and postmenopausal women with at least 14 bothersome vasomotor symptoms per week. Interventions included 10-20 mg escitalopram per day, nonaerobic yoga, aerobic exercise, 1.8 g per day omega-3 fatty acid supplementation, 0.5 mg low-dose oral 17-beta-estradiol (E2) per day, and 75 mg low-dose venlafaxine XR per day. The main outcome measures were changes from baseline in mean daily vasomotor symptom frequency and bother during 8-12 weeks of treatment. Linear regression models estimated differences in outcomes between each intervention and corresponding control group adjusted for baseline characteristics. Models included trial-specific intercepts, effects of the baseline outcome measure, and time. RESULTS: The 8-week reduction in vasomotor symptom frequency from baseline relative to placebo was similar for escitalopram at -1.4 per day (95% confidence interval [CI] -2.7 to -0.2), low-dose E2 at -2.4 (95% CI -3.4 to -1.3), and venlafaxine at -1.8 (95% CI -2.8 to -0.8); vasomotor symptom bother reduction was minimal and did not vary across these three pharmacologic interventions (mean -0.2 to -0.3 relative to placebo). No effects on vasomotor symptom frequency or bother were seen with aerobic exercise, yoga, or omega-3 supplements. CONCLUSION: These analyses suggest that escitalopram, low-dose E2, and venlafaxine provide comparable, modest reductions in vasomotor symptom frequency and bother among women with moderate hot flushes. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00894543 (MsFLASH 01), NCT01178892 (MsFLASH 02), and NCT01418209 (MsFLASH 03).
Authors: Janet S Carpenter; Anna Maria Storniolo; Shelley Johns; Patrick O Monahan; Faouzi Azzouz; Julie L Elam; Cynthia S Johnson; Richard C Shelton Journal: Oncologist Date: 2007-01
Authors: Katherine M Newton; Susan D Reed; Andrea Z LaCroix; Louis C Grothaus; Kelly Ehrlich; Jane Guiltinan Journal: Ann Intern Med Date: 2006-12-19 Impact factor: 25.391
Authors: Claudio N Soares; Helga Arsenio; Hadine Joffe; Bettina Bankier; Paolo Cassano; Laura F Petrillo; Lee S Cohen Journal: Menopause Date: 2006 Sep-Oct Impact factor: 2.953
Authors: Charles L Loprinzi; Jeff A Sloan; Edith A Perez; Susan K Quella; Phillip J Stella; James A Mailliard; Michele Y Halyard; Sandhya Pruthi; Paul J Novotny; Teresa A Rummans Journal: J Clin Oncol Date: 2002-03-15 Impact factor: 44.544
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: Barbara Sternfeld; Andrea LaCroix; Bette J Caan; Andrea L Dunn; Katherine M Newton; Susan D Reed; Katherine A Guthrie; Cathryn Booth-LaForce; Karen J Sherman; Lee Cohen; Marlene P Freeman; Janet S Carpenter; Julie R Hunt; Melanie Roberts; Kristine E Ensrud Journal: Contemp Clin Trials Date: 2013-02-24 Impact factor: 2.261
Authors: Susan D Reed; Andrea Z LaCroix; Garnet L Anderson; Kristine E Ensrud; Bette Caan; Janet S Carpenter; Lee Cohen; Susan J Diem; Ellen W Freeman; Hadine Joffe; Joseph C Larson; Susan M McCurry; Caroline M Mitchell; Katherine M Newton; Barbara Sternfeld; Katherine A Guthrie Journal: Menopause Date: 2020-04 Impact factor: 2.953
Authors: Katherine A Guthrie; Joseph C Larson; Kristine E Ensrud; Garnet L Anderson; Janet S Carpenter; Ellen W Freeman; Hadine Joffe; Andrea Z LaCroix; JoAnn E Manson; Charles M Morin; Katherine M Newton; Julie Otte; Susan D Reed; Susan M McCurry Journal: Sleep Date: 2018-01-01 Impact factor: 6.313
Authors: Susan J Diem; Andrea Z LaCroix; Susan D Reed; Joseph C Larson; Katherine M Newton; Kristine E Ensrud; Nancy F Woods; Katherine A Guthrie Journal: Menopause Date: 2020-10 Impact factor: 3.310
Authors: Valentina Ciappolino; Alessandra Mazzocchi; Paolo Enrico; Marie-Louise Syrén; Giuseppe Delvecchio; Carlo Agostoni; Paolo Brambilla Journal: Int J Mol Sci Date: 2018-06-23 Impact factor: 5.923
Authors: Alberto López García-Franco; José Antonio Baeyens Fernández; Emilia Bailón Muñoz; M José Iglesias Piñeiro; Isabel Del Cura González; Amparo Ortega Del Moral; Jacinta Landa Goñi; Pablo Alonso Coello; Lorenzo Arribas Mir Journal: Aten Primaria Date: 2018-05 Impact factor: 1.137