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Pooled Analysis of Six Pharmacologic and Nonpharmacologic Interventions for Vasomotor Symptoms
Katherine A Guthrie1, Andrea Z LaCroix, Kristine E Ensrud
1MsFLASH 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.
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).
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