학술논문

Pooled Analysis of Six Pharmacologic and Nonpharmacologic Interventions for Vasomotor Symptoms
Document Type
article
Source
Obstetrics and Gynecology. 126(2)
Subject
Clinical Trials and Supportive Activities
Estrogen
Aging
Complementary and Integrative Health
Nutrition
Clinical Research
6.1 Pharmaceuticals
Evaluation of treatments and therapeutic interventions
Reproductive health and childbirth
Citalopram
Cyclohexanols
Dietary Supplements
Double-Blind Method
Estradiol
Estrogens
Exercise
Fatty Acids
Omega-3
Female
Hot Flashes
Humans
Middle Aged
Monitoring
Physiologic
Outcome Assessment
Health Care
Perimenopause
Postmenopause
Serotonin Uptake Inhibitors
Vasomotor System
Venlafaxine Hydrochloride
Yoga
Selective Serotonin Reuptake Inhibitors
Paediatrics and Reproductive Medicine
Obstetrics & Reproductive Medicine
Language
Abstract
ObjectiveTo 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.MethodsAn 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.ResultsThe 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.ConclusionThese 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 registrationClinicalTrials.gov, www.clinicaltrials.gov, NCT00894543 (MsFLASH 01), NCT01178892 (MsFLASH 02), and NCT01418209 (MsFLASH 03).