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Randomized Controlled Trial
. 2015 Aug;126(2):413-422.
doi: 10.1097/AOG.0000000000000927.

Pooled Analysis of Six Pharmacologic and Nonpharmacologic Interventions for Vasomotor Symptoms

Katherine A Guthrie  1 , 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
Affiliations
Randomized Controlled Trial

Pooled Analysis of Six Pharmacologic and Nonpharmacologic Interventions for Vasomotor Symptoms

Katherine A Guthrie et al. Obstet Gynecol. 2015 Aug.

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).

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Figures

Figure 1
Figure 1
Effect of each intervention on changes from baseline in daily mean vasomotor symptom frequency, relative to control.
Figure 2
Figure 2
Effect of each intervention on changes from baseline in daily mean vasomotor symptom bother, relative to control.
See this image and copyright information in PMC

References

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