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Sleep. 2018 Jan 1;41(1). doi: 10.1093/sleep/zsx190.

Effects of Pharmacologic and Nonpharmacologic Interventions on Insomnia Symptoms and Self-reported Sleep Quality in Women With Hot Flashes: A Pooled Analysis of Individual Participant Data From Four MsFLASH Trials.

Author information

1
Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA.
2
Department of Medicine, Division of Epidemiology and Community Health, University of Minnesota, Center for Chronic Disease Outcomes Research, Minneapolis VA Health Care System, Minneapolis, MN.
3
Indiana University School of Nursing, Indianapolis, IN.
4
Departments of Obstetrics/Gynecology and Psychiatry, University of Pennsylvania School of Medicine, Philadelphia, PA.
5
Dana Farber Cancer Institute, Harvard Medical School, Boston, MA.
6
Brigham and Women's Hospital, Harvard Medical School, Boston, MA.
7
Department of Family and Preventive Medicine, University of California-San Diego, La Jolla, CA.
8
Department of Psychology, Universite Laval, Quebec, QC, Canada.
9
Kaiser Permanente Washington Health Research Institute, Seattle, WA.
10
Department of Obstetrics and Gynecology, University of Washington, Seattle, WA.
11
Department of Psychosocial and Community Health, University of Washington, Seattle, WA.

Abstract

Study Objectives:

The Menopause Strategies: Finding Lasting Answers for Symptoms and Health network conducted three randomized clinical trials (RCTs) testing six interventions treating vasomotor symptoms (VMS), and also collected self-reported sleep outcomes. A fourth RCT assessed an intervention for insomnia symptoms among women with VMS. We describe these seven interventions' effects relative to control in women with comparably severe insomnia symptoms and VMS.

Methods:

We analyzed pooled individual-level data from 546 peri- and postmenopausal women with Insomnia Severity Index (ISI) ≥ 12, and ≥14 bothersome VMS/week across the four RCTs. Interventions included the following: escitalopram 10-20 mg/day; yoga; aerobic exercise; 1.8 g/day omega-3 fatty acids; oral 17-beta-estradiol 0.5-mg/day; venlafaxine XR 75-mg/day; and cognitive behavioral therapy for insomnia (CBT-I). Outcome measures were ISI and Pittsburgh Sleep Quality Index (PSQI) over 8-12 weeks of treatment.

Results:

CBT-I produced the greatest reduction in ISI from baseline relative to control at -5.2 points (95% CI -7.0 to -3.4). Effects on ISI were similar for exercise at -2.1 and venlafaxine at -2.3 points. Comparably small decreases in ISI were observed with escitalopram, yoga, and estradiol. The largest reduction in PSQI from baseline was with CBT-I at -2.7 points (-3.9 to -1.5), although PSQI decreases of 1.2 to 1.6 points were significantly better than control with escitalopram, exercise, yoga, estradiol, and venlafaxine. Omega-3 supplements did not improve insomnia symptoms.

Conclusions:

This study's findings support current recommendations for CBT-I as a first line treatment in healthy midlife women with insomnia symptoms and moderately bothersome VMS.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00894543 NCT01178892 NCT01418209 NCT01936441.

KEYWORDS:

insomnia; menopause; vasomotor symptoms

PMID:
29165623
PMCID:
PMC6380606
DOI:
10.1093/sleep/zsx190
[Indexed for MEDLINE]
Free PMC Article

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