Evidence map›Paper›PMID 29165623›Full record

Trial reportSleep2018

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.

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 and 4 more

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Sleep, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05346445 (Citalopram Improves Vasomotor and Urogenital Syndromes in Mexican Patients With Post-menopause), which is not on this map. Cited by 38 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed, 3 pooled it
7.7field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05346445 nacompletednot on this mapstarted 2021, after this paper: background citation

Citalopram Improves Vasomotor and Urogenital Syndromes in Mexican Patients With Post-menopause

TypeinterventionalSponsorHospital Regional 1o de OctubreRan2021 to 2021Enrolled91ConditionsPostmenopause, Hot FlashesArmsFluoxetine 20 MG, Citalopram 20mg
3 · Its place in the literature

Who cites it

38 citing papers in PubMed, 3 syntheses or guidelines pooled it, 94 citations in OpenAlex.

  1. Pooled it
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  7. The Impact of a Randomized Controlled Trial of a Lifestyle Intervention on Sleep Among Latina Postpartum Women.Annals of behavioral medicine : a publication of the Society of Behavioral Medicine · 2021
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  8. A randomized phase II trial evaluating two non-pharmacologic interventions in cancer survivors for the treatment of sleep-wake disturbances: NCCTG N07C4 (Alliance).Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2020
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 9 institutions in 2 countries.

Katherine A GuthriePublic Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA.
Joseph C LarsonPublic Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA.
Kristine E EnsrudDepartment of Medicine, Division of Epidemiology and Community Health, University of Minnesota, Center for Chronic Disease Outcomes Research, Minneapolis VA Health Care System, Minneapolis, MN.
Garnet L AndersonPublic Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA.
Janet S CarpenterIndiana University School of Nursing, Indianapolis, IN.
Ellen W FreemanDepartments of Obstetrics/Gynecology and Psychiatry, University of Pennsylvania School of Medicine, Philadelphia, PA.
Hadine JoffeDana Farber Cancer Institute, Harvard Medical School, Boston, MA.
Andrea Z LaCroixDepartment of Family and Preventive Medicine, University of California-San Diego, La Jolla, CA.
JoAnn E MansonBrigham and Women's Hospital, Harvard Medical School, Boston, MA.
Charles M MorinDepartment of Psychology, Universite Laval, Quebec, QC, Canada.
Katherine M NewtonKaiser Permanente Washington Health Research Institute, Seattle, WA.
Julie OtteIndiana University School of Nursing, Indianapolis, IN.
Susan D ReedDepartment of Obstetrics and Gynecology, University of Washington, Seattle, WA.
Susan M McCurryDepartment of Psychosocial and Community Health, University of Washington, Seattle, WA.
Fred Hutch Cancer Center · USBrigham and Women's Hospital · USIndiana University – Purdue University Indianapolis · USUniversity of Washington · USKaiser Permanente Washington Health Research Institute · USUniversité Laval · CAUniversity of California, San Diego · USUniversity of Minnesota · USUniversity of Pennsylvania · US

Funding

INDIANA CLINICAL AND TRANSLATIONAL SCIENCE INSTITUTE (UL1): BPCAUL1RR025761 · NCRR · INDIANA UNIVERSITY INDIANAPOLIS · PI SHEKHAR, ANANTHA · 2008 to 2011
$21.0M
Menopausal Symptoms Initiative-Finding Lasting Answers for Sweats and Hot FlashesU01AG032699 · NIA · FRED HUTCHINSON CANCER RESEARCH CENTER · PI GUTHRIE, KATHERINE ADAMS, LACROIX, ANDREA Z. · 2008 to 2012
$13.5M
MsFLASH: Living a Healthy MenopauseR01AG048209 · NIA · FRED HUTCHINSON CANCER RESEARCH CENTER · PI GUTHRIE, KATHERINE ADAMS, LACROIX, ANDREA Z. · 2015 to 2019
$7.2M
Menopausal Sleep Fragmentation: Impact on Body Fat Gain Biomarkers in WomenR01AG053838 · NIA · BRIGHAM AND WOMEN'S HOSPITAL · PI JOFFE, HADINE · 2017 to 2020
$3.5M
MSI-FLASH: Relative Efficacy of Hormonal and Non-Hormonal Interventions for VMSU01AG032700 · NIA · MASSACHUSETTS GENERAL HOSPITAL · PI COHEN, LEE S, JOFFE, HADINE · 2008 to 2012
$1.7M
MSI FLASH: An RCT of Yoga and Ultra Low-Dose Estrogen Gel for Vasomotor SymptomsU01AG032682 · NIA · KAISER FOUNDATION HEALTH PLAN OF WASHINGTON · PI NEWTON, KATHERINE M. · 2008 to 2012
$1.7M
MSI-FLASH: Paced Respiration for Breast Cancer SurvivorsU01AG032659 · NIA · INDIANA UNIVERSITY INDIANAPOLIS · PI CARPENTER, JANET S · 2008 to 2012
$1.5M
MSI-FLASH: An Exercise Intervention for Women with Menopausal SymptomsU01AG032669 · NIA · KAISER FOUNDATION RESEARCH INSTITUTE · PI CAAN, BETTE J · 2008 to 2012
$1.5M
NCRR NIH HHS UL1 RR025761NIA NIH HHS R01 AG048209NIA NIH HHS R01 AG053838NIA NIH HHS U01 AG032659NIA NIH HHS U01 AG032669NIA NIH HHS U01 AG032682NIA NIH HHS U01 AG032699NIA NIH HHS U01 AG032700
6 · The paper itself

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.

Indexed as

Antidepressive Agents, Second-GenerationCitalopramCognitive Behavioral TherapyDouble-Blind MethodEstradiolExerciseExercise TherapyFatty Acids, Omega-3FemaleHot FlashesHumansMeditationMenopauseMiddle AgedOutcome Assessment, Health CarePlacebosAntidepressive Agents, Second-GenerationCitalopramEstradiolFatty Acids, Omega-3PlacebosVenlafaxine Hydrochlorideinsomniamenopausevasomotor symptoms

Identifiers

PMID29165623
PMCPMC6380606
OpenAlexW2769889930

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.