Evidence map›Paper›PMID 25405571›Full record

Trial reportMenopause (New York, N.Y.)2015

Effects of estrogen and venlafaxine on menopause-related quality of life in healthy postmenopausal women with hot flashes: a placebo-controlled randomized trial.

Bette Caan, Andrea Z LaCroix, Hadine Joffe, Katherine A Guthrie, Joseph C Larson, Janet S Carpenter, Lee S Cohen, Ellen W Freeman, JoAnn E Manson, Katherine Newton and 5 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Menopause (New York, N.Y.), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 3 pooled it
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Trial
  7. Article
  8. Article
  9. Review
  10. Review
  11. Lights on MsFLASH: a review of contributions.Menopause (New York, N.Y.) · 2020
    Review
  12. Article
  13. Article
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors.

Bette CaanFrom the 1Division of Research, Kaiser Permanente of Northern California, Oakland, CA; 2University of California, San Diego, CA; 3Brigham and Women's Hospital, Boston, MA; 4Dana Farber Cancer Institute, Boston, MA; 5MsFLASH Coordinating Center, Fred Hutchinson Cancer Research Center, Seattle, WA; 6School of Nursing, Indiana University, Indianapolis, IN; 7Massachusetts General Hospital, Boston, MA; 8Harvard Medical School, Boston, MA; 9Departments of Obstetrics/Gynecology and Psychiatry, University of Pennsylvania School of Medicine, Philadelphia, PA; 10Group Health Research Institute, Seattle, WA; 11University of Washington School of Medicine, Seattle, WA; and 12VA Medical Center/University of Minnesota, Minneapolis, MN.
Andrea Z LaCroix
Hadine Joffe
Katherine A Guthrie
Joseph C Larson
Janet S Carpenter
Lee S Cohen
Ellen W Freeman
JoAnn E Manson
Katherine Newton
Susan Reed
Kathy Rexrode
Jan Shifren
Barbara Sternfeld
Kris Ensrud

Funding

HARVARD CLINICAL AND TRANSLATIONAL SCIENCE CENTER (UL1)UL1RR025758 · NCRR · HARVARD MEDICAL SCHOOL · PI NADLER, LEE MARSHALL · 2008 to 2011
$91.4M
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
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
Efficacy of an SSRI for Menopausal Symptoms in Perimenopausal WomenU01AG032656 · NIA · UNIVERSITY OF PENNSYLVANIA · PI FREEMAN, ELLEN W · 2008 to 2012
$1.5M
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 RR025758NIA NIH HHS R01 AG048209NIA NIH HHS U01 AG032656NIA NIH HHS U01 AG032659NIA NIH HHS U01AG032659NIA NIH HHS U01 AG032669NIA NIH HHS U01AG032669NIA NIH HHS U01 AG032682NIA NIH HHS U01AG032682NIA NIH HHS U01 AG032699NIA NIH HHS U01AG032699NIA NIH HHS U01 AG032700NIA NIH HHS U01AG032700
6 · The paper itself

Abstract

objectiveThis study aims to evaluate the effects of low-dose estradiol (E2) or venlafaxine on menopause-related quality of life and associated symptoms in healthy perimenopausal and postmenopausal women with hot flashes.

methodsA double-blind, placebo-controlled, randomized trial of low-dose oral 17β-E2 0.5 mg/day and venlafaxine XR 75 mg/day, versus identical placebo, was conducted among 339 women (aged 40-62 y) experiencing two or more vasomotor symptoms (VMS) per day (mean [SD], 8.07 [5.29]) who were recruited at three clinical sites from November 2011 to October 2012. The primary trial outcome, as reported previously, was frequency of VMS at 8 weeks. Here, we report on secondary endpoints of total and domain scores from the Menopause-Specific Quality of Life Questionnaire (MENQOL) and from measures of pain (Pain, Enjoyment in life, and General activity scale), depression (Patient Health Questionnaire-9), anxiety (Generalized Anxiety Disorder Questionnaire-7), and perceived stress (Perceived Stress Scale).

resultsTreatment with both E2 and venlafaxine resulted in significantly greater improvement in quality of life, as measured by total MENQOL scores, compared with placebo (E2: mean difference at 8 wk, -0.4; 95% CI, -0.7 to -0.2; P < 0.001; venlafaxine: mean difference at 8 wk, -0.2; 95% CI, -0.5 to 0.0; P = 0.04). Quality-of-life domain analyses revealed that E2 had beneficial treatment effects on all domains of the MENQOL except for the psychosocial domain, whereas venlafaxine benefits were observed only in the psychosocial domain. Neither E2 nor venlafaxine improved pain, anxiety, or depressive symptoms, although baseline symptom levels were low. Modest benefits were observed for perceived stress with venlafaxine.

conclusionsBoth low-dose E2 and venlafaxine are effective pharmacologic agents for improving menopause-related quality of life in healthy women with VMS.

Indexed as

PostmenopauseQuality of LifeAdultDose-Response Relationship, DrugDouble-Blind MethodEstradiolEstrogen Replacement TherapyFemaleHot FlashesHumansMiddle AgedSelective Serotonin Reuptake InhibitorsTreatment OutcomeVenlafaxine HydrochlorideEstradiolSelective Serotonin Reuptake InhibitorsVenlafaxine Hydrochloride

Identifiers

PMID25405571
PMCPMC4610378

What OpenQuestion holds

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Registered trials

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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.