Evidence map›Paper›PMID 25004335›Full record

Trial reportObstetrics and gynecology2014

Sexual function in women on estradiol or venlafaxine for hot flushes: a randomized controlled trial.

Susan D Reed, Caroline M Mitchell, Hadine Joffe, Lee Cohen, Jan L Shifren, Katherine M Newton, Ellen W Freeman, Joseph C Larson, JoAnn E Manson, Andrea Z LaCroix and 1 more

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

Trial report in Obstetrics and gynecology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01418209 (MsFLASH-03), which is not on this map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
1.9field-weighted citation impact, top 16% 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.

NCT01418209 nacompletednot on this map

MsFLASH-03: Comparative Efficacy of Low-Dose Estradiol and the SNRI Venlafaxine XR for Treatment of Menopausal Symptoms

TypeinterventionalSponsorFred Hutchinson Cancer CenterRan2011 to 2013Enrolled339ConditionsHot Flashes, Menopause, Vasomotor DisturbanceArmsLow-dose 17-ß-estradiol with progesterone taper, Venlafaxine XR, Placebo
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 1 synthesis or guideline pooled it, 36 citations in OpenAlex.

  1. Pooled it
  2. Trial
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  6. Review
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  12. Review
  13. Lights on MsFLASH: a review of contributions.Menopause (New York, N.Y.) · 2020
    Review
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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

11 authors at 1 institution in 1 country.

Susan D ReedDepartments of Obstetrics and Gynecology and Epidemiology, University of Washington School of Medicine, the Group Health Research Institute, and the Data Coordinating Center, Fred Hutchinson Cancer Research Center, Seattle, Washington; the Departments of Psychiatry and Medicine, Brigham and Women's Hospital, the Departments of Psychiatry and Obstetrics and Gynecology, Massachusetts General Hospital, and Harvard Medical School, Boston, Massachusetts; and the Departments of Obstetrics and Gynecology and Psychiatry, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania.
Caroline M Mitchell
Hadine Joffe
Lee Cohen
Jan L Shifren
Katherine M Newton
Ellen W Freeman
Joseph C Larson
JoAnn E Manson
Andrea Z LaCroix
Katherine A Guthrie
Brigham and Women's Hospital · US

Funding

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
NIA NIH HHS R01 AG048209NIA NIH HHS U01 AG032656NIA NIH HHS U01 AG032659NIA 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

objectiveTo evaluate sexual function in midlife women taking low-dose oral estradiol or venlafaxine for hot flushes.

methodsIn an 8-week randomized controlled trial among women aged 40-62 years, sexual function was compared between 0.5 mg oral estradiol per day or 75 mg venlafaxine per day (both compared with a placebo). Measures included composite and six domain scores from the Female Sexual Function Index and sexually related personal distress.

resultsParticipants were aged 54.6 years (standard deviation [SD] 3.8) years, 59% white, with 8.1 (SD 5.3) daily hot flushes. Median composite baseline Female Sexual Function Index score was 16.3 (SD 11.9, n=256) for all women and 21.7 (SD 9.3, n=198) among sexually active women. Composite mean Female Sexual Function Index change from baseline to week 8 was 1.4 (95% confidence interval [CI] -0.4 to 3.2) for estradiol, 1.1 (95% CI -0.5 to 2.7) for venlafaxine, and -0.3 (95% CI -1.6 to 1.0) for placebo. Composite Female Sexual Function Index and sexually related distress change from baseline did not differ between estradiol and placebo (P=.38, P=.30) or venlafaxine and placebo (P=.79, P=.48). Among sexually active women, Female Sexual Function Index domain score change from baseline differences (active compared with placebo) in desire was 0.3 (95% CI 0.0-0.6) for estradiol, -0.6 (95% CI -1.2 to 0.0) in orgasm for venlafaxine, and 0.9 (95% CI 0.2-1.6) in penetration pain for venlafaxine. No women reported adverse events related to sexual dysfunction.

conclusionOverall sexual function among nondepressed midlife women experiencing hot flushes did not change over 8 weeks with low-dose oral estradiol or venlafaxine (compared with placebo), although a subtle increase in desire (estradiol) and decreases in orgasm and pain (venlafaxine) may exist. CLINICAL

trial registrationClinicalTrials.gov, www.clinicaltrials.gov, NCT01418209. LEVEL OF EVIDENCE: I.

Indexed as

AdultCyclohexanolsDouble-Blind MethodDyspareuniaEstradiolEstrogensFemaleHot FlashesHumansMiddle AgedOrgasmPerimenopausePostmenopauseProspective StudiesSelective Serotonin Reuptake InhibitorsSexual BehaviorCyclohexanolsEstradiolEstrogensSelective Serotonin Reuptake InhibitorsVenlafaxine Hydrochloride

Identifiers

PMID25004335
PMCPMC4113909
OpenAlexW2101409995

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.