Evidence map›Paper›PMID 29738424›Full record

Trial reportMenopause (New York, N.Y.)2018

Effects of vaginal estradiol tablets and moisturizer on menopause-specific quality of life and mood in healthy postmenopausal women with vaginal symptoms: a randomized clinical trial.

Susan J Diem, Katherine A Guthrie, Caroline M Mitchell, Susan D Reed, Joseph C Larson, Kristine E Ensrud, Andrea Z LaCroix

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Menopause (New York, N.Y.), 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 4 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

14 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Efficacy of Hormonal and Nonhormonal Approaches to Vaginal Atrophy and Sexual Dysfunctions in Postmenopausal Women: A Systematic Review.Revista brasileira de ginecologia e obstetricia : revista da Federacao Brasileira das Sociedades de Ginecologia e Obstetricia · 2022
    Pooled it
  4. The Effect of Exogenous Sex Steroids on the Vaginal Microbiota: A Systematic Review.Frontiers in cellular and infection microbiology · 2021
    Pooled it
  5. Trial
  6. Trial
  7. Review
  8. Review
  9. Review
  10. Article
  11. Review
  12. Lights on MsFLASH: a review of contributions.Menopause (New York, N.Y.) · 2020
    Review
  13. Review
  14. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors.

Susan J DiemDepartment of Medicine and Epidemiology and Community Health, University of Minnesota, Minneapolis, MN.
Katherine A GuthriePublic Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA.
Caroline M MitchellVincent Obstetrics and Gynecology, Massachusetts General Hospital and Harvard Medical School, Boston, MA.
Susan D ReedDepartment of Obstetrics and Gynecology, University of Washington, Seattle, WA.
Joseph C LarsonPublic Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA.
Kristine E EnsrudDepartment of Medicine and Epidemiology and Community Health, University of Minnesota, Minneapolis, MN.
Andrea Z LaCroixDepartment of Family Medicine and Public Health, University of California at San Diego, La Jolla, CA.

Funding

MsFLASH: Living a Healthy MenopauseR01AG048209 · NIA · FRED HUTCHINSON CANCER RESEARCH CENTER · PI GUTHRIE, KATHERINE ADAMS, LACROIX, ANDREA Z. · 2015 to 2019
$7.2M
NIA NIH HHS R01 AG048209
6 · The paper itself

Abstract

objectiveCompare the effects of a vaginal estradiol tablet and a vaginal moisturizer, each to placebo, on menopause-related quality of life and mood in postmenopausal women with moderate-severe vulvovaginal symptoms.

methodsA total of 302 postmenopausal women enrolled in a 12-week, double-blind, placebo-controlled randomized trial were assigned to vaginal 10 μg estradiol tablet plus placebo gel (n = 102), vaginal moisturizer plus placebo tablet (n = 100), or dual placebo (n = 100). We measured change from randomization to 12 weeks in total score of the Menopause-Specific Quality of Life (MENQOL) questionnaire. We also evaluated the four MENQOL domains, depressive symptoms as measured by the Patient Health Questionnaire 8, and anxiety symptoms as measured by the Generalized Anxiety Disorder (GAD-7) questionnaire.

resultsTreatment with vaginal estradiol resulted in significantly greater improvement in total MENQOL scores compared to dual placebo (mean difference between arms -0.3 at 12 weeks (95% confidence interval [CI] -0.5, 0.0; P = 0.01). A statistically significant group mean difference favoring vaginal estradiol was observed for the MENQOL sexual function domain (-0.4 at 12 weeks; 95% CI -1.0, 0.1; P = 0.005), but not for any of the other domains. Treatment with vaginal moisturizer did not provide greater improvement compared to placebo in total MENQOL scores (mean difference 0.2 at 12 weeks; 95% CI -0.1, 0.4; P = 0.38) or in any of the MENQOL domains. Neither treatment group showed improvement compared with placebo in the Patient Health Questionnaire 8 or Generalized Anxiety Disorder Questionnaire .

conclusionsTreatment with low-dose vaginal estradiol, but not vaginal moisturizer, modestly improved menopause-related quality of life and sexual function domain scores in postmenopausal women with moderate-severe vulvovaginal symptoms.

Indexed as

Quality of LifeVaginal Creams, Foams, and JelliesAdministration, IntravaginalAffectAgedAnxietyDepressionDouble-Blind MethodEstradiolEstrogen Replacement TherapyFemaleFollow-Up StudiesHumansMiddle AgedPostmenopauseSexual Dysfunction, PhysiologicalEstradiolVaginal Creams, Foams, and Jellies

Identifiers

PMID29738424
PMCPMC6136971

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.