Evidence map›Paper›PMID 31688579›Full record

Trial reportMenopause (New York, N.Y.)2019

Effects of perimenopausal transdermal estradiol on self-reported sleep, independent of its effect on vasomotor symptom bother and depressive symptoms.

Paul J Geiger, Tory Eisenlohr-Moul, Jennifer L Gordon, David R Rubinow, Susan S Girdler

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Menopause (New York, N.Y.), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
2.1field-weighted citation impact, top 12% 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.

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

11 citing papers in PubMed, 30 citations in OpenAlex.

  1. Trial
  2. Review
  3. Review
  4. Review
  5. Article
  6. Optimizing sleep across the menopausal transition.Climacteric : the journal of the International Menopause Society · 2023
    Article
  7. Review
  8. Article
  9. The 2020 Menopausal Hormone Therapy Guidelines.Journal of menopausal medicine · 2020
    Review
  10. Review
  11. Observational
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

5 authors at 3 institutions in 2 countries.

Paul J GeigerUniversity of North Carolina at Chapel Hill, Chapel Hill, NC.
Tory Eisenlohr-MoulUniversity of Illinois at Chicago, Chicago, IL.
Jennifer L GordonUniversity of Regina, Regina, Saskatchewan, Canada.
David R RubinowUniversity of North Carolina at Chapel Hill, Chapel Hill, NC.
Susan S GirdlerUniversity of North Carolina at Chapel Hill, Chapel Hill, NC.
University of North Carolina at Chapel Hill · USUniversity of Illinois Chicago · USUniversity of Regina · CA

Funding

Depression, Estrogen Replacement, and Cardiovascular Health in the PerimenopauseR01MH087619 · NIMH · UNIV OF NORTH CAROLINA CHAPEL HILL · PI GIRDLER, SUSAN S., RUBINOW, DAVID R. · 2010 to 2014
$4.0M
Postdoctoral Training in Reproductive Mood DisordersT32MH093315 · NIMH · UNIV OF NORTH CAROLINA CHAPEL HILL · PI SUSAN Scott GIRDLER, David R. Rubinow · 2012 to 2026
$2.8M
Ovarian Hormone Withdrawal and Suicide Risk: An Experimental ApproachR00MH109667 · NIMH · UNIVERSITY OF ILLINOIS AT CHICAGO · PI EISENLOHR-MOUL, TORY ANNE · 2018 to 2020
$747k
NIMH NIH HHS R00 MH109667NIMH NIH HHS R01 MH087619NIMH NIH HHS T32 MH093315
6 · The paper itself

Abstract

objectiveThe aim of this study was to determine the efficacy of transdermal estradiol (E2) plus intermittent progesterone (EPT) for improving self-reported sleep in perimenopausal women, after controlling for vasomotor symptoms (VMS) bother and depressive symptoms.

methodsUsing a double-blind, placebo-controlled design, 172 healthy women meeting STRAW+10 criteria for being in the menopausal transition or early postmenopause were randomized to 12 months of transdermal E2 (0.1 mg/d) + 200 mg progesterone (12 d every 3 mo) or placebo. Using standard questionnaires, self-reported sleep, depression, and VMS bother were obtained at baseline and bimonthly postrandomization.

resultsControlling for baseline levels, EPT (vs placebo) led to reductions in minutes to fall asleep (estimate = -0.12, P = 0.002) and number of awakenings (estimate = -0.24, P = 0.04) over the 12 months. Controlling for changes in VMS bother and depressive symptoms, EPT still predicted reductions in minutes to fall asleep (estimate = -0.28, P = 0.02) and number of awakenings (estimate = -0.11, P = 0.02) over the 12 months.

conclusionsWe extend existing research by demonstrating that hormone therapy (HT) in subjective sleep cannot be fully explained by improvements in VMS bother or depressive symptoms. Research to examine the mechanism (s) underlying HT's effects on sleep would have public health significance for perimenopausal women and also advance our general understanding of the pathophysiology of impaired sleep.

Indexed as

PerimenopauseAdministration, CutaneousDepressionDouble-Blind MethodEstradiolEstrogen Replacement TherapyEstrogensFemaleHot FlashesHumansMiddle AgedProgesteroneSelf ReportSleepTreatment OutcomeVasomotor SystemEstradiolEstrogensProgesterone

Identifiers

PMID31688579
PMCPMC8294069
OpenAlexW2969873335

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.