Evidence map›Paper›PMID 21525161›Full record

Trial reportThe Journal of clinical endocrinology and metabolism2011

Increased estradiol and improved sleep, but not hot flashes, predict enhanced mood during the menopausal transition.

Hadine Joffe, Laura Fagioli Petrillo, Alexia Koukopoulos, Adele C Viguera, April Hirschberg, Ruta Nonacs, Brittny Somley, Erica Pasciullo, David P White, Janet E Hall and 1 more

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

Trial report in The Journal of clinical endocrinology and metabolism, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04841499 (Effects of a Seven-day BASIS™ Supplementation on Menopausal Syndromes and Measurements of the Urinary Vitamin B3 and Estradiol Levels in Pre-, Peri- and Post-menopause), which is not on this map. Cited by 53 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
53citing papers in PubMed, 5 pooled it
3.5field-weighted citation impact, top 7% 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.

NCT04841499 nacompletednot on this mapstarted 2021, after this paper: background citation

Effects of a Seven-day BASIS™ Supplementation on Menopausal Syndromes and Measurements of the Urinary Vitamin B3 and Estradiol Levels in Pre-, Peri- and Post-menopause

TypeinterventionalSponsorUniversity of South AlabamaRan2021 to 2021Enrolled40ConditionsMenopauseArmsBASIS™ (Crystalline Nicotinamide Riboside 250mg and Pterostilbene 50mg)
3 · Its place in the literature

Who cites it

53 citing papers in PubMed, 5 syntheses or guidelines pooled it, 110 citations in OpenAlex.

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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 4 institutions in 1 country.

Hadine JoffeCenter for Women’s Mental Health, Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts 02114, USA. hjoffe@partners.org
Laura Fagioli Petrillo
Alexia Koukopoulos
Adele C Viguera
April Hirschberg
Ruta Nonacs
Brittny Somley
Erica Pasciullo
David P White
Janet E Hall
Lee S Cohen
Harvard University · USMassachusetts General Hospital · USBrigham and Women's Hospital · USMass General Brigham · US

Funding

PHYSIOLOGY OF ESTROGEN'S MOOD EFFECT IN MENOPAUSAL WOMENK23MH066978 · NIMH · MASSACHUSETTS GENERAL HOSPITAL · PI JOFFE, HADINE · 2003 to 2007
$885k
NIMH NIH HHS K23 MH066978NIMH NIH HHS K23MH066978
6 · The paper itself

Abstract

backgroundThe antidepressant effect of estrogen in women undergoing the menopause transition is hypothesized to be mediated by central nervous system effects of increasing estradiol on mood or through a pathway involving suppression of hot flashes and associated sleep disturbance. Estrogen therapy (ET) and the hypnotic agent zolpidem were selected as interventions in a three-arm, double-blind, placebo-controlled trial to distinguish the effects of estradiol, sleep, and hot flashes on depression.

methodsWomen with depressive disorders, hot flashes, and sleep disturbance were randomly assigned to transdermal 17β-estradiol 0.05 mg/d, zolpidem 10 mg/d, or placebo for 8 wk. Changes in serum estradiol, perceived sleep quality, objectively measured sleep, and hot flashes were examined as predictors of depression improvement [Montgomery-Åsberg Depression Rating Scale (MADRS)] using multivariate linear regression.

resultsSeventy-two peri/postmenopausal women with depression disorders were randomized to 17β-estradiol (n = 27), zolpidem (n = 31), or placebo (n = 14). There was no significant difference between groups in depression improvement (overall MADRS decrease 11.8 ± 8.6). Increasing estradiol (P = 0.009) and improved sleep quality (P < 0.001) predicted improved mood in adjusted models but reduced hot flashes (P = 0.99) did not. Post hoc subgroup analyses revealed that the therapeutic effect of increasing estradiol levels on mood was seen in perimenopausal (P = 0.009), but not postmenopausal, women.

conclusionsFor women with menopause-associated depression, improvement in depression is predicted by improved sleep, and among perimenopausal women, by increasing estradiol levels. These results suggest that changes in estradiol and sleep quality, rather than hot flashes, mediate depression during the menopause transition. Therapies targeting insomnia may be valuable in treating menopause-associated depression.

Indexed as

Administration, CutaneousAdultAffectDepressive DisorderDouble-Blind MethodEstradiolFemaleFollicle Stimulating HormoneHot FlashesHumansHypnotics and SedativesMiddle AgedPerimenopausePsychiatric Status Rating ScalesPyridinesSleepEstradiolFollicle Stimulating HormoneHypnotics and SedativesPyridinesZolpidem

Identifiers

PMID21525161
PMCPMC3135198
OpenAlexW2114939138

What OpenQuestion holds

Textmetadata
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.