Evidence map›Paper›PMID 26115591›Full record

Trial reportMaturitas2015

Low-dose 17-β-estradiol cream for vaginal atrophy in a cohort without prolapse: Serum levels and vaginal response including tissue biomarkers associated with tissue remodeling.

Jana D Illston, Thomas L Wheeler, C Richard Parker, Michael G Conner, Kathryn L Burgio, Patricia S Goode, Holly E Richter

Open access · greenAbstract readClinical Trial
In one paragraph

Trial report in Maturitas, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.6field-weighted citation impact, top 18% 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

6 citing papers in PubMed, 19 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

7 authors at 1 institution in 1 country.

Jana D IllstonDepartment of Obstetrics and Gynecology, University of Alabama at Birmingham, 1700 6th Ave S, Suite 10382, Birmingham, AL 35233, USA. Electronic address: janaillston@uabmc.edu.
Thomas L WheelerDepartment of Obstetrics and Gynecology, University of South Carolina School of Medicine Greenville, 890 W Faris Road, Suite 520, Greenville, SC 29605, USA.
C Richard ParkerDepartment of Obstetrics and Gynecology, University of Alabama at Birmingham, 1700 6th Ave S, Suite 10382, Birmingham, AL 35233, USA.
Michael G ConnerDepartment of Obstetrics and Gynecology, University of Alabama at Birmingham, 1700 6th Ave S, Suite 10382, Birmingham, AL 35233, USA.
Kathryn L BurgioDepartment of Medicine, University of Alabama at Birmingham, 933 19th Street South, CH19-201, Birmingham, AL 35294, USA; Birmingham/Atlanta Geriatric Research, Education, and Clinical Center, Department of Veterans Affairs Birmingham VAMC, GRECC 11G 700 19th Street South, Birmingham, AL 35233, USA.
Patricia S GoodeDepartment of Medicine, University of Alabama at Birmingham, 933 19th Street South, CH19-201, Birmingham, AL 35294, USA; Birmingham/Atlanta Geriatric Research, Education, and Clinical Center, Department of Veterans Affairs Birmingham VAMC, GRECC 11G 700 19th Street South, Birmingham, AL 35233, USA.
Holly E RichterDepartment of Obstetrics and Gynecology, University of Alabama at Birmingham, 1700 6th Ave S, Suite 10382, Birmingham, AL 35233, USA.
University of Alabama at Birmingham · US

Funding

Mid Career Award in Patient Oriented Pelvic Floor ResearchK24DK068389 · NIDDK · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI RICHTER, HOLLY E · 2005 to 2014
$1.7M
NIDDK NIH HHS 2K24-DK068389NIDDK NIH HHS K24 DK068389
6 · The paper itself

Abstract

objectivesDescribe the effect of 50 mcg vaginal 17-β-estradiol (E2) cream on vaginal maturation, serum estrogen levels, atrophic symptoms, and biomarkers of oxidative stress and tissue remodeling in postmenopausal women without prolapse.

methodsSeventeen women, 65 years or older, applied intravaginal E2 cream nightly for eight weeks, then twice weekly for eight weeks. Vaginal biopsies, serial blood draws, and atrophic symptoms were obtained at baseline, eight, and sixteen weeks. Changes in atrophic symptoms, vaginal maturation indices (VMI), and serum E2 were measured. Immunohistochemical staining characterized levels of transforming growth factor-beta (TGF-β), nuclear factor kappa B (NFKB), inducible nitric oxide synthase (iNOS), endothelial nitric oxide synthase (eNOS), and thrombospondin (TSP).

resultsSerum E2 levels (pg/ml) were unchanged from baseline (mean (SD)) 7.7 (3.3) to eight 9.7 (5.7) and sixteen 8.7 (5.8) (p=0.24) weeks. VMI (mean (SD)) improved from baseline 34.2 (18.3) to eight 56.7 (13.1) and sixteen 54.5 (11.3) (p<0.001) weeks with no difference between eight and sixteen weeks. Vaginal dryness (p=0.03) and itching (p=0.02) improved. Tissue biomarker levels did not change (TGF-β p=0.35, NFKB p=0.74, eNOS p=0.80, iNOS p=0.24, TSP p=0.80). DISCUSSION: Vaginal E2 improved atrophic symptoms and VMI without elevating serum E2. Tissue remodeling biomarkers did not change.

Indexed as

Administration, IntravaginalAgedAged, 80 and overAtrophyBiomarkersEstradiolEstrogensFemaleHumansPostmenopauseProlapseVaginaVaginal DiseasesBiomarkersEstradiolEstrogensEstradiolTissue biomarkersVaginal atrophyVaginal estrogen

Identifiers

PMID26115591
PMCPMC4515379
OpenAlexW1832642849

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.