Evidence map›Paper›PMID 23422867›Full record

Trial reportMenopause (New York, N.Y.)2013

Effect of isoflavone soy protein supplementation on endometrial thickness, hyperplasia, and endometrial cancer risk in postmenopausal women: a randomized controlled trial.

Alexander M Quaas, Naoko Kono, Wendy J Mack, Howard N Hodis, Juan C Felix, Richard J Paulson, Donna Shoupe

Open access · greenAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Menopause (New York, N.Y.), 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 7 pooled it
3.0field-weighted citation impact, top 10% 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

24 citing papers in PubMed, 7 syntheses or guidelines pooled it, 53 citations in OpenAlex.

  1. Pooled it
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  6. Efficacy of phytoestrogens for menopausal symptoms: a meta-analysis and systematic review.Climacteric : the journal of the International Menopause Society · 2015
    Pooled it
  7. Phytoestrogens for menopausal vasomotor symptoms.The Cochrane database of systematic reviews · 2013
    Pooled it
  8. Trial
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  19. Phytochemicals in Gynecological Cancer Prevention.International journal of molecular sciences · 2021
    Review
  20. Therapeutic Potential of Isoflavones with an Emphasis on Daidzein.Oxidative medicine and cellular longevity · 2021
    Review
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.

Alexander M QuaasDepartment of Ob/Gyn, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA. Alexander.Quaas@med.usc.edu
Naoko Kono
Wendy J Mack
Howard N Hodis
Juan C Felix
Richard J Paulson
Donna Shoupe
University of Southern California · US

Funding

Phytoestrogens/Progression of Atherosclerosis SUPPLEMENTU01AT001653 · NCCIH · UNIVERSITY OF SOUTHERN CALIFORNIA · PI HODIS, HOWARD NEIL · 2003 to 2008
$9.2M
NCCIH NIH HHS U01 AT001653NCCIH NIH HHS U01AT-001653
6 · The paper itself

Abstract

objectiveThis study aims to determine whether long-term isoflavone soy protein (ISP) supplementation affects endometrial thickness and rates of endometrial hyperplasia and cancer in postmenopausal women.

methodsIn this randomized, double-blind, placebo-controlled trial, 350 postmenopausal women aged 45 to 92 years were randomized to a total daily dose of 154 mg of ISP or a milk protein-matched placebo for a 3-year period. Women with a surgically absent uterus were excluded from the analysis (final study population, N = 224). The main outcome measures were as follows: mean change in endometrial thickness on transvaginal ultrasound from baseline until up to 36 months of follow-up and the incidence of endometrial sampling, endometrial hyperplasia, and endometrial cancer.

resultsA total of 666 visits among 224 participants were evaluated. Treatment groups did not significantly differ on the mean baseline or on-trial changes in endometrial thickness. Of the 103 placebo-treated participants, 7 (6.8%) underwent endometrial biopsy; 6 (85.7%) of these biopsies were benign. One woman in the placebo group was diagnosed with complex endometrial hyperplasia with atypia and underwent hysterectomy. The pathology result from this surgical operation was stage IB endometrial cancer. Of the 121 participants in the soy group, 9 (7.4%) underwent endometrial biopsy. The results were benign in all nine cases (100%). Although the rate of hyperplasia/malignancy was higher in the placebo group (14.3% vs 0%), the difference was not statistically significant.

conclusionsThree-year ISP supplementation has no effect on endometrial thickness or on the rates of endometrial hyperplasia and cancer in postmenopausal women.

Indexed as

PostmenopauseAgedAged, 80 and overBiopsyDietary SupplementsDouble-Blind MethodEndometrial HyperplasiaEndometrial NeoplasmsEndometriumFemaleHumansIsoflavonesMiddle AgedPhytoestrogensPlacebosRisk FactorsIsoflavonesPhytoestrogensPlacebosSoybean Proteins

Identifiers

PMID23422867
PMCPMC3934100
OpenAlexW2020521433

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.