Evidence map›Paper›PMID 25003624›Full record

Trial reportMenopause (New York, N.Y.)2015

Soy Isoflavones for Reducing Bone Loss Study: effects of a 3-year trial on hormones, adverse events, and endometrial thickness in postmenopausal women.

D Lee Alekel, Ulrike Genschel, Kenneth J Koehler, Heike Hofmann, Marta D Van Loan, Bonnie S Beer, Laura N Hanson, Charles T Peterson, Mindy S Kurzer

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Menopause (New York, N.Y.), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06398236 (Multicentre, Exploratory, Prospective, Open-labelled, Non-controlled Study to Evaluate the Effect of SE5-OH Tablets on Healthy Women With Menopausal Symptoms), which is not on this map. Cited by 16 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 2 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.

NCT06398236 nacompletednot on this mapstarted 2023, after this paper: background citation

Multicentre, Exploratory, Prospective, Open-labelled, Non-controlled Study to Evaluate the Effect of SE5-OH Tablets on Healthy Women With Menopausal Symptoms

TypeinterventionalSponsorNutrition & Sante IberiaRan2023 to 2024Enrolled170ConditionsMenopauseArmsSE5-OH tablets
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Review
  6. Review
  7. Article
  8. Review
  9. Review
  10. Article
  11. Review
  12. Nutritional prevention of cognitive decline and dementia.Acta bio-medica : Atenei Parmensis · 2018
    Review
  13. Article
  14. Review
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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

9 authors.

D Lee AlekelFrom the 1National Institutes of Health, Bethesda, MD; 2Department of Statistics, Iowa State University, Ames, IA; 3US Department of Agriculture-Agricultural Research Service, Western Human Nutrition Research Center, University of California at Davis, Davis, CA; 4McFarland Clinic, Ames, IA; 5Mayo Validation Support Services, Rochester, MN; 6Center for Devices and Radiological Health, Food and Drug Administration, White Oak, MD; and 7Department of Food Science and Nutrition, University of Minnesota, St Paul, MN.
Ulrike Genschel
Kenneth J Koehler
Heike Hofmann
Marta D Van Loan
Bonnie S Beer
Laura N Hanson
Charles T Peterson
Mindy S Kurzer

Funding

UC DAVIS CLINICAL AND TRANSLATIONAL SCIENCE CENTER: BPCAUL1RR024146 · NCRR · UNIVERSITY OF CALIFORNIA AT DAVIS · PI BERGLUND, LARS F · 2006 to 2011
$27.0M
Bone Response to Soy Isoflavones in WomenR01AR046922 · NIAMS · IOWA STATE UNIVERSITY · PI ALEKEL, D. LEE · 2002 to 2008
$3.1M
USE OF POSITRON TOMOGRAPHY (PET) TO STUDY FRONTOTEMPORAL DEMENTIASM01RR019975 · NCRR · UNIVERSITY OF CALIFORNIA DAVIS · PI POMEROY, CLAIRE · 2004 to 2006
$2.5M
NCRR NIH HHS 1M01RR1997501NCRR NIH HHS M01 RR019975NCRR NIH HHS UL1 RR024146NIAMS NIH HHS R01 AR046922NIAMS NIH HHS R01AR046922
6 · The paper itself

Abstract

objectiveThis study aims to assess the overall safety and potential endometrium-stimulating effects of soy isoflavone tablets consumed (3 y) by postmenopausal women and to determine endometrial thickness response to treatment among compliant women, taking into account hormone concentrations and other hypothesized modifying factors.

methodsWe randomized healthy postmenopausal women (aged 45.8-65.0 y) to placebo control or two doses (80 or 120 mg/d) of soy isoflavones at two sites. We used intent-to-treat analysis (N = 224) and compliant analysis (>95%; N = 208) to assess circulating hormone concentrations, adverse events, and endometrial thickness (via transvaginal ultrasound).

resultsMedian values for endometrial thickness (mm) declined from baseline through 36 months. Nonparametric analysis of variance for treatment differences among groups showed no differences in absolute (or percentage of change) endometrial thickness (χ(2) P ranged from 0.12 to 0.69) or in circulating hormones at any time point. A greater number of adverse events in the genitourinary system (P = 0.005) were noted in the 80 mg/day group compared with the 120 mg/day group, whereas other systems showed no treatment effects. The model predicting endometrial thickness response (using natural logarithm) to treatment among compliant women across time points was significant (P ≤ 0.0001), indicating that estrogen exposure (P = 0.0013), plasma 17β-estradiol (P = 0.0086), and alcohol intake (P = 0.023) contributed significantly to the response. Neither the 80 mg/day dose (P = 0.57) nor the 120 mg/day dose (P = 0.43) exerted an effect on endometrial thickness across time.

conclusionsOur randomized controlled trial verifies the long-term overall safety of soy isoflavone tablet intake by postmenopausal women who display excellent compliance. We find no evidence of treatment effects on endometrial thickness, adverse events, or circulating hormone concentrations, most notably thyroid function, across a 3-year period.

Indexed as

AgedDouble-Blind MethodEndometriumEstradiolEstrogensEstroneFemaleHumansIntention to Treat AnalysisIsoflavonesMiddle AgedOsteoporosis, PostmenopausalSex Hormone-Binding GlobulinSoybean ProteinsThyrotropinUltrasonographyEstradiolEstrogensEstroneestrone sulfateIsoflavonesSex Hormone-Binding GlobulinSoybean ProteinsThyrotropin

Identifiers

PMID25003624
PMCPMC4286538

What OpenQuestion holds

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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.