Evidence map›Paper›PMID 27490103›Full record

Trial reportPloS one2016

Co-Administration of Soy Isoflavones and Vitamin D in Management of Irritable Bowel Disease.

Mahsa Jalili, Azita Hekmatdoost, Homayoon Vahedi, Hossein Poustchi, Behnam Khademi, Mohsen Saadi, Maryam Zemestani, Leila Janani

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

Trial report in PloS one, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02026518 (Effect of Cholecalciferol, Soy Isoflavones in Patients With Irritable Bowel Syndrome), which is not on this map. Cited by 24 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 5 pooled it
2.8field-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.

NCT02026518 phase4completednot on this map

Effect of Cholecalciferol, Soy Isoflavones in Patients With Irritable Bowel Syndrome

TypeinterventionalSponsorShahid Beheshti University of Medical SciencesRan2014 to 2014Enrolled100ConditionsIrritable Bowel DiseaseArmsSoy isoflavones, cholecalciferol, Placebo of soy isoflavones, placebo of cholecalciferol
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 5 syntheses or guidelines pooled it, 49 citations in OpenAlex.

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  7. Vitamin D supplementation in adolescents with irritable bowel syndrome: Is it useful? A randomized controlled trial.Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association
    Trial
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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

8 authors at 6 institutions in 2 countries.

Mahsa JaliliDepartment of Biology, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.ORCID http://orcid.org/0000-0001-7825-9483
Azita HekmatdoostNational Nutrition and Food Technology Research Institute, Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Homayoon VahediDigestive disease research center (DDRC), Digestive Disease Research Institute, Tehran, Iran.
Hossein PoustchiLiver and pancreatic biliary research group, Digestive Disease Research Institute, Tehran, Iran.
Behnam KhademiStudents' Research Committee, Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Mohsen SaadiStudents' Research Committee, Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Maryam ZemestaniStudents' Research Committee, Faculty of Nutrition, Tabriz University of Medical Sciences, Tabriz, Iran.
Leila JananiDepartment of Biostatistics, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.
Digestive Disease Research InstituteShahid Beheshti University of Medical Sciences · IRIran University of Medical Sciences · IRNational Nutrition and Food Technology Research Institute · IRNorwegian University of Science and Technology · NOTabriz University of Medical Sciences · IR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

aimsThe substantial characteristics of Irritable Bowel Syndrome (IBS) are associated with estrogens in women. Both soy isoflavones and vitamin D can modulate estrogen receptors in the colonic smooth muscles. The aim of this study was to investigate the effects of soy isoflavones, vitamin D and their probable interactions in women with IBS.

methodsIn a factorial blinded randomized clinical trial, 100 women with IBS (age:18-75yr, were randomly assigned in 4 arms to receive either placebo of vitamin D and placebo of soy isoflavones (P+P), or placebo of vitamin D and soy isoflavones (P+S), or vitamin D and placebo of soy isoflavones (D+P), or vitamin D and soy isoflavones (D+S) for 6 weeks. Dosage of soy isoflavone was 2 capsules of 20 mg soy isoflavones per day, and dosage of vitamin D was one pearl of 50'000 IU biweekly. The clinical outcomes were IBS symptoms severity scores (IBS-SSS), disease- specific quality of life (IBS-QOL) and total score (IBS-TS) that evaluated at weeks 0, 6, and 10, and compared to each other.

resultsIBS-TS improved significantly in both S+P and D+P groups (p- value = 0.004, 0.015). The interaction effect of soy isoflavones and vitamin D on IBS-TS was significant (p<0.05). The interaction effect of soy isoflavones with vitamin D and the main effect of vitamin D on IBS-SSS were not statistically significant, whereas IBS-SSS decreased significantly in S+P and D+P groups (p-value = 0.001, 0.047 respectively).

conclusionOur results indicate that co-administration of soy isoflavones with vitamin D did not improve the IBS- SSS and IBS- QOL; however, it improved the IBS-TS.

trial registrationClinical Trials.gov NCT02026518.

Indexed as

AdolescentAdultAgedDouble-Blind MethodDrug Administration ScheduleGlycine maxHumansIrritable Bowel SyndromeIsoflavonesMiddle AgedPlacebo EffectQuality of LifeSeverity of Illness IndexSurveys and QuestionnairesTreatment OutcomeVitamin DIsoflavonesVitamin D

Identifiers

PMID27490103
PMCPMC4973900
OpenAlexW2498068237

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.