Evidence map›Paper›PMID 30267294›Full record

ArticleQuality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation2019

The impact of treatment with eluxadoline on health-related quality of life among adult patients with irritable bowel syndrome with diarrhea.

Jessica L Abel, Robyn T Carson, David A Andrae

Registry-linked trialAbstract read
In one paragraph

Article in Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04716738 (Sexual Dysfunction, Quality of Life and Visceral Hyperalgesia in Women With Irritable Bowel Syndrome), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–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.

NCT04716738 unknown statusnot on this mapstarted 2023, after this paper: background citation

Sexual Dysfunction, Quality of Life and Visceral Hyperalgesia in Women With Irritable Bowel Syndrome

Typeobservational_patient_registrySponsorHospital General de MexicoRan2023 to 2023Enrolled20ConditionsIrritable Bowel Syndrome, Sexual DysfunctionArmsBlood analyses and coprological
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
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

3 authors.

Jessica L AbelAllergan plc, 5 Giralda Farms, Madison, NJ, 07940, USA. Jessica.Abel@allergan.com.
Robyn T CarsonAllergan plc, 5 Giralda Farms, Madison, NJ, 07940, USA.
David A AndraeAllergan plc, 5 Giralda Farms, Madison, NJ, 07940, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeIrritable bowel syndrome with diarrhea (IBS-D) significantly impacts health-related quality of life (HRQOL). This post hoc analysis of two phase III trials evaluated the effects of eluxadoline treatment on disease-specific HRQOL among patients with IBS-D.

methodsAdult patients meeting Rome III criteria for IBS-D were randomized to oral eluxadoline (75 mg or 100 mg) or placebo twice daily in two phase III clinical trials for 52 weeks (IBS-3001) and 26 weeks (IBS-3002). The Irritable Bowel Syndrome Quality of Life (IBS-QOL) questionnaire assessed disease-specific HRQOL throughout the study. Changes from baseline to Week 26 in IBS-QOL total and subscale scores were analyzed using an analysis of covariance model. Percentages of IBS-QOL responders with ≥ 14- and 20-point changes were evaluated for IBS-QOL total and subscale scores. A longitudinal mixed-effects model was fitted to evaluate mean IBS-QOL total scores. A cumulative distribution function for change from baseline to Week 26 in IBS-QOL total score was plotted.

resultsMean changes from baseline to Week 26 for the IBS-QOL total and all subscale scores were significantly higher for patients treated with eluxadoline (both doses) compared to placebo. A significantly greater proportion of eluxadoline-treated patients were responders compared to placebo. Mean and mixed-effects model estimated mean IBS-QOL total scores were consistently higher for eluxadoline versus placebo over 52 weeks.

conclusionsCompared to placebo, twice-daily eluxadoline treatment significantly improved HRQOL among patients with IBS-D in two phase III trials.

Indexed as

AdultDiarrheaFemaleGastrointestinal AgentsHumansImidazolesIrritable Bowel SyndromeMaleMiddle AgedPhenylalanineQuality of LifeSurveys and QuestionnaireseluxadolineGastrointestinal AgentsImidazolesPhenylalanineDiarrheaEluxadolineHealth-related quality of lifeIBS-QOLIrritable bowel syndrome

Identifiers

PMID30267294
PMCPMC6373309

What OpenQuestion holds

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LicenceCC BY
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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.