Evidence map›Paper›PMID 30663077›Full record

Trial reportAlimentary pharmacology & therapeutics2019

Randomised clinical trial: pregabalin vs placebo for irritable bowel syndrome.

Yuri A Saito, Ann E Almazar, Katherine E Tilkes, Rok Seon Choung, Michael D Van Norstrand, Cathy D Schleck, Alan R Zinsmeister, Nicholas J Talley

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Alimentary pharmacology & therapeutics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed
6.9field-weighted citation impact, top 3% 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, 75 citations in OpenAlex.

  1. Trial
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  16. Pain in irritable bowel syndrome: Does anything really help?Neurogastroenterology and motility · 2022
    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

8 authors at 2 institutions in 2 countries.

Yuri A SaitoDivision of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.ORCID 0000-0003-4155-6315
Ann E AlmazarDivision of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.
Katherine E TilkesDivision of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.
Rok Seon ChoungDivision of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.
Michael D Van NorstrandDivision of Gastroenterology, Mayo Clinic Health System, LaCrosse, Wisconsin.
Cathy D SchleckDivision of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, Minnesota.
Alan R ZinsmeisterDivision of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, Minnesota.
Nicholas J TalleyDivision of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.
Mayo Clinic · USMayo Clinic Health System · US

Funding

Mayo Clinic Center for Clinical and Translational Science (CCaTS UL1 Supplement - Dr. Timothy Curry)UL1TR002377 · NCATS · MAYO CLINIC ROCHESTER · PI VESNA D GAROVIC · 2017 to 2026
$78.4M
Mayo Clinic Center for Translational Science ActivitiesUL1TR000135 · NCATS · MAYO CLINIC ROCHESTER · PI KHOSLA, SUNDEEP · 2012 to 2015
$41.2M
NCATS NIH HHS UL1 TR000135NCATS NIH HHS UL1 TR002377Pfizer
6 · The paper itself

Abstract

backgroundPregabalin is a calcium channel α2δ ligand that modifies visceral hypersensitivity in IBS patients. Clinical data for pregabalin in IBS are lacking.

aimTo test the efficacy of pregabalin on gastrointestinal symptoms in IBS patients.

methodsA double-blind, placebo-controlled trial was performed. Adults meeting IBS Rome III criteria with ≥3 pain attacks per month were randomised to pregabalin 225 mg vs placebo twice daily for 12 weeks. Questionnaires were completed weekly. The primary endpoint was average pain Bowel Symptom Scale (BSS) scores weeks 9-12. An intention-to-treat analysis of covariance evaluated treatment effects on quantitative endpoints, adjusting for age and gender. Adequate relief and change in pain score were assessed using a chi-squared test.

resultsEighty-five patients were recruited and randomised. Sample characteristics include: mean age 39.4 (SD = 14.6); 73 (86%) female; 37 (44%) IBS-D, 29 (35%) IBS-M, 18 (21%) IBS-C. The pregabalin arm had lower average pain-BSS scores weeks 9-12 (25 vs 42, P = 0.008). Compared with placebo, the overall IBS BSS severity score was lower in the pregabalin arm (26 vs 42, P = 0.009). Differences were observed for the diarrhoea-BSS and bloating-BSS scores (P = 0.049 and 0.016, respectively). No differences between groups were seen for constipation-BSS scores. Adequate relief was not different between the two arms (46% vs 36%, P = 0.35). 63% pregabalin vs 45% placebo had a change in pain score ≥30 at week 12 from baseline (P = 0.10). Post-treatment IBS-QoL scores did not differ between groups.

conclusionThis trial suggests that pregabalin may be beneficial for IBS abdominal pain, bloating and diarrhoea.

Indexed as

Abdominal PainAdultConstipationDiarrheaDouble-Blind MethodFemaleHumansIrritable Bowel SyndromeMaleMiddle AgedPain MeasurementPregabalinSurveys and QuestionnairesTreatment OutcomeYoung AdultPregabalin

Identifiers

PMID30663077
PMCPMC6349499
OpenAlexW2914307537

What OpenQuestion holds

Textmetadata
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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.