Evidence map›Paper›PMID 23602047›Full record

Trial reportBMC gastroenterology2013

Management of irritable bowel syndrome in primary care: the results of an exploratory randomised controlled trial of mebeverine, methylcellulose, placebo and a self-management website.

Hazel Everitt, Rona Moss-Morris, Alice Sibelli, Laura Tapp, Nicholas Coleman, Lucy Yardley, Peter Smith, Paul Little

2 registry-linked trialsOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC gastroenterology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 36 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 10 pooled it
4.0field-weighted citation impact, top 6% 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.

NCT00934973 phase4completednot on this map

Management of Irritable Bowel Syndrome in Primary Care: Feasibility Randomised Controlled Trial of Mebeverine, Methylcellulose, Placebo and a Patient Self-management Cognitive Behavioural Therapy Website. (MIBS Trial)

TypeinterventionalSponsorHazel EverittRan2010 to 2011Enrolled135ConditionsIrritable Bowel SyndromeArmsmebeverine, methylcellulose, placebo, CBT website with support, No website
NCT07008404 naterminatednot on this mapstarted 2024, after this paper: background citation

A Pilot Study to Assess the Feasibility of an Online Cognitive Behavioural Therapy Application (Mahana IBS™, Mahana Therapeutics) in the Management of Irritable Bowel Syndrome

TypeinterventionalSponsorNottingham University Hospitals NHS TrustRan2024 to 2025Enrolled20ConditionsIrritable Bowel Syndrome (IBS)Armsonline cognitive behavioral therapy
3 · Its place in the literature

Who cites it

36 citing papers in PubMed, 10 syntheses or guidelines pooled it, 84 citations in OpenAlex.

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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 5 institutions in 1 country.

Hazel Everitt
Rona Moss-Morris
Alice Sibelli
Laura Tapp
Nicholas Coleman
Lucy Yardley
Peter Smith
Paul Little
University of Southampton · GBCamborne Redruth Community Hospital · GBLondon Bridge Hospital · GBUniversity College London · GBUniversity Hospital Southampton NHS Foundation Trust · GB

Funding

Department of Health PB-PG-0807-13081
6 · The paper itself

Abstract

backgroundMany patients with IBS suffer on-going symptoms. The evidence base is poor for IBS drugs but they are widely prescribed and advised in Guidelines. Cognitive Behavioural Therapy (CBT) can be helpful, but availability is poor in the NHS. We developed a web-based CBT self-management programme (Regul8) in partnership with patients and trialled it and common IBS medications in an exploratory factorial RCT to test trial procedures and provide information for a larger trial.

methodsPatients, 16 to 60 years, with IBS symptoms fulfilling Rome III criteria were recruited via GP practices and randomised to over-encapsulated mebeverine, methylcellulose or placebo for 6 weeks and to 1 of 3 website conditions: Regul8 with a nurse telephone session and email support, Regul8 with minimal email support, or no website.

results135 patients recruited from 26 GP practices. Mean IBS SSS score 241.9 (sd 87.7), IBS-QOL 64 (sd 20) at baseline. 91% follow-up at 12 weeks. Mean IBS SSS decreased by 35 points from baseline to 12 weeks. There was no significant difference in IBS SSS or IBS-QOL score between medication or website groups at 12 weeks, or in medication groups at 6 weeks, or IBS-QOL in website groups at 6 weeks. However, IBS SSS at 6 weeks was lower in the No website group than the website groups (IBS SSS no website =162.8 (95% CI 137.4-188.3), website 197.0 (172.4 - 221.7), Website + telephone support 208.0 (183.1-233.0) p = 0.037).

conclusionsThis exploratory study demonstrates feasibility and high follow-up rates and provides information for a larger trial. Primary outcomes (IBS SS and IBS QOL) did not reach significance at 6 or 12 weeks, apart from IBS SSS being lower in the no-website group at 6 weeks - this disappeared by 12 weeks. Improved Enablement suggests patients with access to the Regul8 website felt better able to cope with their symptoms than the non-website group. Improved SGA score in the Regul8 groups may indicate some overall improvement not captured on other measures.

trial registrationClinicalTrials.gov Identifier (NCT number): NCT00934973.

Indexed as

AdolescentAdultCognitive Behavioral TherapyFollow-Up StudiesHumansInternetIrritable Bowel SyndromeLaxativesMethylcelluloseMiddle AgedParasympatholyticsPatient CompliancePhenethylaminesPilot ProjectsPrimary Health CareSelf CareLaxativesmebeverineMethylcelluloseParasympatholyticsPhenethylamines

Identifiers

PMID23602047
PMCPMC3651308
OpenAlexW2098473606

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.