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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

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
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
Background: many 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.

Methods: patients, 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.

Results: 135 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). Enablement and Subjects Global Assessment of relief (SGA) were significantly improved in the Regul8 groups compared to the non-website group at 12 weeks (Enablement = 0 in 56.8% of No website group, 18.4% website, 10.5% Website + support, p = 0.001) (SGA; 32.4% responders in No website group, 45.7% website group, 63.2% website + support group, p = 0.035)

Conclusions: This 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 registration: ClinicalTrials.gov Identifier (NCT number): NCT00934973.
irritable bowel syndrome, cognitive behavioural therapy, web-based intervention, self-management, primary care
1-13
Everitt, Hazel
80b9452f-9632-45a8-b017-ceeeee6971ef
Moss-Morris, Rona
a502f58a-d319-49a6-8aea-9dde4efc871e
Sibelli, Alice
64b9c97c-3cf9-4915-8af0-c40b7805a8f1
Tapp, Laura
799396df-0da9-4963-be3c-eeb1db648105
Coleman, Nicholas
f7742d57-6646-4ce0-bbc0-60e2da09b01b
Yardley, Lucy
64be42c4-511d-484d-abaa-f8813452a22e
Smith, Peter
961a01a3-bf4c-43ca-9599-5be4fd5d3940
Little, Paul
1bf2d1f7-200c-47a5-ab16-fe5a8756a777
Everitt, Hazel
80b9452f-9632-45a8-b017-ceeeee6971ef
Moss-Morris, Rona
a502f58a-d319-49a6-8aea-9dde4efc871e
Sibelli, Alice
64b9c97c-3cf9-4915-8af0-c40b7805a8f1
Tapp, Laura
799396df-0da9-4963-be3c-eeb1db648105
Coleman, Nicholas
f7742d57-6646-4ce0-bbc0-60e2da09b01b
Yardley, Lucy
64be42c4-511d-484d-abaa-f8813452a22e
Smith, Peter
961a01a3-bf4c-43ca-9599-5be4fd5d3940
Little, Paul
1bf2d1f7-200c-47a5-ab16-fe5a8756a777

Everitt, Hazel, Moss-Morris, Rona, Sibelli, Alice, Tapp, Laura, Coleman, Nicholas, Yardley, Lucy, Smith, Peter and Little, Paul (2013) 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. BMC Gastroenterology, 13 (68), 1-13. (doi:10.1186/1471-230X-13-68). (PMID:23602047)

Record type: Article

Abstract

Background: many 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.

Methods: patients, 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.

Results: 135 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). Enablement and Subjects Global Assessment of relief (SGA) were significantly improved in the Regul8 groups compared to the non-website group at 12 weeks (Enablement = 0 in 56.8% of No website group, 18.4% website, 10.5% Website + support, p = 0.001) (SGA; 32.4% responders in No website group, 45.7% website group, 63.2% website + support group, p = 0.035)

Conclusions: This 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 registration: ClinicalTrials.gov Identifier (NCT number): NCT00934973.

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Published date: 21 April 2013
Keywords: irritable bowel syndrome, cognitive behavioural therapy, web-based intervention, self-management, primary care
Organisations: Primary Care & Population Sciences

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Local EPrints ID: 352890
URI: https://eprints.soton.ac.uk/id/eprint/352890
PURE UUID: e995fe7b-74dc-4097-83d3-6183b44ba46e
ORCID for Hazel Everitt: ORCID iD orcid.org/0000-0001-7362-8403
ORCID for Lucy Yardley: ORCID iD orcid.org/0000-0002-3853-883X
ORCID for Peter Smith: ORCID iD orcid.org/0000-0003-4423-5410

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Date deposited: 21 May 2013 15:02
Last modified: 20 Jul 2019 01:23

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