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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)

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)
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)
Background: IBS affects 10-22% of the UK population. Abdominal pain, bloating and altered bowel habit affect
quality of life, social functioning and time off work. Current GP treatment relies on a positive diagnosis, reassurance,lifestyle advice and drug therapies, but many suffer ongoing symptoms. A recent Cochrane review highlighted the lack of research evidence for IBS drugs. Neither GPs, nor patients have good evidence to inform prescribing decisions. However, IBS drugs are widely used: In 2005 the NHS costs were nearly £10 million for mebeverine and over £8 million for fibre-based bulking agents. CBT and self-management can be helpful, but poor availability in the NHS restricts their use. We have developed a web-based CBT selfmanagement programme, Regul8, based on an existing evidence based self-management manual and in partnership with patients. This could increase access with minimal increased costs.

Methods/Design: The aim is to undertake a feasibility factorial RCT to assess the effectiveness of the commonly
prescribed medications in UK general practice for IBS: mebeverine (anti-spasmodic) and methylcellulose(bulkingagent)and Regul8, the CBT based self-management website. 135 patients aged 16 to 60 years with IBS symptoms fulfilling Rome III criteria, recruited via GP practices, will be randomised to 1 of 3 levels of the drug condition: mebeverine, methylcellulose or placebo for 6 weeks and to 1 of 3 levels of the website condition, Regul8 with a nurse telephone session and email support, Regul8 with minimal
email support, or no website, thus creating 9 groups.
Outcomes: Irritable bowel symptom severity scale and IBS-QOL will be measured at baseline, 6 and 12 weeks as
the primary outcomes. An intention to treat analysis will be undertaken by ANCOVA for a factorial trial.

Discussion: This pilot will provide valuable information for a larger trial. Determining the effectiveness of
commonly used drug treatments will help patients and doctors make informed treatment decisions regarding drug
management of IBS symptoms, enabling better targeting of treatment. A web-based self-management CBT programme for IBS developed in partnership with patients has the potential to benefit large numbers of patients with low cost to the NHS. Assessment of the amount of email or therapist support required for the website will
enable economic analysis to be undertaken.

Trial Registration: ClinicalTrials.gov Identifier (NCT number): NCT00934973.
Everitt, Hazel A.
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Moss-Morris, Rona E.
a502f58a-d319-49a6-8aea-9dde4efc871e
Sibelli, Alice
64b9c97c-3cf9-4915-8af0-c40b7805a8f1
Tapp, Laura
799396df-0da9-4963-be3c-eeb1db648105
Coleman, Nicholas S.
feac66d1-ee77-481a-8ab0-66db39d820dc
Yardley, Lucy
64be42c4-511d-484d-abaa-f8813452a22e
Smith, Peter W.
961a01a3-bf4c-43ca-9599-5be4fd5d3940
Little, Paul S.
1bf2d1f7-200c-47a5-ab16-fe5a8756a777
Everitt, Hazel A.
80b9452f-9632-45a8-b017-ceeeee6971ef
Moss-Morris, Rona E.
a502f58a-d319-49a6-8aea-9dde4efc871e
Sibelli, Alice
64b9c97c-3cf9-4915-8af0-c40b7805a8f1
Tapp, Laura
799396df-0da9-4963-be3c-eeb1db648105
Coleman, Nicholas S.
feac66d1-ee77-481a-8ab0-66db39d820dc
Yardley, Lucy
64be42c4-511d-484d-abaa-f8813452a22e
Smith, Peter W.
961a01a3-bf4c-43ca-9599-5be4fd5d3940
Little, Paul S.
1bf2d1f7-200c-47a5-ab16-fe5a8756a777

Everitt, Hazel A., Moss-Morris, Rona E., Sibelli, Alice, Tapp, Laura, Coleman, Nicholas S., Yardley, Lucy, Smith, Peter W. and Little, Paul S. (2010) 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). BMC Gastroenterology, 10 (136). (doi:10.1186/1471-230X-10-136).

Record type: Article

Abstract

Background: IBS affects 10-22% of the UK population. Abdominal pain, bloating and altered bowel habit affect
quality of life, social functioning and time off work. Current GP treatment relies on a positive diagnosis, reassurance,lifestyle advice and drug therapies, but many suffer ongoing symptoms. A recent Cochrane review highlighted the lack of research evidence for IBS drugs. Neither GPs, nor patients have good evidence to inform prescribing decisions. However, IBS drugs are widely used: In 2005 the NHS costs were nearly £10 million for mebeverine and over £8 million for fibre-based bulking agents. CBT and self-management can be helpful, but poor availability in the NHS restricts their use. We have developed a web-based CBT selfmanagement programme, Regul8, based on an existing evidence based self-management manual and in partnership with patients. This could increase access with minimal increased costs.

Methods/Design: The aim is to undertake a feasibility factorial RCT to assess the effectiveness of the commonly
prescribed medications in UK general practice for IBS: mebeverine (anti-spasmodic) and methylcellulose(bulkingagent)and Regul8, the CBT based self-management website. 135 patients aged 16 to 60 years with IBS symptoms fulfilling Rome III criteria, recruited via GP practices, will be randomised to 1 of 3 levels of the drug condition: mebeverine, methylcellulose or placebo for 6 weeks and to 1 of 3 levels of the website condition, Regul8 with a nurse telephone session and email support, Regul8 with minimal
email support, or no website, thus creating 9 groups.
Outcomes: Irritable bowel symptom severity scale and IBS-QOL will be measured at baseline, 6 and 12 weeks as
the primary outcomes. An intention to treat analysis will be undertaken by ANCOVA for a factorial trial.

Discussion: This pilot will provide valuable information for a larger trial. Determining the effectiveness of
commonly used drug treatments will help patients and doctors make informed treatment decisions regarding drug
management of IBS symptoms, enabling better targeting of treatment. A web-based self-management CBT programme for IBS developed in partnership with patients has the potential to benefit large numbers of patients with low cost to the NHS. Assessment of the amount of email or therapist support required for the website will
enable economic analysis to be undertaken.

Trial Registration: ClinicalTrials.gov Identifier (NCT number): NCT00934973.

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MIBS_protocol_BMC_gastroenterology.pdf - Version of Record
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Published date: 2010

Identifiers

Local EPrints ID: 173957
URI: http://eprints.soton.ac.uk/id/eprint/173957
PURE UUID: 091a9b48-72b9-41a3-b3cf-7e3748d274b3
ORCID for Hazel A. Everitt: ORCID iD orcid.org/0000-0001-7362-8403
ORCID for Lucy Yardley: ORCID iD orcid.org/0000-0002-3853-883X
ORCID for Peter W. Smith: ORCID iD orcid.org/0000-0003-4423-5410

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Date deposited: 09 Feb 2011 11:03
Last modified: 09 Jan 2022 03:02

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Contributors

Author: Rona E. Moss-Morris
Author: Alice Sibelli
Author: Laura Tapp
Author: Nicholas S. Coleman
Author: Lucy Yardley ORCID iD
Author: Peter W. Smith ORCID iD
Author: Paul S. Little

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