Title
Management of Irritable Bowel Syndrome in Primary Care (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)
Phase
Phase 4Lead Sponsor
University of SouthamptonStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Irritable Bowel SyndromeIntervention/Treatment
mebeverine methylcellulose ...Study Participants
135Aims:
To pilot an randomized, controlled trial (RCT) to assess the effectiveness of the commonly prescribed medications in UK general practice for IBS: mebeverine (anti-spasmodic) and methylcellulose (bulking-agent) and of the patient CBT based self-management website.
To assess the level of support needed for patients using the patient CBT based self-management website for IBS (i.e., initial 30 minute telephone support session with a nurse and email support or not).
Background:
Irritable bowel syndrome (IBS) affects 10-22% of the United Kingdom (UK) population, with National Health Service (NHS) costs over £200 million a year. Abdominal pain, bloating and altered bowel habit affect quality of life, social functioning and time off work. Current general practitioner (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: NHS costs 2005 of nearly £10 million for mebeverine and over £8 million for fiber-based bulking agents.
Cognitive behavioral therapy (CBT) and self-management can be helpful, but poor availability in the NHS restricts its use. Development of web-based CBT could increase access without increased costs.
Plan of Investigation:
135 patients aged 16-60 years with IBS symptoms fulfilling the Rome III criteria, recruited via GP practices, will be randomised to: mebeverine, methylcellulose or placebo for 6 weeks and to the CBT based website with a nurse telephone session and email support, website with minimal 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. An intention to treat analysis will be undertaken by analysis of covariance (ANCOVA) for a factorial trial.
Potential Impact:
Development of a web-based self-management CBT program for IBS developed in partnership with patients has the potential to benefit large numbers of patients with low cost to the NHS. CBT has been shown to be of benefit for IBS but it's availability is limited due to the high cost and therapist time required for face-to-face CBT. A website can be accessed at a time and place convenient to the patient and the CBT program undertaken at a pace determined by patient needs. The website could be used as a long term support for self-management.
Determining the effectiveness of commonly used drug treatments will help patients and doctors in making informed treatment decisions regarding the drug management of IBS symptoms, enabling better targeting of treatment to those who may benefit.
overencapsulated mebeverine 135 mg tds for 6 weeks
overencapsulated methylcellulose 3 tablets bd for 6 weeks
overencapsulated placebo tablets 1 tds for 6 weeks
cognitive behavioral therapy with nurse telephone session and email support
No CBT website
mebeverine 135mg tds and access to website
Mebeverine 135mg tds for 6 weeks
methylcellulose 3 tablets twice a day for 6 weeks
methylellulose 3 tablets twice a day and access to website
placebo tablets and access to website
mebeverine 135mg tds and access to website with nurse support session
methylcellulose 3 tablets twice a day and access to website with nurse support
placebo tablets and access to website with nurse support
Inclusion Criteria: Patients aged 16 to 60 years with symptoms of irritable bowel syndrome that fulfill the Rome III criteria Exclusion Criteria: Atypical symptoms (unexplained weight loss, rectal bleeding) Diagnosis of inflammatory bowel disease, coeliac disease or peptic ulcer disease Pregnant or breast feeding Currently taking or allergy to mebeverine or methylcellulose
