Clinical trial NCT00934973: Management of Irritable Bowel Syndrome in Primary Care (MIBS Trial)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Irritable Bowel Syndrome
Keywords: irritable bowel syndrome
treatment
Lead sponsor: University of Southampton
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
First posted: 2009-07-08
Enrollment: 135
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Aims:

1. 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.
2. 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).

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: IBS Symptom Severity Score
timeFrame: Baseline, 6 and 12 weeks
measure: IBS QOL
timeFrame: Baseline, 6 and 12 weeks
Secondary outcomes:
measure: Subjects Global Assessment of relief
timeFrame: 6 weeks and 12 weeks
measure: Enablement
timeFrame: 6 and 12 weeks
measure: HADs
timeFrame: Baseline, 6 and 12 weeks
Other outcomes:
Locations:
city: Southampton
country: United Kingdom
facility: University of Southampton
state: Hampshire
Study officials:
affiliation: University of Southampton
name: Hazel A Everitt, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
citation: Everitt H, Moss-Morris R, Sibelli A, Tapp L, Coleman N, Yardley L, Smith P, Little P. 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 Gastroenterol. 2013 Apr 21;13:68. doi: 10.1186/1471-230X-13-68.
citation: Everitt HA, Moss-Morris RE, Sibelli A, Tapp L, Coleman NS, Yardley L, Smith PW, Little PS. 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 Gastroenterol. 2010 Nov 18;10:136. doi: 10.1186/1471-230X-10-136.