Management of Irritable Bowel Syndrome in Primary Care (MIBS Trial)

Hazel Everitt

Status and phase: Completed; Phase 4

Conditions: Irritable Bowel Syndrome

Treatments: Drug: methylcellulose; Behavioral: CBT website with support; Behavioral: CBT website with minimal support; Behavioral: No website; Drug: placebo; Drug: mebeverine

Study type: Interventional

Funder types: Other

Identifiers

NCT00934973

2009-013426-16 (EudraCT Number)

5953

Details and patient eligibility

About

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).

Full 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.

Enrollment: 135 patients

Sex: All

Ages: 16 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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135 participants in 9 patient groups, including a placebo group

mebeverine + no website

Active Comparator group

Description:

Mebeverine 135mg tds for 6 weeks

Treatment:

Behavioral: No website

Drug: mebeverine

methylcellulose + no website

Active Comparator group

Description:

methylcellulose 3 tablets twice a day for 6 weeks

Treatment:

Drug: methylcellulose

Behavioral: No website

placebo + no website

Placebo Comparator group

Description:

placebo tablets

Treatment:

Behavioral: No website

Drug: placebo

mebeverine + CBT website minimal support

Active Comparator group

Description:

mebeverine 135mg tds and access to website

Treatment:

Behavioral: CBT website with minimal support

Drug: mebeverine

methylcellulose + CBT website

Active Comparator group

Description:

methylellulose 3 tablets twice a day and access to website

Treatment:

Drug: methylcellulose

Behavioral: CBT website with minimal support

placebo + CBT website minimal support

Placebo Comparator group

Description:

placebo tablets and access to website

Treatment:

Drug: placebo

Behavioral: CBT website with minimal support

mebeverine + CBT website with support

Active Comparator group

Description:

mebeverine 135mg tds and access to website with nurse support session

Treatment:

Behavioral: CBT website with support

Drug: mebeverine

methylcellulose + CBT website support

Active Comparator group

Description:

methylcellulose 3 tablets twice a day and access to website with nurse support

Treatment:

Drug: methylcellulose

Behavioral: CBT website with support

placebo + CBT website with support

Placebo Comparator group

Description:

placebo tablets and access to website with nurse support

Treatment:

Behavioral: CBT website with support

Drug: placebo