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

Study Overview
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Brief Summary
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Aims: 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).

Detailed Description
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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.

Official Title
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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)

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Drug: mebeverine
* Drug: methylcellulose
* Drug: placebo
* Behavioral: CBT website with support
* Behavioral: No website
* Behavioral: CBT website with minimal support


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: mebeverine + no website<br>Mebeverine 135mg tds for 6 weeks | Drug: mebeverine<br>* overencapsulated mebeverine 135 mg tds for 6 weeks<br>Behavioral: No website<br>* No CBT website<br>|
| Active Comparator: methylcellulose + no website<br>methylcellulose 3 tablets twice a day for 6 weeks | Drug: methylcellulose<br>* overencapsulated methylcellulose 3 tablets bd for 6 weeks<br>Behavioral: No website<br>* No CBT website<br>|
| Placebo Comparator: placebo + no website<br>placebo tablets | Drug: placebo<br>* overencapsulated placebo tablets 1 tds for 6 weeks<br>Behavioral: No website<br>* No CBT website<br>|
| Active Comparator: mebeverine + CBT website minimal support<br>mebeverine 135mg tds and access to website | Drug: mebeverine<br>* overencapsulated mebeverine 135 mg tds for 6 weeks<br>Behavioral: CBT website with minimal support<br> <br> |
| Active Comparator: methylcellulose + CBT website<br>methylellulose 3 tablets twice a day and access to website | Drug: methylcellulose<br>* overencapsulated methylcellulose 3 tablets bd for 6 weeks<br>Behavioral: CBT website with minimal support<br> <br> |
| Placebo Comparator: placebo + CBT website minimal support<br>placebo tablets and access to website | Drug: placebo<br>* overencapsulated placebo tablets 1 tds for 6 weeks<br>Behavioral: CBT website with minimal support<br> <br> |
| Active Comparator: mebeverine + CBT website with support<br>mebeverine 135mg tds and access to website with nurse support session | Drug: mebeverine<br>* overencapsulated mebeverine 135 mg tds for 6 weeks<br>Behavioral: CBT website with support<br>* cognitive behavioral therapy with nurse telephone session and email support<br>|
| Active Comparator: methylcellulose + CBT website support<br>methylcellulose 3 tablets twice a day and access to website with nurse support | Drug: methylcellulose<br>* overencapsulated methylcellulose 3 tablets bd for 6 weeks<br>Behavioral: CBT website with support<br>* cognitive behavioral therapy with nurse telephone session and email support<br>|
| Placebo Comparator: placebo + CBT website with support<br>placebo tablets and access to website with nurse support | Drug: placebo<br>* overencapsulated placebo tablets 1 tds for 6 weeks<br>Behavioral: CBT website with support<br>* cognitive behavioral therapy with nurse telephone session and email support<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IBS Symptom Severity Score |  | Baseline, 6 and 12 weeks | 
| IBS QOL | Quality of life | Baseline, 6 and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjects Global Assessment of relief | Subjects global assessment of relief | 6 weeks and 12 weeks | 
| Enablement | Assessment of Enablement | 6 and 12 weeks | 
| HADs | Hospital Anxiety and Depression Score | Baseline, 6 and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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irritable bowel syndrome, treatment