Management of Irritable Bowel Syndrome in Primary Care (MIBS Trial)
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): mebeverine; methylcellulose; placebo; CBT website with support; No website; CBT website with minimal support
Intervention type(s): Drug; Drug; Drug; Behavioral; Behavioral; Behavioral
Intervention description(s): 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
Intervention MeSH terms: Mebeverine; Alverine
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: irritable bowel syndrome; treatment