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).
abstract: BACKGROUND
  IBS affects 10-22% of the UK population. Abdominal pain, bloating and altered bowel habit affect quality of life, social functioning and time off work. Current 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: In 2005 the NHS costs were nearly £10 million for mebeverine and over £8 million for fibre-based bulking agents. CBT and self-management can be helpful, but poor availability in the NHS restricts their use. We have developed a web-based CBT self-management programme, Regul8, based on an existing evidence based self-management manual and in partnership with patients. This could increase access with minimal increased costs.
  
  
  METHODS
  The aim is to undertake a feasibility factorial RCT to assess the effectiveness of the commonly prescribed medications in UK general practice for IBS: mebeverine (anti-spasmodic) and methylcellulose (bulking-agent) and Regul8, the CBT based self-management website.135 patients aged 16 to 60 years with IBS symptoms fulfilling Rome III criteria, recruited via GP practices, will be randomised to 1 of 3 levels of the drug condition: mebeverine, methylcellulose or placebo for 6 weeks and to 1 of 3 levels of the website condition, Regul8 with a nurse telephone session and email support, Regul8 with minimal email support, or no website, thus creating 9 groups.
  
  
  RESULTS
  Irritable bowel symptom severity scale and IBS-QOL will be measured at baseline, 6 and 12 weeks as the primary outcomes. An intention to treat analysis will be undertaken by ANCOVA for a factorial trial.
  
  
  CONCLUSIONS
  This pilot will provide valuable information for a larger trial. Determining the effectiveness of commonly used drug treatments will help patients and doctors make informed treatment decisions regarding drug management of IBS symptoms, enabling better targeting of treatment. A web-based self-management CBT programme for IBS developed in partnership with patients has the potential to benefit large numbers of patients with low cost to the NHS. Assessment of the amount of email or therapist support required for the website will enable economic analysis to be undertaken.
authors.affiliation: Primary Medical Care, School of Medicine, University of Southampton, Southampton SO17 1BJ, UK. H.A.Everitt@soton.ac.uk
authors.forename: Hazel A
authors.initials: HA
authors.lastname: Everitt
authors.forename: Rona E
authors.initials: RE
authors.lastname: Moss-Morris
authors.forename: Alice
authors.initials: A
authors.lastname: Sibelli
authors.forename: Laura
authors.initials: L
authors.lastname: Tapp
authors.forename: Nicholas S
authors.initials: NS
authors.lastname: Coleman
authors.forename: Lucy
authors.initials: L
authors.lastname: Yardley
authors.forename: Peter W
authors.initials: PW
authors.lastname: Smith
authors.forename: Paul S
authors.initials: PS
authors.lastname: Little
mesh_terms: D000293:Adolescent; D000328:Adult; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D006801:Humans; D020407:Internet; D043183:Irritable Bowel Syndrome / Q000188:drug therapy* / Q000191:economics / Q000523:psychology; D008747:Methylcellulose / Q000627:therapeutic use; D008875:Middle Aged; D010276:Parasympatholytics / Q000627:therapeutic use; D010627:Phenethylamines / Q000627:therapeutic use; D010865:Pilot Projects; D010919:Placebos / Q000627:therapeutic use; D011320:Primary Health Care; D011788:Quality of Life; D012107:Research Design; D012648:Self Care / Q000379:methods*; D012720:Severity of Illness Index; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D010276:Parasympatholytics; D010627:Phenethylamines; D010919:Placebos; C005096:mebeverine; D008747:Methylcellulose