title: A protocol for a trial of homeopathic treatment for irritable bowel syndrome.
abstract: BACKGROUND
  Irritable bowel syndrome is a chronic condition with no known cure. Many sufferers seek complementary and alternative medicine including homeopathic treatment. However there is much controversy as to the effectiveness of homeopathic treatment. This three-armed study seeks to explore the effectiveness of individualised homeopathic treatment plus usual care compared to both an attention control plus usual care and usual care alone, for patients with irritable bowel syndrome.
  
  
  METHODS
  This is a three-armed pragmatic randomised controlled trial using the cohort multiple randomised trial methodology. Patients are recruited to an irritable bowel syndrome cohort from primary and secondary care using GP databases and consultants lists respectively. From this cohort patients are randomly selected to be offered, 5 sessions of homeopathic treatment plus usual care, 5 sessions of supportive listening plus usual care or usual care alone. The primary clinical outcome is the Irritable Bowel Syndrome Symptom Severity at 26 weeks.From a power calculation, it is estimated that 33 people will be needed for the homeopathic treatment arm and 132 for the usual care arm, to detect a minimal clinical difference at 80 percent power and 5 percent significance allowing for loss to follow up. An unequal group size has been used for reasons of cost. Analysis will be by intention to treat and will compare homeopathic treatment with usual care at 26 weeks as the primary analysis, and homeopathic treatment with supportive listening as an additional analysis.
  
  
  CONCLUSIONS
  This trial has received NHS approval and results are expected in 2013.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN90651143.
authors.affiliation: School of Healthcare, University of Leeds, Leeds, UK. hcejp@leeds.ac.uk
authors.forename: Emily J
authors.initials: EJ
authors.lastname: Peckham
authors.forename: Clare
authors.initials: C
authors.lastname: Relton
authors.forename: Jackie
authors.initials: J
authors.lastname: Raw
authors.forename: Clare
authors.initials: C
authors.lastname: Walters
authors.forename: Kate
authors.initials: K
authors.lastname: Thomas
authors.forename: Christine
authors.initials: C
authors.lastname: Smith
mesh_terms: D006705:Homeopathy; D006801:Humans; D057194:Intention to Treat Analysis; D043183:Irritable Bowel Syndrome / Q000188:drug therapy*; D008419:Materia Medica / Q000627:therapeutic use; D017063:Outcome Assessment, Health Care; D012107:Research Design; D012720:Severity of Illness Index; D059039:Standard of Care
chemical_list: D008419:Materia Medica