title: Acupuncture for irritable bowel syndrome: a protocol for a pragmatic randomised controlled trial.
abstract: BACKGROUND
  There is insufficient evidence on the effectiveness of acupuncture for irritable bowel syndrome (IBS) for conclusions to be drawn. Given the current interest in acupuncture by patients, it is in the public interest to establish more rigorous evidence. Building on the positive findings from a pilot study, in this paper we present the protocol for a fully-powered trial designed to establish whether or not acupuncture is effective and cost-effective.
  
  
  METHODS
  In this pragmatic randomised controlled trial we will randomise patients recruited directly from GP databases to either 10 sessions of acupuncture plus usual GP care or to usual GP care alone. The primary clinical outcome will be the IBS Symptom Severity Score (SSS) (maximum score 500) at three months, and at 12 month assessing whether there is an overall benefit. We estimate the sample size required to detect a minimum clinical difference at 90% power and 5% significance to be 188 patients. To allow for loss to follow up we will recruit 220 patients drawn from an estimated primary care population of 140 000. Analysis will be by intention-to-treat, and multiple imputation is to be used for missing data.In a nested qualitative study using in-depth interviews, we will explore how patients, acupuncturists, and GPs explain and subsequently understand acupuncture to work. We will use purposive sampling to identify patients and flexible topic guides for the interviews. The data analysis will lead to a thematic description of how patients and practitioners explain how acupuncture works, and whether or not the explanations influence treatment outcome and/or referrals.We will undertake a cost-effectiveness analysis at 12 months by comparing resource use in the two groups with any treatment benefit. We will use the EQ-5D to measure health-related quality of life and convert into quality adjusted life years (QALYs). We will generate cost effectiveness acceptability curves (CEACs) exploring the probability that acupuncture will produce an acceptable cost per QALY at different cost-effectiveness thresholds.
  
  
  CONCLUSIONS
  The trial has received NHS ethics approval and recruited 233 patients between November 2008 and June 2009. Results are expected in 2011.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN08827905.
authors.affiliation: Department of Health Sciences, University of York, UK. hm18@york.ac.uk
authors.forename: Hugh
authors.initials: H
authors.lastname: MacPherson
authors.forename: Martin
authors.initials: M
authors.lastname: Bland
authors.forename: Karen
authors.initials: K
authors.lastname: Bloor
authors.forename: Helen
authors.initials: H
authors.lastname: Cox
authors.forename: David
authors.initials: D
authors.lastname: Geddes
authors.forename: Arthur
authors.initials: A
authors.lastname: Kang'ombe
authors.forename: Julie
authors.initials: J
authors.lastname: Reynolds
authors.forename: Eugena
authors.initials: E
authors.lastname: Stamuli
authors.forename: Tracey
authors.initials: T
authors.lastname: Stuardi
authors.forename: Helen
authors.initials: H
authors.lastname: Tilbrook
authors.forename: David
authors.initials: D
authors.lastname: Torgerson
authors.forename: Peter
authors.initials: P
authors.lastname: Whorwell
mesh_terms: D015670:Acupuncture Therapy / Q000191:economics; D003362:Cost-Benefit Analysis; D005260:Female; D006801:Humans; D043183:Irritable Bowel Syndrome / Q000191:economics / Q000628:therapy*; D008297:Male; D017063:Outcome Assessment, Health Care; D010821:Physicians, Family; D011788:Quality of Life; D019057:Quality-Adjusted Life Years; D012720:Severity of Illness Index; D016896:Treatment Outcome