Abstract
BackgroundThere 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/DesignIn 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.DiscussionThe trial has received NHS ethics approval and recruited 233 patients between November 2008 and June 2009. Results are expected in 2011.Trial RegistrationCurrent Controlled Trials ISRCTN08827905
Highlights
There is insufficient evidence on the effectiveness of acupuncture for irritable bowel syndrome (IBS) for conclusions to be drawn
We will generate cost effectiveness acceptability curves (CEACs) exploring the probability that acupuncture will produce an acceptable cost per quality adjusted life years (QALYs) at different cost-effectiveness thresholds
Irritable bowel syndrome (IBS) is the most common disorder encountered by gastroenterologists and the most common functional bowel disorder seen by doctors in primary care [1]
Summary
Irritable bowel syndrome (IBS) is the most common disorder encountered by gastroenterologists and the most common functional bowel disorder seen by doctors in primary care [1]. The rationale for this unblinded pragmatic design is that it will best answer practical questions regarding the clinical and cost implications of offering acupuncture as an additional treatment option within primary care [15] This trial design will not ascertain the extent that 'placebo' effects contribute to the overall outcome. We will use a net monetary benefit approach to generate cost effectiveness acceptability curves (CEACs) exploring the probability that acupuncture will produce an acceptable cost per QALY at different cost-effectiveness thresholds This approach accounts directly for uncertainty around the estimates of costs and effects, which is important as this trial is powered on the basis of the clinical effectiveness measure (IBS SSS) rather than the economic outcome measure (EQ-5D). If the intervention is found to be not cost-effective at 12 months, evaluation over a longer time frame may be considered
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