Acupuncture for irritable bowel syndrome: A protocol for a pragmatic randomised controlled trial

BMC Gastroenterology SAtucdyupprotuocnolcture for irritable bowel syndrome: A protocol for a pragmatic randomised controlled trial Hugh MacPherson 0 Martin Bland 0 Karen Bloor 0 Helen Cox 0 David Geddes 2 Arthur Kang'ombe 0 Julie Reynolds 1 Eugena Stamuli 0 Tracey Stuardi 0 Helen Tilbrook 0 David Torgerson 0 Peter Whorwell 3 0 Department of Health Sciences, University of York UK 1 College of Traditional Acupuncture , Hatton, Warwickshire , UK 2 NHS York and North Yorkshire , York , UK 3 Wythenshawe Hospital , Manchester , UK 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/Design: 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. Discussion: The trial has received NHS ethics approval and recruited 233 patients between November 2008 and June 2009. Results are expected in 2011. Trial Registration: Current Controlled Trials ISRCTN08827905 - Background 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 causes of the disorder are unknown but sufferers are said to experience an increased gastrointestinal stress response consistent with an up-regulation in neural processing between the gut and the brain, termed the "brain-gut axis" [2]. Irritable bowel syndrome is thought to be exacerbated by psychosocial stressors, so treatment is most successful when a multi-component, comprehensive approach is used. Therefore usual care involves a number of interventions as options, including pharmaceuticals, psychological interventions and dietary changes. According to a Cochrane review, bulking agents and antidepressants lack a clear benefit in treating IBS, while antispasmodics, as a category, provide relief of abdominal pain [3]. A review of conventional treatments found that they are rarely effective in managing IBS symptoms [4], a finding that is supported by the Cochrane review [3]. Conventional treatments for IBS are associated with risks including adverse events, worsening of symptoms, and financial costs [5]. The direct and indirect costs associated with IBS are potentially considerable [6]. Some patients are satisfied with current therapies, but many others are frustrated, feeling that advice lacks clarity, conflicts with other GPs' advice and may not work [7]. In this context it is not surprising that patients are increasingly turning to complementary and alternative medicine [8]. An estimated 10% of the UK population uses complementary and alternative medicine [9]. Alternative and complementary techniques are used by between 11% and 43% of patients with gastrointestinal disorders [10]. A survey of GPs found that there is an "effectiveness gap" in currently available treatments in primary care for IBS [11]. Among acupuncture patients, 5% state that their primary complaint is gastrointestinal, most commonly IBS [12]. According to a recent Cochrane review of acupuncture for IBS, the studies to date are of poor quality, heterogeneous in terms of interventions, controls and outcomes, and therefore provide insufficient evidence to determine if acupuncture is an effective treatment for IBS [13]. A recent safety survey of patient reports over a three month period found that acupuncture treatments performed by competent practitioners are rarely associated with adverse events [14]. In this study, we used our pilot study (ISRCTN32823720) as a platform to design a full-scale trial of acupuncture in order to provide robust evidence on acupuncture as a potential referral option in primary care. The primary objective is to establish rigorous evidence of the clinical effectiveness and cost-effectiveness of acupuncture plus usual GP care when compared to usual GP care alone for patients with irritable bowel syndrome (IBS) in primary care. The secondary objective is to perform a qualitative exploration of the experience of patients, GPs and acupuncturists in using acupuncture to treat irritable bowel syndrome. Methods/Design We will conduct a parallel-arm randomised controlled trial to determine the effectiveness and cost-effectiveness of acupuncture plus usual care compared to usual care alone for the treatment of IBS. 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. This design will not be able to ascertain the contribution to the overall effect from expectation, belief and other non-specific factors such as time and attention. In pragmatic terms, even if some of the effect of the treatment process is due to "placebo", acupuncture cannot be delivered without it, and therefore as with all complex interventions, the important question is whether the overall effect is worth paying for. For patients the primary objective is (...truncated)