Department of Health Sciences, University of York, UK.
BMC Gastroenterol. 2010 Jun 17;10:63. doi: 10.1186/1471-230X-10-63.
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.
The trial has received NHS ethics approval and recruited 233 patients between November 2008 and June 2009. Results are expected in 2011.
Current Controlled Trials ISRCTN08827905.
目前尚无足够证据表明针灸对肠易激综合征（IBS）有效，因此无法得出结论。鉴于目前患者对针灸的浓厚兴趣，为公众建立更严格的证据是符合其利益的。基于一项试点研究的积极发现，本文提出了一项全面的试验方案，旨在确定针灸是否有效且具有成本效益。
方法/设计：在这项实用的随机对照试验中，我们将直接从全科医生数据库中招募的患者随机分为 10 次针灸加常规全科医生护理组或仅常规全科医生护理组。主要临床结局是三个月时的 IBS 症状严重程度评分（SSS）（最高 500 分），并在 12 个月时评估是否有整体获益。我们估计在 90%的功效和 5%的显著性水平下，需要 188 例患者才能检测到最小的临床差异。为了允许随访丢失，我们将从估计的 14 万例初级保健人群中招募 220 例患者。分析将按意向治疗进行，对于缺失数据将使用多重插补法。在一项使用深入访谈的嵌套定性研究中，我们将探讨患者、针灸师和全科医生如何解释并随后理解针灸的作用。我们将使用目的抽样法来确定患者和灵活的访谈主题指南。数据分析将导致对患者和从业者如何解释针灸作用的主题描述，以及解释是否影响治疗效果和/或转介。我们将在 12 个月时通过比较两组的资源使用情况与任何治疗益处进行成本效益分析。我们将使用 EQ-5D 来衡量健康相关的生活质量，并将其转换为质量调整生命年（QALYs）。我们将生成成本效益可接受性曲线（CEACs），探讨在不同的成本效益阈值下，针灸每 QALY 产生可接受成本的概率。
该试验已获得英国国家卫生服务体系伦理委员会的批准，并于 2008 年 11 月至 2009 年 6 月期间招募了 233 例患者。预计结果将于 2011 年公布。
当前对照试验 ISRCTN08827905。
