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

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.

Acupuncture for depression: first steps toward a clinical evaluation.

AIM OF STUDY: To explore issues that need to be addressed in the design of a clinical trial of acupuncture for people with depression. METHODS: In this study we conducted a focus group with 6 volunteer participants with experiences of depression, and a prospective case series of 10 patients who received acupuncture treatment for their depression. In the case series study, 10 patients were referred by their general practitioner, and received up to 10 individualized acupuncture treatments from one of two acupuncturists. Acupuncturists recorded traditional acupuncture diagnoses and details of the treatment provided. Measures of depression (Beck Depression Inventory and the Hospital Anxiety and Depression Scale) and health status (SF-36) were taken at baseline and 10 weeks later. Changes in mean before and after scores were analyzed using the Wilcoxon signed ranks test. Adverse events were also monitored. RESULTS: The focus group and the case series both identified considerable heterogeneity among people with depression. In the case series, only 6 patients both received treatment and completed 10-week questionnaires; however, significant improvements between before and after were found in their levels of depression (p < 0.05). Many factors, as well as the acupuncture, may have contributed to these improvements. No serious adverse events occurred. In the context of designing a clinical trial of acupuncture for depression, a series of methodological challenges is explored. CONCLUSION: This study highlighted the complexities of evaluating acupuncture for patients with depression. Successfully addressing the identified methodological challenges in the design of a trial will increase its relevance and impact.