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.
RCT Entities:
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.
Authors: Peter Fisher; Robbert van Haselen; Kate Hardy; Saul Berkovitz; Rob McCarney Journal: J Altern Complement Med Date: 2004-08 Impact factor: 2.579
Authors: Stephanie A Leong; Victoria Barghout; Howard G Birnbaum; Crystal E Thibeault; Rym Ben-Hamadi; Feride Frech; Joshua J Ofman Journal: Arch Intern Med Date: 2003-04-28
Authors: Eric Manheimer; Ke Cheng; L Susan Wieland; Li Shih Min; Xueyong Shen; Brian M Berman; Lixing Lao Journal: Cochrane Database Syst Rev Date: 2012-05-16
Authors: Seunghoon Lee; Ui Min Jerng; Yan Liu; Jung Won Kang; Dongwoo Nam; Jae-dong Lee Journal: Support Care Cancer Date: 2014-03-08 Impact factor: 3.603
Authors: Eric Manheimer; L Susan Wieland; Ke Cheng; Shih Min Li; Xueyong Shen; Brian M Berman; Lixing Lao Journal: Am J Gastroenterol Date: 2012-04-10 Impact factor: 10.864
Authors: Hugh MacPherson; Helen E Tilbrook; Stewart J Richmond; Karl Atkin; Kathleen Ballard; Martin Bland; Janet Eldred; Holly N Essex; Ann Hopton; Harriet Lansdown; Usman Muhammad; Steve Parrott; David Torgerson; Aniela Wenham; Julia Woodman; Ian Watt Journal: Trials Date: 2013-07-10 Impact factor: 2.279
Authors: Hugh MacPherson; Helen Tilbrook; J Martin Bland; Karen Bloor; Sally Brabyn; Helen Cox; Arthur Ricky Kang'ombe; Mei-See Man; Tracy Stuardi; David Torgerson; Ian Watt; Peter Whorwell Journal: BMC Gastroenterol Date: 2012-10-24 Impact factor: 3.067