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NIHR Number: PB-PG-0407-13241

NIHR Programme:
RfPB

Competition:
RfPB Competition 4

Project Title:
Acupuncture for IBS: a randomised controlled trial to evaluate effectiveness and cost-effectiveness

Principal Investigator:
Dr Hugh Macpherson

Principal Investigator's Institution:
North Yorkshire And York Primary Care Trust

Contract Organisation:
North Yorkshire And York Primary Care Trust

Region:
Yorkshire and Humber

Grant:
£261,581.00

Start Date:
01 October 2008

End Date:
30 September 2011

Scientific Summary Background:
The treatment of irritable bowel syndrome (IBS) in primary care is an ongoing challenge. Many patients and GPs perceive current conventional treatments as ineffective and this may explain why increasing numbers of patients with IBS are turning to complementary medicine, including acupuncture. There is weak but inconclusive evidence of acupuncture’s efficacy for irritable bowel syndrome (IBS), and there is no evidence on cost-effectiveness. Given that many patients with IBS are already self-referring for acupuncture, it is in the public interest to know whether or not acupuncture is effective.

Scientific Summary Aims:
The aim of this study is to establish rigorous evidence on the effectiveness and cost-effectiveness of acupuncture for IBS. As secondary aims, we will explore the patient experience, including the acceptability and safety of acupuncture and we will also explore the potential influence of patient preference, belief and expectation on patient outcome.

Scientific Summary Plan of Investigation:
A pragmatic randomised controlled trial will be conducted to evaluate effectiveness and cost-effectiveness. GPs will refer patients with a diagnosis of irritable bowel syndrome, and consenting patients will be randomised to 10 sessions of acupuncture plus usual GP care or to usual GP care alone. Based on our primary outcome measure, the IBS Symptom Severity Score at three months, for which a change of 50 points is clinically significant, our sample size calculations from our pilot study (ISRCTN 32823720) indicate that 110 patients per arm are required. Analysis will be by intention-to-treat, and multiple imputation will be used for missing data. The economic analysis will be based on both an NHS and a societal perspective, and the cost per QALY gained will be estimated at 12 months.

Scientific Summary Potential Impact:
The take up of conventional treatments for IBS in primary care is limited, in part as a result of to the weak evidence base. In this context, the proposed trial will make an important contribution to the evidence, establishing whether or not acupuncture provides clinically and statistically significant improvements over and above the routine treatment commonly provided in primary care. Economic data on acupuncture for IBS is non-existent, so the cost-effectiveness analysis will be the first in this area. The clinical and economic results of the trial will contribute crucial evidence for people wanting to make a decision about acupuncture for IBS, whether from the perspective of patients, practitioners, providers, or commissioners of services.

Lay Summary:
Irritable bowel syndrome is a difficult condition to treat in primary care, and it is an area where patients often seek alternative treatments. Interest in complementary therapies has been growing, and patients can be intuitively attracted to treatments such as acupuncture, that treat the whole person. However the current evidence for acupuncture is inconclusive, mainly because there have been insufficient good quality trials. This contrast between increasing patient utilisation and lack of evidence leads us to call for more definitive research in this area. To this end we have already conducted a pilot study which has shown promising results. Our proposal in this application is a full-scale trial to determine the potential impact on patients if GPs could offer the option of a referral to a professional acupuncturist. We will determine whether there is a difference in outcomes between patients provided with a course of 10 acupuncture sessions in addition to their normal GP care when compared to those patients who are offered usual GP care alone. To answer this question in a scientific way we need to set up a randomised controlled trial with two identical groups, one of which will be offered acupuncture. At three months we will measure change in both groups, using powerful statistical techniques to see whether any difference is clinically worthwhile, as well as to ensure that such a result is not caused by chance. In parallel the costs in both arms over a twelve month period will be monitored, and we will estimate the differences in costs and health gains to see if these are sufficiently cost-effective to be worthwhile. Our results will be of value for making decisions about acupuncture’s potential role in treating IBS. For this reason we will ensure that the results are widely disseminated to patients and patient support groups, as well as those providing or commissioning IBS services on the NHS.