Acupuncture for Irritable Bowel Syndrome (IBS)

ISRCTN	ISRCTN08827905
DOI	https://doi.org/10.1186/ISRCTN08827905
Protocol serial number	PB-PG-0407-13241
Sponsor	University of York (UK)
Funder	National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme

Submission date: 07/07/2008
Registration date: 12/09/2008
Last edited: 18/03/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://www.nres.npsa.nhs.uk/researchsummaries/?entryid29=19031&q=0%c2%ac08%2fH1311%2f66%c2%ac

Contact information

Dr Hugh MacPherson
Scientific

Department of Health Sciences
Area 3, Seebohm Rowntree Building
University of York
Heslington
York
YO10 5DD
United Kingdom

Phone	+44 (0)1904 321394
Email	hm18@york.ac.uk

Study information

Primary study design	Interventional
Study design	Two-armed multicentre open pragmatic randomised trial design. The qualitative aspect of this study is designed using a phenomenological approach.
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Acupuncture for Irritable Bowel Syndrome (IBS): a randomised controlled trial to evaluate effectiveness and cost-effectiveness
Study acronym	Acupuncture for IBS
Study objectives	The aim is to establish rigorous evidence on the clinical effectiveness and cost effectiveness of acupuncture plus usual general practitioner (GP) care when compared to usual GP care alone for patients with irritable bowel syndrome (IBS) in primary care. The null hypothesis is that there is no difference between outcome in groups in our primary clinical outcome measure, the IBS Symptom Severity Score, at three months. Our related aim with the cost-effectiveness analysis is to determine at twelve months what the cost per quality assisted life years (QALY) gained is, and whether this is at a level that might be thought acceptable if it were to be considered by the National Institute for Clinical Excellence. Our secondary aim is to explore patient experiences of acupuncture, and this will include addressing areas of acceptability and safety directly with patients. In addition, we will also explore the potential influence of patient preferences, beliefs and expectations on patient outcome. We will do this by measuring these using accepted scales prior to randomisation, and assessing whether they modify the outcomes at three months.
Ethics approval(s)	York Research Ethics Committee, Learning and Research Centre, 06/06/2008, ref: 08/H1311/66
Health condition(s) or problem(s) studied	Irritable bowel syndrome (IBS)
Intervention	Patients will be randomised to 10 sessions of acupuncture plus usual GP care or to usual GP care alone. Acupuncture will be provided by professional acupuncturists who are registered with the British Acupuncture Council, and have at least three years experience. The acupuncture will be provided at independent clinics, and comprise up to 10 treatment sessions over a three month period. Acupuncturists will follow a treatment protocol adapted from one that has been devised previously and tested by acupuncturists taking part in the pilot trial of acupuncture for IBS. All patients will remain under the care of their general practitioner and will continue to receive their usual NHS treatment. Both groups will be able seek care elsewhere according to need. Patients in both arms will be seen for 3 months, on an average of once a week for approximately one hour per session.
Intervention type	Other
Primary outcome measure(s)	1. IBS Symptom Severity Score (IBS SSS) at 3 months 2. Cost-effectiveness study: European quality of life questionnaire (EQ-5D) at 12 months 3. Medication use at baseline, 3 months, 6 months, 9 months and 12 months 4. Health services used at baseline, 3 months, 6 months, 9 months and 12 months 5. Days lost from work at baseline, 3 months, 6 months, 9 months and 12 months
Key secondary outcome measure(s)	Secondary outcomes at 3, 6, 9, and 12 months: 1. IBS Non-Colonic Symptom Score (which includes lethargy and tiredness, "wind", backache, and other symptoms) 2. The 12-item short form (SF-12) to evaluate patients' general well-being 3. The Hospital Anxiety and Depression Scale (HADS) 4. Information associated with hospitalisations; open text questions will be used to gather qualitative data on patient experiences of acupuncture, including adverse events at three months 5. Safety and treatment processes, gained from logs completed by the acupuncturists 6. Acceptability, assessed through patient reports on satisfaction and willingness to try acupuncture again, as well as the uptake of acupuncture 7. For the qualitative analysis, we will use in-depth interviews with flexible topic guides to collect data. Additionally, interview participants will be allowed to illustrate their explanation how acupuncture works. Researchers will record detailed field notes to track the development of emerging themes.
Completion date	30/09/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	220
Key inclusion criteria	1. Aged 18 or older, either sex 2. A diagnosis of IBS from GP or being given medication to treat IBS symptoms (such as antispasmodics or bulking agents) 3. Have had a primary care consultation within the last two years regarding IBS or its symptoms 4. Screened for IBS symptoms according to the Rome III diagnostic criteria
Key exclusion criteria	1. Doesn't speak English 2. Score less than 100 on the IBS Symptom Severity Score (SSS) 3. Have a current diagnosis of haemophilia or cancer 4. Have had major gastrointestinal surgery in the previous six months 5. Receiving acupuncture at the time
Date of first enrolment	01/10/2008
Date of final enrolment	30/09/2011

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

University of York

York
YO10 5DD
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	exploratory results	01/03/2008		Yes	No
Results article	results	24/10/2012		Yes	No
Results article	substudy results	01/09/2014		Yes	No
Results article	results	01/03/2017		Yes	No
Protocol article	protocol	17/06/2010		Yes	No
Other publications	cost analysis	24/10/2012		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

18/03/2016: Publication reference added.