Acupuncture for Irritable Bowel Syndrome (IBS)
| ISRCTN | ISRCTN08827905 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN08827905 |
| Secondary identifying numbers | PB-PG-0407-13241 |
- 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
http://www.nres.npsa.nhs.uk/researchsummaries/?entryid29=19031&q=0%c2%ac08%2fH1311%2f66%c2%ac
Contact information
Dr Hugh MacPherson
Scientific
Scientific
Department of Health Sciences
Area 3, Seebohm Rowntree Building
University of York
Heslington
York
YO10 5DD
United Kingdom
| Phone | +44 (0)1904 321394 |
|---|---|
| hm18@york.ac.uk |
Study information
| Study design | Two-armed multicentre open pragmatic randomised trial design. The qualitative aspect of this study is designed using a phenomenological approach. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 hypothesis | 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 |
| Condition | 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 | 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 |
| Secondary outcome measures | 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. |
| Overall study start date | 01/10/2008 |
| Overall study end date | 30/09/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 220 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 01/10/2008 |
| Recruitment end date | 30/09/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of York
York
YO10 5DD
United Kingdom
YO10 5DD
United Kingdom
Sponsor information
University of York (UK)
University/education
University/education
c/o Mrs S Final
Heslington
York
YO10 5DD
England
United Kingdom
| Phone | +44 (0)1904 430000 |
|---|---|
| smf3@york.ac.uk | |
| Website | http://www.york.ac.uk |
"ROR" |
https://ror.org/04m01e293 |
Funders
Funder type
Government
National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 | |
| Protocol article | protocol | 17/06/2010 | Yes | No | |
| Other publications | cost analysis | 24/10/2012 | 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 |
Editorial Notes
18/03/2016: Publication reference added.
