Condition category
Digestive System
Date applied
07/07/2008
Date assigned
12/09/2008
Last edited
18/03/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Hugh MacPherson

ORCID ID

Contact details

Department of Health Sciences
Area 3
Seebohm Rowntree Building
University of York
Heslington
York
YO10 5DD
United Kingdom
+44 (0)1904 321394
hm18@york.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PB-PG-0407-13241

Study information

Scientific title

Acupuncture for Irritable Bowel Syndrome (IBS): a randomised controlled trial to evaluate effectiveness and cost-effectiveness

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

York Research Ethics Committee, Learning and Research Centre, 06/06/2008, ref: 08/H1311/66

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

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/10/2008

Overall trial end date

30/09/2011

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

220

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

United Kingdom

Trial participating centre

University of York
York
YO10 5DD
United Kingdom

Sponsor information

Organisation

University of York (UK)

Sponsor details

c/o Mrs S Final
Heslington
York
YO10 5DD
United Kingdom
+44 (0)1904 430000
smf3@york.ac.uk

Sponsor type

University/education

Website

http://www.york.ac.uk

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2008 exploratory results in: http://www.ncbi.nlm.nih.gov/pubmed/18356794
2. 2010 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/20565790
3. 2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/23095376
4. 2012 cost analysis in: http://www.ncbi.nlm.nih.gov/pubmed/23095351
5. 2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/23095376
6. 2014 substudy results in: http://www.ncbi.nlm.nih.gov/pubmed/24972761
7. 2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26980547

Publication citations

  1. Exploratory results

    Reynolds JA, Bland JM, MacPherson H, Acupuncture for irritable bowel syndrome an exploratory randomised controlled trial., Acupunct Med, 2008, 26, 1, 8-16.

  2. Protocol

    MacPherson H, Bland M, Bloor K, Cox H, Geddes D, Kang'ombe A, Reynolds J, Stamuli E, Stuardi T, Tilbrook H, Torgerson D, Whorwell P, Acupuncture for irritable bowel syndrome: a protocol for a pragmatic randomised controlled trial., BMC Gastroenterol, 2010, 10, 63, doi: 10.1186/1471-230X-10-63.

  3. Results

    MacPherson H, Tilbrook H, Bland JM, Bloor K, Brabyn S, Cox H, Kang'ombe AR, Man MS, Stuardi T, Torgerson D, Watt I, Whorwell P, Acupuncture for irritable bowel syndrome: primary care based pragmatic randomised controlled trial., BMC Gastroenterol, 2012, 12, 150, doi: 10.1186/1471-230X-12-150.

  4. Cost analysis

    Stamuli E, Bloor K, MacPherson H, Tilbrook H, Stuardi T, Brabyn S, Torgerson D, Cost-effectiveness of acupuncture for irritable bowel syndrome: findings from an economic evaluation conducted alongside a pragmatic randomised controlled trial in primary care., BMC Gastroenterol, 2012, 12, 149, doi: 10.1186/1471-230X-12-149.

  5. Results

    MacPherson H, Tilbrook H, Bland JM, Bloor K, Brabyn S, Cox H, Kang'ombe AR, Man MS, Stuardi T, Torgerson D, Watt I, Whorwell P, Acupuncture for irritable bowel syndrome: primary care based pragmatic randomised controlled trial., BMC Gastroenterol, 2012, 12, 150, doi: 10.1186/1471-230X-12-150.

  6. Substudy results

    Brabyn S, Adamson J, MacPherson H, Tilbrook H, Torgerson DJ, Short message service text messaging was feasible as a tool for data collection in a trial of treatment for irritable bowel syndrome., J Clin Epidemiol, 2014, 67, 9, 993-1000, doi: 10.1016/j.jclinepi.2014.05.004.

  7. Results

    MacPherson H, Tilbrook H, Agbedjro D, Buckley H, Hewitt C, Frost C, Acupuncture for irritable bowel syndrome: 2-year follow-up of a randomised controlled trial, Acupunct Med, 2016, doi: 10.1136/acupmed-2015-010854.

Additional files

Editorial Notes

18/03/2016: Publication reference added.