Irritable bowel syndrome (IBS) Digestive System Irritable bowel syndrome
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United Kingdom