Creed 2003.
| Methods | Multicentre RCT with 3 parallel conditions. Participants were stratified by hospital and severity | |
| Participants | 257 adults with severe IBS recruited from gastroenterology clinics Inclusion criteria: Rome I criteria for IBS satisfied, IBS symptoms > 6 months, failure to respond to usual medical treatment for ≥ 3 months, severe abdominal pain, no contraindications to psychotherapy or paroxetine, ability to complete questionnaires, aged 18‐65 years |
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| Interventions | Intervention 1: PIT based on Hobson 1985, manualised, for 1 long, 2‐hr session, and 7, 45‐min sessions over 3 months Intervention 2: paroxetine 20 mg orally each day for 3 months Control: 'TAU', continuing to see gastroenterologist or GP for duration of study For the psychotherapy or paroxetine groups, after 3 months they returned to GP to decide on further management |
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| Outcomes | Trial entry, 3 months, 1‐year post‐treatment. IBS symptoms ‐ VAS of severity of abdominal pain, record of days of pain, change in symptoms. SF‐36 (health related quality of life), GSI of SCL‐90, healthcare costs, utilisation | |
| Notes | VAS scale data for abdominal pain used for somatic symptoms SCL‐90 score data used for general psychiatric symptom measures in long‐term follow‐up comparison; 20% of sample lost in the 3‐month follow‐up assessment | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Stratified". "Randomization was performed in blocks of 12 subjects using randomization lists supplied by the trial statistician drawn from a computer generated series of random numbers" |
| Allocation concealment (selection bias) | Low risk | Comment: an independent trial administrator co‐ordinated the allocation process and clinicians and researchers were blinded to allocation |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Comment: self report data (SCL‐90, SF‐36, VAS) considered low risk of detection bias No psychotherapist was blinded to the treatment delivered Blinding participants to treatment group not possible |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: all participants followed and measured and ITT analyses used |
| Selective reporting (reporting bias) | Unclear risk | Comment: insufficient information to permit judgement. No published report on pre‐specified outcomes |
| Other bias | Unclear risk | Comment: insufficient information to permit judgement |