West 2004.
| Methods | Randomized controlled trial with blinded investigators and participants Intention to treat Eighteen week trial |
|
| Participants | Patients aged with a diagnosis of CD that was complicated by at least one perianal fistula (N = 24) | |
| Interventions | Patients were randomised to receive oral ciprofloxacin 500 mg twice daily (n = 11) or oral placebo (n = 13) All patients also received 5 mg/kg infliximab at weeks 6, 8, and 12. Three patients received intravenous hydrocortisone prior to infliximab infusion |
|
| Outcomes |
Primary outcome: Clinical response (50% or greater reduction in draining fistulae confirmed by no drainage despite firm finger compression) Secondary outcomes: PDAI and 3D endoscopic ultrasound with 3% hydrogen peroxide used as a contrast medium |
|
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Method of randomisation not described |
| Allocation concealment (selection bias) | Unclear risk | Not described |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Both patients and investigators were blinded to treatment assignments |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Both patients and investigators were blinded to treatment assignments |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Rate of discontinuation was similar in both treatment groups 2/11 in ciprofloxacin group and 2/13 in placebo group |
| Selective reporting (reporting bias) | Low risk | All expected outcomes were reported |
| Other bias | Low risk | No other apparent sources of bias |