Colombel 1999.
| Methods | Randomized active comparator trial. Study participants and investigators were not blinded Intention to treat not performed 6 week trial |
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| Participants | Patients aged >18 with acute ileal or colonic CD with no need for steroid treatment and a CDAI between 150 and 300 (N = 40) | |
| Interventions | Oral ciprofloxacin 500 mg BID (n = 18) or oral mesalazine 2g BID (n = 22) for 6 weeks | |
| Outcomes |
Primary outcome: Clinical remission (CDAI ≤ 150) at 6 weeks Secondary outcomes: Partial remission (CDAI ≤ 150 but change in CDAI between 50‐75), treatment failure (increase in CDAI value or insufficient improvement at week 3 with change in CDAI > 50 or absence of complete or partial remission at week 6) |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not discussed |
| Allocation concealment (selection bias) | Unclear risk | Not discussed |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Trial was not blinded |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Trial was not blinded |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Two patients stopped treatment in ciprofloxacin group (one for intolerance, one for personal reasons) One patient was lost to follow up in mesalamine group |
| Selective reporting (reporting bias) | Low risk | All expected outcomes were reported |
| Other bias | Low risk | No other apparent sources of bias |