Selby 2007.
| Methods | Randomized, placebo controlled trial with blinded investigators and patients Intention to treat not performed Induction phase 16 weeks in duration, maintenance phase 104 weeks in duration, trial 156 weeks total; all patients were started on a 16‐week tapering course of prednisolone starting at 40 mg/day |
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| Participants | Patients over age 18 with active CD (CDAI >200) (N = 213 for induction phase and N = 122 for maintenance phase) |
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| Interventions | Randomized to oral clarithromycin 750 mg/day, oral rifabutin 450 mg/ day, oral clofazimine 50 mg/day (n = 102) or oral placebo (three placebo pills were given to placebo group) (n = 111) Maintenance phase: antibiotics (n = 67), placebo (n = 55) |
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| Outcomes |
Primary outcomes: The number of patients who had at least 1 relapse by 52, 104 or 156 weeks Secondary outcomes: Clinical remission at week 16 (CDAI ≤ 150), relapses within each study phase, time to first relapse, adverse events, endoscopic remission, need for surgery and quality of life |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not described |
| Allocation concealment (selection bias) | Unclear risk | Not described |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double blind: matched placebo |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Investigators and participants were blinded to treatment allocation. Investigators were more likely to identify those on active treatment |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Ninety‐one subjects were withdrawn during the induction phase (56 placebo group, 35 antibiotic group). Reasons included |
| Selective reporting (reporting bias) | Low risk | All expected outcomes were reported |
| Other bias | Low risk | No other apparent sources of bias |