Lieper 2008.
| Methods | Randomized, placebo‐controlled trial. Investigators were blinded. Intention to treat Twelve week trial |
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| Participants | Patients age 18 and older with active CD (CDAI > 200 and CRP ≥ 10 mg/L) (N = 41) | |
| Interventions | Patients were randomised to oral clarithromycin 1g daily (n = 19) or oral placebo (n = 22) for 3 months | |
| Outcomes |
Primary outcome: Clinical remission (CDAI ≤ 150) or clinical response (fall in CDAI by ≥70 from pre‐treatment level) at 3 months Secondary outcomes: Decrease in van Hees Activity Index, remission as per Harvey Bradshaw Index (≤ 4), improvement in IBDQ and decrease in serum CRP |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomization was carried out by pharmacist independent of the trial. Randomization was performed by a random allocation sequence in blocks of four (two active and two placebo) |
| Allocation concealment (selection bias) | Low risk | Centralized randomization by pharmacy |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Patients and investigators were blinded to treatment allocation Placebo was identical in size, colour and taste |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Investigators were blinded to randomisation assignments |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | More patients withdrawn from placebo group (7/19 from clarithromycin group, 12/22 of placebo group). More patients had worsening baseline disease in placebo group (4 in treatment group versus 9 in placebo group) |
| Selective reporting (reporting bias) | Low risk | All expected outcomes were reported |
| Other bias | Low risk | No other apparent sources of bias |