Sutherland 1991.
Methods | Randomized, double‐blind, placebo controlled Intention to treat Sixteen week trial |
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Participants | N = 105, Patients with active CD with CDAI between 180‐450 (age not mentioned) | |
Interventions | Patients were randomised to oral metronidazole 20 mg/kg (n = 33) or oral metronidazole 10 mg/kg (n = 30) or oral placebo (n = 36) | |
Outcomes |
Primary outcome: Clinical remission (CDAI < 150) at week 16 Secondary outcomes: Changes in plasma orosomucoid and C reactive protein levels Authors also looked at the effect of metronidazole on disease location |
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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 | Both patients and investigators were blinded to the treatment assignment |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Both patients and investigators were blinded to the treatment assignment. No clinical measures were part of outcomes |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Equal discontinuation rate among study groups, metronidazole 10 mg/kg 11/33, metronidazole 20 mg/kg 9/30. But higher attrition rate in placebo group 20/36 |
Selective reporting (reporting bias) | Low risk | All expected outcomes were reported |
Other bias | Low risk | No other apparent sources of bias |