Paraskeva 2000.
Methods | Randomized, active control trial | |
Participants | Patients (N = 16), aged 18‐58 years, with acute, steroid resistant Ulcerative colitis, which had previously responded and tolerated IV cyclosporin (4 mg/kg/day). Pateints were in maintenance therapy on tapered steroids and 5‐ASA | |
Interventions | Group A: n = 8, oral azathioprine (2.5 mg/kg/day) for 6 months Group B: n = 8, oral cyclosporin (4 mg/kg/day) for 6 months All patients were on tapering steroids and were on maintenance therapy with 5‐ASA Follow‐up after medication discontinuation for another 12 months |
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Outcomes | Primary outcome: Proportion of patients still in remission Secondary outcome: Safety data |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described in abstract |
Allocation concealment (selection bias) | Unclear risk | Not described in abstract |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not described in abstract |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Missing/withdrawn data was accounted for with explanation. Intention to treat analysis used |
Selective reporting (reporting bias) | Low risk | No protocol was available, all outcomes were reported |
Other bias | Low risk | The study appears not to have any other forms of bias |