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. 2016 May 18;2016(5):CD000478. doi: 10.1002/14651858.CD000478.pub4

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
Outcomes Primary outcome: Proportion of patients still in remission
Secondary outcome: Safety data
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 All outcomes Low risk Missing/withdrawn data was accounted for with explanation.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