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

Sood 2003.

Methods Randomized controlled trial open label, active comparison (sulfasalazine)
 Induction period included (steroid tapering)
 Study duration 18 months
Participants Newly diagnosed ulcerative colitis, severely active (SEO > 220)
 n = 25
Interventions Azathioprine 2.5 mg/kg/day for 18 months
 Compared to sulfasalazine 6 g/day
Co‐medication induction period: prednisolone 1 mg/kg/day;
 Taper off by 10 mg/day every fortnight until 20 mg/day, then 5 mg/day every 2 weeks
 Co‐medication maintenance: not reported
Outcomes Main: maintenance of remission (after successful induction) for 18 months
 Treatment failure within 18 months
 Secondary:
 Failure to attain remission in induction phase
 Course of mean activity index
 Adverse events
Notes The author was approached for clarification of the randomization and allocation concealment; no response was received
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "generating pseudo‐random numbers ranging from 0‐1 using a scientific calculator"
Allocation concealment (selection bias) Unclear risk Unclear, not described in the published study
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Quote: "open‐label"
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Two withdrawals due to side effects
Selective reporting (reporting bias) Unclear risk All outcomes reported, except endoscopic evaluation
Other bias Low risk Nothing of note