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

Sood 2000.

Methods Randomized controlled trial
 Single (patient) blind placebo controlled
 Induction period included (steroid tapering)
 Study duration 12 months
Participants Diagnosis of ulcerative colitis
 Relapse within 2 months of steroid withdrawal following successful induction of remission
 n = 50
Interventions Azathioprine 2.0 mg/kg/d for 1 year
 Compared to placebo
Co‐medication induction period: i.v. hydrocortisone 400 mg/day, sulfasalazine 6‐8 g/day, ciprofloxacin and metronidazole for 5 days
 Taper off of steroids to 1 mg/kg/day P.O., then by 10 mg every 10 days to 20 mg, then by 5 mg every 10 days
 Co‐medication maintenance: sulfasalazine 6 g/day
Outcomes Main: Complete or partial remission at 1 year (after successful induction)
 Secondary: 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: "pseudorandom numbers ranging from 0‐1 generated by a scientific calculator"
Allocation concealment (selection bias) Unclear risk Not described in the published study
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Quote: "single‐blind"
Quote: "identical matched placebo drugs"
Quote: "drugs were provided by a single coordinator (VK) to the patients in identical blister packs"
Quote: "The treating physician was aware of the drug treatment"
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Quote: "Five patients...were excluded because of noncompliance and violation of treatment protocol"
It is difficult to determine how these were dealt with in the analysis
Selective reporting (reporting bias) Low risk All outcome were reported
Other bias Low risk Nothing of note