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 |
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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 |