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 |