Methods |
Single center, randomized, investigator‐blind trial |
Participants |
Adult patients (> 18 years) with confirmed ulcerative colitis in clinical, endoscopic and histological remission (N = 156) |
Interventions |
Asacol 2.4 g/day (n = 80) or 1.2 g/day (n = 76) for 12 months |
Outcomes |
Primary: maintenance of remission (Truelove and Witts). Secondary: time to relapse, adverse events |
Notes |
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Not described |
Allocation concealment (selection bias) |
Unclear risk |
Not described |
Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Investigator‐blinded |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Drop‐outs balanced across intervention groups with similar reasons for withdrawal |
Selective reporting (reporting bias) |
Low risk |
Expected outcomes were reported |
Other bias |
Low risk |
The study appears to be free of other sources of bias |