| 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 |
