| Methods |
Multicenter, randomized, double‐blind, double‐dummy, non‐inferiority trial |
| Participants |
Adult patients (aged > 16 to < 65 years) with quiescent (UC‐DAI of 2 or less and bloody stool score of 0) ulcerative colitis (N = 131) |
| Interventions |
Pentasa 2.25 g/day (n = 66) or Asacol 2.4 g/day (n = 65) for 48 weeks |
| Outcomes |
Primary outcome: the proportion of patients without bloody stools. Secondary outcomes were time to bloody stools, proportion of patients without relapse, time to relapse, decrease in UC‐DAI and adverse events. Relapse was defined as a bloody stool score of 1 or more and UC‐DAI of 3 or more |
| Notes |
One patient from the Pentasa group was excluded from the ITT analysis due to a GCP violation |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Computer generated. Treatment assignment was balanced using a biased‐coin minimization algorithm |
| Allocation concealment (selection bias) |
Low risk |
Centralized randomization: A person independent from the study was in charge of the random allocation. The randomization code was sealed and stored until the blind was removed |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Double‐blind, double‐dummy |
| 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 |
