| Methods |
Multicenter, randomized, double‐blind, double‐dummy, parallel‐group study |
| Participants |
Adult patients (18 to 70 years) with mild to moderately active ulcerative colitis (N = 233) |
| Interventions |
Mesalazine pellets (Salofalk; n = 115) or mesalazine tablets (n = 118) at an initial dose of 1.5 g/day. In case of inadequate response the dose could be increased up to 3 g/day after the first follow‐up visit at 2 weeks. Patients were treated for 8 weeks |
| Outcomes |
The primary outcome was complete response (clinical remission) defined as CAI < 4 at individual study end. Secondary outcomes: time to first response; endoscopic remission (defined as EI < 4) and improvement; histological improvement; and physician’s global assessment |
| 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 |
Double‐blind, double‐dummy: Placebos of identical appearance to 5‐ASA tablets and pellets were used to ensure double‐blind performance of the trial |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
13.5% drop‐out rate. Drop‐outs were balanced across groups. Reasons for dropping out were summarized across both groups |
| 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 |
