| Methods |
Multicenter, randomized, double‐blind, parallel group study |
| Participants |
Patients (aged 15 to 64 years) with moderately active ulcerative colitis (modified Mayo score 6 to 8 points) (N = 123) |
| Interventions |
2.25 g/day mesalazine (3 round 250 mg tablets, 3 times per day; n = 63) or 4.0 g/day mesalazine (4 oval 500 mg tablets, 2 times per day; n = 60) |
| Outcomes |
Primary outcome: mean change in UC‐DAI. Secondary outcomes: mean change in each UC‐DAI variable (stool frequency, rectal bleeding, mucosal appearance, and physician’s overall assessment of disease), clinical remission, clinical improvement and adverse events |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Biased‐coin minimization algorithm |
| Allocation concealment (selection bias) |
Low risk |
Centralized randomization by independent CRO |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Double‐blind, double‐dummy: Study medication consisted of a round tablet containing 250 mg of mesalazine, an oval tablet containing 500 mg of mesalazine and placebo tablets identical in size and appearance to the study drugs |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
4 patients dropped out from the 2.25 g/day group and 1 patient dropped out from the 4.0 gh/day group |
| 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 |
