| Methods |
Multicenter, randomized, double‐blind, double‐dummy, parallel dose‐response study |
| Participants |
Adult patients (aged 18 to 65 years) with clinically mild active ulcerative colitis based on Truelove and Witts criteria (N = 73) |
| Interventions |
Mesalazine (Asacol 400 mg tablets) at daily doses of 1.2 g (n = 25), 2.4 g (n = 24) or 3.6 g (n = 24) for 4 weeks |
| Outcomes |
Clinical remission or improvement, endoscopic and histological improvement. Clinical remission was defined as no more than two bowel movements per day with no visible blood in the stool in the symptom less patient. Clinical improvement defined as a clear decrease in severity of symptoms and signs not satisfying remission criteria |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Computer‐generated |
| Allocation concealment (selection bias) |
Unclear risk |
Not described |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Double‐blind, double‐dummy: identical placebo tablets |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
Eleven patients did not complete the study (5 in 1.2 g/day group; 4 in 2.4 g/day group; and 2 in 3.6 g/day group because of worsening of disease in five, lack of improvement in 4 and loss to follow‐up and intercurrent disease in one). It is not clear which reasons apply to each group |
| Selective reporting (reporting bias) |
Low risk |
All expected outcomes were reported |
| Other bias |
Low risk |
The study appears to be free of other sources of bias |
