| Methods |
Randomized, multicenter, double‐blind, parallel‐group, dose‐ranging study |
| Participants |
Adult patients (aged > 18 years) with histologically confirmed, newly diagnosed or relapsing mild‐to‐moderately active ulcerative colitis (N = 38) |
| Interventions |
MMX mesalazine (SPD476) 1.2 (n = 13), 2.4 (n = 14) or 4.8 g/day (n = 11) given once daily for 8 weeks |
| Outcomes |
Primary outcome: remission defined as a UC‐DAI score < 1 with a score of 0 for rectal bleeding and stool frequency, and at least a 1‐point reduction from baseline in sigmoidoscopy score. Secondary outcomes: change in UC‐DAI score, sigmoidoscopic appearance and histology from baseline to week 8, and the change in symptoms (rectal bleeding and stool frequency) from baseline to weeks 2, 4 and 8 for the three dose groups |
| 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: MMX mesalazine and placebo tablets were identical in appearance |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
The 1.2 g/day group had 6 withdrawals (6/13) compared to 3 (3/14) in the 2.4 g/day and 1 (1/11) in the 4.8 g/day groups. LOCF was used to address incomplete outcome data |
| 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 |
