D'Haens 2006.
Study characteristics | ||
Methods | Randomized, multicenter, double‐blind, parallel‐group, dose‐ranging study | |
Participants | Adultss (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 3 dose groups | |
Notes | Study was funded by Shire Pharmaceuticals Inc. Conflicts of interest were not reported |
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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 |