Hiwatashi 2011.
Study characteristics | ||
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 a day; n = 63) or 4.0 g/day mesalazine (4 oval 500 mg tablets, 2 times a 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 |
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Notes | Funding support and conflicts of interest were not reported | |
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 participants dropped out from the 2.25 g/day group and 1 participant dropped out from the 4.0 g/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 |