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. 2020 Aug 12;2020(8):CD000543. doi: 10.1002/14651858.CD000543.pub5

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
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