Ito 2010.
| Study characteristics | ||
| Methods | Multicenter, randomized, double‐blind, double‐dummy, placebo‐controlled trial | |
| Participants | Patients (aged > 16 to < 65 years) with mild to moderately‐active ulcerative colitis. Disease activity was assessed using the UC‐DAI (Sutherland 1987). Patients with mild‐to‐moderate active ulcerative colitis who had a score of 3 to 8 on the UC‐DAI with a bloody stool score of > 1 were eligible for the study (N = 229) | |
| Interventions | The objective of the study was to demonstrate the superiority of Asacol 3.6 g/day and non‐inferiority of Asacol 2.4 g/day against pentasa 2.25 g/day. Participants were randomized to Asacol 3.6 g/day (n = 65), Asacol 2.4 g/day (n = 66), pentasa 2.25 g/day (n = 65) or placebo (n = 33) for 8 weeks | |
| Outcomes | Participants were evaluated at baseline and week 8 or at early withdrawal Primary outcome: Reduction in UC‐DAI score from baseline Secondary outcomes: Reduction in each UC‐DAI item score, the proportion of participants achieving remission (a UC‐DAI score of < 2 and zero points for bloody stool score); the proportion of participants achieving efficacy (remission or participant who did not achieve remission but whose reduction of UC‐DAI score is > 2) |
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| Notes | Study was supported by ZERIA Pharmaceutical Co., Ltd., Research and Development
Division Author conflicts of interest are reported in the manuscript |
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| 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: A person independent from the study was in charge of the random allocation. The randomization code was sealed and stored until the blind was removed |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Double‐blind, double‐dummy: the appearance of the medication was identical |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Dropouts balanced across intervention groups with similar reasons for withdrawal |
| Selective reporting (reporting bias) | Low risk | All expected outcomes reported |
| Other bias | Low risk | The study appears to be free of other sources of bias |