Aoyama 2015.
Methods | Multicenter, randomised, double‐blind, placebo‐controlled trial (N = 165) | |
Participants | Patients with active, mild‐to‐moderate UC | |
Interventions | Group 1: budesonide foam (2 mg/25 mL) once daily Group 2: budesonide foam (2 mg/25 mL) twice daily Group 3: placebo |
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Outcomes | Primary outcome: remission at week 6 (rectal bleeding subscore = 0, endoscopic subscore < 1 and stool frequency subscore = 0 or decrease > 1) | |
Notes | Reported in abstract form only (unclear how many patients randomised to each group); not included in quantitative synthesis | |
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 of participants and personnel (performance bias) All outcomes | Unclear risk | Not described |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not described |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not described |
Selective reporting (reporting bias) | Low risk | All expected outcomes were reported |
Other bias | Unclear risk | Reported in abstract form only |