Gross 2011.

Methods	Randomised, double‐blind, double‐dummy, multicenter trial comparing budesonide with mesalamine The study was conducted across 48 centres in Europe
Participants	Adult patients (age 18‐75 years), with mild to moderate active ulcerative colitis (N = 343) Patients were required to have a Clinical Activity Index (CAI) of ≥ 6 and an Endoscopic Index (EI) ≥ 4 (Rachmilewitz 1989) Participants with disease limited to the rectum were excluded Participants were also excluded if they had toxic megacolon, a diagnosis of Crohn's disease, indeterminate colitis, ischemic colitis, radiation colitis or microscopic colitis Other exclusion criteria included: gastrointestinal infection, diarrhoea due to other GI conditions, bleeding diathesis, active peptic ulcer disease, prior or concurrent history of colorectal malignancy, the use of immunosuppressant or corticosteroid medication within the preceding 3 months and 4 weeks, respectively Patients who were experiencing a relapse while being treated with a maintenance dose of mesalamine of > 2.4 g/day were also excluded
Interventions	Patients received budesonide 9 mg once daily (3 x 3 mg capsules) for 8 weeks (n = 177) or mesalamine 3 g once daily (3 x 1000 mg tablets) for 8 weeks (n = 166)
Outcomes	The primary outcome was clinical remission (CAI ≤ 4, with rectal bleeding and stool frequency sub‐scores of '0') at week 8 Subgroup analysis included clinical remission rates according to disease location and disease severity at the outset Secondary outcomes included CAI score changes, mucosal healing (EI ≤ 1), endoscopic remission (EI ≤ 3), histological remission and therapeutic success and benefit (defined by Physician Global Assessment (Hanauer 1993))
Notes	This trial was supported by Dr. Falk Pharma GmbH, manufacturers of the budesonide evaluated in the study
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	The investigators used a computer‐generated randomisation list using randomly permuted blocks
Allocation concealment (selection bias)	Low risk	Allocation was concealed from all study investigators
Blinding (performance bias and detection bias) All outcomes	Low risk	Outcome assessors were blinded to the treatment allocation
Blinding (performance bias and detection bias) Treatment Allocation	Low risk	Physicians, patients and outcome assessors were blinded to the treatment allocation
Incomplete outcome data (attrition bias) All outcomes	Low risk	Outcome data appear to be complete
Selective reporting (reporting bias)	Low risk	The published report includes all expected outcomes
Other bias	Low risk	The study appears to be free of other sources of bias