Rubin 2014.

Methods	Randomised double‐blind, placebo controlled trial
Participants	Non‐pregnant patients, age 18‐75 years, with active mild to moderate UC (UCDAI score ≥ 4 and ≤ 10) with a mucosal appearance score of ≥ 1, despite the use of oral 5‐ASA (≥ 2.4g daily for at least 6 weeks) were included (N = 510) Patients with disease limited to the rectum were excluded Other exclusion criteria included infectious colitis, malignancy within the past 5 years (with the exception of non‐melanoma skin cancers), active peptic ulcer disease, a history of toxic megacolon, Crohn's disease or indeterminate colitis. Patient with tuberculosis, Hepatitis B, Hepatitis C or HIV were excluded. Patients with severe disease in other organs or systems were excluded, including those with type 1 diabetes The use of oral corticosteroids, other than budesonide, the use of immunosuppressant medications and the use of biologic therapy, within 4 weeks, 8 weeks and 3 months of randomisation, respectively, were also exclusion criteria Patients who had used rectal 5‐ASA or corticosteroid products within 2 weeks of randomisation were also excluded
Interventions	Budesonide multi‐matrix system (MMX®) 9 mg (n =230) Placebo (n = 228)
Outcomes	Primary outcome: induction of remission (combination of clinical and endoscopic remission) following 8 weeks of therapy Secondary outcomes: clinical remission, clinical response, histologic remission and histologic healing, evaluation of treatment failures, quality of life, C‐reactive protein and fecal calprotectin levels at 8 weeks
Notes	Currently only published in abstract form Modified intention‐to‐treat population was 458 This trial was supported by Santarus, Inc. a wholly owned subsidiary of Salix Pharmaceuticals, Inc. which manufactures budesonide‐MMX®.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomisation
Allocation concealment (selection bias)	Low risk	Centralized randomisation via an interactive voice response system
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	Unclear risk	Abstract publication
Selective reporting (reporting bias)	Unclear risk	Abstract publication
Other bias	Unclear risk	Abstract publication