D'Haens 2010.

Methods	Randomised double‐blind study comparing Budesonide‐MMX® with placebo at 4 weeks Patients who had worsening of their disease or who were not improving after 2 weeks were switched to open‐label budesonide therapy In an open‐label extension, from 4 to 8 weeks, all patients received oral Budesonide‐MMX® Only outcomes following the first arm of the trial were considered in this review
Participants	Adult patients with mild to moderate, active left‐sided ulcerative colitis (N = 36) Active disease was defined as a clinical activity index (CAI) of < 14 (Rachmilewitz 1989) Stable doses of immunomodulators (methotrexate or azathioprine) or 5‐ASA products were allowed Participants were excluded if they had severe disease (CAI > 14), extensive disease (inflammation extending proximal to the splenic flexure) or distal proctitis Additional exclusion criteria included the use of systemic or topical steroids within the preceding 4 weeks, or previous use of TNF‐α antagonists.
Interventions	Budesonide‐MMX® 9 mg once daily for 8 weeks (n = 18), or placebo (n = 18) for 4 weeks followed by Budesonide‐MMX® for a further 4 weeks
Outcomes	Primary outcome was the proportion of patients achieving clinical remission (CAI ≤ 4) or a clinical improvement (50% reduction in their CAI score) at 4 weeks Secondary outcomes included a reduction in clinical symptoms at 8 weeks, a reduction in CAI by 70% and changes in the Rachmilewitz Endoscopic Index Score at 4 and 8 weeks In both groups, morning cortisol levels were tested and ACTH stimulation tests were performed at 4 and 8 weeks
Notes	This trial was supported by Crinos S.p.A., Italy and Cosmo Technologies, Ireland, manufacturers of budesonide‐MMX®
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 (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Incomplete outcome data (attrition bias) All outcomes	Low risk	One patient was withdrawn at 2 weeks because of treatment failure (treatment group not stated) 5 patients who were initially randomised to the placebo arm were switched to open label treatment with budesonide at 2 weeks because of failure to improve or disease worsening with placebo
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