Löfberg 1996.

Methods	Double‐blind, double dummy, randomised controlled trial, comparing oral budesonide with prednisolone
Participants	Adult patients with mild to moderate, extensive and left‐sided UC, participated in the study (N = 72) Both hospitalised and outpatient UC patients were eligible for study inclusion Eligible patients had an endoscopic index score ≥ 2 in one or more colonic segments (Appendix 5) and had at least 4 bloody stools per day Oral sulphasalazine or 5‐ASA products were the only concomitant medications permitted, the doses of which were kept constant for the study duration Patients were excluded if they were treated with corticosteroids within 2 weeks of the study start date or if they were receiving acid‐blocking medications (H2‐antagonists and proton‐pump inhibitors) Pregnant and breast‐feeding patients were excluded in addition to patients with liver disease, diabetes or untreated hypertension Participants were withdrawn from the trial if their medical condition deteriorated significantly or if there was no improvement after 2 weeks of treatment
Interventions	Intervention: Budesonide Capsules, starting dose 6 mg in the morning and 4 mg in the evening, for the first 4 weeks (n = 34) During weeks 5 to 7 the dose was reduced to 4 mg in the morning and evening. For the final 2 weeks, the dose administered was 4 mg in the morning The active drug was contained within a capsule and consisted of acid‐resistant pellets, designed to have a sustained release throughout the colon Active Control: Prednisolone, starting dose was 40 mg once daily (n =38) Tapering began after 2 weeks, with a reduction in the dose of 5 mg weekly until week 8, during which patients received 7.5 mg once daily A dose of 5 mg daily was administered during week 9
Outcomes	The primary outcome was a change in endoscopic and histological scores of inflammation and an improvement in laboratory parameters. Clinical symptoms (daily bowel motions, presence or absence of blood or mucus) were recorded in a daily diary. Patients had a colonoscopy at study entry and following 4 weeks of therapy. A sigmoidoscopy was performed at the 2 and 9 week visits. Biopsies were taken from each colonic segment and from the most severely inflamed sites. The authors also aimed to evaluate to effect of budesonide on the adrenocortical system. At each follow‐up visit an early morning cortisol level was measured. Outcomes were assessed at 2, 4 and 9 weeks.
Notes	This trial was supported by Astra Draco AB, Lund Sweden, the manufacturers of the budesonide evaluated in the study
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Patients were randomly allocated to treatment with either oral budesonide or oral prednisolone from blocks of four at each of the participating nine centres
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding (performance bias and detection bias) All outcomes	Unclear risk	All biopsy specimens were examined for the presence of inflammation by a pathologist who was blinded to the patient treatment group It is unclear if endoscopists were blinded to the patient treatment group.
Blinding (performance bias and detection bias) Treatment Allocation	Unclear risk	Patients were blinded to their treatment ‐ dummy pills of the alternative medication were used throughout the study The pathologist was blinded to the treatment group for their assessment of endoscopic inflammation We are not told whether the treating physicians were also blinded to the treatment allocation
Incomplete outcome data (attrition bias) All outcomes	Low risk	Missing outcome data were balanced in numbers across intervention groups with similar reasons for missing data across groups
Selective reporting (reporting bias)	Low risk	Analyses and results are in accordance with the predefined study protocol
Other bias	Low risk	The study appears to be free of other sources of bias