Oren 1996.

Methods	Randomized, double‐blind, placebo‐controlled Duration of treatment and study was 9 months Prepackaged coded sets (equal number of methotrextae or placebo tablets) were delivered to each centre If all of these were used up subsequent randomization was performed by a central pharmacy
Participants	Patients with definite, chronic active ulcerative colitis (Mayo clinic score of > or = 7 at entry). Chronicity was defined as steroid therapy at > or = 7.5 mg/day for at least 4 months of the proceeding year. Ulcerative colitis was diagnosed by clinical, radiographic, endoscopic, and pathological criteria.(N = 67)
Interventions	Oral methotrexate (n=30; 12.5 mg/wk ‐ 2.5 mg/day) or identical placebo (n=37) for 9 months
Outcomes	Remission: a Mayo clinic score of < or = 3 (or Mayo score of < or = 2 without sigmoidoscopy results) Relapse: an increase of 3 or more points in the Mayo clinic score (not including sigmoidoscopy) and or reintroduction of steroids at a dose of > or = 300 mg/month.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	At the start of the study, each center received 4‐6 prepackaged code sets containing an equal number of methotrexate or placebo tablets sufficient for 9 months of therapy. Subsequent randomization was performed by the central pharmacy.
Allocation concealment (selection bias)	Low risk	Centralized pharmacy randomization
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Double blind. The investigators were blinded to treatment assignment. An unblinded independent observer was the only person who had access to the "drug key" in cases in which there was a compelling medical reason to break the code (and discontinue the trial) Methotrexate and placebo were in the same dosage form and quantities, and the tablets were administered in the similar fashion
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Double blind trial design
Incomplete outcome data (attrition bias) All outcomes	Low risk	A total of 11/67 patients withdrew from the study (methotrexate n = 2; placebo n = 9 , P < 0.052) All analyses were performed on an intention to treat basis
Selective reporting (reporting bias)	Low risk	All outcome were reported
Other bias	Low risk	No other issues