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. 2014 Aug 6;2014(8):CD003459. doi: 10.1002/14651858.CD003459.pub4

Feagan 1995.

Methods Randomized, double‐blind placebo‐control
 7 centers
Participants Active disease, symptoms at least 3 months despite prednisone > 12.5 mg/day, at least one attempt to discontinue
Stratified according to prednisone dose < or > 20 mg/day
 N = 141
Interventions Intramuscular methotrexate 25 mg/week (n = 94) or placebo (n = 47) for 16 weeks
 Prednisone co‐intervention: all patients, dose adjusted to 20 mg daily at the start of the study, constant dose 2 weeks, then tapered 2.5 mg/week, dose increased to maximum 40 mg/week for worsening; tapering 5 mg/week until 20 mg, then 2.5 mg/week
 5‐aminosalicylates: not permitted
Outcomes Remission: prednisone stopped and CDAI < 150
 Mean CDAI score
 Quality of life (IBDQ)
 Steroid sparing effect
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer generated randomization
Allocation concealment (selection bias) Low risk Centralized randomization
Blinding (performance bias and detection bias) 
 All outcomes Low risk Double‐blind
The placebo was identical in appearance to the active drug and the investigators were unaware of the treatment assignments
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No patients were lost to follow‐up
The same proportion of patients were withdrawn from treatment prematurely in the two groups (28%)
Selective reporting (reporting bias) Low risk All outcomes were reported
Other bias Low risk No other issues
HHS Vulnerability Disclosure