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 |
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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data (attrition bias) All outcomes | Low risk | No patients were lost to follow‐up The same proportion of patients were withdrawn from treatment prematurely in the two groups (28%) |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 |