Oren 1997.
Methods | Randomized, double‐blind, placebo‐controlled, multi‐center trial | |
Participants | Chronic active Crohn's disease (HBI > 7), on steroids (> 7.5 mg/day; prednisone equivalent dose) and/or immunosuppressives for at least 4 months during the past year, no immunosuppressives 3 months prior to entry Unacceptable steroid side effects or failure to respond to high‐dose steroids were also considered reasons for inclusion (N = 84) | |
Interventions | Oral methotrexate (12.5 mg/wk, n = 26), 6‐mercaptopurine (50 mg/day, n = 32) or placebo (n = 26) for 9 months Prednisone and 5‐ASA were continued at the discretion of the physician | |
Outcomes | Remission (HBS < 3) and not receiving steroids Maintenance of remission in patients entering first remission up to the 9 month follow‐up Relapse was defined as a rise of 3 or more points on the HBI and/or a reintroduction of steroids at a dose of > 300 mg/month Decrease in steroid requirement General well being All data analysis was performed on an intention to treat basis |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | The manuscript does not describe the method used for randomization |
Allocation concealment (selection bias) | Unclear risk | The manuscript does not describe methods used for allocation concealment |
Blinding (performance bias and detection bias) All outcomes | Low risk | The investigators were blinded to treatment assignment An unblinded independent observer and the pharmacist were the only persons who had access to the drug key |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Dropouts and treatment failures were not significantly different between the three groups ITT analysis was used |
Selective reporting (reporting bias) | Low risk | The published report included all expected outcomes |
Other bias | Low risk | The study appears to be free of other sources of bias |