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. 2014 Aug 1;2014(8):CD010233. doi: 10.1002/14651858.CD010233.pub2
Methods Randomised, multi‐centre double‐blind, double‐dummy, controlled trial
Participants CD patients before postoperative hospital discharge after ileocolic resection with a primary anastomosis for disease confined to the ileum and adjacent colon (N = 131)
Patients were excluded if there was evidence of disease proximal or distal to the site of resection
Interventions 6‐mercaptopurine 50 mg/day for 24 months (n = 47)
mesalamine 3 g/day for 24 months (n = 44)
placebo for 24 months (n = 40)
Outcomes Primary outcomes: clinical relapse (score of > 2 on the clinical recurrence grading scale) at 6, 12 and 24 months, radiographic relapse (a score of > 2 on the radiological recurrence grading scale) or endoscopic recurrence (score of > 2 on the Rutgeerts endoscopic scoring system) at 12 and 24 months
Secondary outcome: adverse events
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer randomisation in blocks of 6
Allocation concealment (selection bias) Low risk Centralized pharmacy randomisation
Blinding of participants and personnel (performance bias) All outcomes Low risk Double‐blind
Identical matching placebo
Incomplete outcome data (attrition bias) All outcomes Low risk Full data reported
Selective reporting (reporting bias) Low risk Appropriate data reported
Other bias Low risk None apparent