Maté‐Jiménez 2000.
| Methods | Randomized (in 2:2:1 ratio to methotrexate, 6‐MP, and 5‐ASA), single‐center, controlled clinical trial | |
| Participants | Radiological or endoscopic diagnosis of CD or UC and steroid dependent (N = 72) Steroid dependent was defined as those patients whose prednisone could not be lowered to 20 mg/day without presenting inflammatory activity determined by a Mayo Clinic Score of 7 or more or having presented more than two episodes in the last 6 months or more than 3 in the last 12 months None of the patients had received 6‐MP or methotrexate prior to entry Numbers for ulcerative colitis participants: Methotrexate n = 12, 6‐mercaptopurine n = 14, 5‐aminosalicylic acid n = 8 |
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| Interventions | Oral methotrexate 15 mg/wk or 6‐mercaptopurine 1.5 mg/kg/day or 5‐aminosalicylic acid 3 g/day for 30 weeks For 2 weeks after randomization no attempt was made to decrease prednisone dose, thereafter prednisone was decreased by 8 mg/week Prednisone was reduced if the condition of the patient remained stable or improved and discontinued if clinical remission was achieved Methotrexate was reduced to 10 mg/week and the 6‐mercaptopurine dose to 1 mg/kg/day if clinical remission was achieved Patients in the 5‐aminosalicylic acid group continued to receive 3 g/day after achieving remission and stopping prednisone |
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| Outcomes | Remission: prednisone stopped and Mayo Clinic Score < 7 | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not described in published study |
| Allocation concealment (selection bias) | Unclear risk | Not described in published study |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Not mentioned in published study Authors assumed the study was unblinded |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not described in published study |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 24/72 patients dropped out in the first 30 weeks of the trial (worst outcome assumed) |
| Selective reporting (reporting bias) | Unclear risk | Primary outcomes were reported Some post hoc outcomes were also reported |
| Other bias | Low risk | No other issues |