A Cochrane review included 2 studies with a total of 101 subjects. The first study randomized 30 patients to methotrexate 12.5 mg orally weekly and 37 patients to placebo for 9 months. During the study period, 14/30 patients (47%) assigned to methotrexate, and 18/37 patients (49%) assigned to placebo achieved remission and complete withdrawal from steroids (OR 0.92, 95% CI 0.35 to 2.42; P = 0.87). The mean time to remission was 4.1 months in the methotrexate group and 3.4 months in the placebo group.
The other study (n = 34) compared oral methotrexate (15 mg/week) to 6-mercaptopurine (1.5 mg/kg/day) and 5-aminosalicylic acid (3 g/day). There were no statistically significant differences in the proportion of patients who achieved clinical remission and withdrawal from steroids. At 30 weeks, 58% (7/12) of methotrexate patients achieved clinical remission and withdrawal from steroids compared to 79% (11/14) of 6-mercaptopurine patients (RR 0.74, 95% CI 0.43 to 1.29) and 25% of 5-aminosalicylic acid patients (RR 2.33, 95% CI 0.64 to 8.49).
Comment: The quality of evidence is downgraded by imprecise results (few patients and wide confidence intervals) and by indirectness (low dose).