A Cochrane review [Abstract] 1 included 3 studies with a total of 116 subjects. One 12-month trial compared naproxen plus methotrexate (MTX) with naproxen alone. Two 24-week trials compared different doses of MTX with placebo. No statistically significant differences were found for the primary outcome measures of physical function, pain, spinal mobility, peripheral joints/entheses pain, swelling and tenderness, changes in spine radiographs and patient and physician global assessment. Only the response rate in one trial showed a statistically significant benefit of 36% for a composite outcome index in the MTX group compared to the placebo group (RR 3.18, 95% CI 1.03 to 9.79). However, no single outcome showed a statistically significant difference between the MTX and placebo groups when endpoint results were compared. No serious side effects were reported in these trials.
Comment: The quality of evidence is downgraded by imprecise results (limited study size for each comparison) and by inconsistency (heterogeneity in outcomes).
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