Double-blind comparison of the antirheumatic activity and gastric side-effects of indomethacin used alone or in combination with a gastro-protective agent, proglumide.

A double-blind placebo controlled trial was carried out in 32 hospitalized patients with various rheumatic disorders to assess the therapeutic effectiveness and gastric tolerance of indomethacin (150 mg/day) used alone or in combination with proglumide (900 mg/day). Patients were treated for periods ranging from 20 to 28 days. The therapeutic response to both treatments, as assessed by objective criteria and final overall evaluation, was not significantly different. There was, however, a marked difference in gastric disturbance between the two groups. Uropepsinogen levels increased significantly during treatment in patients receiving indomethacin plus placebo but decreased significantly after Day 10 in those receiving proglumide. Although stomach X-ray or faecal occult blood investigations showed litle change from normal in either group, no gastric side-effects were reported in the proglumide patients whereas only 2 of the 16 patients receiving indomethacin plus placebo were entirely free of such side-effects throughout the trial, and most had developed gastric symptoms by the 9th day of treatment.