A placebo-controlled, double-blind study of sucralfate in the short-term treatment of duodenal ulcer.

Seventy-six outpatients with endoscopically proven duodenal ulcer were entered into a double-blind, randomized, placebo-controlled study to assess the efficacy of sucralfate in ulcer healing. The patients were assigned to either sucralfate or placebo given in a dose of 2 tablets of 500 mg 4 times daily. Sixty-five patients were re-evaluated endoscopically at the end of the fourth week of treatment. Complete healing was observed in 24 of the 33 patients (72.7%) on sucralfate and 8 of 32 patients (25.0%) on placebo (Fisher's exact test; p = 0.0003). The improvement of subjective symptoms and the amount of antacid consumed were similar in the two groups. No serious side effects were noted.