Effect of sucralfate on peptic ulcer recurrence: a controlled double-blind multicenter study

We entered 174 patients with healed duodenal ulcer and 77 with healed gastric ulcer into a double-blind, placebo-controlled, 6-month trial to investigate the efficacy of 1 g sucralfate twice daily in preventing ulcer recurrence. Endoscopy was performed after 6 months or earlier for symptoms compatible with ulcer disease. The relapse rate in the 126 patients with duodenal ulcer who could be evaluated for efficacy was 14/66 (21.2%) under sucralfate and 30/60 (50%) under placebo treatment (p less than 0.01). No significant difference in relapse rate was found in the 55 gastric ulcer patients who could be evaluated; 11 of 30 (37%) relapsed on sucralfate and 11 of 25 (44%) relapsed on placebo. Among the duodenal ulcer patients in the placebo group, those who had been treated initially with H2-receptor blockers for acute ulcer had significantly more relapses than patients who had been treated with other drugs. The recurrence rate was independent of prior treatment in the sucralfate group. Duodenal ulcer patients with a history of multiple episodes of active ulcer disease had a significantly higher rate of relapse than patients with only a few previous episodes. Both treatments were well tolerated. Two patients in each treatment group complained of nausea and epigastric pain immediately after drug intake. No other drug-related symptoms were observed. We conclude that sucralfate is effective in the prophylaxis of duodenal ulcer. No significant effect was found in the prevention of gastric ulcer recurrence.(ABSTRACT TRUNCATED AT 250 WORDS)