Efficacy of sucralfate in corpus, prepyloric, and duodenal ulcer-associated gastric ulcers. A double-blind, placebo-controlled study

Abstract

A 12-week study with two weekly endoscopic assessments was performed in 138 patients to compare the efficacy of sucralfate fine granules (900 mg one-half hour before breakfast, lunch, and dinner, and at bedtime) versus placebo in the healing of gastric ulcers prestratified into corpus, prepyloric, and duodenal ulcer-associated. For corpus and prepyloric ulcers, the respective healing rates achieved by sucralfate at six weeks (69 and 80 percent) and at eight weeks (80 and 93 percent) were significantly (p < 0.005) better than those obtained with placebo (33 and 25 percent at six weeks, and 41 and 33 percent at eight weeks). The design of the study permitted life-table analysis that further demonstrated the efficacy of sucralfate in these two ulcer types (p < 0.0001). Symptomatic response was likewise significantly better than with placebo. Similar healing rates and symptomatic responses were observed for patients with duodenal ulcer-associated gastric ulcer but were not significantly better with sucralfate than with placebo. From 38 prospectively obtained clinical, personal, physiological, and endoscopic characteristics, it was found that ulcer size and a history of pain had significant influence on healing with sucralfate. It is concluded that sucralfate is safe and effective for the treatment of corpus and prepyloric ulcers.