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 less than 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 less than 0.0001). Symptomatic response was likewise significantly better with
sucralfate 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, physiologic, 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.