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Abstract
A multicenter randomized double-blind study was performed to compare a cyto-protective agent (sucralfate) and an acid-reducing agent (cimetidine) in the treatment of duodenal ulcer. Patients with acute ulcerations in the pyloric ring and duodenal bulb confirmed by endoscopy were included in the trial. All patients were examined after 4 and, if not cured, after 8 weeks. A total of 371 patients from 15 centers completed the trial. The patient groups were comparable. At 8 weeks 86% of 177 patients receiving sucralfate treatment were cured, compared with 92% of 194 receiving cimetidine (NS). The corresponding figures at 4 weeks were 71 % (sucralfate) and 77% (cimetidine) (NS). The 95% confidence interval for the difference in ulcer healing efficacy of sucralfate compared with cimetidine at 8 weeks was -12% to + 5%. Antacid intake and symptoms decreased rapidly in both groups. Three patients were withdrawn owing to side effects. It is concluded that sucralfate and cimetidine. representing two different approaches to ulcer therapy, are both very effective and compare well with regard to ulcer healing, symptom relief, and side effects in the short-term treatment of acute duodenal ulcer.