Treatment of acute duodenal ulcer--a Swedish multicenter study.

Medical ulcer therapy focuses on enhancing mucosal defence mechanisms or reducing intraluminal acidity. In this Swedish multicenter, randomized double-blind study these two principles were compared in the treatment of acute duodenal ulcerations. Sucralfate (Andapsin 1g X 4) or cimetidine (Tagamet 400mg X 2), together with antacid tablets (Novalucol), were supplied to patients with acute ulcerations in the pyloric ring or duodenal bulb. Endoscopy was performed at inclusion, after four weeks and in some patients also after eight weeks. Besides healing rate, symptoms and antacid intake, smoking and side effects were recorded on a special protocol. 371 patients from 15 centers completed the trial. At inclusion the patient groups did not differ in any essential aspect. At four weeks 71% of 177 patients on sucralfate and 77% of 194 on cimetidine were healed. The corresponding figures for eight weeks were 86% (suc) and 92% (cim). The difference is not significant, the 95% confidence interval for the difference in ulcer healing efficacy of sucralfate compared with cimetidine at eight weeks was -12% to +5%. Antacid intake and symptoms decreased rapidly and equally in both groups. Side effects related to the treatments were uncommon. It is concluded that sucralfate and cimetidine, representing two different principles in medical ulcer treatment, are both very effective and compare well in the short term treatment of acute duodenal ulcer.