Comparison of sucralfate and ranitidine in the treatment of chronic nonerosive gastritis: A randomized, multicenter trial

Abstract

In a randomized trial involving 20 Italian centers, the effectiveness of 1 g sucralfate three times a day and 150 mg ranitidine twice a day in the treatment of chronic gastritis was assessed and compared. Five hundred outpatients with dyspeptic symptoms and endoscopic evidence of chronic nonerosive gastritis were randomly assigned to either treatment for a period of eight weeks. Endoscopic scores were determined at the beginning and at the end of the study. The severity of dyspeptic symptoms was assessed at Weeks 0, 2, 4, 6, and 8. Four hundred seventy-three patients completed the study. In 331 cases, biopsies were taken during endoscopy, and a histologic evaluation was also performed, according to Whitehead's criteria. Sucralfate was significantly more effective than ranitidine in inducing healing or improvement of both endoscopic (p <0.02) and histologic (p <0.001) features. At the end of the study, 77.6 percent of the patients in the sucralfate group and 79.4 percent in the ranitidine group were symptom free. Ranitidine was significantly more efficacious at relieving pain during the first four weeks of therapy. Mild side effects were reported by 4.9 percent of patients treated with sucralfate and by 3.6 percent of patients treated with ranitidine. Treatment was withdrawn in one patient treated with sucralfate because of nausea. In conclusion, sucralfate appears significantly superior to ranitidine in improving endoscopic and histologic aspects of chronic nonerosive gastritis. The symptomatic activity of the two drugs is similar, although more rapid relief is obtained with ranitidine.