[Efficacy of ranitidine and cimetidine in the treatment of gastric or duodenal ulcer resistant to an initial treatment with cimetidine. Multicenter controlled therapeutic trial]

Abstract

In a controlled clinical trial conducted in 28 centers, 354 ambulatory patients with a cimetidine-resistant duodenal or gastric ulcer (at least six weeks of treatment at a dose of 1 g/day) confirmed by endoscopy were allocated at random to either ranitidine or cimetidine treatment: 166 patients received cimetidine (1.6 g/day in 4 oral doses), and 188, ranitidine (0.3 g/day in 2 oral doses). The two groups differed significantly with regard to sex and history of gastrointestinal hemorrhage but not with regard to age, weight, history of peptic disease, history of perforated ulcer, duodenal/gastric ulcer ratio, number of smokers and alcohol consumers. The criterion of effectiveness was endoscopic healing of the ulcer after six weeks of treatment; in case of doubt, vital staining with methyl blue was performed. A significant difference was observed between the results of the two treatments in the duodenal group (p less than 0.05) but not in the gastric group, the healing rates being respectively 71 p. 100 and 65 p. 100 with ranitidine, and 59 p. 100 and 44 p. 100 with cimetidine. Twelve patients developed side-effects with a highly significant difference between the two groups: 11 patients under cimetidine and one patient under ranitidine (p less than 0.001). These results show the effectiveness of ranitidine as a complementary treatment in cimetidine-resistant peptic ulcers of duodenal location.