Single nocturnal dose of ranitidine in the treatment of duodenal ulcer: results of an open multicenter, comparative trial

This prospective multicentric randomized open trial was designed to evaluate the efficacy of ranitidine 150 mg bid vs 300 mg nocte in the short-term (4 weeks) treatment of duodenal ulcer in 15 Brazilian centers. On the basis of a randomization table 190 patients with endoscopically confirmed duodenal ulcer were allocated to receive either ranitidine 150 mg bid (94 pts) or 300 mg nocte (96 pts). The 2 treatment groups were well matched for age, sex, duration of ulcer disease, number and size of ulcers, duration of current episode, intensity of ulcer pain, alcohol and coffee intake and smoking habits. They were endoscopically controlled at the end of the 4 weeks. At 4 weeks 78 of 94 patients (83.0%) had their ulcers healed with the 150 mg bid regimen as opposed to 79 of 96 patients (82.3%) allocated to the 300 mg nocte dosage. This difference was not statistically significant. Ulcer symptoms diminished with treatment in both groups. The tolerability and compliance was excellent in both groups. The results show that ranitidine 300 mg nocte is as effective in the short-term treatment of duodenal ulcer as ranitidine 150 mg bid. Considering the greater simplicity of administration enhancing patient compliance, the treatment with 300 mg nocte is preferable.