Cimetidine in the treatment of duodenal ulcer. A multicenter double blind study

The effect of cimetidine in duodenal ulcer disease was assessed in a double blind, controlled, prospective, multicenter clinical trial in both inpatients and outpatients. Endoscopic evidence of ulcer healing and symptom evaluation were monitored in 308 patients who received either 1.2 g of cimetidine per day or placebo for periods varying from 2 to 6 weeks. Both groups of patients received antacids only for symptom relief. At the end of 2 weeks of inpatient therapy, 56% of the cimetidine-treated patients and 37% of the patients treated with placebo (P < 0.05) showed evidence of ulcer healing. Similarly, 46 and 26% of the outpatients treated with cimetidine or placebo, respectively, for 2 weeks had ulcer healing (P < 0.05). At all other time intervals, ulcer healing occurred more frequently in the cimetidine patients than in the control group, but these differences did not achieve statistical significance. Evaluation of symptom relief (day pain, night pain, and severity of pain), "global efficacy," and antacid consumption rates supported the efficacy of cimetidine compared with placebo. The data from gastric secretory studies suggested that those patients treated with cimetidine who had lower rates of gastric acid secretion had an increased incidence of ulcer healing. In both the cimetidine- and placebo-treated groups there was little correlation between ulcer healing and symptom improvement. The results of this study demonstrate an acceleration of duodenal ulcer healing and an increased symptom response with cimetidine therapy.