Cimetidine vs placebo in duodenal ulcer therapy. Six-week controlled double-blind investigation without any antacid therapy.

We studied the healing efficacy of cimetidine or placebo in 23 endoscopically proven duodenal ulcer outpatients in a randomized, controlled, prospective, double-blind trial. There were 11 patients in the cimetidine (1200 mg daily) treatment group and 12 patients in the placebo-treated group. No antacid was allowed, but a placebo antacid with no neutralizing capacity was given as needed for pain. The incidence of complete endoscopic healing at 2, 4, and 6 weeks was 54%, 63%, and 72% in the cimetidine-treated patients and 8%, 50%, and 67% in the placebo-treated patients. There was a statistically significant difference (P < 0.05) in complete duodenal ulcer healing between both treatment groups after 2 weeks of therapy, but there was no significant difference at the 4- and 6-week observation periods. The incidence of complete pain relief at 2 and 4 weeks was 64% and 82% in the cimetidine-treated patients and 67% and 75% in the placebo-treated patients. At 6 weeks of treatment there was no increase in the number of patients with complete pain relief in either group. There was no significant difference between the two groups in the incidence of ulcer pain relief at any of the three observation periods. Duodenal ulcer healing rates and duodenal ulcer pain relief were compared at 2, 4, and 6 weeks. There was no statistical association between ulcer healing and complete pain relief in the placebo treatment group at the 2-week evaluation period, but there was statistical association (P < 0.05) in the cimetidine treatment group at 2 weeks and both treatment groups at the 4- and 6-week evaluation periods. The results of this study demonstrate that in duodenal ulcer out-patients treated for 6 weeks: (1) cimetidine increases the incidence of duodenal ulcer healing during the first 2 weeks of treatment; (2) more than 50% of duodenal ulcers will spontaneously heal during a 4 to 6-week observation period which is not statistically modified by cimetidine treatment; (3) the complete relief of duodenal ulcer pain is not influenced by treatment with cimetidine when compared to placebo.