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.