Effect of fifteen months of double-blind treatment with cimetidine and placebo on peptic ulcer recurrence.

Forty-Five consecutive patients with chronic peptic ulcer disease completed a double-blind controlled trial in which they were given cimetidine 0.8 g daily or placebo in order to evaluate the preventative effect of the drug on ulcer recurrence. On entering the trial all patients had endoscopically healed ulcers. Endoscopy was performed again at 6 and 15 months, or if there were severe epigastric pains. The period of medication was 15 months, and the patients still in remission at that time were observed for a further 9 months. During the course of the study 11 out of 23 patients (47.8%) in the placebo group developed re-ulceration, whereas 4 out of 22 (18.2%) patients relapsed while on cimetidine (p less than 0.05). There were significantly fewer weeks of dyspepsia and better general well-being in the cimetidine group as compared to the placebo group. No early ulcer recurrence or increased rebound acid secretion was noted after cessation of the cimetidine treatment. Vitamin B12 absorption was not affected by the 15-month cimetidine treatment. Two men developed gynaecomastia, one died of myocardial infarction and one had transient sinus bradycardia during cimetidine medication. Cimetidine improves the symptomatic state and postpones ulcer recurrence as long as treatment is maintained.

RCT Entities:   Population Interventions Outcomes