Efficacy of once-daily cimetidine in preventing recurrence of duodenal ulcer.

In a prospective multicenter trial, 88 patients with acute duodenal ulcers that were healed with ranitidine were randomly assigned to receive maintenance treatment with either cimetidine 400 mg (n = 45) or placebo (n = 43) at bedtime for six months. Ten percent of the patients experienced moderate or severe pain both during the day and at night while on placebo during the maintenance phase. The average proportion of cimetidine patients experiencing moderate or severe pain during the day or night was 50% and 80% lower than placebo, respectively. Ulcer-like symptoms prompted endoscopy in 44% (19 of 43) of the placebo patients compared with 18% (eight of 45) of patients receiving cimetidine (P = 0.009). At the completion of the maintenance study, cumulative symptomatic ulcer recurrence rates were 28% (12 of 43) for those on placebo compared with 13% (six of 45) for cimetidine patients. The adverse drug effects noted were similar between treatment groups, with no unexpected reactions reported. A low dose of cimetidine (400 mg) at bedtime effectively reduced the incidence of gastrointestinal symptoms that were severe enough to prompt endoscopy as well as the actual recurrence of ulcers in those patients who had responded to initial therapy with ranitidine, but who continued to be at increased risk of reulceration.