Maintenance Ranitidine Treatment after Haemorrhage from a Duodenal Ulcer: A 3-Year Study

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Abstract
Forty patients with a recently healed duodenal ulcer (DU) that presented with haemorrhage were entered into a blind, randomized study of maintenance ranitidine therapy (150 mg at night) versus a placebo preparation, to determine whether prolonged ranitidine therapy could influence the natural history of the ulcer diathesis. Duodenal ulceration or duodenal cap erosions of Lanza grade 3 recurred in 24 of the 40 patients studied during the 2-year trial period but was associated with further bleeding in only 2 cases. Maintenance ranitidine therapy significantly reduced the incidence and symptoms of DU/erosion recurrence at all time intervals beyond 3 months, the maximum protective effect being observed after 12 to 15 months of treatment (incidence, p < 0.001; symptoms, p < 0.03). The DU/erosion recurrence rate without treatment after 2 years of successful maintenance ranitidine therapy was significantly less than for patients randomized to the placebo group at entry to the study (p < 0.03). Two years of maintenance ranitidine therapy appear to be beneficial for patients who have a healed DU that presented with haemorrhage. This treatment, however, cannot be recommended without reservation until the implications of the associated high incidence of asymptomatic duodenal ulceration have been fully evaluated.