Maintenance ranitidine treatment after haemorrhage from a duodenal ulcer. A 3-year study.

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 less than 0.001; symptoms, p less than 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 less than 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.

RCT Entities:   Population Interventions Outcomes