Controlled trial of medical therapy for active upper gastrointestinal bleeding and prevention of rebleeding

Abstract This multicentered, placebo-controlled trial evaluated the efficacy of medical therapy to stop bleeding in 285 patients with active upper gastrointestinal bleeding (bleeding phase) and 194 patients who had ceased gastrointestinal bleeding and in whom therapy was instituted to prevent rebleeding during the same hospitalization (prevention phase). Patients in the bleeding phase were given cimetidine (300 mg every six hours) or intravenous placebo. There was no significant overall difference between intravenous cimetidine (71 percent) and placebo (77 percent) in stopping acute upper gastrointestinal bleeding. There was also no significant difference noted between intravenous cimetidine and placebo when specific bleeding lesions were evaluated. Once gastrointestinal bleeding had stopped, recurrence of bleeding while receiving prevention therapy (cimetidine tablets 300 mg one three times a day and at bedtime, or Mylanta II liquid 30 ml every hour, or cimetidine plus hourly antacids, or placebo) was evaluated in 194 of the patients in the bleeding phase. Twenty-four percent (12 of 51 patients) rebled while receiving cimetidine, 13 percent (five of 39 patients) rebled while receiving hourly antacids, 11 percent (six of 54 patients) rebled while receiving cimetidine plus hourly antacids, and 26 percent (13 of 50 patients) rebled while receiving placebo. None of these prevention regimens reached statistical significance (p = 0.13). Evaluation of specific bleeding lesions within this group also failed to show any significant value of prevention therapy. In conclusion: (1) intravenous cimetidine offers no advantage over placebo in stopping active upper gastrointestinal bleeding; (2) the occurrence of rebleeding during the same hospitalization does not appear to be significantly affected by any of the medical regimens used for prevention. These findings would suggest that the cessation of active bleeding and the prevention of recurrent upper gastrointestinal bleeding during a single hospitalization appear to be unaffected by therapy directed at acid neutralization or reduction.