A Randomized Controlled Study of Propranolol for Prevention of Recurrent Gastrointestinal Bleeding in Patients with Cirrhosis: A Final Report
Article first published online: 24 JUL 2008
Copyright © 1984 American Association for the Study of Liver Diseases
Volume 4, Issue 3, pages 355–358, May-June 1984
How to Cite
Lebrec, D., Poynard, T., Bernuau, J., Bercoff, E., Nouel, O., Capron, J.-P., Poupon, R., Bouvry, M., Rueff, B. and Benhamou, J.-P. (1984), A Randomized Controlled Study of Propranolol for Prevention of Recurrent Gastrointestinal Bleeding in Patients with Cirrhosis: A Final Report. Hepatology, 4: 355–358. doi: 10.1002/hep.1840040301
- Issue published online: 24 JUL 2008
- Article first published online: 24 JUL 2008
- Manuscript Accepted: 13 DEC 1983
- Manuscript Received: 21 SEP 1982
We have previously reported the results of a controlled trial showing that continuous oral administration of propranolol reduced the risk of recurrent gastrointestinal bleeding in patients with cirrhosis; only part of our patients had been followed for 1 year. This controlled trial was continued for an additional year; accordingly, all of our patients have now been followed for at least 2 years. The purpose of the present study is to determine whether prolonged administration enhances the efficacy of this therapy.
Seventy-four patients with cirrhosis, admitted for an episode of gastrointestinal bleeding, were included in this study; ascites, jaundice and encephalopathy were absent or mild and transient. The patients were randomly assigned to two groups; one group of 38 patients received propranolol twice daily at doses that reduced the resting heart rate by 25%, the other group of 36 patients received a placebo twice daily. The cumulative percentages of patients free of recurrent gastrointestinal bleeding 1 and 2 years after inclusion were 87 and 79% in the propranolol group, and 42 and 32% in the placebo group; both differences were highly significant (p < 0.0001). Furthermore, the cumulative percentages of surviving patients 1 and 2 years after inclusion were 94 and 90% in the propranolol group, and 84 and 57% in the placebo group; the difference between the two groups was not significant at 1 year, but was statistically significant at 2 years (p < 0.02). We conclude that, in patients with cirrhosis in good condition, propranolol reduced the risk of recurrent gastrointestinal bleeding and the mortality rate during the 2-year period of continuous oral administration of the drug.