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A Randomized Controlled Study of Propranolol for Prevention of Recurrent Gastrointestinal Bleeding in Patients with Cirrhosis: A Final Report
Author(s) -
Lebrec Didier,
Poynard Thierry,
Bernuau Jacques,
Bercoff Eric,
Nouel Olivier,
Capron JeanPierre,
Poupon Raoul,
Bouvry Michel,
Rueff Bernard,
Benhamou JeanPierre
Publication year - 1984
Publication title -
hepatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 5.488
H-Index - 361
eISSN - 1527-3350
pISSN - 0270-9139
DOI - 10.1002/hep.1840040301
Subject(s) - medicine , cirrhosis , propranolol , gastrointestinal bleeding , placebo , hepatic encephalopathy , gastroenterology , randomized controlled trial , ascites , upper gastrointestinal bleeding , surgery , endoscopy , alternative medicine , pathology
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.