Propranolol and endoscopic sclerosis of esophageal varices are the two approaches currently used in prophylaxis of the first gastrointestinal hemorrhage in the cirrhotic patient. One hundred twenty-six cirrhotic patients with esophageal varices and no histories of bleeding were included in the trial regardless of the gravity of the cirrhosis or the size of the esophageal varices. Patients with hepatocarcinomas or other cancers, clearly impossible follow-up, previous treatment for portal hypertension or contraindication to β-blockers were excluded. After randomization, 43 patients received propranolol twice daily at a dose reducing the heart rate by 25%; 42 patients were treated with intravariceal and extravariceal injections of Polidocanol; 41 control patients received vitamin K orally as placebo. The patients were seen at 3-mo intervals for 2 yr. On entry to the trial the three groups were comparable in terms of clinical and biological parameters, including size of esophageal varices (grade I = 51, grade II = 54, grade III = 17), Child-Pugh classification (A = 29, B = 61, C = 32) and the origin of cirrhosis (alcoholic in 79% of cases).
Twenty-four patients bled (two bled in the propranolol group, nine bled in the endoscopic sclerosis of esophageal varices group and 13 bled in the placebo group). Actuarial estimates (Kaplan-Meier) of the time of onset of first bleeding showed that the differences were significant between propranolol and placebo (p < 0.004) and between propranolol and sclerotherapy (p < 0.03) but not between sclerotherapy and placebo. The multivariate Cox model indicated that the size of esophageal varices and the Child-Pugh class were prognostic factors for the onset of GI bleeding; the treatment effect remained after adjusting for these factors. No significant difference in survival was observed among the three treatment groups. The multivariate Cox model indicated that female gender and Child-Pugh class were factors predictive of survival and that treatment played no part in predicting survival. In conclusion, our study suggests that propranolol is effective in preventing the first gastrointestinal bleeding in the cirrhotic patient but does not improve the survival rate. (HEPATOLOGY 1990;12:1413–1419).