One hundred eighteen cirrhotics with esophageal varices were blindly randomized to receive 20 mg of isosorbide-5-mononitrate three times a day (n = 57) or propranolol (n = 61) up to the maximum tolerated dose . Both groups also received ranitidine (150 mg/day). The median follow-up was 29 months. Eighteen patients died (9 in the isosorbide-treated group), 6 due to bleeding. The 1- and 2-year actuarial percentages of patients free of bleeding was 90.8% and 82.2% in the isosorbide-5-mononitrate, and 93.9% and 85.8% in the propranolol-treated groups, respectively (P = NS). There were few major side effects in either group. The 2-year survival rate did not differ between the two groups (82.2% vs. 85.4%).
Comment: The quality of evidence is downgraded by imprecise results (limited study size).