A prospective, randomised, multicentre, single-blind comparison of propranolol with placebo in the primary prevention of upper gastrointestinal haemorrhage was conducted in 230 cirrhotic patients with large oesophageal varices. The dose of propranolol was progressively increased until resting heart rate was reduced by 20 to 25%. The final doses were 40 mg of conventional propranolol and 160 and 320 mg of long-acting propranolol daily in 22, 60 and 18% of patients, respectively. Patients who survived without bleeding were followed up for 436 +/- 172 days (mean +/- SD). After 2 years, the cumulative percentages of patients free from bleeding were 74% in the propranolol group and 39% in the placebo group (p less than 0.05). Similarly, cumulative 2-year survival was 72% in the propranolol group and 51% in the placebo group (p less than 0.05). Propranolol was well tolerated and only 13 patients were withdrawn from treatment. We concluded that propranolol treatment decreased the incidence of first bleeding and death during a period of 2 years in patients with cirrhosis and large esophageal varices.