This controlled trial was designed to evaluate the prophylactic effect of
nadolol on gastrointestinal
bleeding in cirrhotic patients with large oesophageal
varices who had never bled.
Nadolol or placebo was given randomly to two groups of 53 patients. The percentage of patients free of gastrointestinal
bleeding 1 year after inclusion in the study was 83 +/- 6% (mean +/- S.D.) in the
nadolol group and 80 +/- 6% in the placebo group. In the
nadolol and placebo groups, 40 and 47 patients, respectively, were compliant, i.e., took
nadolol or placebo continuously. The percentage of patients who were free of
bleeding 1 year after inclusion was 97 +/- 3% in the subgroup of compliant
nadolol patients. This percentage was significantly higher than that of patients who were free of
bleeding in the placebo group (P less than 0.03) as well as in the subgroup of compliant placebo patients (77 +/- 6%; P less than 0.02). We concluded that, although there was no overall significant effect of
nadolol on the risk of
bleeding in cirrhotic patients in good condition with large oesophageal
varices, this study suggests that
nadolol reduced the risk of
bleeding in compliant patients.