Propranolol alone may not be acceptable to prevent first esophageal variceal bleeding in Japanese cirrhotic patients: randomized controlled trial

Abstract

Background and aim: In Japan, endoscopic injection sclerotherapy (EIS) is widely used to prevent first esophageal variceal bleeding, in contrast to pharmacological therapy which is the main treatment used in the rest of the world. The present study investigated if propranolol alone is acceptable to prevent first esophageal variceal bleeding in Japanese cirrhotic patients. This was compared with EIS.

Methods: Twenty-five Japanese cirrhotic patients with endoscopically proven, likely to bleed esophageal varices were randomly assigned for propranolol administration (12 patients; group A) and EIS (13 patients; group B) to prevent first esophageal variceal bleeding. Complications, non-recurrence rate, bleeding rate and probability of survival were compared between the two groups.

Results: One patient in group A had severe bradycardia with loss of consciousness that seriously worsened his quality of life. The cumulative non-recurrence rate of group A was significantly lower compared with that of group B (P < 0.05). In group A, 2 of the 12 patients requested to discontinue taking propranolol and were excluded from the trial. The EIS treatment (group B) showed excellent results. No patient in group A or group B bled from esophageal varices throughout this study. The two groups showed no statistically significant differences in probability of survival.

Conclusions: Propranolol alone may not be acceptable to prevent first esophageal variceal bleeding in Japanese cirrhotic patients.