Comparative study between nadolol and 5-isosorbide mononitrate vs. endoscopic band ligation plus sclerotherapy in the prevention of variceal rebleeding in cirrhotic patients: a randomized controlled trial

Aliment Pharmacol Ther. 2006 Aug 15;24(4):601-11. doi: 10.1111/j.1365-2036.2006.03007.x. Epub 2006 Jul 10.


Background: After variceal bleeding, cirrhotic patients should receive secondary prophylaxis.

Aim: To compare nadolol plus 5-isosorbide mononitrate (5-ISMN) with endoscopic band ligation. The end points were rebleeding, treatment failure and death.

Methods: One hundred and nine cirrhotic patients with a recent variceal bleeding were randomized: nadolol plus 5-ISMN in 57 patients and endoscopic band ligation in 52 patients.

Results: The mean follow-up was 17 and 19 months in nadolol plus 5-ISMN and endoscopic band ligation groups, respectively. No differences were observed between groups in upper rebleeding (47% vs. 46%), variceal rebleeding (40% vs. 36%), failure (32% vs. 22%), major complications (7% vs. 13.5%) and death (19% vs. 20%), respectively. The actuarial probability of remaining free of rebleeding, failure and deaths were similar in both groups. Time to rebleeding shows that endoscopic band ligation patients had an early rebleed, with a median of 0.5 month (95% CI: 0.0-4.2) compared with patients from nadolol plus 5-ISMN, 7.6 months (95% CI: 2.9-12.3, P < 0.013). Multivariate analysis indicated that outcome-specific predictive factor(s) for rebleeding was Child A vs. B + C (P < 0.01); for failure was Child A vs. B + C (P < 0.02); and for death ascites (P < 0.01) and rebleeding (P < 0.02).

Conclusion: This trial suggests no superiority of endoscopic band ligation over nadolol plus 5-ISMN mononitrate for the prevention of rebleeding in cirrhotic patients.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Endoscopy, Gastrointestinal
  • Esophageal and Gastric Varices / drug therapy*
  • Female
  • Gastrointestinal Hemorrhage / prevention & control*
  • Humans
  • Isosorbide Dinitrate / analogs & derivatives*
  • Isosorbide Dinitrate / therapeutic use
  • Ligation / methods
  • Liver Cirrhosis / drug therapy*
  • Male
  • Middle Aged
  • Nadolol / therapeutic use*
  • Sclerotherapy / methods
  • Secondary Prevention


  • Nadolol
  • Isosorbide Dinitrate
  • isosorbide-5-mononitrate