[The randomized controlled trial of isosorbide mononitrate plus propranolol compared with propranolol alone for the prevention of variceal rebleeding]
Author(s): Zhang Q, Yuan R, Wang H
Affiliation(s): Gastroenterology Department, The Branch of Shanghai First People's Hospital. Shanghai 200081, China.
Publication date & source: 2002-09-10, Zhonghua Yi Xue Za Zhi., 82(17):1157-9.
Publication type: Clinical Trial; Randomized Controlled Trial
OBJECTIVE: The aim of this study was to test the effectiveness of isosorbide-5-mononitrate (IM) as an adjunct to propranolol (PR) in the prevention of variceal rebleeding. METHODS: Seventy-six cirrhotic patients with variceal bleeding were randomly assigned to treatment with PR + IM (34 patients) or PR alone (32 patients). RESULTS: Seven patients in the PR + IM group and 13 in the PR group had rebleeding during the 1 year after randomization. The actuarial probability of rebleeding 1 years after randomization was lower in the PR + IM group but the difference was not significant (P = 0.09). However, by adding an additional 8 months of follow-up, the decrease in the risk of rebleeding reached statistical significance (P = 0.05). No significant difference was found in rebleeding index and survival. The multivariate Cox analysis indicated both treatment (P = 0.04), severity of liver disease (P = 0.03) and age (P = 0.045) were factors predictive of rebleeding and second, that PR + MI reduced the risk of rebleeding by half (relative risk: 0.54). CONCLUSION: These results suggest that the addition of IM improves the efficacy of PR alone in the prevention of variceal rebleeding in cirrhotic patients. However no beneficial effects were observed on other parameters reflecting the efficacy of treatment.