[Randomized trial and meta-analysis of somatostatin versus placebo in bleeding esophageal varices]

Ugeskr Laeger. 1996 Apr 22;158(17):2393-6.
[Article in Danish]

Abstract

We studied whether somatostatin or its derivative, octreotide, is more effective than placebo in the treatment of bleeding oesophageal varices in a randomised, double-blind trial and a meta-analysis with blinded data analysis and manuscript writing. Patients suspected of bleeding from oesophageal varices and of having cirrhosis of the liver were eligible. Eighty-six patients were randomised; 16 died in each group within six weeks (95% confidence interval (CI) for difference in mortality -19% to 22%). There were no differences between somatostatin and placebo in median number of blood transfusions (8 vs 5, p = 0.07, CI 0 to 4 transfusions) or in numbers of patients who needed balloon tamponade (16 vs 13, p = 0.54, CI -11% to 28%). In a meta-analysis of three trials, involving 290 patients, somatostatin had no effect on survival compared with placebo (p = 0.59, odds ratio 1.16, CI 0.67 to 2.01). For blood transfusions and use of balloon tamponade there was heterogeneity between the trials with no convincing evidence in favour of somatostatin.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II
  • English Abstract
  • Meta-Analysis
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Esophageal and Gastric Varices / drug therapy*
  • Female
  • Gastrointestinal Agents / therapeutic use
  • Gastrointestinal Hemorrhage / drug therapy*
  • Hormone Antagonists / therapeutic use*
  • Humans
  • Male
  • Middle Aged
  • Neurotransmitter Agents / therapeutic use*
  • Octreotide / therapeutic use
  • Somatostatin / therapeutic use*

Substances

  • Gastrointestinal Agents
  • Hormone Antagonists
  • Neurotransmitter Agents
  • Somatostatin
  • Octreotide