Somatostatin v placebo in bleeding oesophageal varices: randomised trial and meta-analysis.

OBJECTIVE

To study whether somatostatin or its derivative octreotide is more effective than placebo for treating bleeding oesophageal varices.

METHODS

Randomised, double blind trial and meta-analysis with blinded analysis of data and writing of manuscripts.

SETTING

Departments of medical and surgical gastroenterology in Copenhagen.

SUBJECTS: Patients suspected of bleeding from oesophageal varices and of having cirrhosis of the liver.

MAIN OUTCOME MEASURES: Survival, number of blood transfusions, and use of Sengstaken-Blakemore tube.

RESULTS

86 patients were randomised; in each group 16 died within six weeks (95% confidence interval for difference in mortality--19% to 22%). There were no differences between those treated with somatostatin or placebo in median number of blood transfusions (8 v 5, P = 0.07, 0 to 4 transfusions) or in numbers of patients who needed balloon tamponade (16 v 13, P = 0.54, -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; 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. No placebo controlled trials have been performed with octreotide.

CONCLUSION

Within the limited power of this study and meta-analysis we were unable to show a clinical benefit of somatostatin in the emergency treatment of bleeding oesophageal varices.