SOMATOSTATIN V PLACEBO IN BLEEDING ESOPHAGEAL-VARICES - RANDOMIZED TRIAL AND METAANALYSIS

Objective-To study whether somatostatin or its derivative octreotide i s more effective than placebo for treating bleeding oesophageal varice s. Methods-Randomised, double blind trial and meta-analysis with blind ed analysis of data and writing of manuscripts. Setting-Departments of medical and surgical gastroenterology in Copenhagen. Subjects-Patient s suspected of bleeding from oesophageal varices and of having cirrhos is of the liver. Main outcome measures-Survival, number of blood trans fusions, and use of Sengstaken-Blakemore tube. Results-86 patients wer e randomised; in each group 16 died within six weeks (95% confidence i nterval for difference in mortality -19% to 22%). There were no differ ences between those treated with somatostatin or placebo in median num ber of blood transfusions (8 v 5, P=0.07, 0 to 4 transfusions) or in n umbers 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 so matostatin had no effect on survival compared with placebo (P=0.59, od ds ratio 1.16; 0.67 to 2.01). For blood transfusions and use of balloo n tamponade there was heterogeneity between the trials with no convinc ing evidence in favour of somatostatin. No placebo controlled trials h ave been performed with octreotide. Conclusion-Within the limited powe r of this study and meta-analysis we were unable to show a clinical be nefit of somatostatin in the emergency treatment of bleeding oesophage al varices.