title: [Randomized trial and meta-analysis of somatostatin versus placebo in bleeding esophageal varices].
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.
authors.affiliation: Medicinsk gastroenterologisk afdeling, Hvidovre Hospital.
authors.forename: P C
authors.initials: PC
authors.lastname: Gøtzsche
authors.forename: I E
authors.initials: IE
authors.lastname: Gjørup
authors.forename: H
authors.initials: H
authors.lastname: Bonnén
authors.forename: N E
authors.initials: NE
authors.lastname: Brahe
authors.forename: P U
authors.initials: PU
authors.lastname: Becker
authors.forename: F
authors.initials: F
authors.lastname: Burcharth
mesh_terms: D000368:Aged; D004932:Esophageal and Gastric Varices / Q000188:drug therapy*; D005260:Female; D005765:Gastrointestinal Agents / Q000627:therapeutic use; D006471:Gastrointestinal Hemorrhage / Q000188:drug therapy*; D006727:Hormone Antagonists / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D018377:Neurotransmitter Agents / Q000627:therapeutic use*; D015282:Octreotide / Q000627:therapeutic use; D013004:Somatostatin / Q000627:therapeutic use*
chemical_list: D005765:Gastrointestinal Agents; D006727:Hormone Antagonists; D018377:Neurotransmitter Agents; D013004:Somatostatin; D015282:Octreotide
vernacular_title: Randomiseret undersøgelse og metaanalyse af somatostatin over for placebo ved blødende esophagusvaricer.