Somatostatin v placebo in bleeding oesophageal varices: randomised trial and meta-analysis
BMJ 1995; 310 doi: https://doi.org/10.1136/bmj.310.6993.1495 (Published 10 June 1995) Cite this as: BMJ 1995;310:1495
- Peter C Gotzsche, registrara,
- Ida Gjorup, registrarb,
- Helen Bonnen, registrara,
- Niels Erik Bille Brahe, senior registrarb,
- Ulrik Becker, senior registrara,
- Flemming Burcharth, chief physicianb
- a Department of Medical Gastroenterology, Hvidovre Hospital, Denmark
- b Department of Surgical Gastroenterology, Herlev Hospital, Denmark
- Correspondence to: Dr Gotzsche, Director of Nordic Cochrane Centre, Research and Development Secretariat, Rigshospitalet, Blegdamsvej 9, DK-2100 Copenhagen O, Denmark.
- Accepted 4 April 1995
Abstract
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.
Key messages
Key messages
This study failed to show a benefit of somatostatin
Meta-analysis of the placebo controlled studies also failed to show a benefit
Treatment with somatostatin or octreotide cannot be recommended at present
Larger studies are needed to give a definitive answer
Footnotes
- Accepted 4 April 1995