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. 1995 Jun 10;310(6993):1495–1498. doi: 10.1136/bmj.310.6993.1495

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

P C Gøtzsche 1, I Gjørup 1, H Bonnén 1, N E Brahe 1, U Becker 1, F Burcharth 1
PMCID: PMC2549875  PMID: 7787594

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.

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Selected References

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  1. Bornman P. C., Krige J. E., Terblanche J. Management of oesophageal varices. Lancet. 1994 Apr 30;343(8905):1079–1084. doi: 10.1016/s0140-6736(94)90186-4. [DOI] [PubMed] [Google Scholar]
  2. Burroughs A. K., McCormick P. A., Hughes M. D., Sprengers D., D'Heygere F., McIntyre N. Randomized, double-blind, placebo-controlled trial of somatostatin for variceal bleeding. Emergency control and prevention of early variceal rebleeding. Gastroenterology. 1990 Nov;99(5):1388–1395. doi: 10.1016/0016-5085(90)91166-4. [DOI] [PubMed] [Google Scholar]
  3. Greco A. V., Bianco A., Altomonte L., D'Acquarica L., Ghirlanda G. Effect of somatostatin on lower esophageal sphincter (les) pressure and serum gastrin in normal and achalasic subjects. Horm Metab Res. 1982 Jan;14(1):26–28. doi: 10.1055/s-2007-1018911. [DOI] [PubMed] [Google Scholar]
  4. Hanisch E., Doertenbach J., Usadel K. H. Somatostatin in acute bleeding oesophageal varices. Pharmacology and rationale for use. Drugs. 1992;44 (Suppl 2):24–72. doi: 10.2165/00003495-199200442-00005. [DOI] [PubMed] [Google Scholar]
  5. Kleber G., Sauerbruch T., Fischer G., Paumgartner G. Somatostatin does not reduce oesophageal variceal pressure in liver cirrhotics. Gut. 1988 Feb;29(2):153–156. doi: 10.1136/gut.29.2.153. [DOI] [PMC free article] [PubMed] [Google Scholar]
  6. Sheppard M., Shapiro B., Pimstone B., Kronheim S., Berelowitz M., Gregory M. Metabolic clearance and plasma half-disappearance time of exogenous somatostatin in man. J Clin Endocrinol Metab. 1979 Jan;48(1):50–53. doi: 10.1210/jcem-48-1-50. [DOI] [PubMed] [Google Scholar]
  7. Shulkes A., Wilson J. S. Somatostatin in gastroenterology. BMJ. 1994 May 28;308(6941):1381–1382. doi: 10.1136/bmj.308.6941.1381. [DOI] [PMC free article] [PubMed] [Google Scholar]
  8. Valenzuela J. E., Schubert T., Fogel M. R., Strong R. M., Levine J., Mills P. R., Fabry T. L., Taylor L. W., Conn H. O., Posillico J. T. A multicenter, randomized, double-blind trial of somatostatin in the management of acute hemorrhage from esophageal varices. Hepatology. 1989 Dec;10(6):958–961. doi: 10.1002/hep.1840100611. [DOI] [PubMed] [Google Scholar]
  9. Williams S. G., Westaby D. Management of variceal haemorrhage. BMJ. 1994 May 7;308(6938):1213–1217. doi: 10.1136/bmj.308.6938.1213. [DOI] [PMC free article] [PubMed] [Google Scholar]
  10. Yusuf S., Peto R., Lewis J., Collins R., Sleight P. Beta blockade during and after myocardial infarction: an overview of the randomized trials. Prog Cardiovasc Dis. 1985 Mar-Apr;27(5):335–371. doi: 10.1016/s0033-0620(85)80003-7. [DOI] [PubMed] [Google Scholar]

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