Somatostatin analogues for acute bleeding oesophageal varices.
BACKGROUND
Somatostatin and its derivatives are often used for emergency treatment of bleeding oesophageal varices in patients with cirrhosis of the liver.


OBJECTIVE
To study whether somatostatin or analogues improve survival or reduce the need for blood transfusions in patients with bleeding oesophageal varices.


METHODS
MEDLINE and The Cochrane Library were searched; last search in Febr 2004. Reference lists of articles, contacted authors.


METHODS
All randomised trials comparing somatostatin or analogues with placebo or no treatment in patients suspected of acute or recent bleeding from oesophageal varices.


METHODS
The effect variables extracted were: mortality, blood transfusions, use of balloon tamponade, initial haemostasis and rebleeding. Intention-to-treat analyses including all randomised patients were conducted; a random effects analysis was preferred if there was significant heterogeneity between the trials (P < 0.10). The trials were divided in two quality groups; the better trials had concealed allocation of patients and were double-blind.


RESULTS
We included 20 trials (2518 patients). The drugs did not reduce mortality significantly (relative risk 0.96, 95% confidence interval 0.74 to 1.24, for the high-quality trials, and 0.79 for low-quality trials). Units of blood transfused were 0.7 (0.3 to 1.2) less with drugs in the high-quality trials and 1.5 (0.9 to 2.0) less in the low-quality trials. Number of patients failing initial haemostasis was reduced, relative risk 0.67 (0.53 to 0.86). Number of patients with rebleeding was not significantly reduced for the high-quality trials, relative risk 0.82 (0.45 to 1.49) while it was substantially reduced in the low-quality trials, relative risk 0.35 (0.18 to 0.67). Use of balloon tamponade was rarely reported.


CONCLUSIONS
The effect corresponded to one half unit of blood saved per patient. It is doubtful whether this effect is worthwhile. The findings do not suggest a need for further placebo-controlled studies of the type reviewed here. A large placebo controlled trial enrolling thousands of patients is needed if one wishes to rule out the possibility that a worthwhile effect on mortality may have been overlooked.
Gøtzsche
P C
PC
Nordic Cochrane Centre, Rigshospitalet, Dept. 7112, Blegdamsvej 9, Copenhagen Ø, Denmark, 2100. pcg@cochrane.dk
Hróbjartsson
A
A
D000208:Acute Disease; D001803:Blood Transfusion / Q000706:statistics & numerical data; D004932:Esophageal and Gastric Varices / Q000188:drug therapy* / Q000401:mortality; D006471:Gastrointestinal Hemorrhage / Q000188:drug therapy* / Q000401:mortality; D006490:Hemostatics / Q000627:therapeutic use*; D006801:Humans; D015282:Octreotide / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D013004:Somatostatin / Q000627:therapeutic use*
D006490:Hemostatics; D013004:Somatostatin; D015282:Octreotide