Randomized, double-blind, placebo-controlled trial of somatostatin for variceal bleeding. Emergency control and prevention of early variceal rebleeding.
A randomized, double-blind, placebo-controlled trial of somatostatin was conducted among 120 patients admitted for bleeding esophageal varices (59 placebo, 61 somatostatin). An initial 250-micrograms bolus of somatostatin followed by a 5-day continuous infusion of 250 micrograms/h and an identical administration of placebo were evaluated for both the control of bleeding and prevention of early rebleeding from varices. Failure to control bleeding occurred in 22 (36%) somatostatin patients vs. 35 (59%) placebo patients, with time to failure occurring earlier with placebo (P = 0.036). blood and plasma transfused per hour during drug infusion of trial drug was reduced in the somatostatin group: median 0.033 vs. 0.105 unit/h (P = 0.025). Use of balloon tamponade was halved in somatostatin-treated patients. The average effect of somatostatin was a 41% reduction in the hazard of failure (95% confidence interval, -1% to 65%, P = 0.0545) after adjustment for the severity of liver disease, which was the only other variable having a significant influence on time to failure. There was no difference in 30-day mortality per admission (7 placebo, 9 somatostatin) or complications. It is concluded that somatostatin is safe and more effective than placebo for the control of variceal bleeding.
Burroughs
A K
AK
Hepato-biliary and Liver Transplantation Unit, Royal Free Hospital, Hampstea, London, England.
McCormick
P A
PA
Hughes
M D
MD
Sprengers
D
D
D'Heygere
F
F
McIntyre
N
N
D000293:Adolescent; D000328:Adult; D000368:Aged; D021721:Balloon Occlusion; D001803:Blood Transfusion; D002404:Catheterization; D003131:Combined Modality Therapy; D004311:Double-Blind Method; D004932:Esophageal and Gastric Varices / Q000150:complications*; D005260:Female; D006471:Gastrointestinal Hemorrhage / Q000188:drug therapy* / Q000209:etiology / Q000628:therapy; D006801:Humans; D007275:Injections, Intravenous; D008297:Male; D008875:Middle Aged; D013004:Somatostatin / Q000008:administration & dosage / Q000627:therapeutic use*
D013004:Somatostatin