Multicenter randomized controlled trial comparing different schedules of somatostatin in the treatment of acute variceal bleeding

Background/Aims: The dose of somatostatin used for variceal bleeding (250 μg/h) is lower than that proven to effectively decrease portal pressure and azygos blood flow (500 μg/h). Moreover, i.v. somatostatin boluses have greater effects than continuous infusions. The aim of this study was to investigate whether higher doses of somatostatin and repeated boluses may increase its efficacy in controlling variceal bleeding. Methods: A total of 174 patients with acute variceal bleeding were randomized to receive for 48 h: (A) one 250 μg bolus+250 μg/h infusion; (B) three 250 μg boluses+250 μg/h infusion; (C) three 250 μg boluses+500 μg/h infusion. Results: The three schedules of somatostatin were equally effective in controlling variceal bleeding (73, 75 and 81%, respectively, NS). Multivariate analysis showed active bleeding at endoscopy (n=75) as the only predictor of failure to control bleeding. In these patients, the 500 μg/h infusion dose achieved a higher rate of control of bleeding (82 vs. 60%, P<0.05), less transfusions (3.7±2.7 vs. 2.5±2.3 UU, P=0.07) and better survival (93 vs. 70%, P<0.05) than schedules A/B. Conclusions: Somatostatin is highly effective in controlling variceal bleeding. Patients with active bleeding at emergency endoscopy may benefit from higher doses of somatostatin infusion.