OBJECTIVE Endoscopic sclerotherapy is considered a first line therapy to stop bleeding from esophageal varices, but acute variceal bleeding is still associated with high risk of rebleeding and death. We compared the use of octreotide with endoscopic sclerotherapy versus sclerotherapy alone to control acute variceal bleeding and prevent rebleeding in patients with cirrhosis. METHODS In a prospective controlled trial, 68 patients with cirrhosis and acute variceal bleeding who underwent emergency sclerotherapy were randomly assigned to receive a continuous infusion of octreotide or placebo for two days. The primary outcome measure was 7-day mortality. RESULTS After seven days the overall mortality was 19.1%, and the proportion of patients who died in octreotide group (8 of 40, or 20%) was similar to the placebo group (5 of 28, or 17.85%; p = 0.74). Rebleeding occurred in 20.6% (14 of 68 patients), being 20% (8 of 40) in the octreotide group vs. 21.4% (6 of 28) in the placebo group (p = 0.88). The mean number of units of blood transfused after sclerotherapy was 2.05 units in the octreotide group vs. 2.08 units in the placebo group (p = 0.96). Thirty patients needed intensive care support (20 of 40 in the octreotide group vs. 10 of 28 in the placebo group; p = 0.24). The differences remained without statistical significance even after adjustment for hepatic function and endoscopic bleeding stigmata by a linear regression model analysis test. CONCLUSIONS In patients with cirrhosis, octreotide intravenous per 48h associated with sclerotherapy is not superior to sclerotherapy alone in terms of 7-day mortality, frequency of rebleeding, number of units of packet red blood cell transfusion and length of stay in intensive care setting.