SCLEROTHERAPY WITH OR WITHOUT OCTREOTIDE FOR ACUTE VARICEAL BLEEDING

Background. Sclerotherapy is considered the most effective way to stop bleeding from esophageal varices, but acute variceal bleeding is stil l associated with a high risk of rebleeding and death. We compared scl erotherapy alone with sclerotherapy and octreotide to control acute va riceal bleeding and prevent early rebleeding in patients with cirrhosi s. Methods. In a double-blind, prospective trial, 199 patients with ci rrhosis and acute variceal bleeding who underwent emergency sclerother apy were randomly assigned to receive a continuous infusion of octreot ide (25 mu g per hour) or placebo for five days. The primary outcome m easure was survival without rebleeding five days after sclerotherapy. Results. After five days, the proportion of patients who had survived without rebleeding was higher in the octreotide group (85 of 98 patien ts, or 87 percent) than in the placebo group (72 of 101, or 71 percent ; 95 percent confidence interval for the difference, 4 to 27 percent; P = 0.009). The mean number of units of blood transfused within the fi rst 24 hours after sclerotherapy was lower in the octreotide group (1. 2 units; range, 0 to 7) than in the placebo group (2.0 units; range, 0 to 10; P=0.006). A logistic-regression analysis showed that the treat ment assignment (P=0.003) and the number of blood units transfused bef ore any other treatment was undertaken (P = 0.002) were the only two v ariables independently associated with survival without rebleeding. Af ter adjustment for base-line differences between the two groups, the o dds ratio for treatment failure in the placebo group, as compared with the octreotide group, was 3.3 (95 percent confidence interval, 1.5 to 7.3). The mean (+/-SD) 15-day cumulative survival rate (estimated by the Kaplan-Meier method) was 88+/-12 percent in both groups. Side effe cts were minor, and their incidence was similar in the two groups. Con clusions. In patients with cirrhosis, the combination of sclerotherapy and octreotide is more effective than sclerotherapy alone in controll ing acute variceal bleeding, but there is no difference between the ov erall mortality rates associated with the two approaches to treatment.