AIM: Combined pharmacological and endoscopic therapy is recommended for initial treatment of acute variceal bleeding (AVB). The optimal duration of therapy with a vasoactive agent is not well established. The aim of this study was to compare the efficacy and safety of 3-day and 5-day somatostatin treatment in the prevention of early rebleeding after endoscopic variceal ligation (EVL). METHODS: In a double-blind, prospective trial, cirrhotic patients with AVB who underwent EVL were randomly assigned to receive a continuous infusion of somatostatin for either 3 days or 5 days. RESULTS: A total of 95 patients were enrolled; 50 patients in the 3-day group and 45 patients in the 5-day group after initial hemostasis by combination therapy withsomatostatin and EVL. Both groups were comparable in terms of baseline data. Very early and early rebleeding within 5 days and 42 days occurred in one and three patient (2%, 6%) in the 3-day group and three and two patients (6.67%, 4.45%) in the 5-day group (P = 0.342, 0.735), respectively. Overall, eight patients died (three from variceal rebleeding and five from causes other than variceal bleed); four (8%) in the 3-day group and four (8.89%) in the 5-day group (P = 0.876). Multivariate analysis revealed that none of the factors was a predictor of rebleeding. No serious side-effects and complications were observed. CONCLUSION: A 3-day course of somatostatin is as effective as a 5-day course for the control of variceal bleeding and prevention of early rebleeding when used as combination therapy with EVL.
RCT Entities:
AIM: Combined pharmacological and endoscopic therapy is recommended for initial treatment of acute variceal bleeding (AVB). The optimal duration of therapy with a vasoactive agent is not well established. The aim of this study was to compare the efficacy and safety of 3-day and 5-day somatostatin treatment in the prevention of early rebleeding after endoscopic variceal ligation (EVL). METHODS: In a double-blind, prospective trial, cirrhotic patients with AVB who underwent EVL were randomly assigned to receive a continuous infusion of somatostatin for either 3 days or 5 days. RESULTS: A total of 95 patients were enrolled; 50 patients in the 3-day group and 45 patients in the 5-day group after initial hemostasis by combination therapy with somatostatin and EVL. Both groups were comparable in terms of baseline data. Very early and early rebleeding within 5 days and 42 days occurred in one and three patient (2%, 6%) in the 3-day group and three and two patients (6.67%, 4.45%) in the 5-day group (P = 0.342, 0.735), respectively. Overall, eight patients died (three from variceal rebleeding and five from causes other than variceal bleed); four (8%) in the 3-day group and four (8.89%) in the 5-day group (P = 0.876). Multivariate analysis revealed that none of the factors was a predictor of rebleeding. No serious side-effects and complications were observed. CONCLUSION: A 3-day course of somatostatin is as effective as a 5-day course for the control of variceal bleeding and prevention of early rebleeding when used as combination therapy with EVL.