Somatostatin plus isosorbide 5-mononitrate versus somatostatin in the control of acute gastro-oesophageal variceal bleeding: a double blind, randomised, placebo controlled clinical trial

Background-Variceal bleeding is a severe complication of portal hypertensio n. Somatostatin reduces portal pressure by decreasing splanchnic blood flow and nitrates by diminishing intrahepatic resistance. Experimental studies have shown that the combination of somatostatin and nitrates has an additiv e effect in decreasing portal pressure. Aim-To compare the therapeutic efficacy of either intravenous infusion of s omatostatin plus oral isosorbide 5-mononitrate or somatostatin alone in gas tro-oesophageal variceal bleeding associated with liver cirrhosis. Methods-A unicentre, double blind, placebo controlled, clinical trial was c onducted. Sixty patients bleeding from oesophageal or gastric varices were randomised to receive intravenous infusion of somatostatin (250 mu g/hour) plus oral isosorbide 5-mononitrate (40 mg/12 hours) (group I) or somatostat in infusion plus placebo (group II) for 72 hours. Results-The two groups of patients had similar clinical, endoscopic, and ha ematological characteristics. Control of bleeding was achieved in 18 out of 30 patients (60%) in group I and 26 out of 30 patients (87%) in group II ( p<0.05). There was no significant difference in mean transfusion requiremen ts between the two groups: 2.6 (2.2) v 1.8 (1.6) respectively; means (SD). Mortality and side effects were similar in the two groups, but development of ascites was higher in group I (30%) than in group 11 (7%) (p<0.05). Conclusion-In cirrhotic patients with acute gastro-oesophageal variceal ble eding, addition of isosorbide 5-mononitrate to somatostatin does not improv e therapeutic efficacy, induces more adverse effects, and should not be use d.