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

Abstract

Background-Variceal bleeding is a severe complication of portal hypertension. 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 additive eVect in decreasing portal pressure. Aim-To compare the therapeutic efficacy of either intravenous infusion of somatostatin plus oral isosorbide 5-mononitrate or somatostatin alone in gastrooesophageal variceal bleeding associated with liver cirrhosis. Methods-A unicentre, double blind, placebo controlled, clinical trial was conducted. Sixty patients bleeding from oesophageal or gastric varices were randomised to receive intravenous infusion of somatostatin (250 µg/hour) plus oral isosorbide 5-mononitrate (40 mg/12 hours) (group I) or somatostatin infusion plus placebo (group II) for 72 hours. Results-The two groups of patients had similar clinical, endoscopic, and haematological 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 diVerence in mean transfusion requirements between the two groups: 2.6 (2.2) v 1.8 (1.6) respectively; means (SD). Mortality and side eVects were similar in the two groups, but development of ascites was higher in group I (30%) than in group II (7%) (p<0.05). Conclusion-In cirrhotic patients with acute gastro-oesophageal variceal bleeding, addition of isosorbide 5-mononitrate to somatostatin does not improve therapeutic eYcacy, induces more adverse eVects, and should not be used.

Variceal Bleeding and Portal Hypertension: Still a Therapeutic Challenge?

“…A single-center, double-blind, placebo-controlled trial was conducted by Junquera et al [11] to compare the effectiveness of somatostatin infusion alone to that of somatostatin plus oral isosorbide 5-mononitrate. Sixty patients with bleeding from esophageal or gastric varices were randomly assigned to receive a somatostatin infusion (250 µg/h) plus oral isosorbide 5-mononitrate (40 mg/12 h) (group I) or somatostatin plus a placebo (group II) for 72 hours.…”

A correlation between gastrointestinal dysfunction and cirrhosis severity

“…[ 5 ] Impaired gastric accommodation mainly causes upper GI symptoms such as early satiety, bloating and abdominal pain, and it is more likely to occur in patients with functional dyspepsia, diabetes mellitus, and those who have undergone fundoplication, vagotomy, or subtotal gastrectomy. [ 6 ] It has been found that the change in gastric receptivity during a meal was more prominent in cirrhotic patients than in healthy controls. [ 7 ] However, gastrointestinal (GI) stimulation, especially gastric dilation following food intake, may also cause corresponding GI symptoms.…”