trials have shown that somatostatin (SMT) is as effective as sclerotherapy in the treatment of acute variceal bleeding and that the combination of both treatments is more effective than sclerotherapy alone. To assess whether the addition of sclerotherapy improves the efficacy of SMT alone, all patients admitted to our unit with gastrointestinal bleeding and with suspected cirrhosis received a continuous infusion of SMT (250 g/h). Endoscopy was performed between 1 and 5 hours later, and patients with esophageal variceal bleeding were randomized to receive or not to receive sclerotherapy. In both groups, SMT infusion was continued for 5 days. Fifty patient admissions were allocated to each group. Therapeutic failure occurred in 21 cases of the SMT group and in 7 cases of the combinedtherapy group (P ؍ .002). Failure to control the acute episode occurred in 24% vs. 8% (P ؍ .03) and early rebleeding in 24% vs. 7% (P ؍ .03), respectively. Transfusional requirements were significantly higher in the SMT group, while the incidence of complications was lower (8% vs. 24%; P ؍ .029). In the multivariate analysis, the presence of shock at admission and active bleeding during endoscopy were the variables that better predicted the failure of therapy with SMT alone. Mortality at 6 weeks was similar. These data demonstrate that the addition of sclerotherapy significantly improves the efficacy of SMT alone for the treatment of acute variceal bleeding, although it also increases the rate of complications. Patients with shock and those with active bleeding are more likely to benefit from this combined therapy. (HEPATOLOGY 1999;30:384-389.) Despite recent therapeutic advances, acute esophageal variceal hemorrhage is still one of the leading causes of death in patients with cirrhosis. 1 Sclerotherapy is widely used as the main emergency treatment in most institutions. Randomized, controlled trials have shown that emergency sclerotherapy (EST) is effective for the control of acute esophageal variceal bleeding, 1 and meta-analysis of comparative studies has suggested that it fares better than balloon tamponade and vasopressin. 1 It has also been suggested that EST reduces the frequency of early rebleeding, 1 which is an important indicator of death risk. 2 However, EST is not always successful, it is associated with a non-negligible rate of serious complications, and it requires a skilled endoscopist, a necessity not always available. 3 Somatostatin (SMT) was introduced for the treatment of acute variceal hemorrhage because of its capacity to decrease portal pressure and collateral splanchnic blood flow, without the adverse effects of vasopressin on the systemic circulation. 4 One placebo-controlled trial failed to show any beneficial effect with SMT, 5 although the high spontaneous success rate observed with placebo suggests that some inadvertent bias could occur in this study. 5 Furthermore, several randomized, controlled trials have shown that SMT is more effective than placebo, 6 and as effective as vasopressin, 7,8 vasopressin associated with nitroglycerin, 9 terlipressin, 10,11 and balloon tamponade, 12,13 with fewer side-effects in most of these studies. Both SMT and octreotide, a synthetic SMT analogue, have shown an efficacy similar to that of EST for the control of acute variceal bleeding, [14][15][16][17] and for the prevention of early rebleeding, 18 while morbidity significantly decreased. [14][15][16][17][18] The meta-analysis of these trials showed no differences between the 2 treatments in terms of bleeding control, in hospital rebleeding rate, or mortality. 1 On the other hand, the results of recent randomized, controlled trials have shown that the association of vasoactive drugs such as octreotide, [19][20][21]22 or terlipressin 21 significantly improves the efficacy of endoscopic treatment alone for the control of acute variceal bleeding, with a similar incidence of side-effects and overall mortality. [19][20][21][22] However, whether the combination of EST with vasoactive drugs may improve the efficacy of pharmacological treatment alone has not been adequately investigated. The present study was performed to assess whether the addition of EST to SMT treatment improves the results of SMT alone in the management of acute esophageal variceal bleeding.
PATIENTS AND METHODS
Design of the Study. During the study period, all patients admitted to our hospital were considered for inclusion in this prospective, randomized study if they fulfilled the following criteria: 1) age over 18 years; 2) presence of hematemesis and/or melena, confirmed by the hospital staff; 3) clinical suspicion of chronic liver disease or portal hypertension; 4) referred patients should be seen within 24 hours of admission at the referring hospital and not having received balloon tamponade or EST; 5) rerandomization was only allowed if a Abbreviations: EST, emergency sclerotherapy; SMT, somatostatin; RR, relative risk.