Somatostatin alone or combined with emergency sclerotherapy in the treatment of acute esophageal variceal bleeding: A prospective randomized trial

Abstract

Recent 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 ...

Clinical trial: the effect of somatostatin vs. octreotide in preventing post‐endoscopic increase in hepatic venous pressure gradient in cirrhotics with bleeding varices

“…34 It has also been demonstrated that the addition of sclerotherapy significantly improves the efficacy of SST alone for the treatment of acute variceal bleeding. 35 The results of our study support the beneficial role of SST in combination with endoscopic therapy but not OCT in the optimal management of BEVs. The 6-week rebleeding and mortality in our study was low, in accordance with recent studies who found a vast improvement in the outcome of acute bleeding episode in cirrhotics.…”

Escleroterapia versus somatostatina na hemorragia digestiva alta por ruptura de varizes esofágicas

“…Existem estudos que recomendam sua utilização precocemente, antes mesmo da endoscopia. No entanto, a associação com a escleroterapia deveria ser limitada àqueles casos em que existe instabilidade hemodinâmica (choque) ou sangramento ativo no momento do exame (41) . Espera-se que outros estudos referendem o posicionamento aqui assumido, para que se possa, então, propor uma conduta mais definitiva.…”

“…No entanto, recentemente (41) , foi demonstrado que o uso combinado só apresenta vantagens à utilização isolada de somatostatina em pacientes com alto risco de insucesso com o uso da terapia farmacológica, ou seja, em pacientes em choque ou naqueles com sangramento ativo durante a endoscopia.…”

Reply:

“…4,5 Even in nonactive bleeders, sclerotherapy offers a therapeutic advantage. 6 Thus, endoscopic therapy is recommended in nonactive bleeders, although specific, randomized, clinical trials are lacking. 4 AGUSTÍN ALBILLOS, M.D.…”

“…Interferon was used to treat non-A non-B hepatitis starting in the 1980s, at least in clinical trials. 6 When anti-HCV testing became available in the early 1990s, a growing number of patients started antiviral treatments.…”