A prospective randomized trial comparing somatostatin and sclerotherapy in the treatment of acute variceal bleeding

Abstract

Somatostatin and endoscopic sclerotherapy are widely used in the treatment of acute variceal bleeding. Although objective evidence does exist about the advantages of either treatment, data comparing both procedures are scarce. In order to compare the effectiveness and safety of somatostatin and sclerotherapy in the treatment of acute variceal bleeding, 70 consecutive cirrhotic patients suffering from esophageal variceal hemorrhage and meeting the inclusion criteria were randomly assigned to treatment with somatostatin (35 patients) or sclerotherapy (35 patients). No differences in age, sex, alcohol intake, etiology of cirrhosis and severity of liver failure were found between groups. Failure of treatment (defined as persistence of bleeding despite therapy or subsequent rebleeding within the 48-hr trial period) occurred in seven patients (20%) in the somatostatin group and in six (17.1%) in the sclerotherapy group (NS). Early rebleeding occurred in seven of 28 patients (25%) in the somatostatin group and in five of 29 (17.2%) in the sclerotherapy group (NS). Mortality within the first 6 wk was no different between both groups: 10 (28.5%) and eight (22.8%) in the somatostatin and sclerotherapy groups, respectively. Sclerotherapy, but not somatostatin, was associated with major complications in five cases (14.2%) (p = 0.026), two of which resulted in patient's death. These results suggest that somatostatin is safer, and as effective as sclerotherapy, in controlling acute variceal bleeding until an elective treatment can be established.

Sclerotherapy with or without Octreotide for Acute Variceal Bleeding

“…Shields et al 20 and Sung et al 12 found that Child-Pugh class C hepatic function was independently associated with early rebleeding after sclerotherapy or treatment with somatostatin or octreotide, although Barsoum et al, 21 who compared sclerotherapy with balloon tamponade, did not report an association with class C function. Planas et al 11 compared the efficacy of somatostatin with that of sclerotherapy and stratified patients according to the presence or absence of active bleeding and clinical signs of severe liver disease, since the Child-Pugh score could not be determined in the emergency setting. No factors predictive of treatment failure during the first 48 hours were identified.…”

“…The rate of controlled bleeding in our placebo group was similar to that reported in randomized studies involving a single sclerotherapy session. Planas et al 11 controlled bleeding for seven days in 24 of 35 patients (69 percent), and Shields et al 20 controlled bleeding for five days in 34 of 41 patients (83 percent). Burroughs et al 5 reported a 62 percent success rate (control of bleeding in 31 of 50 patients) five days after sclerotherapy in a group of patients with uncontrolled bleeding after transfusions and the administration of vasoactive drugs.…”

“…Somatostatin and octreotide are the only vasoactive drugs known to be as effective as emergency sclerotherapy. 11,12 The combination of somatostatin and balloon tamponade does not appear to be more effective than either treatment used alone. 13 There are few clinical data, however, on the effectiveness of sclerotherapy combined with vasoactive drugs.…”

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

“…Moreover, different studies have shown that SMS is as effective as sclerotherapy in controlling bleeding, preventing early rebleeding, and patient survival 1126 27 Endoscopic variceal banding28 as well as transjugular portosystemic shunting29 may be useful in bleeding control, mainly when pharmacological treatment has failed.…”

Management of bleeding in the cirrhotic patient

“…Somatostatin decreases portal pressure and portal blood flow without the systemic effects of vasopressin 5 . Somatostatin, 6–9 and its long‐acting analog octreo‐tide , 10–12 have been shown to be as effective as sclerotherapy in stopping variceal bleeding. These drugs should be used in combination with endoscopic therapy in patients with bleeding varices.…”