Somatostatin analogues for acute bleeding oesophageal varices

TY - JOUR

T1 - Somatostatin analogues for acute bleeding oesophageal varices

AU - Gøtzsche, Peter C.

AU - Hrobjartsson, A.

PY - 2008

Y1 - 2008

N2 - BACKGROUND: Somatostatin and its derivatives are sometimes used for emergency treatment of bleeding oesophageal varices in patients with cirrhosis of the liver. OBJECTIVES: To study whether somatostatin or its analogues improve survival or reduce the need for blood transfusions in patients with bleeding oesophageal varices. SEARCH STRATEGY: PubMed and The Cochrane Library were searched (November 2007). Reference lists of publications, contacts with authors. SELECTION CRITERIA: All randomised trials comparing somatostatin or analogues with placebo or no treatment in patients suspected of acute or recent bleeding from oesophageal varices. DATA COLLECTION AND ANALYSIS: The outcome measures extracted were: mortality, blood transfusions, use of balloon tamponade, initial haemostasis and rebleeding. Intention-to-treat analyses including all randomised patients were conducted if possible; a random-effects analysis was preferred if there was significant heterogeneity between the trials (P < 0.10). The trials were divided in two groups: trials with a low risk of bias, which had concealed allocation of patients and were double-blind, and other trials. MAIN RESULTS: We included 21 trials (2588 patients). The drugs did not reduce mortality significantly (relative risk 0.97, 95% confidence interval (CI) 0.75 to 1.25, for the trials with a low risk of bias, and 0.80, 95% CI 0.63 to 1.01, for the other trials). Units of blood transfused were 0.7 (0.2 to 1.1) less with drugs in the trials with a low risk of bias and 1.5 (0.9 to 2.0) less in the other trials. Number of patients failing initial haemostasis was reduced, relative risk 0.68 (0.54 to 0.87). Number of patients with rebleeding was not significantly reduced for the trials with a low risk of bias, relative risk 0.84 (0.52 to 1.37) while it was substantially reduced in the other trials, relative risk 0.36 (0.19 to 0.68). Use of balloon tamponade was rarely reported. AUTHORS' CONCLUSIONS: The need for blood transfusions corresponded to one half unit of blood saved per patient. It is doubtful whether this effect is worthwhile. The findings do not suggest a need for further placebo-controlled trials of the type reviewed here. A large placebo controlled trial enrolling thousands of patients is needed if one wishes to rule out the possibility that a worthwhile effect on mortality might have been overlooked Udgivelsesdato: 2008

AB - BACKGROUND: Somatostatin and its derivatives are sometimes used for emergency treatment of bleeding oesophageal varices in patients with cirrhosis of the liver. OBJECTIVES: To study whether somatostatin or its analogues improve survival or reduce the need for blood transfusions in patients with bleeding oesophageal varices. SEARCH STRATEGY: PubMed and The Cochrane Library were searched (November 2007). Reference lists of publications, contacts with authors. SELECTION CRITERIA: All randomised trials comparing somatostatin or analogues with placebo or no treatment in patients suspected of acute or recent bleeding from oesophageal varices. DATA COLLECTION AND ANALYSIS: The outcome measures extracted were: mortality, blood transfusions, use of balloon tamponade, initial haemostasis and rebleeding. Intention-to-treat analyses including all randomised patients were conducted if possible; a random-effects analysis was preferred if there was significant heterogeneity between the trials (P < 0.10). The trials were divided in two groups: trials with a low risk of bias, which had concealed allocation of patients and were double-blind, and other trials. MAIN RESULTS: We included 21 trials (2588 patients). The drugs did not reduce mortality significantly (relative risk 0.97, 95% confidence interval (CI) 0.75 to 1.25, for the trials with a low risk of bias, and 0.80, 95% CI 0.63 to 1.01, for the other trials). Units of blood transfused were 0.7 (0.2 to 1.1) less with drugs in the trials with a low risk of bias and 1.5 (0.9 to 2.0) less in the other trials. Number of patients failing initial haemostasis was reduced, relative risk 0.68 (0.54 to 0.87). Number of patients with rebleeding was not significantly reduced for the trials with a low risk of bias, relative risk 0.84 (0.52 to 1.37) while it was substantially reduced in the other trials, relative risk 0.36 (0.19 to 0.68). Use of balloon tamponade was rarely reported. AUTHORS' CONCLUSIONS: The need for blood transfusions corresponded to one half unit of blood saved per patient. It is doubtful whether this effect is worthwhile. The findings do not suggest a need for further placebo-controlled trials of the type reviewed here. A large placebo controlled trial enrolling thousands of patients is needed if one wishes to rule out the possibility that a worthwhile effect on mortality might have been overlooked Udgivelsesdato: 2008

M3 - Journal article

SN - 1361-6137

SP - CD000193-

JO - Cochrane Database of Systematic Reviews

JF - Cochrane Database of Systematic Reviews

IS - 3

ER -