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. 2003 Jan 20;2003(1):CD002147. doi: 10.1002/14651858.CD002147

Feu 1996.

Methods Randomised: yes, by computer in blocks of eight. 
 Concealment. Pre‐packed, numbered boxes. 
 Double Blind: yes, adequate double‐dummy method. 
 Description of withdrawals/dropouts: yes, one in terlipressin and three in somatostatin lost to follow‐up. 
 Length of FU: 42 days. 
 Jadad score: 5/5.
Participants Country: Spain. 
 Diagnosis of bleeding: by endoscopy. 
 Source of bleeding: all confirmed or unconfirmed varices. 
 Endoscopy performed on all patients within six hours. 
 Diagnosis of cirrhosis: Histological or clinical. 
 161 patients with 161 episodes. 
 Child's A = 22%, B = 49%, C = 29%. 
 Alcoholic cirrhosis = 54%.
Interventions Terlipressin versus somatostatin.
Rx1:terlipressin 2 mg iv every 4 h for 48 h. 
 Rx2: somatostatin 250 mcg iv bolus then 250 mcg/h infusion for 48 h plus boluses for rebleeding. 
 Time from admission to treatment: 4.2 hours.
Initial sclerotherapy: none.
Outcomes 1. Mortality at six weeks. 
 2. Failure of initial haemostasis at up to 48 h. 
 3. Rebleeding at six weeks. 
 4. Procedures required for haemostasis. 
 5. Blood transfusions (PC). 
 6. LOS: (PC).
Notes Source of funding: Ferring AB (Malmo, Sweden) and Fondo de Investigaciones Sanitarias.
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Low risk A ‐ Adequate