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

Silvain 1993.

Methods Randomised: yes, by table of random numbers. 
 Concealment: method not described. 
 Double‐blind: no. 
 Description of withdrawals/dropouts: no. 
 Length of FU: 30 days. 
 Jadad score: 2/5.
Participants Country: France 
 Diagnosis of bleeding: by endoscopy. 
 Source of bleeding: all actively bleeding varices. 
 Endoscopy performed in all patients prior to randomisation. 
 Diagnosis of cirrhosis: histological or clinical. 
 84 patients with 87 episodes. 
 Child's A = 16%, B = 37%, C = 47%. 
 Alcoholic cirrhosis = 91%.
Interventions Terlipressin versus octreotide.
Rx1: terlipressin 2 mg iv once then 1 mg iv every 4 h for 24 h plus NTG transdermal 10 mg every 12h for 24h. 
 Rx2: Octreotide 25 mcg/h infusion for 12 h then 100 mcg sc at 12 h and 18h. 
 Time from admission to treatment: within 4h. 
 Initial sclerotherapy: none.
Outcomes 1. Mortality at 30 days. 
 2. Failure of initial haemostasis at 12 h. 
 3. Rebleeding at 30 days. 
 4. Procedures required for haemostasis. 
 5. Blood Transfusions. 
 6. LOS: NR
Notes Source of Funding: Government
Study was terminated at intermediate analysis because of two major adverse reactions in the terlipressin group.
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Unclear risk B ‐ Unclear