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. |
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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. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear risk | B ‐ Unclear |