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. |
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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 |