OBJECTIVE: Efficacy of endoscopic variceal sclerotherapy (EVS) alone and in combination with octreotide in controlling acute variceal bleeding and preventing early rebleeding was compared in a double-blind study. METHODS:Consecutive patients presenting with variceal bleeding with low-risk liver cirrhosis were randomized into two groups. Group A received EVS with 3-5 ml of ethanolamine oleate per varix and placebo injection at 50 microg/h; group B received the combined therapy of EVS and octreotide 50 microg/h continuously for 5 days. A total of 70 patients (mean age, 38.4 +/- 8.6 yr) were selected for the study, which included 56 men (mean age, 37.9 +/- 8.5 yr) and 14 women (mean age, 40.6 +/- 9.0 yr). Thirty-five patients were allocated in each group. RESULTS: In group A bleeding was controlled in 30 patients (85.7%) and in group B in 33 (94.3%) (p = 0.24). The number of patients who rebled during the first 5 days after sclerotherapy was eight (22.9%) and two (5.7%) in groups A and B, respectively (p = 0.04). The mean packs of blood transfused to the patients of groups A and B were 2.1 +/- 1.2 packs and 1.5 +/- 0.7 packs, respectively (p = 0.03). The mean hospital stay of group A was 6.6 +/- 1.3 days, whereas that in group B was 5.9 +/- 1.2 days (p = 0.04). One patient from each group died during the course of the study. CONCLUSIONS: No significant difference was observed in arrest of bleeding in the two groups, but episodes of early rebleeding, blood transfusions, and hospital stay was significantly less in group B.
RCT Entities:
OBJECTIVE: Efficacy of endoscopic variceal sclerotherapy (EVS) alone and in combination with octreotide in controlling acute variceal bleeding and preventing early rebleeding was compared in a double-blind study. METHODS: Consecutive patients presenting with variceal bleeding with low-risk liver cirrhosis were randomized into two groups. Group A received EVS with 3-5 ml of ethanolamine oleate per varix and placebo injection at 50 microg/h; group B received the combined therapy of EVS and octreotide 50 microg/h continuously for 5 days. A total of 70 patients (mean age, 38.4 +/- 8.6 yr) were selected for the study, which included 56 men (mean age, 37.9 +/- 8.5 yr) and 14 women (mean age, 40.6 +/- 9.0 yr). Thirty-five patients were allocated in each group. RESULTS: In group A bleeding was controlled in 30 patients (85.7%) and in group B in 33 (94.3%) (p = 0.24). The number of patients who rebled during the first 5 days after sclerotherapy was eight (22.9%) and two (5.7%) in groups A and B, respectively (p = 0.04). The mean packs of blood transfused to the patients of groups A and B were 2.1 +/- 1.2 packs and 1.5 +/- 0.7 packs, respectively (p = 0.03). The mean hospital stay of group A was 6.6 +/- 1.3 days, whereas that in group B was 5.9 +/- 1.2 days (p = 0.04). One patient from each group died during the course of the study. CONCLUSIONS: No significant difference was observed in arrest of bleeding in the two groups, but episodes of early rebleeding, blood transfusions, and hospital stay was significantly less in group B.
Authors: Danielle Roberts; Lawrence Mj Best; Suzanne C Freeman; Alex J Sutton; Nicola J Cooper; Sivapatham Arunan; Tanjia Begum; Norman R Williams; Dana Walshaw; Elisabeth Jane Milne; Maxine Tapp; Mario Csenar; Chavdar S Pavlov; Brian R Davidson; Emmanuel Tsochatzis; Kurinchi Selvan Gurusamy Journal: Cochrane Database Syst Rev Date: 2021-04-10