PURPOSE/ BACKGROUND:Severe alcoholic hepatitis (AH) is a life-threatening liver disease with a potential of 30-40 % mortality at 1 month. While steroids remain to be a first line therapy, they provide only about 50 % survival benefit. The aim of the study was to evaluate the efficacy of glucocorticoids plus S-adenosylmethionine (SAMe), as compared to glucocorticoids alone, in patients with severe alcoholic hepatitis. METHODS:Forty patients with severe AH were randomized in two groups and enrolled in the prospective trial. Group 1 (n = 20) patients received prednisolone 40 mg/daily per os, and group 2 (n = 20) patients were managed with prednisolone 40 mg/daily per os plus SAMe 800 mg i.v. TREATMENT: Duration was 28 days. RESULTS: The response rate assessed by Lille model was significantly higher in the prednisolone plus SAMe group (19 of 20; 95 %) than in the prednisolone group (13 of 20; 65 %), p = 0.044. Two (10 %) patients died, both from the prednisolone group. There were no lethal outcomes in the prednisolone plus SAMe group. The Kaplan-Meier method showed no significant differences between the two groups (p = 0.151, log-rank). Hepatorenal syndrome (HRS) occurred in 20 % in the prednisolone group (4 of 20 patients) while no HRS cases were registered in the prednisolone plus SAMe group (p = 0.035). CONCLUSIONS: Management of severe alcoholic hepatitis with prednisolone plus SAMe was associated with better therapy response (p = 0.044) and less frequent HRS occurrence (p = 0.035). Mortality was not significantly lower in the prednisolone-SAMe group than in the prednisolone-only group at 28 days (10 vs. 0 %, p = 0.151).
RCT Entities:
PURPOSE/ BACKGROUND: Severe alcoholic hepatitis (AH) is a life-threatening liver disease with a potential of 30-40 % mortality at 1 month. While steroids remain to be a first line therapy, they provide only about 50 % survival benefit. The aim of the study was to evaluate the efficacy of glucocorticoids plus S-adenosylmethionine (SAMe), as compared to glucocorticoids alone, in patients with severe alcoholic hepatitis. METHODS: Forty patients with severe AH were randomized in two groups and enrolled in the prospective trial. Group 1 (n = 20) patients received prednisolone 40 mg/daily per os, and group 2 (n = 20) patients were managed with prednisolone 40 mg/daily per os plus SAMe 800 mg i.v. TREATMENT: Duration was 28 days. RESULTS: The response rate assessed by Lille model was significantly higher in the prednisolone plus SAMe group (19 of 20; 95 %) than in the prednisolone group (13 of 20; 65 %), p = 0.044. Two (10 %) patients died, both from the prednisolone group. There were no lethal outcomes in the prednisolone plus SAMe group. The Kaplan-Meier method showed no significant differences between the two groups (p = 0.151, log-rank). Hepatorenal syndrome (HRS) occurred in 20 % in the prednisolone group (4 of 20 patients) while no HRS cases were registered in the prednisolone plus SAMe group (p = 0.035). CONCLUSIONS: Management of severe alcoholic hepatitis with prednisolone plus SAMe was associated with better therapy response (p = 0.044) and less frequent HRS occurrence (p = 0.035). Mortality was not significantly lower in the prednisolone-SAMe group than in the prednisolone-only group at 28 days (10 vs. 0 %, p = 0.151).
Entities:
Keywords:
Alcoholic hepatitis; Hepatorenal syndrome; Prednisolone; SAMe
Authors: J M Mato; J Cámara; J Fernández de Paz; L Caballería; S Coll; A Caballero; L García-Buey; J Beltrán; V Benita; J Caballería; R Solà; R Moreno-Otero; F Barrao; A Martín-Duce; J A Correa; A Parés; E Barrao; I García-Magaz; J L Puerta; J Moreno; G Boissard; P Ortiz; J Rodés Journal: J Hepatol Date: 1999-06 Impact factor: 25.083
Authors: Chavdar S Pavlov; Giovanni Casazza; Dimitrinka Nikolova; Emmanuel Tsochatzis; Andrew K Burroughs; Vladimir T Ivashkin; Christian Gluud Journal: Cochrane Database Syst Rev Date: 2015-01-22
Authors: Elena Buzzetti; Maria Kalafateli; Douglas Thorburn; Brian R Davidson; Maja Thiele; Lise Lotte Gluud; Cinzia Del Giovane; Gro Askgaard; Aleksander Krag; Emmanuel Tsochatzis; Kurinchi Selvan Gurusamy Journal: Cochrane Database Syst Rev Date: 2017-03-31