title: Prednisolone plus S-adenosil-L-methionine in severe alcoholic hepatitis.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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).
authors.affiliation: I.M. Sechenov First Moscow State Medical University, Moscow, Russian Federation. dr.ptk@mail.ru.
authors.forename: Petr
authors.initials: P
authors.lastname: Tkachenko
authors.affiliation: I.M. Sechenov First Moscow State Medical University, Moscow, Russian Federation.
authors.forename: Marina
authors.initials: M
authors.lastname: Maevskaya
authors.affiliation: I.M. Sechenov First Moscow State Medical University, Moscow, Russian Federation.
authors.forename: Alexander
authors.initials: A
authors.lastname: Pavlov
authors.affiliation: I.M. Sechenov First Moscow State Medical University, Moscow, Russian Federation.
authors.forename: Inna
authors.initials: I
authors.lastname: Komkova
authors.affiliation: I.M. Sechenov First Moscow State Medical University, Moscow, Russian Federation.
authors.forename: Chavdar
authors.initials: C
authors.lastname: Pavlov
authors.affiliation: I.M. Sechenov First Moscow State Medical University, Moscow, Russian Federation.
authors.forename: Vladimir
authors.initials: V
authors.lastname: Ivashkin
mesh_terms: D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage* / Q000627:therapeutic use; D006519:Hepatitis, Alcoholic / Q000188:drug therapy* / Q000401:mortality; D006801:Humans; D008297:Male; D008875:Middle Aged; D011239:Prednisolone / Q000008:administration & dosage* / Q000627:therapeutic use; D011446:Prospective Studies; D011897:Random Allocation; D012436:S-Adenosylmethionine / Q000008:administration & dosage* / Q000627:therapeutic use; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D005938:Glucocorticoids; D012436:S-Adenosylmethionine; D011239:Prednisolone
keywords: Alcoholic hepatitis; Hepatorenal syndrome; Prednisolone; SAMe