BACKGROUND: The objective of this study is to assess if there were any changes in liver biopsies after treatment with S-adenosyl-L-methionine(SAMe) in alcoholic liver disease patients. METHODS:Liver biopsies of 14 patients were randomized for SAMe treatment at week 0 (biopsy #1) and at 24 weeks (biopsy #2). Patients received 1.2g of SAMe or placebo by mouth daily and stopped alcohol intake. Biopsies were semi-quantitatively scored for: steatosis, inflammation, necrosis, fibrosis, apoptosis by TUNEL stain, percent fibrosis per square field, smooth muscle actin stain, Kupffer cells, polymorphonuclear leukocytes, lipogranules, lymphocytes, balloon cell formation, Mallory-Denk bodies, and duct metaplasia. RESULTS: Comparing treatment arm to placebo arm, no significant difference was found between biopsy #1 and biopsy #2. However, when both study arms were grouped together, there was decrease in smooth muscle actin stain, where the P-value=0.027. CONCLUSION: Treatment with SAMe did not show a statistically significant difference in the characteristics studied. However, when both the treatment and placebo arm data were grouped together to increase the n and power, there was a decrease in the smooth muscle actin stain, reflecting a decrease in stellate cells activation, likely due to the alcohol abstinence. This study suggests that it may not be beneficial to wait for more definitive treatment, like liver transplant in alcoholic liver disease patients, since the liver tissue remained largely with the same degree of pathology six months out, regardless of treatment.
RCT Entities:
BACKGROUND: The objective of this study is to assess if there were any changes in liver biopsies after treatment with S-adenosyl-L-methionine(SAMe) in alcoholic liver diseasepatients. METHODS: Liver biopsies of 14 patients were randomized for SAMe treatment at week 0 (biopsy #1) and at 24 weeks (biopsy #2). Patients received 1.2g of SAMe or placebo by mouth daily and stopped alcohol intake. Biopsies were semi-quantitatively scored for: steatosis, inflammation, necrosis, fibrosis, apoptosis by TUNEL stain, percent fibrosis per square field, smooth muscle actin stain, Kupffer cells, polymorphonuclear leukocytes, lipogranules, lymphocytes, balloon cell formation, Mallory-Denk bodies, and duct metaplasia. RESULTS: Comparing treatment arm to placebo arm, no significant difference was found between biopsy #1 and biopsy #2. However, when both study arms were grouped together, there was decrease in smooth muscle actin stain, where the P-value=0.027. CONCLUSION: Treatment with SAMe did not show a statistically significant difference in the characteristics studied. However, when both the treatment and placebo arm data were grouped together to increase the n and power, there was a decrease in the smooth muscle actin stain, reflecting a decrease in stellate cells activation, likely due to the alcohol abstinence. This study suggests that it may not be beneficial to wait for more definitive treatment, like liver transplant in alcoholic liver diseasepatients, since the liver tissue remained largely with the same degree of pathology six months out, regardless of treatment.
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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: Jesus A Villanueva; Farah Esfandiari; Mollie E White; Sridevi Devaraj; Samuel W French; Charles H Halsted Journal: Alcohol Clin Exp Res Date: 2007-09-11 Impact factor: 3.455
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