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Human placental extract treatment for nonalcoholic steatohepatitis nonresponsive to lifestyle intervention: a pilot study.
MedLine Citation:
PMID:  25297827     Owner:  NLM     Status:  Publisher    
AIM: No pharmacological therapies have been established for nonalcoholic steatohepatitis (NASH), which can lead to liver-related mortality. Human placental extract (HPE), which has anti-inflammatory effects, has been expected to be a promising treatment for chronic liver disease. This pilot study was conducted to evaluate the efficacy of HPE for biopsy-diagnosed NASH.
METHODS: After a lifestyle intervention for 12 weeks, 10 subjects with abnormal ALT (>30 IU/L) and biopsy-proven NASH (NAFLD activity score [NAS] > 4) received intramuscular injections of HPE (Laennec) at a dose of 4 ml/day twice per week for 24 weeks, and seven of them underwent a second liver biopsy after the treatment. Liver biopsies were scored for NAS and fibrosis. Histological response was defined as a decrease of 2 points or more in NAS and no increase in fibrosis.
RESULTS: Serum transaminase activities were significantly lower at 8 weeks compared to pre-treatment levels in 9 patients who continued treatment for 24 weeks. One patient refused to continue the treatment soon after starting therapies. In seven patients undergoing post-treatment biopsies, NAS (mean [SD]) mildly decreased from 5.29 [0.95] to 4.00 [1.83] without reaching statistical significance (p=0.078). Histological response was observed in all of 3 obese patients and in only one of 5 non-obese ones. No significant changes were observed in body mass index, lipid profiles, and diabetic control/insulin resistance.
CONCLUSIONS: In NASH patients who received HPE treatment, significant reductions in serum liver enzymes were obtained after 8 weeks. Histological efficacy might be better in obese patients than in non-obese ones.
Hideto Shimokobe; Yoshio Sumida; Saiyu Tanaka; Kohjiro Mori; Yoko Kitamura; Kohei Fukumoto; Akira Kakutani; Tomoyuki Ohno; Kazuyuki Kanemasa; Shunsuke Imai; Sawako Hibino; Toshikazu Yoshikawa
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2014-10-9
Journal Detail:
Title:  Hepatology research : the official journal of the Japan Society of Hepatology     Volume:  -     ISSN:  1386-6346     ISO Abbreviation:  Hepatol. Res.     Publication Date:  2014 Oct 
Date Detail:
Created Date:  2014-10-9     Completed Date:  -     Revised Date:  2014-10-10    
Medline Journal Info:
Nlm Unique ID:  9711801     Medline TA:  Hepatol Res     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
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