title: Human placental extract treatment for non-alcoholic steatohepatitis non-responsive to lifestyle intervention: A pilot study.
abstract: OBJECTIVE
  No pharmacological therapies have been established for non-alcoholic 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 alanine aminotransferase (≥30 IU/L) and biopsy-proven NASH (Non-Alcoholic Fatty Liver Disease Activity Score [NAS], ≥4) received i.m. 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 with pretreatment levels in nine 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 [standard deviation]) 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 three obese patients and in only one of four 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 may be better in obese patients than in non-obese ones.
authors.affiliation: Center for Digestive and Liver Diseases, Nara City Hospital, Nara, Japan.
authors.forename: Hideto
authors.initials: H
authors.lastname: Shimokobe
authors.affiliation: Department of Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine, Kyoto, Japan.
authors.forename: Yoshio
authors.initials: Y
authors.lastname: Sumida
authors.affiliation: Center for Digestive and Liver Diseases, Nara City Hospital, Nara, Japan.
authors.forename: Saiyu
authors.initials: S
authors.lastname: Tanaka
authors.affiliation: Center for Digestive and Liver Diseases, Nara City Hospital, Nara, Japan.
authors.forename: Kojiro
authors.initials: K
authors.lastname: Mori
authors.affiliation: Center for Digestive and Liver Diseases, Nara City Hospital, Nara, Japan.
authors.forename: Yoko
authors.initials: Y
authors.lastname: Kitamura
authors.affiliation: Center for Digestive and Liver Diseases, Nara City Hospital, Nara, Japan.
authors.forename: Kohei
authors.initials: K
authors.lastname: Fukumoto
authors.affiliation: Center for Digestive and Liver Diseases, Nara City Hospital, Nara, Japan.
authors.forename: Akira
authors.initials: A
authors.lastname: Kakutani
authors.affiliation: Center for Digestive and Liver Diseases, Nara City Hospital, Nara, Japan.
authors.forename: Tomoyuki
authors.initials: T
authors.lastname: Ohno
authors.affiliation: Center for Digestive and Liver Diseases, Nara City Hospital, Nara, Japan.
authors.forename: Kazuyuki
authors.initials: K
authors.lastname: Kanemasa
authors.affiliation: Department of Pathology, Nara City Hospital, Nara, Japan.
authors.forename: Shunsuke
authors.initials: S
authors.lastname: Imai
authors.affiliation: Anti-Aging Medical Science, Division of Basic Research, Louis Pasteur Center for Medical Research, Kyoto, Japan.
authors.forename: Sawako
authors.initials: S
authors.lastname: Hibino
authors.affiliation: Kyoto Prefectural University of Medicine, Kyoto, Japan.
authors.forename: Toshikazu
authors.initials: T
authors.lastname: Yoshikawa
keywords: human placental extract; liver biopsy; non-alcoholic steatohepatitis; transaminase