title: Efficacy and safety of human placental extract for alcoholic and nonalcoholic steatohepatitis: an open-label, randomized, comparative study.
abstract: Human placental extract (HPE) is a traditional medicine that has been used for the symptomatic treatment of liver disease without any verifying clinical evidence. This study aimed to evaluate the efficacy and safety of HPE in patients with alcoholic or nonalcoholic steatohepatitis (ASH or NASH). We designed this clinical trial as a multicenter, open-label, randomized, comparative noninferiority study to improve the reliability of analyses. The enrollment criteria were limited to ASH or NASH patients with serum alanine aminotransferase (ALT) 1.5-fold higher than the normal level. Patients in the control group were treated with a commercially available mixture of liver extract and flavin adenine dinucleotide (LE–FAD). Intention-to-treat (ITT) analysis was applied to 194 patients, and per-protocol (PP) analysis was available for 154 patients. The rate of primary goal achievement of treatment efficacy was arbitrarily defined as 20% or greater improvement in ALT level compared with the pretreatment level and did not differ significantly between the HPE and control groups [62.9% (44/70) vs. 48.8% (41/84); p=0.0772]. ITT and modified ITT analysis showed results similar to those of PP analysis. Adverse drug reactions (ADRs) of minimal to moderate degree occurred in 3.1% of patients. The ADR and treatment compliance rates were similar in both groups. In conclusion, the clinical value of HPE in the treatment of ASH and NASH is equivalent to that of LE–FAD.
authors.affiliation: Hepatology Center, Bundang Jesaeng General Hospital; Seongnam 463–774, Republic of Korea
authors.forename: Jin Young
authors.initials: JY
authors.lastname: Choi
authors.forename: Kyeheui
authors.initials: K
authors.lastname: Lee
authors.forename: Seung Min
authors.initials: SM
authors.lastname: Lee
authors.forename: Sun Hong
authors.initials: SH
authors.lastname: Yoo
authors.forename: Seong Gyu
authors.initials: SG
authors.lastname: Hwang
authors.forename: Jong Young
authors.initials: JY
authors.lastname: Choi
authors.forename: Sang Wook
authors.initials: SW
authors.lastname: Lee
authors.forename: Jae Seok
authors.initials: JS
authors.lastname: Hwang
authors.forename: Kyoung Kon
authors.initials: KK
authors.lastname: Kim
authors.forename: Hee Cheol
authors.initials: HC
authors.lastname: Kang
authors.forename: Gab Jin
authors.initials: GJ
authors.lastname: Cheon
authors.forename: Young Min
authors.initials: YM
authors.lastname: Park
mesh_terms: D000328:Adult; D005235:Fatty Liver, Alcoholic / Q000188:drug therapy*; D005260:Female; D005182:Flavin-Adenine Dinucleotide / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D008110:Liver Extracts / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D065626:Non-alcoholic Fatty Liver Disease / Q000188:drug therapy*; D010924:Placental Extracts / Q000627:therapeutic use*
chemical_list: D008110:Liver Extracts; D010924:Placental Extracts; C102331:Adelavin 9; D005182:Flavin-Adenine Dinucleotide