title: Efficacy of Berberine in Patients with Non-Alcoholic Fatty Liver Disease.
abstract: OBJECTIVE
  A randomized, parallel controlled, open-label clinical trial was conducted to evaluate the effect of a botanic compound berberine (BBR) on NAFLD.
  
  
  METHODS
  A randomized, parallel controlled, open-label clinical trial was conducted in three medical centers (NIH Registration number: NCT00633282). A total of 184 eligible patients with NAFLD were enrolled and randomly received (i) lifestyle intervention (LSI), (ii) LSI plus pioglitazone (PGZ) 15mg qd, and (iii) LSI plus BBR 0.5g tid, respectively, for 16 weeks. Hepatic fat content (HFC), serum glucose and lipid profiles, liver enzymes and serum and urine BBR concentrations were assessed before and after treatment. We also analyzed hepatic BBR content and expression of genes related to glucose and lipid metabolism in an animal model of NAFLD treated with BBR.
  
  
  RESULTS
  As compared with LSI, BBR treatment plus LSI resulted in a significant reduction of HFC (52.7% vs 36.4%, p = 0.008), paralleled with better improvement in body weight, HOMA-IR, and serum lipid profiles (all p<0.05). BBR was more effective than PGZ 15mg qd in reducing body weight and improving lipid profile. BBR-related adverse events were mild and mainly occurred in digestive system. Serum and urine BBR concentrations were 6.99ng/ml and 79.2ng/ml, respectively, in the BBR-treated subjects. Animal experiments showed that BBR located favorably in the liver and altered hepatic metabolism-related gene expression.
  
  
  CONCLUSIONS
  BBR ameliorates NAFLD and related metabolic disorders. The therapeutic effect of BBR on NAFLD may involve a direct regulation of hepatic lipid metabolism.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT00633282.
authors.affiliation: Department of Endocrinology and Metabolism, Zhongshan Hospital, Fudan University, Shanghai, 200032, China.
authors.forename: Hong-Mei
authors.initials: HM
authors.lastname: Yan
authors.affiliation: Department of Endocrinology and Metabolism, Zhongshan Hospital, Fudan University, Shanghai, 200032, China.
authors.forename: Ming-Feng
authors.initials: MF
authors.lastname: Xia
authors.affiliation: Institute of Materia Medica, Chinese Academy of Medical Sciences, and Peking Union Medical College, Beijing, 100050, China.
authors.forename: Yan
authors.initials: Y
authors.lastname: Wang
authors.affiliation: Department of Endocrinology and Metabolism, Zhongshan Hospital, Fudan University, Shanghai, 200032, China.
authors.forename: Xin-Xia
authors.initials: XX
authors.lastname: Chang
authors.affiliation: Department of Radiology, Zhongshan Hospital, Fudan University, Shanghai, 200032, China.
authors.forename: Xiu-Zhong
authors.initials: XZ
authors.lastname: Yao
authors.affiliation: Department of Radiology, Zhongshan Hospital, Fudan University, Shanghai, 200032, China.
authors.forename: Sheng-Xiang
authors.initials: SX
authors.lastname: Rao
authors.affiliation: Department of Radiology, Zhongshan Hospital, Fudan University, Shanghai, 200032, China.
authors.forename: Meng-Su
authors.initials: MS
authors.lastname: Zeng
authors.affiliation: Department of Endocrinology and Metabolism, The Sixth People's Hospital, Shanghai Jiaotong University, Shanghai, 200233, China.
authors.forename: Yin-Fang
authors.initials: YF
authors.lastname: Tu
authors.affiliation: Institute of Materia Medica, Chinese Academy of Medical Sciences, and Peking Union Medical College, Beijing, 100050, China.
authors.forename: Ru
authors.initials: R
authors.lastname: Feng
authors.affiliation: Department of Endocrinology and Metabolism, The Sixth People's Hospital, Shanghai Jiaotong University, Shanghai, 200233, China.
authors.forename: Wei-Ping
authors.initials: WP
authors.lastname: Jia
authors.affiliation: Department of Endocrinology and Metabolism, The Fifth People's Hospital, Fudan University, Shanghai, 200240, China.
authors.forename: Jun
authors.initials: J
authors.lastname: Liu
authors.affiliation: School of public health, Fudan University, Shanghai, 200032, China.
authors.forename: Wei
authors.initials: W
authors.lastname: Deng
authors.affiliation: Institute of Materia Medica, Chinese Academy of Medical Sciences, and Peking Union Medical College, Beijing, 100050, China.
authors.forename: Jian-Dong
authors.initials: JD
authors.lastname: Jiang
authors.affiliation: Department of Endocrinology and Metabolism, Zhongshan Hospital, Fudan University, Shanghai, 200032, China.
authors.forename: Xin
authors.initials: X
authors.lastname: Gao
mesh_terms: D050154:Adiposity / Q000187:drug effects / Q000235:genetics; D000284:Administration, Oral; D000818:Animals; D001599:Berberine / Q000009:adverse effects / Q000097:blood / Q000494:pharmacology / Q000627:therapeutic use*; D001786:Blood Glucose / Q000378:metabolism; D001835:Body Weight / Q000187:drug effects; D059305:Diet, High-Fat; D004195:Disease Models, Animal; D004734:Energy Metabolism / Q000187:drug effects; D005260:Female; D005786:Gene Expression Regulation / Q000187:drug effects; D006801:Humans; D008099:Liver / Q000187:drug effects / Q000201:enzymology / Q000473:pathology; D008297:Male; D055442:Metabolome / Q000187:drug effects; D008875:Middle Aged; D065626:Non-alcoholic Fatty Liver Disease / Q000097:blood / Q000188:drug therapy* / Q000235:genetics; D010641:Phenotype; D017207:Rats, Sprague-Dawley; D016896:Treatment Outcome
chemical_list: D001786:Blood Glucose; D001599:Berberine