Efficacy of Berberine in Patients with Non-Alcoholic Fatty Liver Disease

• Published in: PloS one 2015-08, Vol.10 (8), p.e0134172-e0134172
• Main Authors: Yan, Hong-Mei, Xia, Ming-Feng, Wang, Yan, Chang, Xin-Xia, Yao, Xiu-Zhong, Rao, Sheng-Xiang, Zeng, Meng-Su, Tu, Yin-Fang, Feng, Ru, Jia, Wei-Ping, Liu, Jun, Deng, Wei, Jiang, Jian-Dong, Gao, Xin
• Format: Article
• Language: English
• Subjects: Adiposity - drug effects; Adiposity - genetics; Administration, Oral; Animal models; Animal research; Animals; Berberine; Berberine - adverse effects; Berberine - blood; Berberine - pharmacology; Berberine - therapeutic use; Blood Glucose - metabolism; Body weight; Body Weight - drug effects; Care and treatment; Clinical trials; Control methods; Development and progression; Diabetes; Diet, High-Fat; Digestive system; Disease control; Disease Models, Animal; Drugs; Endocrinology; Energy Metabolism - drug effects; Fatty liver; Female; Gene expression; Gene Expression Regulation - drug effects; Glucose; Glucose metabolism; Health care facilities; Hospitals; Humans; Hydrofluorocarbons; Insulin resistance; Kinases; Lipid metabolism; Liver; Liver - drug effects; Liver - enzymology; Liver - pathology; Liver diseases; Male; Medical services; Metabolic disorders; Metabolism; Metabolites; Metabolome - drug effects; Middle Aged; Non-alcoholic Fatty Liver Disease - blood; Non-alcoholic Fatty Liver Disease - drug therapy; Non-alcoholic Fatty Liver Disease - genetics; Patient outcomes; Patients; Phenotype; Physiological aspects; Pioglitazone; Randomization; Rats, Sprague-Dawley; Risk factors; Studies; Treatment Outcome; Urine; Weight reduction
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0134172

A randomized, parallel controlled, open-label clinical trial was conducted to evaluate the effect of a botanic compound berberine (BBR) on NAFLD. 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. 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