Format

Send to

Choose Destination
PLoS One. 2015 Aug 7;10(8):e0134172. doi: 10.1371/journal.pone.0134172. eCollection 2015.

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

Author information

1
Department of Endocrinology and Metabolism, Zhongshan Hospital, Fudan University, Shanghai, 200032, China.
2
Institute of Materia Medica, Chinese Academy of Medical Sciences, and Peking Union Medical College, Beijing, 100050, China.
3
Department of Radiology, Zhongshan Hospital, Fudan University, Shanghai, 200032, China.
4
Department of Endocrinology and Metabolism, The Sixth People's Hospital, Shanghai Jiaotong University, Shanghai, 200233, China.
5
Department of Endocrinology and Metabolism, The Fifth People's Hospital, Fudan University, Shanghai, 200240, China.
6
School of public health, Fudan University, Shanghai, 200032, China.

Abstract

OBJECTIVES:

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.

CONCLUSION:

BBR ameliorates NAFLD and related metabolic disorders. The therapeutic effect of BBR on NAFLD may involve a direct regulation of hepatic lipid metabolism.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00633282.

PMID:
26252777
PMCID:
PMC4529214
DOI:
10.1371/journal.pone.0134172
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for Public Library of Science Icon for PubMed Central
Loading ...
Support Center