Randomized, vitamin E-controlled trial of bicyclol plus metformin in non-alcoholic fatty liver disease patients with impaired fasting glucose.
Clin Drug Investig
; 34(1): 1-7, 2014 Jan.
Article
em En
| MEDLINE
| ID: mdl-24081374
ABSTRACT
BACKGROUND:
Non-alcoholic fatty liver disease (NAFLD) is associated with a high morbidity in patients with impaired fasting glucose (IFG). Bicyclol is a synthetic compound known to protect the liver against oxidation and lipid injuries.OBJECTIVE:
The objective of this study was to evaluate the efficacy and safety of metformin and bicyclol in the treatment of NAFLD patients with IFG.METHODS:
After lifestyle changes and metformin treatment (500 mg orally three times daily), the 248 patients enrolled with NAFLD and IFG were equally randomized to two 24-week treatment groups bicyclol 25 mg three times daily or vitamin E (α-tocopherol) 100 mg three times daily (control). Anthropometric measurements, serum biochemistry, liver/spleen computed tomography ratio, and changes in liver histological parameters were compared before and after treatments.RESULTS:
A total of 223 patients completed the treatment, and there were significant improvements in body mass index, waist-to-hip ratio, and biochemical parameters in both groups (P < 0.01). Compared with the control group, the improvement in serum alanine aminotransferase levels in the bicyclol group was statistically significant (P < 0.01). Liver histological assessments revealed that steatosis, inflammation, hepatocellular ballooning, and NAFLD activity scores (NAS) were all decreased in both groups after treatment (P < 0.01). However, decreases in inflammation and NAS in the bicyclol group were statistically significant compared with the vitamin E group (P < 0.01). Adverse events in the bicyclol and control groups occurred in 1.79 and 1.80 %, respectively.CONCLUSION:
Metformin combined with bicyclol is effective and safe in the treatment of patients with NAFLD and IFG. However, further studies with a larger sample size are needed to confirm the efficacy and safety of the combination.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Vitamina E
/
Compostos de Bifenilo
/
Hepatopatia Gordurosa não Alcoólica
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Hipoglicemia
/
Metformina
Tipo de estudo:
Clinical_trials
Limite:
Female
/
Humans
/
Male
Idioma:
En
Ano de publicação:
2014
Tipo de documento:
Article