Original articlePancreas, biliary tract, and liverA Randomized Trial of Silymarin for the Treatment of Nonalcoholic Steatohepatitis
Section snippets
Methods
The study conformed to the ethical guidelines of the 1975 Declaration of Helsinki and ethical approval was obtained from our institutional review board prior to the commencement of the study (Approval Date: May 25, 2011; Reference No.: 853.1). All subjects who participated in the study provided written informed consent. The study was registered at ClinicalTrials.gov (NCT02006498). All authors had access to the study data and had reviewed and approved the final manuscript.
Consecutive adult NAFLD
Study Subjects and Compliance
Screening began in November 2012 and ended in August 2014 when a sufficient number of subjects have been enrolled. Of the 148 subjects who underwent screening, 99 subjects were eligible for the study and underwent randomization. There were 49 subjects in the silymarin group and 50 subjects in the placebo group (Supplementary Figure 1). The baseline characteristics were comparable between the groups except the serum triglyceride and total cholesterol levels, and the controlled attenuation
Discussion
This is the first study on the use of silymarin for the treatment of NASH that utilized paired liver biopsies and provides histological confirmation of previous observations that silymarin may be useful for the treatment of NAFLD. Furthermore, the randomized, double-blinded, placebo-controlled design eliminates the potential of confounding by lifestyle modifications and the potential biases that may be seen in open-labeled, uncontrolled studies. Treatment with silymarin for 48 weeks did not
References (40)
- et al.
Weight loss through lifestyle modification significantly reduces features of nonalcoholic steatohepatitis
Gastroenterology
(2015) - et al.
Farnesoid X nuclear receptor ligand obeticholic acid for non-cirrhotic, non-alcoholic steatohepatitis (FLINT): a multicentre, randomised, placebo-controlled trial
Lancet
(2015) - et al.
Milk thistle (Silybum marianum) for the therapy of liver disease
Am J Gastroenterol
(1998) - et al.
Silibinin protects mice from T cell-dependent liver injury
J Hepatol
(2003) - et al.
Silybin, a component of sylimarin, exerts anti-inflammatory and anti-fibrogenic effects on human hepatic stellate cells
J Hepatol
(2009) - et al.
Silybin combined with phosphatidylcholine and vitamin E in patients with nonalcoholic fatty liver disease: a randomized controlled trial
Free Radic Biol Med
(2012) - et al.
The metabolic syndrome–a new worldwide definition
Lancet
(2005) - et al.
Long-term (12 months) treatment with an anti-oxidant drug (silymarin) is effective on hyperinsulinemia, exogenous insulin need and malondialdehyde levels in cirrhotic diabetic patients
J Hepatol
(1997) - et al.
Effects of Silybum marianum (L.) Gaertn. (silymarin) extract supplementation on antioxidant status and hs-CRP in patients with type 2 diabetes mellitus: a randomized, triple-blind, placebo-controlled clinical trial
Phytomedicine
(2015) - et al.
Epidemiology of a fast emerging disease in the Asia-Pacific region: non-alcoholic fatty liver disease
Hepatol Int
(2013)
Meta-analysis: natural history of non-alcoholic fatty liver disease (NAFLD) and diagnostic accuracy of non-invasive tests for liver disease severity
Ann Med
Liver transplantation and non-alcoholic fatty liver disease
World J Gastroenterol
Pioglitazone, vitamin E, or placebo for nonalcoholic steatohepatitis
N Engl J Med
Silybin and the liver: from basic research to clinical practice
World J Gastroenterol
Effect of the flavanolignans of Silybum marianum L. on lipid peroxidation in rat liver microsomes and freshly isolated hepatocytes
Pharmacol Res
Silymarin in non alcoholic fatty liver disease
World J Hepatol
A placebo-controlled trial of silymarin in patients with nonalcoholic fatty liver disease
Hepat Mon
Effects of metformin, pioglitazone, and silymarin treatment on non-alcoholic Fatty liver disease: a randomized controlled pilot study
Hepat Mon
Silymarin in treatment of non-alcoholic steatohepatitis: A randomized clinical trial
Caspian J Intern Med
Effect of silymarin plus vitamin E in patients with non-alcoholic fatty liver disease. A randomized clinical pilot study
Eur Rev Med Pharmacol Sci
Cited by (162)
Flavonoids-based nanomedicines for the treatment of liver fibrosis: A recent progress
2024, Journal of Drug Delivery Science and TechnologyA review on ethnopharmacology, phytochemistry, pharmacology and potential uses of Portulaca oleracea L.
2024, Journal of EthnopharmacologyAnthocyanins: Potential phytochemical candidates for the amelioration of non-alcoholic fatty liver disease
2024, Annales Pharmaceutiques FrancaisesAlleviation of acetaminophen-induced liver failure using silibinin nanoliposomes: An in vivo study
2023, Biochemical and Biophysical Research CommunicationsNatural products in non-alcoholic fatty liver disease (NAFLD): Novel lead discovery for drug development
2023, Pharmacological Research
Conflicts of interest The authors disclose no conflicts.
Funding This study was funded by the University of Malaya Research Grant (Project Number: RG536-13HTM) and Meda Group. University of Malaya and Meda Group were not involved in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; and in the decision to submit the paper for publication.