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Silymarin in non-cirrhotics with non-alcoholic steatohepatitis: A randomized, double-blind, placebo controlled trial
Open accessAbstract
The botanical product silymarin, an extract of milk thistle, is commonly used by patients to treat chronic liver disease and may be a treatment for NASH due to its antioxidant properties. We aimed to assess the safety and efficacy of higher than customary doses of silymarin in non-cirrhotic patients with NASH. This exploratory randomized double-blind placebo controlled multicenter Phase II trial tested a proprietary standardized silymarin preparation (Legalon®, Rottapharm|Madaus, Mylan) and was conducted at 5 medical centers in the United States. Eligible adult patients had liver biopsy within 12 months showing NASH without cirrhosis with NAFLD Activity Score (NAS) ≥4 per site pathologist's assessment. Participants were randomized to Legalon® 420 mg, 700 mg, or placebo t.i.d. for 48 weeks. The primary endpoint was histological improvement ≥2 points in NAS. Of 116 patients screened, 78 were randomized. There were no significant differences in adverse events among the treatment groups. After 48-50 weeks, 4/27 (15%) in the 700 mg dose, 5/26 (19%) participants randomized to 420 mg, and 3/25 (12%) of placebo recipients reached the primary endpoint (p = 0.79) among all randomized participants, indicating no benefit from silymarin in the intention to treat analysis Review by a central pathologist demonstrated that a substantial number of participants (49, 63%) did not meet histological entry criteria and that fibrosis stage improved most in the placebo treated group, although not significantly different from other groups. Silymarin (Legalon®) at the higher than customary doses tested in this study is safe and well tolerated. The effect of silymarin in patients with NASH remains inconclusive due to the substantial number of patients who entered the study but did not meet entry histological criteria, the lack of a statistically significant improvement in NAS of silymarin treated patients, and the unanticipated effect of placebo on fibrosis indicate the need for additional clinical trials. Trial Registration: clinicaltrials.gov, Identifier: NCT00680407.
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“Silymarin (an extract of milk thistle) may improve liver enzymes but the few, small, RCTs available 395,396 did not document histological improvement.”
From EASL-EASD-EASO Clinical Practice Guidelines on the management of metabolic dysfunction-associated steatotic liver disease (MASLD). (2024) · cites this paper as [396]
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Metadata
- Authors
- Navarro, V. J., Belle, S. H., D’Amato, M., Adfhal, N., Brunt, E. M., Fried, M. W., Reddy, K. R., Wahed, A. S., Harrison, S., & on behalf of the Silymarin in NASH and C Hepatitis (SyNCH) Study Group
- Affiliations
- Jefferson Einstein Philadelphia Hospital (US)
- University of Pittsburgh (US)
- Beth Israel Deaconess Medical Center (US)
- Washington University in St. Louis (US)
- University of North Carolina at Chapel Hill (US)
- University of Pennsylvania (US)
- Brooke Army Medical Center (US)
- Corresponding author
- Navarro, Victor J.
- Venue
- PLoS ONE
- Publisher
- Public Library of Science (PLoS)
- Published
- 2019-09-19
- Volume
- 14
- Issue
- 9
- Pages
- e0221683
- ISSN
- 1932-6203 (ISSN-L)
- PMC
- PMC6752871
- OpenAlex
- W2973727343
- Cited by
- 125
- References
- 14
- Citations by year
- 2026: 13 · 2025: 17 · 2024: 30 · 2023: 16 · 2022: 19 · 2021: 18 · 2020: 9 · 2019: 1
- FWCI
- 8.64
- Type
- journal article
- Language
- en
- Update notices
- correction (2019-10-10)
- Open access
- gold
- doi.org
- Licence
- Locations
- PLoS ONE (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Digital Commons@Becker (Washington University School of Medicine) (submittedVersion)
- The Medicine Forum (submittedVersion, cc-by)
- RePEc: Research Papers in Economics (submittedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Figshare (submittedVersion, cc-by)
- Funders
- Rottapharm|Madaus
- Topics
- Health Sciences › Medicine › Hepatology › Silymarin and Mushroom Poisoning
- Health Sciences › Medicine › Hepatology › Liver Disease Diagnosis and Treatment
- Health Sciences › Medicine › Complementary and alternative medicine › Nigella sativa pharmacological applications
- Keywords
- silymarin, Silybum marianum, nonalcoholic steatohepatitis, non-cirrhotic liver disease, NAFLD activity score, liver fibrosis, antioxidant therapy, herbal supplement safety, dose comparison, histological improvement
- MeSH terms
- Adult, Antioxidants, Double-Blind Method, Female, Humans, Male, Middle Aged, Silymarin, Treatment Outcome, Intention to Treat Analysis, Non-alcoholic Fatty Liver Disease
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