Metformin in the treatment of non-alcoholic steatohepatitis: a pilot open label trial
Abstract
BACKGROUND: Insulin sensitizing agents may be useful in treatment of non-alcoholic fatty liver disease. AIM: A pilot study to evaluate the efficacy and safety of metformin in non-alcoholic fatty liver disease. METHODS: In an open labelled study, patients with histologically confirmed non-alcoholic fatty liver disease were given metformin (20 mg/kg) for 1 year. Insulin resistance (by log homeostasis assessment model analysis for insulin resistance and Quantitative Insulin Sensitivity Check Index) and post-treatment hepatic histology were compared with pre-treatment histology. RESULTS: Fifteen patients completed 1 year of treatment. During the initial 3 months, there was improvement in alanine aminotransferase and aspartate aminotransferase (P-value 0.01 and 0.02, respectively) along with improvement in insulin sensitivity. However, after 3 months, there was no further improvement in insulin sensitivity and there was gradual rise in aspartate aminotransferase and alanine aminotransferase back to pre-treatment levels. Among the 10 patients with post-treatment biopsy, three (33%), showed improvement in steatosis, two (20%) showed improvement in inflammation score and one (10%) showed improvement in fibrosis. CONCLUSION: Metformin treatment was associated with only a transient improvement in liver chemistries. A progressive, sustainable reduction in insulin sensitivity was not noted during treatment.
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Small and uncontrolled initial trials of metformin have shown an ALT reduction and an insulin-sensitising effect, but were not followed by sufficiently large and well-conducted RCTs.
“Small and uncontrolled initial trials of metformin have shown an ALT reduction and an insulin-sensitising effect, 428,429 but were not followed by suf fi ciently large and well-conducted RCTs.”
From EASL-EASD-EASO Clinical Practice Guidelines on the management of metabolic dysfunction-associated steatotic liver disease (MASLD). (2024) · cites this paper as [428]
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- Authors
- Nair, S., Diehl, A. M., Wiseman, M., Farr, G. H., & Perrillo, R. P.
- Affiliations
- Ochsner Medical Center (US)
- Johns Hopkins University (US)
- Corresponding author
- Nair, S.
- ORCID
- Venue
- Alimentary Pharmacology & Therapeutics
- Publisher
- Wiley
- Published
- 2004-06-14
- Volume
- 20
- Issue
- 1
- Pages
- 23-28
- ISSN
- 0269-2813 (ISSN-L)
- 1365-2036
- OpenAlex
- W2056505063
- Cited by
- 369
- References
- 37
- Citations by year
- 2026: 1 · 2025: 3 · 2024: 13 · 2023: 13 · 2022: 7 · 2021: 10 · 2020: 9 · 2019: 6 · 2018: 14 · 2017: 13 · 2016: 9 · 2015: 22 · 2014: 21 · 2013: 21 · 2012: 17
- FWCI
- 20.68
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Alimentary Pharmacology & Therapeutics (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Epidemiology › Liver Disease Diagnosis and Treatment
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Drug-Induced Hepatotoxicity and Protection
- Keywords
- metformin, nonalcoholic steatohepatitis, non-alcoholic fatty liver disease, insulin sensitizers, insulin resistance, HOMA-IR, QUICKI, hepatic steatosis, liver fibrosis, liver inflammation, alanine aminotransferase, aspartate aminotransferase, drug safety and efficacy
- MeSH terms
- Alanine Transaminase, Aspartate Aminotransferases, Drug Evaluation, Female, Hepatitis, Humans, Hypoglycemic Agents, Insulin Resistance, Male, Metformin, Middle Aged, Patient Compliance, Pilot Projects, Treatment Outcome
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