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Overview of causality assessment in drug‐induced liver injury
Open accessAbstract
The diagnosis of drug-induced (or herbal/dietary supplement-induced) liver injury (DILI) remains largely a diagnosis of exclusion.Research into diagnostic serum markers has made great progress, but few markers have made it into clinical use.For now, two diagnostic methods are in widest use: the Roussel Uclaf Causality Assessment Model (RUCAM) and expert consensus opinion.1,2 Only the former is available to the clinician.Both methods have obvious weaknesses, and developing a better diagnostic is a clear mandate.
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Causality assessment was performed using the 7-point Roussel Uclaf Causality Assessment Method (RUCAM).
“Thereafter, the causality assessment was performed to diagnose highly probable (score >8), probable (6-8), possible (3-5), and unlikely(1-2 or less) DILI using the 7-point Roussel Uclaf Causality Assessment Method (RUCAM).14”
From Ashwagandha-induced liver injury—A case series from India and literature review (2023) · cites this paper as [14]
Table 1 (SUMMARY; page unavailable) presents RUCAM with seven assessment criteria, and Table 2 gives the stated thresholds for highly probable, probable, and possible DILI. The citing sentence's unlikely category does not match Table 2, which lists unlikely as 1 to 3 and separately lists scores below 1 as excluded. (LLM, conf=0.88)
Experimental — accuracy not yet measuredMultiple reports have been published on ashwagandha-related liver injury, mostly from centers in the United States.
“Recently, ashwagandha was implicated in multiple reports of herb-induced liver injury (HILI), mainly from the United States.”
From Ashwagandha-induced liver injury—A case series from India and literature review (2023) · cites this paper as [14]
The Expert Consensus Opinion section describes the US Drug-Induced Liver Injury Network and its case registry, but does not identify ashwagandha or discuss reports involving it. Searches for ashwagandha-related liver injury and US reports found no passage supporting the claimed number or location of reports. (LLM, conf=0.76)
Experimental — accuracy not yet measuredLarge numbers of self-reported adverse events, such as severe itching, have been reported for ashwagandha based on analysis of commercial websites.
“Multiple reports have been published on ashwagandha-related liver injury, mostly from centers in the United States, along with large numbers of self-reported adverse events, such as severe itching, based on analysis of commercial websites.14”
From Ashwagandha-induced liver injury—A case series from India and literature review (2023) · cites this paper as [14]
The Abstract discusses drug- and supplement-induced liver injury generally, while the Expert Consensus Opinion section describes how DILIN assesses cases (page numbers unavailable). Neither those passages nor searches for ashwagandha, severe itching, and commercial-website adverse-event reports address the attributed claim. (LLM, conf=0.76)
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Research works printed but not linked: 10
- 1993, Causality assessment of adverse reactions to drugs—I. A novel method based on the conclusions of international consensus meetings: application to drug‐induced liver injuries, J Clin Epidemiol, 46, 1323, 10.1016/0895-4356(93)90101-6 · DOI · Paper page
- 2009, Drug‐Induced Liver Injury Network (DILIN) prospective study: rationale, design and conduct, Drug Saf, 32, 55, 10.2165/00002018-200932010-00005 · DOI · Paper page
- 2008, Reliability of the Roussel Uclaf Causality Assessment Method for assessing causality in drug‐induced liver injury, Hepatology, 48, 1175, 10.1002/hep.22442 · DOI
- 1993, Causality assessment of adverse reactions to drugs—II. An original model for validation of drug causality assessment methods: case reports with positive rechallenge, J Clin Epidemiol, 46, 1331, 10.1016/0895-4356(93)90102-7 · DOI · Paper page
- 2009, Causality assessment in drug‐induced liver injury, Semin Liver Dis, 29, 348, 10.1055/s-0029-1240003 · DOI
- 2007, Comparison between expert opinion and RUCAM for assignment of causality in drug‐induced liver injury, Gastroenterology, 132, A
- 2015, Reliability of causality assessment for drug, herbal and dietary supplement hepatotoxicity in the Drug‐Induced Liver Injury Network (DILIN), Liver Int, 35, 1623, 10.1111/liv.12540 · DOI
- 2016, A novel computerized drug induced liver injury causaltiy assessment tool (DILI‐CAT), Hepatology, 64, 320A
- 2015, Scandinavian epidemiological research in gastroenterology and hepatology, Scand J Gastroenterol, 50, 636, 10.3109/00365521.2015.1034168 · DOI
- 2016, The Latin American DILI Registry experience: a successful ongoing collaborative strategic initiative, Int J Mol Sci, 17, 313, 10.3390/ijms17030313 · DOI
Cited by
Sorted by citations
Ashwagandha-induced liver injury—A case series from India and literature review
Philips, C. A., Valsan, A., Theruvath, A. H., Ravindran, R., Oommen, T. T., Rajesh, S., Bishnu, S., Augustine, P., & India, O. B. O. T. L. R. C. (2023) · Hepatology Communications · doi:10.1097/hc9.0000000000000270 · Cited by 62
Metadata
- Authors
- Hayashi, P. H.
- Affiliations
- University of North Carolina at Chapel Hill (US)
- Corresponding author
- Hayashi, Paul H.
- ORCID
- Hayashi, Paul H.
- Venue
- Clinical Liver Disease
- Published
- 2017-02
- Volume
- 9
- Issue
- 2
- Pages
- 29-33
- ISSN
- 2046-2484 (ISSN-L)
- PMC
- PMC6467140
- OpenAlex
- W2594154646
- Cited by
- 16
- References
- 0
- Citations by year
- 2025: 1 · 2024: 1 · 2023: 5 · 2022: 2 · 2021: 5 · 2019: 2
- FWCI
- 0.38
- Type
- journal article
- Language
- en
- Update notices
- erratum (2019-07-02)
- Open access
- bronze
- doi.org
- Licence
- Locations
- Clinical Liver Disease (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Drug-Induced Hepatotoxicity and Protection
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
- Health Sciences › Medicine › Hepatology › Liver Disease Diagnosis and Treatment
- Keywords
- drug-induced liver injury, causality assessment, adverse drug reactions, drug safety, hepatotoxicity
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