Evidence map›Paper›PMID 39354283›Full record

ArticleDrug safety2025

Investigation of the Role of Chemical Analysis in Causality Assessment of Herbal and Dietary Supplement-Induced Liver Injury.

Dina Halegoua-DeMarzio, Victor J Navarro, Ashley Davis, Jawad Ahmad, Bharathi Avula, Huiman Barnhart, A Sidney Barritt, Herbert L Bonkovsky, Vincent L Chen, Gina Choi and 13 more

Abstract read
In one paragraph

Article in Drug safety, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

23 authors.

Dina Halegoua-DeMarzioSidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, PA, USA.ORCID http://orcid.org/0000-0001-8298-5381
Victor J NavarroJefferson-Einstein Medical Center, Philadelphia, PA, USA. victor.navarro@jefferson.edu.
Ashley DavisJefferson-Einstein Medical Center, Philadelphia, PA, USA.
Jawad AhmadIcahn School of Medicine at Mount Sinai, New York, NY, USA.
Bharathi AvulaUniversity of Mississippi, Oxford, MS, USA.
Huiman BarnhartDuke University, Durham, NC, USA.
A Sidney BarrittUniversity of North Carolina, Chapel Hill, NC, USA.
Herbert L BonkovskyWake Forest University School of Medicine, Winston-Salem, NC, USA.
Vincent L ChenUniversity of Michigan, Ann Arbor, MI, USA.
Gina ChoiUniversity of California, Los Angeles, LA, USA.
Robert J FontanaUniversity of Michigan, Ann Arbor, MI, USA.
Marwan S GhabrilIndiana University School of Medicine, Indianapolis, IN, USA.
Ikhlas KhanUniversity of Mississippi, Oxford, MS, USA.
Christopher KohNational Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA.
Joseph OdinIcahn School of Medicine at Mount Sinai, New York, NY, USA.
Don C RockeyMedical University of South Carolina, Charleston, SC, USA.
Hoss RostamiDuke University, Durham, NC, USA.
Jose SerranoNational Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA.
Averell H SherkerNational Cancer Institute, NIH, Bethesda, MD, USA.
Andrew StolzUniversity of Southern California, Los Angeles, CA, USA.
Hans L TillmannEast Carolina University, Greenville, NC, USA.
Raj VuppalanchiIndiana University School of Medicine, Indianapolis, IN, USA.
Drug-Induced Liver Injury Network

Funding

Coordinating Center for the Drug Induced Liver Injury Network (DILIN)U24DK065176 · NIDDK · DUKE UNIVERSITY · PI BARNHART, HUIMAN X · 2018 to 2022
$7.6M
IU Clinical Center: Drug Induced Liver Injury NetworkU01DK065211 · NIDDK · INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS · PI NAGA P CHALASANI · 2003 to 2026
$7.5M
University of North Carolina Clinical Center for DILINU01DK065201 · NIDDK · UNIV OF NORTH CAROLINA CHAPEL HILL · PI PAUL B WATKINS · 2003 to 2026
$7.3M
Michigan Hepatotoxicity Clinical Research Network Renewal 2018U01DK065184 · NIDDK · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI ROBERT J FONTANA · 2003 to 2026
$7.0M
The Drug Induced Liver Injury Network (DILIN): Focus on Herbal and DietarySupplementsU01DK083027 · NIDDK · THOMAS JEFFERSON UNIVERSITY · PI Dina Halegoua-DeMarzio · 2008 to 2026
$7.0M
USC-UCLA Drug-Induced Liver Injury (DILI) Clinical Center.U01DK083020 · NIDDK · UNIVERSITY OF SOUTHERN CALIFORNIA · PI Lily Dara · 2008 to 2026
$5.9M
Mount Sinai Regional Drug Induced Liver Injury Network SiteU01DK100928 · NIDDK · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · PI AHMAD, JAWAD, ODIN, JOSEPH · 2013 to 2022
$4.0M
NIDDK/NIH U01DK065184 (University of Michigan)NIDDK/NIH U01DK065201 (University of North Carolina-Chapel Hill)NIDDK/NIH U01DK065211 (Indiana University)NIDDK/NIH U01DK083020 (University of Southern California)NIDDK/NIH U01DK083027 (Thomas Jefferson University/Albert Einstein Medical Center)NIDDK/NIH U01DK100928 (Icahn School of Medicine at Mount Sinai)NIDDK/NIH U24DK065176 (Duke University).NIDDK NIH HHS U01 DK065184NIDDK NIH HHS U01 DK065201NIDDK NIH HHS U01 DK065211NIDDK NIH HHS U01 DK083020NIDDK NIH HHS U01 DK083027NIDDK NIH HHS U01 DK100928NIDDK NIH HHS U24 DK065176
6 · The paper itself

Abstract

backgroundThe attribution of drug-induced liver injury (DILI) to specific herbal and dietary supplements (HDS) is confounded by inaccurate labels and undisclosed ingredients. The US Drug-Induced Liver Injury Network (DILIN) determines the attribution of injury to an agent through its structured expert opinion causality assessment process, but without the use of chemical analysis data of HDS. We aimed to determine the impact of chemical analysis of HDS products on prior causality assessment scores.

methodsObtained samples of HDS consumed by DILIN-enrolled patients were analyzed by high-performance liquid chromatography-mass spectrometry (HPLC-MS). Chemical analysis data were compared to label accuracy and detect whether the product contained botanical and non-botanical compounds. A comparison of the causality scores reassessed with chemical analysis was compared with the original scores.

resultsA total of 54 previously adjudicated cases with chemical analysis available were reassessed for causality with chemical analysis data; reviewers were blinded to original causality scores. Using the chemical analysis data, 37% (n = 20) of the 54 cases were scored with a higher likelihood of DILI compared with the original causality scores; 14 of the 20 (70%) moved from probable to highly likely; 52% had no change in causality score; and 11% of cases were scored as a lower likelihood of DILI.

conclusionsOur study demonstrates that there is value in using HDS chemical analysis data in the causality assessment process for DILI. In more than a third of cases, chemical analysis of products led to an increased confidence in DILI attribution to HDS. These findings suggest that chemical analysis is an important tool in causality assessment for HDS agents, specifically in challenging situations, and further studies are needed to confirm its applicability in clinical practice.

Indexed as

Chemical and Drug Induced Liver InjuryDietary SupplementsPlant PreparationsAgedChromatography, High Pressure LiquidFemaleHumansMaleMass SpectrometryMiddle AgedPlant Preparations

Identifiers

PMID39354283
PMCPMC11785658

What Socratic holds

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LicenceCC BY-NC
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.