Evidence map›Paper›PMID 22711078›Full record

ArticleAnnals of internal medicine2012

Acute liver injury due to flavocoxid (Limbrel), a medical food for osteoarthritis: a case series.

Naga Chalasani, Raj Vuppalanchi, Victor Navarro, Robert Fontana, Herbert Bonkovsky, Huiman Barnhart, David E Kleiner, Jay H Hoofnagle

Open access · greenAbstract read
In one paragraph

Article in Annals of internal medicine, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
8.1field-weighted citation impact, top 3% of its field
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

14 citing papers in PubMed, 53 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
  4. Article
  5. Review
  6. Heavy Consumption of Alcohol is Not Associated With Worse Outcomes in Patients With Idiosyncratic Drug-induced Liver Injury Compared to Non-Drinkers.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2018
    Article
  7. Flavocoxid exerts a potent antiviral effect against hepatitis B virus.Inflammation research : official journal of the European Histamine Research Society ... [et al.] · 2018
    Article
  8. Article
  9. Review
  10. Review
  11. Article
  12. Observational
  13. Article
  14. Herbal medicine for rheumatic diseases: promises kept?Current rheumatology reports · 2012
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 1 institution in 1 country.

Naga ChalasaniDivision of Gastroenterology and Hepatology, Indiana University School of Medicine, 1050 Wishard Boulevard, RG 4100, Indianapolis, IN 46202, USA. nchalasa@iupui.edu
Raj Vuppalanchi
Victor Navarro
Robert Fontana
Herbert Bonkovsky
Huiman Barnhart
David E Kleiner
Jay H Hoofnagle
Indiana University – Purdue University Indianapolis · US

Funding

Histology Core LaboratoryZICBC010687 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI CHINQUEE, JOSEPH · 2009 to 2025
$35.1M
Drug Induced Liver Injury Network Data Coordinating CenterU01DK065176 · NIDDK · DUKE UNIVERSITY · PI Huiman X Barnhart · 2003 to 2026
$25.5M
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
Hepatotoxicity Clinical Research NetworkU01DK065238 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI DAVERN, TIMOTHY JAMES · 2003 to 2012
$1.9M
UT Southwestern: Clinical Site for the Drug-Induced Liver Injury NetworkU01DK083023 · NIDDK · UT SOUTHWESTERN MEDICAL CENTER · PI LEE, WILLIAM M · 2008 to 2012
$1.3M
Uppper Midwest Drug Hepatoxicity ConsortiumU01DK082992 · NIDDK · MAYO CLINIC ROCHESTER · PI TALWALKAR, JAYANT A · 2008 to 2012
$1.1M
Intramural NIH HHSNIDDK NIH HHS U01 DK065176NIDDK NIH HHS U01 DK065184NIDDK NIH HHS U01 DK065201NIDDK NIH HHS U01 DK065211NIDDK NIH HHS U01 DK065238NIDDK NIH HHS U01 DK082992NIDDK NIH HHS U01 DK083020NIDDK NIH HHS U01 DK083023NIDDK NIH HHS U01 DK083027
6 · The paper itself

Abstract

backgroundFlavocoxid is a prescription medical food that is used to treat osteoarthritis. It is a proprietary blend of 2 flavonoids, baicalin and catechins, which are derived from the botanicals Scutellaria baicalensis and Acacia catechu, respectively.

objectiveTo describe characteristics of patients with acute liver injury suspected of being caused by flavocoxid.

designCase series.

settingDrug-Induced Liver Injury Network Prospective Study ongoing at multiple academic medical centers since 2004. PATIENTS: Four adults with liver injury. MEASUREMENTS: Clinical characteristics, liver biochemistry values, and outcomes.

resultsAmong 877 patients enrolled in the prospective study, 4 had liver injury suspected to have been caused by flavocoxid. All were women; ages ranged from 57 to 68 years. All developed symptoms and signs of liver injury within 1 to 3 months after initiating flavocoxid. Liver injury was characterized by marked elevations in levels of alanine aminotransferase (mean peak, 1268 U/L; range, 741 to 1540 U/L), alkaline phosphatase (mean peak, 510 U/L; range, 286 to 770 U/L), and serum bilirubin (mean peak, 160.7 µmol/L [9.4 mg/dL]; range, 34.2 to 356 µmol/L [2.0 to 20.8 mg/dL]). Liver biochemistry values decreased to the normal range within 3 to 12 weeks after flavocoxid was stopped, and all patients recovered without experiencing acute liver failure or chronic liver injury. Causality was adjudicated as highly likely in 3 patients and as possible in 1 patient. LIMITATION: The frequency and mechanism of liver injury could not be assessed.

conclusionFlavocoxid can cause clinically significant liver injury, which seems to resolve within weeks after cessation.

Indexed as

AgedAlanine TransaminaseAlkaline PhosphataseBilirubinCatechinChemical and Drug Induced Liver InjuryDietary SupplementsDrug CombinationsFemaleHumansMiddle AgedOsteoarthritisProspective StudiesAlanine TransaminaseAlkaline PhosphataseBilirubinCatechinDrug Combinationsflavocoxid

Identifiers

PMID22711078
PMCPMC3825458
OpenAlexW2041150833

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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 OpenQuestion graph.