Case series / case reportindependent cross-checkabstract checked I-SUP-119 standard review
Liver injury from supplements in the US
Liver injury from herbals and dietary supplements in the U.S. Drug-Induced Liver Injury Network.
Overview
Navarro VJ et al.. Hepatology 2014 · PMID 25043597 · DOI 10.1002/hep.27317
About one in six drug-related liver injuries in a US network were caused by supplements, mainly bodybuilding and multi-ingredient products.
Does the study support the specific claim? Partly · Methodological quality: moderate
Plain-language summary
Study explained simply
- What did the researchers want to find out?
To describe liver injury from supplements.
- How was the study done?
Prospective case registry.
- How many people, animals or samples were studied?
130 supplement-related cases among 839.
- What was actually found?
Share rose from 7% to 20%; non-bodybuilding products caused severe cases.
- How large was the observed effect?
Death/transplant 13% vs 3%.
- What do the results mean in everyday life?
Certain supplements can seriously harm the liver.
- What are the study's limitations?
No information on how many users are affected.
- What does it say about Elawady's specific claim?
Partly supports C-SUP-08 but not its universal form.
- Do the results apply to Germany and Europe?
US product market.
- What can explicitly not be concluded from this study?
Cannot show that ordinary vitamins damage the liver.
Scientific in-depth review
1. Full reference
- Authors
- Navarro VJ et al.
- Journal
- Hepatology
- Year
- 2014
- Identifier
- PMID 25043597 DOI 10.1002/hep.27317 · PMC4293199
- Verification
- verified – PubMed efetch 2026-10-26; Crossref works API 2026-10-26
- Retracted
- no
- Corrections
- none
- Extent checked
- abstract only
- Conflicts of interest and funding
No COI statement in PubMed record; funding listed: NIDDK NIH HHS
2. Research question
Characteristics and outcomes of liver injury from herbal and dietary supplements (HDS) vs medications.
3. Study design and population
- Study design
- Case series / case report – Prospective registry analysis (US Drug-Induced Liver Injury Network)
- Population
Patients with suspected drug/HDS liver injury at 8 US referral centres
- Country
USA
- Period
2004-2013
- Sample size
839 cases; 130 attributed to HDS (45 bodybuilding, 85 non-bodybuilding)
- Inclusion and exclusion criteria
Consecutive referred patients with liver injury; causality by expert opinion
4. Methods and endpoints
- Exposure / intervention
HDS (bodybuilding vs other)
- Comparator
Conventional medications (709 cases)
- Endpoints
Proportion of cases, clinical pattern, death or liver transplantation
- Statistical methods
Descriptive comparisons
5. Actual results
- Results
HDS caused 15.5% of DILIN cases, rising from 7% to 20% during the study (P<0.001). Bodybuilding HDS: prolonged jaundice (median 91 days) in young men, no deaths or transplants. Non-bodybuilding HDS: hepatocellular injury mainly in middle-aged women; death or transplantation 13% vs 3% for medications (P<0.05).
- Absolute risks
Not a population incidence study
- Authors' conclusion
The proportion of liver injury attributed to HDS has increased; non-bodybuilding HDS injury is more severe.
6. Strengths
- Prospective, standardised causality assessment
7. Weaknesses
- Referral-centre case series; no denominator of users
- Overlaps with data summarised in I-SUP-10
8. Risk of bias
- Orienting tool
- none applicable
- Type of assessment
- simplified assessment (abstract only)
- Full formal assessment
- no
- Overall risk of bias
- not assessable
- Rationale
Case series; cannot estimate risk per user.
9. Assessment of the statistical interpretation
Proportions of injury cases, not risks.
10. Relevance to the specific claim
Confirms that some supplements cause serious liver injury, concentrated in bodybuilding and multi-ingredient products; does not show that all supplements harm the liver.
11. Independent contrary findings
No denominator; most supplement users never develop liver injury.
12. Transferability to Germany and Europe
Product mix differs between US and EU/Egypt.
13. Overall methodological judgement
Real but product-specific hazard.
| Multidimensional assessment | |
|---|---|
| Authenticity of the source | verified |
| Methodological quality | moderate |
| Risk of bias | not assessable |
| Precision of results | not applicable |
| Directness | direct |
| Reproducibility | partly replicated |
| Consistency with the overall evidence | consistent |
| Regional transferability | moderate |
| Adequacy of the interpretation (by the archive) | not applicable |
14. Open questions
Population incidence by product type.