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Causality imputation between herbal products and HILI: An algorithm evaluation in a systematic review
Pedro Felipe Soares1, Maria Tereza Calchi Fanti Fernandes1, Andréia de Santana Souza2
1School Medicine of Bahia- University Federal of Bahia, Av. Rector Miguel Calmon, S/N - Vale do Canela, 40110-100, Salvador - BA, Brazil.
The Roussel Uclaf Causality Assessment Method (RUCAM) is the primary algorithm for assessing Herb-Induced Liver Injury (HILI). Most HILI patients are female, presenting with jaundice, and the condition is often reversible.
Area of Science:
- Hepatology
- Clinical Pharmacology
- Toxicology
Background:
- Drug-Induced Liver Injury (DILI) causality scales may not apply to Herb-Induced Liver Injury (HILI).
- Understanding HILI patient profiles and causality assessment is crucial for clinical practice.
Purpose of the Study:
- To determine the clinical and demographic profile of patients with HILI.
- To identify the main algorithmic scales used for HILI causality assessment.
Main Methods:
- Systematic review of articles (1979-2019) in English, Spanish, or Portuguese.
- Inclusion of human studies related to HILI.
- Qualitative and quantitative statistical analysis.
Main Results:
- 203 HILI reports analyzed from 60 articles.
- 59.9% of patients were female, with an average age of 45.8 years.
- Jaundice was the most frequent symptom; hepatocellular injury was most common.
- RUCAM was used in 72.3% of cases for causality assessment.
- 3.0% of cases were severe, and 7.6% were fatal or required transplantation.
Conclusions:
- RUCAM is the predominant algorithm for HILI causality assessment.
- HILI predominantly affects females, with jaundice as a key symptom.
- HILI is frequently reversible.
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