Herbal hepatotoxicity and WHO global introspection method

Area of Science:

• Hepatology
• Pharmacovigilance
• Toxicology

Background:

• Herbal hepatotoxicity diagnosis is complex due to confounding variables.
• The World Health Organization (WHO) global introspection method (WHO method) lacks specificity and validation for assessing herbal liver injury.
• Existing diagnostic methods often overlook crucial factors like dosage, comedications, and pre-existing conditions.

Purpose of the Study:

• To evaluate the limitations of the WHO method in diagnosing herbal hepatotoxicity.
• To advocate for a more reliable and validated diagnostic scale.
• To emphasize the importance of accurate causality assessment in herbal liver injury.

Main Methods:

• Critique of the WHO global introspection method (WHO method) for its lack of liver specificity, validation, and quantitative data.
• Comparison with the Council for International Organizations of Medical Sciences (CIOMS) scale, highlighting its structured, quantitative, and validated approach.
• Discussion of factors ignored by the WHO method, including dosage, temporal aspects, comedications, and differential diagnoses.

Main Results:

• The WHO method is not liver-specific, lacks validation for hepatotoxicity, and fails to quantify causality.
• The WHO method oversimplifies causality assessment, leading to potential overdiagnosis and overreporting of herbal hepatotoxicity.
• The CIOMS scale offers a structured, quantitative, and liver-specific approach validated for hepatotoxicity.

Conclusions:

• The Council for International Organizations of Medical Sciences (CIOMS) scale is the preferred method for assessing herbal hepatotoxicity causality.
• The CIOMS scale ensures accurate diagnosis and exclusion of alternative causes of liver injury.
• The obsolete WHO method should be replaced by validated, liver-specific tools for reliable herbal hepatotoxicity assessment.