USP suspected herbal hepatotoxicity: Quality of causality assessment is more important than quantity of counted cases, not vice versa

摘要

We appreciate the actual commentary by Prof. Mahady and her colleagues1 from the US Pharmacopeia (USP) regarding our report2 because they hereby confirm that the scale of the Council for International Organizations of Medical Sciences (CIOMS) is better suited than the Naranjo scale for assessing reports of liver damage1. Their respective statements and adjustments are indeed a real breakthrough in the long‐standing discussion around the use of the appropriate causality assessment method. They now support the views of others who dismissed before the preferential use of the Naranjo scale by USP2-9 regarding black cohosh (BC)10 and green tea extract.11 In future, we therefore prefer causality assessments performed by USP and other pharmacovigilance centers with the scale of the original CIOMS,12 or better the updated CIOMS,13 rather than the Naranjo scale.2, 8 Nevertheless, their six‐point commentary contains several procedural errors and flaws in the course of their other considerations.