Purpose: Despite its long history of use and preclinical evidence suggesting hepatoprotective effects, Scutellaria baicalensis (SB) has been implicated in sporadic cases of liver injury. This study aimed to systematically analyze the clinical characteristics and causality of SB-associated drug-induced liver injury (DILI) to provide a basis for safe clinical use.Methods: We searched five electronic databases, including Embase, PubMed, the Cochrane Library, Scopus, and RISS, for case reports of SB-associated DILI. Data on patient demographics, causative agents, clinical patterns, and histopathology were extracted. Causality was re-evaluated using the Roussel-Uclaf Causality Assessment Method (RUCAM).Results: Sixteen cases were identified. Most patients were women (81.3%), with a median age of 57. The latency period typically ranged from 2 to 8 weeks. The predominant pattern of injury was hepatocellular (56.3%). Histopathological findings frequently revealed necrosis with eosinophilic infiltration, suggesting an immune-mediated hypersensitivity mechanism. According to RUCAM scores, 11 cases (68.8%) were classified as “highly probable” or “probable,” and 5 cases demonstrated positive re-challenge reactions. All patients recovered after discontinuation of the suspected agents.Conclusion: Although preclinical studies indicate that SB has a high safety profile and hepatoprotective properties, clinical evidence suggests the existence of rare SB-associated DILI. These cases exhibit features of idiosyncratic liver injury, likely driven by immune-mediated mechanisms. Clinicians should be aware of this potential risk and monitor liver function during administration of SB-containing preparations.
Changwoo Han (2025) studied this question.
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