Common adverse events of herbal formulas for developing reporting forms for clinical practice and research: An overview of systematic reviews
Background: Previous research has mainly focused on the adverse events (AEs) of individual medicinal plants rather than those of herbal formulas. This study investigated AEs associated with herbal formulas composed of two or more herbs by summarizing existing systematic reviews (SRs). We aimed to id...
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| Main Authors: | , , |
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| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2025-03-01
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| Series: | Integrative Medicine Research |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2213422024000982 |
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| Summary: | Background: Previous research has mainly focused on the adverse events (AEs) of individual medicinal plants rather than those of herbal formulas. This study investigated AEs associated with herbal formulas composed of two or more herbs by summarizing existing systematic reviews (SRs). We aimed to identify common AEs for the development of a comprehensive reporting form for clinical practice and research, thereby improving herbal medicine safety monitoring in South Korea. Methods: Four international databases (MEDLINE, EMBASE, CENTRAL, and CINAHL) and three Korean databases (KISS, ScienceON, and OASIS) were searched for SRs that reported AEs associated with herbal formulas from inception to September 13, 2024. The inclusion criterion for SRs was that they focused on the AEs associated with herbal formulas composed of two or more herbs. Two researchers independently conducted the search, selection, and data extraction. Methodological and reporting quality were evaluated using A MeaSurement Tool to Assess systematic Reviews (AMSTAR) 2 and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 checklist. AEs were classified using the System Organ Class of the Medical Dictionary for Regulatory Activities. Results: Thirteen SRs were selected for analysis. The most frequently reported organ system was the hepatobiliary system (9 SRs), followed by the nervous and gastrointestinal systems (3 SRs each). Common symptoms reported in the primary studies included nausea (n = 102), diarrhea (n = 80), and vomiting (n = 70). Causality was analyzed in 7 SRs by using various scales. The methodological quality of the included SRs was critically low. Conclusions: Our findings provide a foundation for developing a standardized AE reporting form for herbal formulas. Further high-quality reports with specific patient conditions, herbal constituents, and causality assessments are needed to enhance the safety monitoring and understanding of herbal medicine. Protocol registration: PROSPERO, CRD42023478440. |
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| ISSN: | 2213-4220 |