Common adverse events of herbal formulas for developing reporting forms for clinical practice and research: An overview of systematic reviews

IF 2.8 4区医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE Integrative Medicine Research Pub Date : 2024-12-28 DOI:10.1016/j.imr.2024.101118

Eunbyul Cho , Sungha Kim , Mi Ju Son

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引用次数: 0

Abstract

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 to develop a comprehensive reporting form for clinical practice and research, improving herbal medicine safety monitoring in South Korea.

Methods

Four international (MEDLINE, EMBASE, CENTRAL, CINAHL) and three Korean databases (KISS, ScienceON, OASIS) were searched for SRs on AEs associated with herbal formulas from inception to September 13, 2024. Inclusion criteria were SRs focusing on AEs of 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 2 and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 checklist. AEs were classified using the System Organ Class of the Medical Dictionary for Regulatory Activities.

Results

Thirteen SRs were selected. The most frequently reported organ system was hepatobiliary (9 SRs), followed by nervous and gastrointestinal systems (3 SRs each). Common symptoms in primary studies were nausea (n = 102), diarrhea (n = 80), and vomiting (n = 70). Causality was analyzed in 7 SRs 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 required to enhance herbal medicine safety monitoring and understanding.

Protocol registration

PROSPERO, CRD42023478440.

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来源期刊

Integrative Medicine Research Medicine-Complementary and Alternative Medicine

CiteScore

6.50

自引率

2.90%

发文量

审稿时长

12 weeks

期刊介绍： Integrative Medicine Research (IMR) is a quarterly, peer-reviewed journal focused on scientific research for integrative medicine including traditional medicine (emphasis on acupuncture and herbal medicine), complementary and alternative medicine, and systems medicine. The journal includes papers on basic research, clinical research, methodology, theory, computational analysis and modelling, topical reviews, medical history, education and policy based on physiology, pathology, diagnosis and the systems approach in the field of integrative medicine.