JMIR Publications

ABSTRACT

Background:

Herbal medicines (HMs) are extensively used by consumers/patients worldwide. However, their safety profiles are often poorly reported and characterized. Previous studies have documented adverse events (AEs) associated with HMs such as hepatotoxicity, renal failure, and allergic reactions. However, the prevalence rate of AEs related to HMs has been reported to be low. To date, no systematic review (SR) has comprehensively analyzed AEs of HMs using published data acquired from pharmacovigilance (PV) databases.

Objective:

This study aims to: 1) estimate the reporting rate of AEs of HMs through PV databases; and (2) assess the detail data provided in AEs reports.

Methods:

MEDLINE/PUBMED, SCOPUS, EMBASE, and CINAHL were systematically searched for relevant studies (until December 2023). Der Simonian-Laird random-effects model was used for pooling the data. Crombie’s checklist was used to evaluate the risk of bias (ROB) of the included studies.

Results:

26 studies met the eligibility criteria. The reporting rate of AEs of HMs ranged considerably from 0.03% to 29.84% with an overall pooled estimate of median =1.42% (interquartile range [IQR] 1.12% - 1.72%). Subgroup analyses combined with meta-regression model revealed the reporting rate of AEs of HMs was associated with the source of reporter (P = 0.008). None of the included studies provided full details of suspected herbal medicines, only the main ingredients were disclosed, while other potentially harmful components were not listed.

Conclusions:

The systematic review and meta-analysis highlights risks related to HMs with a wide range of the reporting rates, depending on source of reporters. Continuous efforts are necessary to standardize consumer reporting systems in terms of reporting form, education and follow-up strategy to improve data quality assurance, aiming to enhance the reliability and utility of PV data for monitoring the safety of HMs. Achieving effective monitoring and reporting of these AEs necessitates collaborative efforts from diverse stakeholders, including patients/consumers, manufacturers, physicians, complementary practitioners, sellers/distributors, and health authorities. Clinical Trial: PROSPERO registration (ID number: CRD42021276492)