Kyung Hee University Medical Center, Department of Cardiology and Neurology, College of Korean Medicine, Kyung Hee University, Republic of Korea.
Department of Preventive Medicine, College of Korean Medicine, Kyung Hee University, Republic of Korea.
Complement Ther Med. 2024 Aug;83:103057. doi: 10.1016/j.ctim.2024.103057. Epub 2024 Jun 1.
Herbal decoctions (HDs) are the oldest and most common herbal medicine formulations. Different HDs exist, and some consumers are concerned that they may become contaminated during manufacturing. Therefore, the need for a safety assessment of HDs has been raised. This study aimed to investigate the adverse events (AEs) associated with HDs by comprehensively analyzing randomized controlled trials (RCTs) using systematic reviews and meta-analyses.
A systematic search was conducted on PubMed, Embase, and the Cochrane Library for articles published up to November 2022. The included RCTs compared HDs with other treatments published between 2013 and 2022, and the risk of bias was assessed using RevMan 5.4. Meta-analyses of the number of AEs associated with HDs reported in the included RCTs were also performed.
The systematic review included 26 RCTs, and the meta-analysis included 17 RCTs that reported AEs. The meta-analysis comparing HDs with active controls showed that both the number of AEs (14 studies; risk ratio (RR)= 0.50 cases, 95 % confidence interval (CI) [0.29, 0.88]; I = 42 %) and the number of patients who complained of AEs (seven studies; RR=0.51 patients, 95 % CI [0.28, 0.94]; I =9 %) were fewer in the HDs group than in the active control groups.
This study showed that HDs are safer than other conventional medications based on the results of qualitative and quantitative syntheses of RCTs.
草药汤剂(HDs)是最古老、最常见的草药制剂。不同的 HDs 存在,一些消费者担心它们在制造过程中可能会受到污染。因此,需要对 HDs 进行安全性评估。本研究旨在通过系统评价和荟萃分析综合分析随机对照试验(RCTs)来调查与 HDs 相关的不良事件(AEs)。
系统检索 PubMed、Embase 和 Cochrane Library 中截至 2022 年 11 月发表的文章。纳入的 RCT 比较了 2013 年至 2022 年期间与其他治疗方法的 HDs,使用 RevMan 5.4 评估偏倚风险。还对纳入 RCTs 中报告的与 HDs 相关的 AEs 数量进行了荟萃分析。
系统评价纳入 26 项 RCT,荟萃分析纳入 17 项报告 AEs 的 RCT。与活性对照比较 HDs 的荟萃分析显示,AE 数量(14 项研究;风险比(RR)=0.50 例,95%置信区间(CI)[0.29, 0.88];I = 42%)和报告 AEs 的患者数量(7 项研究;RR=0.51 例,95% CI [0.28, 0.94];I = 9%)在 HDs 组均少于活性对照组。
基于 RCT 的定性和定量综合分析结果,本研究表明 HDs 比其他常规药物更安全。