Department of Oriental Neuropsychiatry, College of Korean Medicine, Dongeui University, Busan 47227, Republic of Korea.
Kyung Hee University Medical Center, Department of Cardiology and Neurology, College of Korean Medicine, Kyung Hee University, Seoul 02447, Republic of Korea.
J Ethnopharmacol. 2024 May 10;325:117664. doi: 10.1016/j.jep.2023.117664. Epub 2024 Jan 8.
Approximately 27% of individuals seeking Korean medicine (KM) services in South Korea are prescribed herbal decoctions. The South Korean government has considered the validity of providing National Health Insurance coverage for herbal decoctions. Therefore, it is important to investigate their safety.
To investigate the safety of herbal decoctions commonly prescribed by KM doctors and to assess their effects on liver and kidney function by comprehensively analyzing Korean clinical studies in a scoping review.
The Arksey and O'Malley framework and modified methods were applied in this scoping review. A comprehensive search of seven electronic health databases was conducted, and relevant clinical studies published between 2000 and 2022 were identified. Subsequently, only clinical studies reporting the results of liver and/or renal function tests in patient prescribed herbal decoctions by KM doctors were included. The characteristics of the included clinical studies and the reported proportion of each liver and/or renal function indicator were analyzed. Meta-analyses of the effects of herbal decoction on liver and/or renal function reported in prospective cohort studies were also performed.
Fifty-nine clinical studies were included in this review. The proportion of prospective cohort studies markedly decreased in the 2010s compared to the 2000s, while there was no noticeable change in the number of relevant clinical studies. Herbal decoctions were prescribed for less than one month in most included studies. Abnormal changes in liver or renal function indicators were identified in a small number of studies (3.70% and 7.69%, respectively). In a meta-analysis of 15 prospective cohort studies, no statistically significant changes in four liver function indices and two renal function indices were observed before and after the prescription of herbal decoctions.
Qualitative and quantitative analyses demonstrated favorable safety profiles for herbal decoctions. This scoping review includes the gaps noted between clinical application and research regarding the safety profiles of herbal decoctions. These findings could be used as evidence to support the inclusion of herbal decoction prescriptions in the National Health Insurance coverage in South Korea.
在韩国寻求韩医学（KM）服务的人群中，约有 27%的人被开了草药汤剂。韩国政府已经考虑为草药汤剂提供国民健康保险覆盖的有效性。因此，调查其安全性很重要。
通过综合分析韩国临床研究，调查 KM 医生常用的草药汤剂的安全性，并评估其对肝肾功能的影响。
本综述采用阿特金森和奥马利框架及改良方法。对七个电子健康数据库进行了全面检索，确定了 2000 年至 2022 年期间发表的相关临床研究。随后，仅纳入报告 KM 医生开草药汤剂后患者肝肾功能检查结果的临床研究。分析纳入临床研究的特征以及报告的每个肝肾功能指标的比例。还对前瞻性队列研究报告的草药汤剂对肝肾功能影响的效应进行了荟萃分析。
本综述纳入了 59 项临床研究。与 2000 年代相比，2010 年代前瞻性队列研究的比例明显下降，而相关临床研究的数量没有明显变化。大多数纳入的研究中，草药汤剂的处方时间不到一个月。少数研究（分别为 3.70%和 7.69%）发现肝或肾功能指标异常变化。对 15 项前瞻性队列研究的荟萃分析显示，在开草药汤剂前后，四个肝功能指标和两个肾功能指标均无统计学意义上的变化。
定性和定量分析表明草药汤剂具有良好的安全性。本综述包括了临床应用和研究之间在草药汤剂安全性方面的差距。这些发现可作为支持将草药汤剂处方纳入韩国国民健康保险覆盖范围的证据。
