Abstract：
BACKGROUND: 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.
OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
摘要：
背景：在韩国寻求韩国医学（KM）服务的个人中约有27％是开处方的草药汤。韩国政府已经考虑了为草药汤剂提供国民健康保险的有效性。因此,调查他们的安全很重要。
目的：通过在范围审查中全面分析韩国的临床研究，调查KM医生通常开的草药汤的安全性，并评估其对肝肾功能的影响。
方法：在本次范围审查中应用了Arksey和O\'Malley框架和改进的方法。对七个电子健康数据库进行了全面检索,并确定了2000年至2022年间发表的相关临床研究。随后，仅纳入了临床研究,这些临床研究报告了KM医生在患者处方中草药汤的肝和/或肾功能检查结果.分析纳入的临床研究的特点和报告的每个肝和/或肾功能指标的比例。还进行了前瞻性队列研究中报道的中药汤剂对肝和/或肾功能影响的荟萃分析。
结果：这篇综述包括了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显着下降，而相关临床研究的数量没有明显变化。在大多数纳入研究中，草药汤剂的处方时间少于一个月。在少数研究中发现了肝或肾功能指标的异常变化（3.70％和7.69％，分别)。在对15项前瞻性队列研究的荟萃分析中，中药汤剂处方前后4项肝功能指标和2项肾功能指标无统计学变化。
结论：定性和定量分析表明草药汤剂具有良好的安全性。此范围审查包括有关草药汤剂安全性的临床应用和研究之间的差距。这些发现可以用作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。
目的：通过在范围审查中全面分析韩国的临床研究，调查KM医生通常开的草药汤的安全性，并评估其对肝肾功能的影响。
方法：在本次范围审查中应用了Arksey和O\'Malley框架和改进的方法。对七个电子健康数据库进行了全面检索,并确定了2000年至2022年间发表的相关临床研究。随后，仅纳入了临床研究,这些临床研究报告了KM医生在患者处方中草药汤的肝和/或肾功能检查结果.分析纳入的临床研究的特点和报告的每个肝和/或肾功能指标的比例。还进行了前瞻性队列研究中报道的中药汤剂对肝和/或肾功能影响的荟萃分析。
结果：这篇综述包括了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显着下降，而相关临床研究的数量没有明显变化。在大多数纳入研究中，草药汤剂的处方时间少于一个月。在少数研究中发现了肝或肾功能指标的异常变化（3.70％和7.69％，分别)。在对15项前瞻性队列研究的荟萃分析中，中药汤剂处方前后4项肝功能指标和2项肾功能指标无统计学变化。
结论：定性和定量分析表明草药汤剂具有良好的安全性。此范围审查包括有关草药汤剂安全性的临床应用和研究之间的差距。这些发现可以用作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。
