Cho Eunbyul, Zhao Hui Yan, Jun Purumea, Jang Jung-Hee
Department of Diagnostics, College of Korean Medicine, Wonkwang University, Iksan, Republic of Korea.
KM Science Research Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.
Complement Med Res. 2025;32(3):244-259. doi: 10.1159/000545937. Epub 2025 May 15.
This systematic review aimed to assess the clinical evidence supporting the combination of syndrome differentiation (SD)-based herbal medicine (HM) and Western medicine (WM) in treating Parkinson's disease (PD)-mild cognitive impairment (PD-MCI) and -dementia (PDD).
Ten electronic bibliographic databases were searched from inception to March 4, 2024, for randomized controlled trials (RCTs) comparing SD-based HM plus conventional therapies with conventional therapies alone for PD-MCI and PDD. Two authors independently screened and selected studies and extracted data related to trial quality, characteristics, and results. The mean difference (MD) was used to analyze continuous variables, and meta-analysis was performed using Reviewer Manager 5.4 software. The risk of bias was assessed using the Cochrane Risk of Bias Tool.
For the 15 articles selected for review, 12 trials were included in the meta-analysis: 9 comprising 688 patients with PD-MCI and 3 comprising 264 patients with PDD and with a type of SD, such as "blood stasis and stirring wind" or "deficiency of the liver-kidney." The meta-analysis showed significant differences favoring HM plus WM with respect to the Montreal Cognitive Assessment score for PD-MCI (MD = 2.30, 95% confidence interval [CI; 1.40, 3.19]; p < 0.00001, I2 = 76%) and PDD (MD = 3.14, 95% CI [0.48, 5.81]; p = 0.02, I2 = 82%) compared with WM alone. Improvement of cognitive impairment treated using "deficiency of the liver-kidney" SD-based HM plus WM in PD-MCI was more beneficial than that treated using WM alone.
SD-based HM may serve as an adjunctive treatment for PD-MCI and PDD, improving cognitive function and alleviating PD symptoms. No severe adverse event was observed in the HM plus WM group, suggesting that HM may be safe for patients with cognitive impairment in PD. However, evidence regarding the efficacy of HM based on SD for PD-MCI and PDD is of poor quality, and all studies were conducted in China. Thus, and rigorous, multicenter, and international RCTs are required.
本系统评价旨在评估支持基于辨证论治的中药与西药联合治疗帕金森病轻度认知障碍（PD-MCI）和帕金森病痴呆（PDD）的临床证据。
检索了10个电子文献数据库，检索时间从建库至2024年3月4日，以查找比较基于辨证论治的中药加常规疗法与单纯常规疗法治疗PD-MCI和PDD的随机对照试验（RCT）。两位作者独立筛选和选择研究，并提取与试验质量、特征和结果相关的数据。采用均数差（MD）分析连续变量，并使用Reviewer Manager 5.4软件进行荟萃分析。使用Cochrane偏倚风险工具评估偏倚风险。
在选定进行综述的15篇文章中，12项试验纳入了荟萃分析：9项试验共688例PD-MCI患者，3项试验共264例PDD患者，且有“血瘀动风”或“肝肾亏虚”等辨证类型。荟萃分析显示，与单纯西药相比，中药加西药在PD-MCI的蒙特利尔认知评估得分方面有显著差异（MD = 2.30，95%置信区间[CI]：1.40，3.19；p < 0.00001，I2 = 76%），在PDD方面也有显著差异（MD = 3.14，95% CI[0.48，5.81]；p = 0.02，I2 = 82%）。在PD-MCI中，采用基于“肝肾亏虚”辨证论治的中药加西药治疗认知障碍的改善情况比单纯西药治疗更有益。
基于辨证论治的中药可作为PD-MCI和PDD的辅助治疗方法，改善认知功能并减轻PD症状。在中药加西药组未观察到严重不良事件，表明中药对PD认知障碍患者可能是安全的。然而，基于辨证论治的中药治疗PD-MCI和PDD疗效的证据质量较差，且所有研究均在中国进行。因此，需要进行严格的、多中心的国际随机对照试验。
