Qu Xiangke, Sun Jianrong, Shen Yue, Dong Jia, Li Xiaofa, Ma Yanchun, Sun Jinhui
Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China.
Graduate School, Beijing University of Chinese Medicine, Beijing, China.
Medicine (Baltimore). 2025 May 2;104(18):e42303. doi: 10.1097/MD.0000000000042303.
Nonalcoholic fatty liver disease (NAFLD) is a chronic liver disease characterized by intrahepatic accumulation and is closely associated with metabolic problems. Some studies have indicated that Chaihu-Shugan-San (CSS) may have a positive effect on NAFLD, but robust evidence-based research to substantiate the application of CSS is scarce. A meta-analysis was conducted to assess the clinical efficacy and safety of CSS in the treatment for NAFLD.
The literature reporting CSS in NAFLD was searched from inception to October 2023 in in 7 Chinese or English databases. Studies were screened and incorporated based on predefined criteria. Data were extracted and quality was assessed independently by 2 researchers according to the Cochrane risk of bias tools. The changes in outcomes were analyzed using the mean difference (MD) and 95% confidence intervals (CIs) with a random- or fixed-effects model to examine the effect of CSS. RevMan5.4 software was used to perform meta-analyses, and the meta package of R 4.0.0 software was used for publication bias analysis.
A total 17 studies involving 1576 participants were screened for meta-analysis. There was high heterogeneity among studies for all continuous outcomes. Compared with common treatments, CSS could decrease aspartate-aminotransferase (MD = -12.02, 95% CI [-15.97, -8.07]), alanine-aminotransferase (MD = -10.89, 95% CI [-16.35, -5.43]), triglyceride and total cholesterol levels. In addition, CSS may increase the high-density lipoprotein cholesterol levels. And, CSS was associated with a lower incidence of adverse events (RR = 0.79, 95% CI [0.33, 1.91]).
Current evidence shows that single or combined use of CSS is effective for NAFLD liver enzymes and blood lipids. Nevertheless, it is challenging to reach a conclusive determination owing to significant heterogeneity and ambiguous risk of bias in some trials. Therefore, more high-quality evidence is required for the clinical implementation of CSS.
非酒精性脂肪性肝病（NAFLD）是一种以肝内脂肪蓄积为特征的慢性肝病，与代谢问题密切相关。一些研究表明，柴胡疏肝散（CSS）可能对NAFLD有积极作用，但缺乏有力的循证研究来证实CSS的应用。本研究进行了一项荟萃分析，以评估CSS治疗NAFLD的临床疗效和安全性。
检索了7个中文或英文数据库，从建库至2023年10月期间报告CSS治疗NAFLD的文献。根据预定义标准筛选并纳入研究。由2名研究人员根据Cochrane偏倚风险工具独立提取数据并评估质量。使用均数差（MD）和95%置信区间（CI），采用随机或固定效应模型分析结局变化，以检验CSS的效果。使用RevMan5.4软件进行荟萃分析，使用R 4.0.0软件的meta包进行发表偏倚分析。
共筛选出17项研究，涉及1576名参与者进行荟萃分析。所有连续性结局的研究间存在高度异质性。与常规治疗相比，CSS可降低天冬氨酸转氨酶（MD = -12.02，95%CI [-15.97，-8.07]）、丙氨酸转氨酶（MD = -10.89，95%CI [-16.35，-5.43]）、甘油三酯和总胆固醇水平。此外，CSS可能会升高高密度脂蛋白胆固醇水平。并且，CSS与不良事件发生率较低相关（RR = 0.79，95%CI [0.33，1.91]）。
目前的证据表明，单独或联合使用CSS对NAFLD的肝酶和血脂有效。然而，由于一些试验中存在显著的异质性和偏倚风险不明确，难以得出确凿的结论。因此，CSS的临床应用需要更多高质量的证据。
