The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine), Hangzhou, China.
Department of First Clinical Medical College, Zhejiang Chinese Medical University, Hangzhou, China.
Medicine (Baltimore). 2024 Feb 2;103(5):e37052. doi: 10.1097/MD.0000000000037052.
The efficacy and safety of traditional Chinese medicine (TCM) combined with Silibinin in the treatment of nonalcoholic fatty liver disease (NAFLD) are still inconclusive. This meta-analysis intends to evaluation to explore the clinical efficacy and quality assessment of traditional Chinese medicine in combination with Silymarin in the treatment of NAFLD, aiming to aims to provide evidence-based data analysis for researchers and clinical practitioners involved in TCM research for NAFLD, with the hope of facilitating wider adoption and application.
In this meta-analysis, we searched PubMed, Embase, Cochrane Library, CNKI, Wanfang, CQVIP and CBM databases from the establishment of the databases to Oct 2023. The study proposed to include studies that reported combination of TCM with Silibinin and Silibinin alone in the treatment of NAFLD, excluding studies for which full text was not available or for which data extraction was not possible; studies using animal studies; reviews and systematic reviews. All data were processed by STATA15.1 statistical software.
16 randomized controlled trials (RCTs) were included in this meta-analysis. The sample size ranged from 48 to 120, with a total of 1335 patients, including 669 in the Combined treatment group and 384 in the Silibinin group. The findings indicated that the total effective rate of combined treatment group was significantly higher than that of Silibinin alone. Levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), total cholesterol (TC), triglycerides (TG), and gamma glutamyl transpeptidase (GGT) of combined treatment group were all significantly lower than that of western medicine alone. Additionally, after treating NAFLD with a combination of TCM and Silibinin, the TCM syndrome score were significantly lower than those observed with Silibinin alone.
Traditional Chinese medicine in conjunction with Silibinin capsules has shown significant efficacy in the treatment of NAFLD, improving clinical symptoms, blood lipid levels, and liver function. Furthermore, it is essential to engage in multi-omics research, investigate iron death, and explore the gut microbiota as potential observational indicators for the diagnosis and inclusion criteria. Conducting more high-quality clinical experiments is necessary to further validate these findings.
中药联合水飞蓟宾治疗非酒精性脂肪性肝病（NAFLD）的疗效和安全性仍存在争议。本荟萃分析旨在评估中药联合水飞蓟宾治疗 NAFLD 的临床疗效和质量评价，旨在为从事 TCM 研究的研究人员和临床医生提供基于循证数据分析，希望促进更广泛的采用和应用。
本荟萃分析检索了 PubMed、Embase、Cochrane Library、CNKI、万方、维普和 CBM 数据库从数据库建立到 2023 年 10 月。研究提出纳入报告中药联合水飞蓟宾与水飞蓟宾单独治疗 NAFLD 的研究，排除无法获取全文或无法进行数据提取的研究；动物研究；综述和系统评价。所有数据均由 STATA15.1 统计软件处理。
本荟萃分析共纳入 16 项随机对照试验（RCT）。样本量范围为 48 至 120，共 1335 例患者，其中联合治疗组 669 例，水飞蓟宾组 384 例。结果表明，联合治疗组总有效率明显高于水飞蓟宾组。联合治疗组的丙氨酸氨基转移酶（ALT）、天冬氨酸氨基转移酶（AST）、总胆固醇（TC）、甘油三酯（TG）和γ-谷氨酰转肽酶（GGT）水平均明显低于水飞蓟宾组。此外，用中药联合水飞蓟宾治疗 NAFLD 后，中医证候评分明显低于水飞蓟宾组。
中药联合水飞蓟宾胶囊治疗 NAFLD 疗效显著，能改善临床症状、血脂水平和肝功能。此外，开展多组学研究、探讨铁死亡、探索肠道微生物群作为潜在的诊断和纳入标准观察指标具有重要意义。有必要开展更多高质量的临床试验来进一步验证这些发现。
