Zhang Quan, Liu Hongyan, Zhang Jiahong, Ouyang Yujie, Fu Xiaoxu, Xie Chunguang
Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China.
TCM Regulating Metabolic Diseases Key Laboratory of Sichuan Province, Chengdu, China.
Front Pharmacol. 2025 Jan 7;15:1501990. doi: 10.3389/fphar.2024.1501990. eCollection 2024.
Type 2 diabetes mellitus (T2DM) is a metabolic disorder characterized by chronic hyperglycemia, mostly resulting from impaired insulin production and diminished glucose metabolism regulation. Qiwei Baizhu San (QWBZS) is a classic formula used in traditional Chinese medicine for the treatment of T2DM. A comprehensive analysis of the efficacy and safety of QWBZS in the treatment of T2DM is essential.
This study's protocol was registered with PROSPERO (CRD42024576129). As of August 2024, we searched eight databases to screen and include randomized controlled trials of QWBZS for T2DM. Heterogeneity sources were examined via subgroup analyses, the robustness of the results was determined by sensitivity analyses, publication bias was evaluated using funnel plots and Egger's test, evidence quality was appraised with GRADEpro, and possible mechanisms of QWBZS for T2DM were categorized and summarized.
This analysis encompassed 14 qualifying trials with a total of 1,169 subjects. The analytical results suggested that QWBZS, when combined with conventional treatment, was more effective than conventional treatment alone in improving FBG, 2hPG, HbA1c, HOMA-IR, TC, TG, LDL-C, and HDL-C. When QWBZS was used alone, it was more effective than conventional therapy in FBG, 2hPG, and HbA1c. And QWBZS could improve the overall effectiveness of clinical treatment in T2DM patients. The impact of QWBZS therapy alone on HOMA-IR and lipid metabolism remained unclear due to the limited number of trials included. Analysis of adverse events suggested that QWBZS was relatively safe.
This study suggested that QWBZS, when combined with conventional treatment, was more effective in improving glucose metabolism, insulin resistance, and lipid metabolism compared to conventional treatment alone in individuals with T2DM. QWBZS alone also contributed to the regulation of blood glucose levels. Meanwhile, QWBZS could improve the overall effective rate of clinical treatment with a relatively high safety profile. Nevertheless, owing to the inferior quality and significant heterogeneity of the existing evidence, additional high-quality studies are requisite to furnish more dependable evidence for the future clinical application of QWBZS.
https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=576129, identifier [CRD42024576129].
2型糖尿病（T2DM）是一种以慢性高血糖为特征的代谢紊乱疾病，主要由胰岛素分泌受损和葡萄糖代谢调节能力下降所致。七味白术散（QWBZS）是中医用于治疗T2DM的经典方剂。全面分析QWBZS治疗T2DM的疗效和安全性至关重要。
本研究方案已在国际前瞻性系统评价注册库（PROSPERO）注册（注册号：CRD42024576129）。截至2024年8月，我们检索了八个数据库，以筛选并纳入QWBZS治疗T2DM的随机对照试验。通过亚组分析检查异质性来源，通过敏感性分析确定结果的稳健性，使用漏斗图和Egger检验评估发表偏倚，使用GRADEpro评估证据质量，并对QWBZS治疗T2DM的可能机制进行分类和总结。
本分析纳入了14项符合条件的试验，共1169名受试者。分析结果表明，QWBZS联合常规治疗在改善空腹血糖（FBG）、餐后2小时血糖（2hPG）、糖化血红蛋白（HbA1c）、稳态模型评估的胰岛素抵抗指数（HOMA-IR）、总胆固醇（TC）、甘油三酯（TG）、低密度脂蛋白胆固醇（LDL-C）和高密度脂蛋白胆固醇（HDL-C）方面比单纯常规治疗更有效。当单独使用QWBZS时，在FBG、2hPG和HbA1c方面比常规治疗更有效。并且QWBZS可以提高T2DM患者临床治疗的总体有效率。由于纳入试验数量有限，单独使用QWBZS治疗对HOMA-IR和脂质代谢的影响仍不明确。不良事件分析表明QWBZS相对安全。
本研究表明，在T2DM患者中，QWBZS联合常规治疗在改善糖代谢、胰岛素抵抗和脂质代谢方面比单纯常规治疗更有效。单独使用QWBZS也有助于调节血糖水平。同时，QWBZS可以提高临床治疗的总体有效率，且安全性较高。然而，由于现有证据质量较低且异质性较大，需要更多高质量研究为QWBZS未来的临床应用提供更可靠的证据。
https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=576129，标识符[CRD420
