Data Sheet 6_Efficacy and safety of traditional Chinese classic prescriptions combined with metformin in the treatment of type 2 diabetes mellitus: a Bayesian network meta-analysis.pdf

BackgroundType 2 diabetes mellitus (T2DM) is a metabolic disorder characterized by chronic hyperglycemia. While biomedicine (e.g., metformin) serves as the first-line treatment, combination therapies involving botanical drugs are increasingly utilized. However, the comparative efficacy of different botanical formulations remains to be systematically evaluated.
AimThis study aims to analyze randomized controlled trials (RCTs) to evaluate the clinical efficacy and safety of eight specific classical botanical drug formulas combined with metformin (Met) for T2DM, providing evidence to support integrated clinical management.
MethodsA Bayesian network meta-analysis (NMA) was performed on RCTs sourced from PubMed, Cochrane Library, Embase, Web of Science, and Chinese databases. The taxonomic validation of all botanical drugs was conducted using MPNS. Outcomes including HbA1c, FPG, and lipid profiles were assessed using the SUCRA and GRADE methodology.
ResultsForty RCTs involving 3,088 patients were included. In terms of glycemic control, the combination of Huanglian Jiedu Decoction (HLJDD) and Met ranked highest for reducing FPG [MD = −1.46, 95% CrIs=(−2.24, −0.68)], while HLJDD, Zhibai Dihuang Decoction (ZBDHD), and Dachaihu Decoction (DCHD) combined with Met emerged as the most effective for reducing HbA1c. Notably, sensitivity analysis restricted to trials ≥8 weeks identified HLJDD [MD = −1.02, 95% CrIs=(−1.39, −0.66)] and ZBDHD [MD = −1.02, 95% CrIs=(−1.28, −0.76)] as the most robust interventions for long-term glycemic control. Safety reporting was limited, with only 8 out of 40 trials (20.0%) providing data on adverse events. While no severe adverse events were reported in these specific trials, the overall safety evidence remains uncertain due to substantial missingness and potential under-reporting.
ConclusionThe current NMA results suggest that HLJDD combined with Met is a consistently effective option for reducing both FPG and HbA1c. For HbA1c improvement, while DCHD combined with Met showed initial potential, sensitivity analysis restricted to trials ≥8 weeks identified HLJDD and ZBDHD as the most physiologically robust interventions. However, given the “Very Low” certainty of evidence for many comparisons, these rankings remain exploratory.

背景：2型糖尿病（Type 2 Diabetes Mellitus, T2DM）是一种以慢性高血糖为特征的代谢紊乱性疾病。尽管二甲双胍（metformin）等西药为一线治疗药物，但植物药联合疗法的临床应用日益增多。然而，不同植物药制剂的比较疗效仍有待系统评估。
研究目的：本研究旨在分析随机对照试验（Randomized Controlled Trial, RCT），评价8种经典植物药方剂联合二甲双胍（Met）治疗2型糖尿病的临床疗效与安全性，为临床整合诊疗提供循证依据。
研究方法：本研究对PubMed、Cochrane图书馆、Embase、Web of Science及中文数据库收录的随机对照试验开展贝叶斯网络荟萃分析（Bayesian Network Meta-Analysis, NMA）。所有纳入研究的植物药均采用MPNS进行分类学验证。采用SUCRA与GRADE方法对糖化血红蛋白（HbA1c）、空腹血糖（FPG）及血脂谱等结局指标进行评价。
研究结果：本研究共纳入40项随机对照试验，共计3088例受试者。在血糖控制方面，黄连解毒汤（Huanglian Jiedu Decoction, HLJDD）联合二甲双胍降低空腹血糖的疗效排名首位[均数差（Mean Difference, MD）=-1.46，95%可信区间（CrIs）=(-2.24, -0.68)]；而黄连解毒汤、知柏地黄汤（Zhibai Dihuang Decoction, ZBDHD）与大柴胡汤（Dachaihu Decoction, DCHD）联合二甲双胍在降低糖化血红蛋白方面疗效最优。值得注意的是，对随访时长≥8周的试验进行敏感性分析后发现，黄连解毒汤[MD=-1.02, 95% CrIs=(-1.39, -0.66)]与知柏地黄汤[MD=-1.02, 95% CrIs=(-1.28, -0.76)]是长期血糖控制的最可靠干预方案。安全性报告数据有限，40项试验中仅8项（20.0%）提供了不良事件相关数据。尽管该亚组试验未报告严重不良事件，但由于大量数据缺失及潜在的报告偏倚，整体安全性证据仍存在不确定性。
研究结论：本次网络荟萃分析结果显示，黄连解毒汤联合二甲双胍在降低空腹血糖与糖化血红蛋白方面均表现出持续稳定的疗效。在糖化血红蛋白改善方面，尽管大柴胡汤联合二甲双胍初始疗效潜力突出，但针对随访时长≥8周的试验进行敏感性分析后，黄连解毒汤与知柏地黄汤成为生理获益最显著的干预方案。然而，由于多数比较的证据等级为"极低"，上述疗效排名仍属于探索性结论。