DataSheet1_Chinese Herbal Medicine for Type 2 Diabetes Mellitus With Nonalcoholic Fatty Liver Disease: A Systematic Review and Meta-Analysis.docx

Objectives: To evaluate the efficacy and safety of Chinese herbal medicine (CHM) for type 2 diabetes mellitus (T2DM) with nonalcoholic fatty liver disease (NAFLD) with current evidence.
Methods: This study was registered in PROSPERO as CRD42021271488. A literature search was conducted in eight electronic databases from inception to December 2021. The primary outcomes were lipid indices and liver functions, including triglyceride (TG), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), alanine transaminase (ALT), and aspartate transaminase (AST). Review Manager 5.2 and Stata v14.0 were applied for analysis.
Results: The research enrolled 18 RCTs with 1,463 participants. Results showed CHM combined with western medicine (WM) was more effective than WM alone in TG (weighted mean differences (WMD) = −0.35.95% confidence interval (CI) [−0.51, −0.19], p < 0.0001), TC (WMD = −0.58.95%CI [−0.80, −0.36], p < 0.00001), LDL-C (WMD = −0.37, 95%CI [−0.47, −0.26], p < 0.00001), HDL-C (WMD = 0.20, 95%CI [0.10, 0.29], p < 0.0001), ALT (WMD = −4.99, 95%CI [−6.64, −3.33], p < 0.00001), AST (WMD = −4.76, 95%CI [−6.35, −3.16], p < 0.00001), homeostatic model assessment of insulin resistance (WMD = −1.01, 95%CI [−1.22, −0.79], p < 0.00001), fasting blood glucose (WMD = −0.87, 95%CI [−1.13, −0.61], p < 0.00001), 2-h postprandial glucose (WMD = −1.45.95%CI [−2.00, −0.91], p < 0.00001), body mass index (WMD = −0.73.95%CI [−1.35, −0.12], p = 0.02), and overall effective rate (risk ratio (RR) = 1.37.95%CI [1.29, 1.46], p < 0.00001).
Conclusion: The CHM in combination with WM seems to be more beneficial in T2DM with NAFLD patients in improving lipid and glucose metabolism, liver function, and insulin resistance as well as improving overall efficiency and reducing body weight. Given the poor quality of reports from these studies and uncertain evidence, these findings should be interpreted cautiously.
Systematic Review Registration:https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021271488, identifier CRD42021271488.

研究目的：基于现有循证证据，评价中草药（Chinese herbal medicine, CHM）治疗合并非酒精性脂肪性肝病（nonalcoholic fatty liver disease, NAFLD）的2型糖尿病（type 2 diabetes mellitus, T2DM）患者的有效性与安全性。
研究方法：本研究已在PROSPERO注册，注册号为CRD42021271488。本研究于建库至2021年12月期间，检索了8个电子数据库的相关文献。本研究的主要结局指标为脂代谢指标与肝功能指标，包括甘油三酯（triglyceride, TG）、总胆固醇（total cholesterol, TC）、低密度脂蛋白胆固醇（low-density lipoprotein cholesterol, LDL-C）、高密度脂蛋白胆固醇（high-density lipoprotein cholesterol, HDL-C）、丙氨酸氨基转移酶（alanine transaminase, ALT）以及天门冬氨酸氨基转移酶（aspartate transaminase, AST）。数据分析采用Review Manager 5.2与Stata v14.0软件完成。
研究结果：本研究共纳入18项随机对照试验（randomized controlled trial, RCT），涉及1463名受试者。结果显示，相较于单纯西医（western medicine, WM）治疗，中西医联合治疗在改善多项指标方面更具优势：甘油三酯（triglyceride, TG）（加权均数差（weighted mean difference, WMD）=-0.35，95%置信区间（confidence interval, CI）[-0.51, -0.19]，p<0.0001）、总胆固醇（total cholesterol, TC）（WMD=-0.58，95%CI[-0.80, -0.36]，p<0.00001）、低密度脂蛋白胆固醇（low-density lipoprotein cholesterol, LDL-C）（WMD=-0.37，95%CI[-0.47, -0.26]，p<0.00001）、高密度脂蛋白胆固醇（high-density lipoprotein cholesterol, HDL-C）（WMD=0.20，95%CI[0.10, 0.29]，p<0.0001）、丙氨酸氨基转移酶（alanine transaminase, ALT）（WMD=-4.99，95%CI[-6.64, -3.33]，p<0.00001）、天门冬氨酸氨基转移酶（aspartate transaminase, AST）（WMD=-4.76，95%CI[-6.35, -3.16]，p<0.00001）、胰岛素抵抗稳态模型评估（homeostatic model assessment of insulin resistance）（WMD=-1.01，95%CI[-1.22, -0.79]，p<0.00001）、空腹血糖（fasting blood glucose）（WMD=-0.87，95%CI[-1.13, -0.61]，p<0.00001）、餐后2小时血糖（2-h postprandial glucose）（WMD=-1.45，95%CI[-2.00, -0.91]，p<0.00001）、体质量指数（body mass index）（WMD=-0.73，95%CI[-1.35, -0.12]，p=0.02）以及总体有效率（overall effective rate，风险比（risk ratio, RR）=1.37，95%CI[1.29, 1.46]，p<0.00001）。
研究结论：对于合并非酒精性脂肪性肝病的2型糖尿病患者，中西医联合治疗可更有效地改善脂代谢与糖代谢、肝功能以及胰岛素抵抗，同时提升总体治疗有效率并降低体质量。鉴于本研究纳入的文献报告质量欠佳且证据存在不确定性，解读本研究结果时应持谨慎态度。
系统综述注册信息：https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021271488，注册号为CRD42021271488。