Yang Yan, Fu Xiaoxu, Zhong Wen, Hu Zhipeng, Tian Yuan, Zhou Hui, Gao Hong, Xie Chunguang
Chengdu University of Traditional Chinese Medicine.
Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, Sichuan, China.
Medicine (Baltimore). 2020 Jul 2;99(27):e20736. doi: 10.1097/MD.0000000000020736.
Diabetes is a chronic disease characterized by chronic hyperglycemia, absolute or relative deficiency of insulin secretion, and chronic inflammation. Shenqi compound (SC) is a traditional Chinese medicine formula widely used in the treatment of diabetes and diabetic complications. Although many randomized clinical trials have proved that SC can benefit a lot from diabetes and its complications, the systematic evaluation of the effect of SC on diabetic blood glucose control and inflammatory markers has not yet appeared. The purpose of this study is to provide evidence that the therapeutic effect of SC on diabetes and its multiple system complications is related to its control of blood glucose and inflammatory mediators.
Three English database and 4 Chinese medical databases will be searched from its inception to May 2020. Then 2 methodological trained researchers will screen the qualified articles by reading the title, abstract, and full texts according to an established inclusion and exclusion criteria. The assessment of risk of bias will be conducted by using the Cochrane collaboration's tool. We will conduct meta-analyses for fasting blood glucose, postprandial blood glucose, glycated hemoglobin, tumor necrosis factor, C-reactive protein or high-sensitivity C-reactive protein, and other outcomes. The heterogeneity of data will be evaluated by Cochrane X and I tests. Subgroup analysis will also be carried out. We will conduct sensitivity analysis to evaluate the stability of the results, funnel plot analysis, and Egger test to evaluate the publication bias, and assessment for the quality of evidence by the grading of recommendations assessment, development, and evaluate system.
The results of our research will be published in a peer-reviewed journal.
In this study, we will systematically evaluate the influences of SC on glycemic measures and inflammatory markers of diabetes mellitus. Our research is supposed to provide evidence-based support for clinical practice.
INPLASY202040179.
糖尿病是一种以慢性高血糖、胰岛素分泌绝对或相对不足以及慢性炎症为特征的慢性疾病。参芪复方（SC）是一种广泛用于治疗糖尿病及其并发症的中药配方。尽管许多随机临床试验已证明SC对糖尿病及其并发症有诸多益处，但尚未出现对SC控制糖尿病血糖及炎症标志物效果的系统评价。本研究的目的是提供证据表明SC对糖尿病及其多系统并发症的治疗作用与其对血糖和炎症介质的控制有关。
从数据库建库至2020年5月，检索三个英文数据库和四个中文医学数据库。然后，两名经过方法学培训的研究人员将根据既定的纳入和排除标准，通过阅读标题、摘要和全文来筛选合格文章。将使用Cochrane协作工具进行偏倚风险评估。我们将对空腹血糖、餐后血糖、糖化血红蛋白、肿瘤坏死因子、C反应蛋白或高敏C反应蛋白等结局进行荟萃分析。将通过Cochrane X和I检验评估数据的异质性。还将进行亚组分析。我们将进行敏感性分析以评估结果的稳定性，进行漏斗图分析和Egger检验以评估发表偏倚，并通过推荐评估、制定和评价系统分级对证据质量进行评估。
我们的研究结果将发表在同行评审期刊上。
在本研究中，我们将系统评价SC对糖尿病血糖指标和炎症标志物的影响。我们的研究应为临床实践提供循证支持。
INPLASY202040179。
