Background: 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.
Methods: 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.
Results: The results of our research will be published in a peer-reviewed journal.
Conclusion: 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.
Registration number: INPLASY202040179.