Efficacy and safety of traditional Chinese patent medicine in collaboration with anti-hyperglycemic drugs on type 2 diabetes: study protocol for a multicenter, prospective cohort study

Abstract

Background: Traditional Chinese patent medicine (TCPM) has potential in the treatment of type 2 diabetes mellitus (T2DM). Some studies have reported TCPMs could effectively reduce blood glucose levels in diabetic patients. To enhance glycemic control, relieve uncomfortable symptoms and delay diabetic complications, integrative TCPM and anti-hyperglycemic drugs is essential. Here, we investigated the efficacy and safety of using TCPM according to syndrome differentiation in co-collaboration with antihyperglycemic drugs.Methods: Participants that met the diagnostic criteria of T2DM and traditional Chinese medicine (TCM) syndrome differentiation were included. This is a two-arm multicenter, prospective cohort study.Two hundred and six participants will be included, the cohorts were divided according to the treatment methods they choose. Both groups will propose a healthy lifestyle, the exposure group used TCPMs based on syndrome differentiation, while the control group do not use other therapies. Basic therapy of antihyperglycemic, lipid-lowering and anti-hypertensive treatment accompanied with both groups. The study duration will be 24 weeks, and being followed up for 2 years afterward. Telephone follow-up will be done every two weeks and participant follow-up will be done every four weeks during the intervention period.The primary outcome will be the changes in glycosylated hemoglobin, the secondary outcomes include the changes of blood glucose, blood pressure, blood lipids, body weight, body mass index, waist circumference, hip circumference, incidence of diabetic microvascular and macrovascular complications and improvement in TCM symptoms. T test, Wilcoxon rank sum test, chi-squared test, or Fisher exact test were regarded as the main statistical methods for comparing the outcome variables. Statistical tests will be two-sided, and significance will be assigned at P<0.05.Discussion: The design of the trial coincides with the real-world practice of TCM. We assume that participants with T2DM will be helped by TCPMs. If succeeded, this study will furnish evidence that TCPM in collaboration with anti-hyperglycemic drugs could improve glycolipid metabolism, relieve subjective symptoms and delay the incidence of diabetic complications.