Effectiveness and safety of Tongxinluo capsule for diabetic kidney disease: A systematic review and meta-analysis.

Abstract

Background: Diabetic kidney disease (DKD), a common microvascular complication of diabetes mellitus, is the primary cause of end-stage renal disease. Tongxinluo capsule (TXLC), a traditional Chinese medicinal compound, is widely utilized in China for treating DKD.

Aim: To analyze the effectiveness and safety of TXLC for treating DKD.

Methods: Eight electronic literature databases were retrieved to obtain randomized controlled trials (RCTs) of TXLC for DKD. RevMan 5.3 software was used for data analysis. Evidence quality was evaluated using the Grading of Recommendations, Assessment, Development, and Evaluation System. Publication bias was detected using Stata 16.0 software.

Results: Twenty-two RCTs involving 1941 patients with DKD were identified. Compared with conventional treatment, TXLC combination therapy significantly improved the primary outcomes, including 24-hour urine proteinuria, urine microalbumin, and urinary albumin excretion rate. Regarding secondary outcomes, TXLC combination therapy significantly reduced serum creatinine, blood urea nitrogen, β2-microglobulin, and cystatin C levels; however, it had no significant effect on creatinine clearance rate. In terms of additional outcomes, TXLC combination therapy significantly reduced total cholesterol, triglycerides, low-density lipoprotein cholesterol, fibrinogen, plasma viscosity, whole blood low shear viscosity, whole blood high shear viscosity, and endothelin-1 levels, while increasing nitric oxide levels. However, the addition of TXLC treatment did not significantly affect fasting plasma glucose, 2-hour postprandial blood glucose, glycosylated hemoglobin, high-density lipoprotein cholesterol, or C-reactive protein levels. The safety of TXLC in DKD remains uncertain due to limited adverse event reporting.

Conclusion: TXLC may benefit individuals with DKD by improving various health parameters, such as urinary protein levels, renal function, blood lipids, hemorheology, and vascular endothelial function. However, TXLC did not improve all studied outcomes.