Key result
Oral Chinese herbal medicine significantly reduced albuminuria compared to placebo in adults with diabetic kidney disease, both without (SMD -0.92) and with (SMD -0.56) concurrent renin-angiotensin system inhibitors.
Why the study?
Diabetic kidney disease is a major cause of end-stage renal disease, and while Tongxinluo capsule is widely used for it in China, its effectiveness and safety required systematic analysis.
Does oral Chinese herbal medicine reduce albuminuria and improve renal outcomes in adults with diabetic kidney disease?
Meta-Analysis (n=2,719)
Does oral Chinese herbal medicine reduce albuminuria and improve renal outcomes in adults with diabetic kidney disease?
Oral Chinese herbal medicine added to conventional therapy may moderately reduce short-term albuminuria and proteinuria in patients with diabetic kidney disease, but long-term clinical benefits remain uncertain.
TXLC adjunct may reduce proteinuria and improve select renal markers in DKD; extends RCT evidence but leaves safety uncertain.
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.
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Wei et al. (2025) conducted a meta-analysis in Diabetic kidney disease (n=2,719). Oral Chinese herbal medicine (CHM) vs. Placebo was evaluated on Albuminuria (without concurrent renin-angiotensin system inhibitors) (SMD -0.92, 95% CI -1.35 to -0.51, p=<0.0001). Oral Chinese herbal medicine significantly reduced albuminuria compared to placebo in adults with diabetic kidney disease, both without (SMD -0.92) and with (SMD -0.56) concurrent renin-angiotensin system inhibitors.
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