Meta-Analysis
Copyright ©The Author(s) 2025. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Diabetes. May 15, 2025; 16(5): 100980
Published online May 15, 2025. doi: 10.4239/wjd.v16.i5.100980
Effectiveness and safety of Tongxinluo capsule for diabetic kidney disease: A systematic review and meta-analysis
Mao-Ying Wei, Yi-Jia Jiang, Yi-Ting Tang, Chu-Ran Wang, Dan Yin, Ai-Jing Li, Jing-Yi Guo, Yan-Bing Gong
Mao-Ying Wei, Yan-Bing Gong, Department of Nephrology and Endocrinology, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China
Yi-Jia Jiang, Yi-Ting Tang, Chu-Ran Wang, Dan Yin, Ai-Jing Li, Jing-Yi Guo, Graduate College, Beijing University of Chinese Medicine, Beijing 100029, China
Author contributions: Wei MY contributed to conceptualization, investigation, data curation, methodology, writing -original draft, and writing-review and editing; Jiang YJ contributed to data curation, formal analysis, and validation; Tang YT and Wang CR contributed to formal analysis, investigation, methodology, and writing-original draft; Yin D contributed to data curation, formal analysis, and visualization; Li AJ and Guo JY contributed to investigation, validation, and visualization; Gong YB contributed to conceptualization, supervision, methodology, and writing-review and editing.
Supported by National Key Research and Development Program of China, No. 2020YFE0201800; Leading Talent Training Program Project of Dongzhimen Hospital of Beijing University of Chinese Medicine, No. DZMG-LJRC0004; China Postdoctoral Science Foundation, No. 2024M750263; the Fundamental Research Funds for the Central Universities, No. 2023-JYB-JBZD-010; and Postdoctoral Fellowship Program of China Postdoctoral Science Foundation, No. GZC20230324.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
PRISMA 2009 Checklist statement: The authors have read the PRISMA 2009 Checklist, and the manuscript was prepared and revised according to the PRISMA 2009 Checklist.
Open Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Yan-Bing Gong, PhD, Professor, Department of Nephrology and Endocrinology, Dongzhimen Hospital, Beijing University of Chinese Medicine, No. 5 Haiyuncang, Dongcheng District, Beijing 100700, China. gyb_1226@163.com
Received: September 1, 2024
Revised: February 25, 2025
Accepted: April 2, 2025
Published online: May 15, 2025
Processing time: 236 Days and 4.2 Hours
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.

Keywords: Tongxinluo capsule; Diabetes mellitus; Chronic kidney disease; Renal protection; Chinese herbal medicines; Systematic review

Core Tip: This is the first English systematic review and meta-analysis of Tongxinluo capsules (TXLC) for diabetic kidney disease (DKD). Twenty-two eligible randomized controlled trials with 1941 individuals with DKD were identified. The meta-analysis demonstrated that TXLCs combined with conventional treatment were more effective in reducing proteinuria and improving multiple parameters, including renal function, lipid profile, hemodynamics, and vascular endothelial function, compared with conventional treatment alone.