Abstract
The objective of this meta-analysis was to systematically assess the efficacy and safety of patented Chinese medicine Fufang Xueshuantong (FFXST) for the treatment of diabetic kidney disease (DKD). Randomized controlled trials (RCTs) of FFXST for DKD treatment were searched until May 31, 2020, in seven electronic databases: PubMed, Embase, Cochrane Library, CNKI, Wanfang, VIP, and Chinese Biomedical Literature. The Cochrane risk test from the Cochrane Handbook was used as a bias tool to assess the methodological quality, and Review Manager (RevMan) 5.3 was used to analyze the results. Grading of Recommendations Assessment, Development, and Evaluation (GRADE) criteria were used to classify the quality of evidence. Thirteen RCTs involving 1,186 patients were included. The meta-analysis revealed that the efficacy of FFXST in treatment of DKD was significantly superior to that of the control treatment (P=0.0006). The urinary albumin excretion rate (P < 0.01), urinary albumin creatinine ratio (P < 0.0001), and microalbumin (P < 0.0001) were lower in the treatment groups than in the control group. There was also a decrease in low-density lipoprotein cholesterol (P < 0.0001), serum triglyceride (P=0.001), and C-reactive protein (P < 0.0001) in the treatment groups compared with those in the control group. No significant difference in hemoglobin A1c level (P=0.76) and systolic blood pressure (P=0.34) was noted between the treatment and control groups. Three studies reported adverse events, including dizziness and intolerance. In the other 10 trials, adverse events were not mentioned. FFXST appears to be effective in the treatment of DKD. However, the low methodological quality of the RCTs suggests that larger, better-designed RCTs are required to verify the clinical effectiveness and safety of FFXST.
Highlights
Diabetic kidney disease (DKD) is one of the most important microvascular complications of diabetes, as well as a key cause of end-stage renal disease (ESRD)
Two studies compared the albumin creatinine ratio (ACR) outcomes of Fufang Xueshuantong (FFXST) plus ACEI/ARB with those of the control group (N 250, standardized mean difference (SMD) −0.6, 95% confidence interval (CI): −0.85–0.34, Z 4.62, P < 0.00001) without heterogeneity (χ2 0.35, P 0.55, I2 0%)
Two of the studies compared changes in TG in FFXST monotherapy treatment with that of control groups, and the results revealed there was no statistical difference TG improvement between the two groups (N 198, mean difference (MD) −0.36, 95% CI: −1.15–0.44, Z 0.87, P 0.38) with heterogeneity (χ2 7.78, P 0.005, I2 87%). e difference between the two studies may have been caused by the difference in intervention measures in the control groups. e control group in one study
Summary
Diabetic kidney disease (DKD) is one of the most important microvascular complications of diabetes, as well as a key cause of end-stage renal disease (ESRD). It increases the risk of cardiovascular disease and all-cause death in patients with diabetes [1, 2]. With the incidence of diabetes increasing annually, the number of DKD cases is increasing. A large number of patients with DKD progress to ESRD or die from complications of vital organs outside the kidney annually; it is necessary
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