Efficacy and safety of Yishen Huashi granules combined with conventional therapy in the treatment of diabetic kidney disease: A systematic review and meta-analysis

Ethnopharmacological relevance: Diabetic kidney disease(DKD) is a complication of diabetes. If not treated in time, it will lead to severe glomerular damage, causing irreversible damage, and ultimately may lead to uremia and even death. Yishen Huashi Granule (YSHS) is a Chinese patent medicine for treating DKD by invigorating the spleen and removing dampness, which has shown a good curative effect.

Aim of the study: This study systematically evaluated the clinical efficacy and blood biochemical improvement of YSHS combined with conventional therapy (CT) in treating DKD.

Materials and methods: By August 2024, four English databases (PubMed, Web of Science, the Cochrane Library, and Embase) and four Chinese databases (China National Knowledge Infrastructure (CNKI), Wanfang Database (WF), China Biological Medicine Database (CBM), and China Science and Technology Journal Database (VIP)) were searched to screen literature, extract information, and evaluate quality according to inclusion and exclusion criteria. The language of these literature is limited to Chinese and English, but not limited to published sources. Meta-analysis and bias analysis were performed using Steata 16 software and Review Manager 5.3 software. The bias risk tool in the Cochrane Handbook was used to assess the quality of the literature. At 95 % confidence interval (CI), relative risk (RR) and Cohen's d were used for the categorical and continuous variables, respectively. To evaluate heterogeneity, the Q test and I² statistics were employed within a random-effects model framework.

Results: A total of 28 randomized controlled trials (RCTs) comprising 2416 patients were included in this study. There were 1200 patients in the control group and 1216 in the treatment group. Compared with CT, combined YSHS therapy is more effective at improving clinical efficiency rate [RR(95 % confidence interval (CI)) = 1.26(1.21, 1.32), I² = 15.83 %], renal function (urinary albumin excretion rate [SMD(95%CI) = -1.72(-2.27, -1.17), I² = 95.5 %], 24-h quantitative urine protein level [SMD(95%CI) = -1.50(-2.51, -0.50), I² = 95.52 %], blood urea nitrogen [SMD(95%CI) = -1.13(-1.46, -0.81), I² = 89.81 %], SCr [SMD(95%CI) = -2.34(-3.36, -1.32), I² = 97.90 %], eGFR [SMD(95%CI) = 0.50(0.18,0.82), I² = 51.51 %]), glucose metabolism levels (FBG [SMD(95%CI) = -0.50(-0.87, -0.14), I² = 89.67 %], 2hPG [SMD(95%CI) = -0.83(-1.39, -0.26), I² = 87.11 %], HbA1c [SMD(95%CI) = -0.79(-1.74, -0.15), I² = 94.6 %]), lipid metabolism levels (TC [SMD(95%CI) = -1.53(-2.32, -0.75), I² = 95.49 %], TG [SMD(95%CI) = -0.96(-1.08, -0.77), I² = 86.05 %], LDL-C [SMD(95%CI) = -1.25(-1.81, -0.69), I² = 90.56 %], HDL-C [SMD(95%CI) = 0.71(0.43, 0.98), I² = 55.92 %]), oxidative stress indicators (SOD [SMD(95%CI) = 6.00(2.77, 9.24, I² = 99.01 %], MDA [SMD(95%CI) = -2.81(-3.58, -2.05), I² = 89.64 %]), ALB [SMD(95%CI) = 1.01(0.63, -1.39), I² = 68.89 %], vWF [SMD(95%CI) = -0.84(-1.08, -0.60), I² = 0 %], ET-1 [SMD(95%CI) = -0.89(-1.13, -0.65), I² = 0 %], and MAP [SMD(95%CI) = -1.76(-3.26, -0.25), I² = 94.05 %]. The incidence of adverse reactions in YSHS combination therapy was not high [SMD(95%CI) = 0.99(0.97, 1.02), I² = 0.03 %].

Conclusion: The meta-analysis revealed that YSHS combined with CT therapy is superior to CT in improving clinical outcomes, renal function, glucose metabolism, lipid metabolism, and oxidative stress. Yishen Huashi granules is more effective and safer for Diabetic kidney disease treatment.