This systematic review and meta-analysis examined 7 randomized controlled trials involving 1,007 patients with early diabetic nephropathy. The intervention was Liuwei Dihuang Pills (Decoction) combined with conventional Western medicine, compared to conventional Western medicine alone. The primary outcome was urinary albumin excretion rate (UAER), with secondary outcomes including renal function indicators, total effective rate, and adverse events.
For the primary outcome, the combination therapy significantly reduced UAER compared to conventional medicine alone (mean difference = -37.30, 95% CI: -47.51 to -27.09, P < 0.00001). Renal function indicators also showed improvement: serum creatinine (MD = -5.96, 95% CI: -9.27 to -2.65, P = 0.0004) and blood urea nitrogen (MD = -0.91, 95% CI: -1.46 to -0.36, P = 0.001). The total effective rate was higher in the combination group (OR = 5.10, 95% CI: 3.38 to 7.68, P < 0.00001).
Safety data showed similar adverse event rates between groups: 12/287 (4.2%) in the experimental group versus 12/277 (4.3%) in the control group (OR = 0.99, 95% CI: 0.43 to 2.30, P = 0.99). Most reported events were mild to moderate, though serious adverse events and discontinuations were not reported.
Important limitations include incomplete safety reporting, lack of blinding and allocation concealment, high heterogeneity in UAER analysis (I² = 93%), limited sample size, insufficient methodological quality, and the subjective nature of the total effective rate indicator. The overall evidence quality is low due to these factors. In practice, Liuwei Dihuang Pills combined with conventional Western medicine may provide additional benefits for patients with early diabetic nephropathy, but these findings require confirmation in higher-quality studies.
View Original Abstract ↓
To systematically evaluate the efficacy and safety of Liuwei Dihuang Pills (Decoction) combined with conventional Western medicine in the treatment of early diabetic nephropathy.
Randomized controlled trials (RCTs) on Liuwei Dihuang Pills (Decoction) combined with conventional treatment for early diabetic nephropathy were retrieved from major domestic and foreign databases from their inception to December 2025. Two researchers independently conducted literature screening, data extraction, and bias risk assessment. Meta-analysis was performed using Reviewer Manager 5.4 software. The primary outcome indicator was urinary albumin excretion rate (UAER); secondary outcomes included renal function indicators, total effective rate, and adverse events.
A total of 11 RCTs involving 1,007 patients were included. Meta-analysis results showed that, compared with conventional Western medicine alone, the combination group significantly reduced UAER (MD = −37.30, 95% CI: −47.51 to −27.09, P < 0.00001), with substantial heterogeneity (I2 = 93%); sensitivity analysis confirmed the robustness of the result after excluding one study. Renal function indicators also improved significantly: serum creatinine (MD = −5.96, 95% CI: −9.27 to −2.65, P = 0.0004) and blood urea nitrogen (MD = −0.91, 95% CI: −1.46 to −0.36, P = 0.001). The total effective rate was higher in the experimental group (OR = 5.10, 95% CI: 3.38 to 7.68, P < 0.00001), though this outcome should be interpreted with caution due to the lack of blinding and the subjective nature of the indicator. Adverse events were reported in only 6 of the 11 studies; the experimental group had 12/287 (4.2%) cases and the control group had 12/277 (4.3%) cases, with most reported events being mild to moderate. The pooled analysis showed no significant difference between groups (OR = 0.99, 95% CI: 0.43 to 2.30, P = 0.99), and most reported events were mild to moderate. However, incomplete safety reporting limits the reliability of this finding.
Liuwei Dihuang Pills (Decoction) combined with conventional Western medicine may provide additional benefits for patients with early diabetic nephropathy, showing potential advantages in improving objective renal function indicators and clinical outcomes. The available safety data suggest no significant increase in adverse events, but this finding is limited by incomplete reporting across the included studies. Due to the limited sample size, insufficient methodological quality (including lack of allocation concealment and blinding), and high heterogeneity in some analyses, and incomplete adverse event reporting, the overall evidence quality is low. High-quality, large-sample, multi-center RCTs with rigorous methodological design and standardized safety reporting are still needed to further verify the above conclusions.
https://www.crd.york.ac.uk/PROSPERO/view/CRD420261280431, identifier: CRD420261280431.
