Impact of liuwei dihuang pills (decoction) on early diabetic nephropathy: a systematic review and meta-analysis

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.