A randomized, double-blind, placebo-controlled trial of Wenshenyang decoction for the improvement of renal function and kidney-yang deficiency syndrome in patients with CKD.

Abstract

Ethnopharmacological relevance: Chronic kidney disease (CKD) poses an increasing challenge to the middle-aged and elderly population. Wenshenyang decoction (WSY), an herbal formula from China, has been shown to have a considerable effect on the recovery of the renal function in a real-world study. However, no randomized, double-blind, placebo-controlled, multicenter clinical trial to evaluate the efficacy and safety yet.

Aim of the study: This study aimed to investigate the efficacy, advantages, limitations, and safety, and provide insights into methods and strategies for utilizing WSY in CKD management.

Materials and methods: Participants were recruited from six tertiary hospitals in Beijing, China. Eligible participants were randomly assigned to receive either WSY and conventional Western medicine or placebo and conventional Western medicine in a 1:1 ratio. The treatment and follow-up cycles each lasted 90 days, with a total of six follow-up visits. The primary outcome measures were the change in 24-hour urine protein excretion (24h UPRO) and serum creatinine (SCR) from baseline at Visit 3 (90 days after the treatment) and Visit 5 (90 days after the follow-up). The secondary outcome measures were the improvement in symptoms and other renal function indicators. Additionally, we explored the correlation between the effect of WSY treatment and CKD type and stage through subgroup analysis. Finally, the safety of this decoction was assessed.

Results: In total, 257 participants were diagnosed with CKD characterized by kidney Yang deficiency. Of these patients, 240 underwent randomization, and 203 were included in the subsequent analysis. After 180 days of treatment and follow-up, there was a significant decrease in the primary outcome 24h UPRO (a 43.19% improvement at Visit 3, 95% CI: 27.68%, 58.71%; a 51.28% improvement at Visit 5, 95% CI: 31.40%, 71.16%), and SCR (a 16.34% improvement at Visit 3, 95% CI: 11.28%, 21.40%; a 20.52% improvement at Visit 5, 95% CI: 14.05%, 26.99%). Compared to the control group, the difference was statistically significant (p < 0.05). Additionally, the secondary outcome of symptom score showed that 79.21% of the patients felt "completely improved" and "greatly improved"; which was much higher than placebo (p < 0.05). Subgroup analysis showed that WSY was more effective for diabetic kidney disease (DKD) and stage 3 of CKD. No severe adverse events occurred during the period.

Conclusions: These results indicate that WSY could improve the renal function and alleviate the kidney Yang deficiency symptoms in patients with CKD without adverse effects. This study provided evidence-based medicine in the treatment of CKD with compound prescriptions of traditional Chinese medicine (TCM) and contributed to promoting the use of phytomedicine.