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
Ge Jin , Wenge Li , Luying Sun , Baokui Wang , Lanying Liu , Chao Dong , Tingting Jiao , Qi Wu , Yunhua Liu , Xinjiang Zhang , Shuyue Wang , Sitong Wang , Kaidong Zhou , Yanmo Cai , Xin Zhou , Xinxue Zhang , Kun Liu , Zongjiang Zhao
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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-h 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.
期刊介绍：
The Journal of Ethnopharmacology is dedicated to the exchange of information and understandings about people''s use of plants, fungi, animals, microorganisms and minerals and their biological and pharmacological effects based on the principles established through international conventions. Early people confronted with illness and disease, discovered a wealth of useful therapeutic agents in the plant and animal kingdoms. The empirical knowledge of these medicinal substances and their toxic potential was passed on by oral tradition and sometimes recorded in herbals and other texts on materia medica. Many valuable drugs of today (e.g., atropine, ephedrine, tubocurarine, digoxin, reserpine) came into use through the study of indigenous remedies. Chemists continue to use plant-derived drugs (e.g., morphine, taxol, physostigmine, quinidine, emetine) as prototypes in their attempts to develop more effective and less toxic medicinals.
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