Abstract
Chinese herbal medicine (CHM) might have benefits in patients with non-diabetic chronic kidney disease (CKD), but there is a lack of high-quality evidence, especially in CKD4. This study aimed to assess the efficacy and safety of Bupi Yishen Formula (BYF) vs. losartan in patients with non-diabetic CKD4. This trial was a multicenter, double-blind, double-dummy, randomized controlled trial that was carried out from 11-08-2011 to 07-20-2015. Patients were assigned (1:1) to receive either BYF or losartan for 48 weeks. The primary outcome was the change in the slope of the estimated glomerular filtration rate (eGFR) over 48 weeks. The secondary outcomes were the composite of end-stage kidney disease, death, doubling of serum creatinine, stroke, and cardiovascular events. A total of 567 patients were randomized to BYF (n = 283) or losartan (n = 284); of these, 549 (97%) patients were included in the final analysis. The BYF group had a slower renal function decline particularly prior to 12 weeks over the 48-week duration (between-group mean difference of eGFR slopes: −2.25 ml/min/1.73 m2/year, 95% confidence interval [CI]: −4.03,−0.47), and a lower risk of composite outcome of death from any cause, doubling of serum creatinine level, end-stage kidney disease (ESKD), stroke, or cardiovascular events (adjusted hazard ratio = 0.61, 95%CI: 0.44,0.85). No significant between-group differences were observed in the incidence of adverse events. We conclude that BYF might have renoprotective effects among non-diabetic patients with CKD4 in the first 12 weeks and over 48 weeks, but longer follow-up is required to evaluate the long-term effects. Clinical Trial Registration: http://www.chictr.org.cn, identifier ChiCTR-TRC-10001518.
Highlights
Chronic kidney disease (CKD) is a major global health problem with poor outcomes and high medical costs, especially when patients progress to end-stage kidney disease (ESKD) (GBD Chronic Kidney Disease Collaboration, 2020)
A total of 1120 patients were screened at 21 centers; 567 agreed to participate and were randomized to BYF (n 283) or losartan (n 284) (Figure 1); 549 participants were included in the full analysis set (FAS) since 18 participants were excluded due to no available postbaseline data
The results showed that eGFR at 48 weeks adjusted for baseline eGFR was higher in the BYF group (p < 0.0001)
Summary
Chronic kidney disease (CKD) is a major global health problem with poor outcomes and high medical costs, especially when patients progress to end-stage kidney disease (ESKD) (GBD Chronic Kidney Disease Collaboration, 2020). Patients with stage 4 CKD accounts for 0.16% of the world’s population (GBD Chronic Kidney Disease Collaboration, 2020). The mainstay of medical management to prevent CKD progression is to achieve optimal control of blood pressure (BP) with antihypertensive agents, angiotensinconverting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB) (Palmer et al, 2015). The use of ACEI/ARB is limited because of high potassium (Ahuja et al, 2000) and aggravated renal failure (Tomlinson et al, 2013) in stage 4 CKD. More than half of users discontinued ACEI/ARB within 5 years of therapy initiation (Qiao et al, 2019)
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