Clin J Am Soc Nephrol. 2023 Jun 12. doi: 10.2215/CJN.0000000000000199. Online ahead of print.
ABSTRACT
BACKGROUND: Diabetes is the leading cause of chronic kidney disease (CKD) and kidney failure We assessed the real-world effectiveness of Rehmannia-6-based Chinese medicine treatment, the most used Chinese medicine formulation, on the change in estimated glomerular filtration rate (eGFR) and albuminuria in diabetic CKD patients with severely increased albuminuria.
METHODS: In this randomized, assessor-blind, standard care-controlled, parallel, multi-center trial, 148 adult patients from outpatient clinics with type 2 diabetes, estimated glomerular filtration rate (eGFR) of 30-90 ml/min/1.73m2 and urinary albumin-to-creatinine ratio (UACR) of 300-5000 mg/g were randomized 1:1 to a 48-week add-on protocolized Chinese medicine treatment program (using Rehmannia-6-based formulations in granule form taken orally) or standard care alone. Primary outcomes were the slope of change in eGFR and UACR between baseline and endpoint (48 weeks after randomization) in the intention-to-treat population. Secondary outcomes included safety, and the change in biochemistry, biomarkers and concomitant drug use.
RESULTS: The mean age, eGFR and UACR were 65 years, 56.7 ml/min/1.73m2 and 753 mg/g, respectively. 95% (n=141) of endpoint primary outcome measures were retrievable. For eGFR, the estimated slope of change was -2.0 (95%CI: -0.1 to -3.9) and -4.7 (95%CI: -2.9 to -6.5) ml/min/1.73m2 in participants treated with add-on Chinese medicine or standard care alone, resulting a 2.7 ml/min/1.73m2 per year (95%CI: 0.1 to 5.3, p=0.04) less decline with Chinese medicine. For UACR, the estimated proportion in the slope of change was 0.88 (0.75 to 1.02) and 0.99 (0.85 to 1.14) in participants treated with add-on Chinese medicine or standard care alone. The inter-group proportional difference (0.89, 11% slower increment in add-on Chinese medicine, 95%CI: 0.72 to 1.10, p=0.28) did not reach statistical significance. 85 adverse events were recorded from 50 participants (add-on Chinese medicine vs control: 22 (31%) vs 28 (36%)).
CONCLUSIONS: Rehmannia-6-based Chinese medicine treatment stabilized eGFR on top of standard care alone after 48 weeks in patients with type 2 diabetes, stage 2 to 3 chronic kidney disease and severely increased albuminuria.
CLINICAL TRIAL REGISTRY: Semi-individualised Chinese Medicine Treatment as an Adjuvant Management for Diabetic Nephropathy (SCHEMATIC), NCT02488252.
PMID:37307005 | DOI:10.2215/CJN.0000000000000199
