Add-on Rehmannia-6–Based Chinese Medicine in Type 2 Diabetes and CKD: A Multicenter Randomized Controlled Trial

Kam Wa Chan, Alfred Siu Kei Kwong, Kathryn Choon Beng Tan, Sing Leung Lui, Gary C.W. Chan, Tai Pang Ip, Wai Han Yiu, Benjamin John Cowling, Vivian Wong Taam, Lixing Lao, Yibin Feng, Kar Neng Lai, Sydney C.W. Tang*

*Corresponding author for this work

Research output: Contribution to journalJournal articlepeer-review

1 Citation (Scopus)

Abstract

Background: Diabetes is the leading cause of 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 eGFR and albuminuria in patients with diabetes and CKD with severely increased albuminuria.

Methods: In this randomized, assessor-blind, standard care–controlled, parallel, multicenter trial, 148 adult patients from outpatient clinics with type 2 diabetes, an eGFR of 30–90 ml/min per 1.73 m2, and a urine 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 the granule form taken orally) or standard care alone. Primary outcomes were the slope of change in eGFR and UACR between baseline and end point (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 per 1.73 m2, and 753 mg/g, respectively. Ninety-five percent (n=141) of end point primary outcome measures were retrievable. For eGFR, the estimated slope of change was −2.0 (95% confidence interval [CI], −0.1 to −3.9) and −4.7 (95% CI, −2.9 to −6.5) ml/min per 1.73 m2 in participants treated with add-on Chinese medicine or standard care alone, resulting in a 2.7 ml/min per 1.73 m2 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 (95% CI, 0.75 to 1.02) and 0.99 (95% CI, 0.85 to 1.14) in participants treated with add-on Chinese medicine or standard care alone, respectively. The intergroup 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. Eighty-five adverse events were recorded from 50 participants (add-on Chinese medicine versus control: 22 [31%] versus 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 2–3 CKD, and severely increased albuminuria.

Clinical Trial Registry: Semi-individualized Chinese Medicine Treatment as an Adjuvant Management for Diabetic Nephropathy (SCHEMATIC), NCT02488252.
Original languageEnglish
Pages (from-to)1163-1174
Number of pages12
JournalClinical journal of the American Society of Nephrology : CJASN
Volume18
Issue number9
DOIs
Publication statusPublished - Sept 2023

Scopus Subject Areas

  • Medicine(all)

User-Defined Keywords

  • Chinese medicine
  • diabetes
  • Chronic kidney disease
  • Rehmannia
  • glomerular filtration rate

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