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TCIM Research

Kam Wa (Chris) Chan (2022-2023 WINNER)

Published on 4/13/2024

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


Kam Wa Chan1, Alfred Siu Kei Kwong2, Kathryn Choon Beng Tan3, Sing Leung Lui4, Gary C W Chan5, Tai Pang Ip4, Wai Han Yiu1, Benjamin John Cowling6, Vivian Taam Wong7, Lixing Lao7,8, Yibin Feng7, Kar Neng Lai1, Sydney C W Tang1

Affiliations:
1 Division of Nephrology, Department of Medicine, The University of Hong Kong, Hong Kong SAR, China
2 Department of Family Medicine and Primary Healthcare, Hong Kong West Cluster, Hospital Authority, Hong Kong SAR, China.
3 Division of Endocrinology & Metabolism, Department of Medicine, The University of Hong Kong, Hong Kong SAR, China.
4 Department of Medicine, Tung Wah Hospital, Hong Kong SAR, China.
5 Department of Medicine, Queen Mary Hospital, Hong Kong SAR, China.
6 Division of Epidemiology and Biostatistics, School of Public Health, The University of Hong Kong, Hong Kong SAR, China.
7 School of Chinese Medicine, The University of Hong Kong, Hong Kong SAR, China.
8 Virginia University of Integrative Medicine, Fairfax, Virginia, USA.

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 m 2 , 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 m 2 , 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 m 2 in participants treated with add-on Chinese medicine or standard care alone, resulting in a 2.7 ml/min per 1.73 m 2 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 .


DOI: 10.2215/CJN.0000000000000199

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