Add-on astragalus in type 2 diabetes and chronic kidney disease: A multi-center, assessor-blind, randomized controlled trial

Kam Wa Chan, Alfred Siu Kei Kwong, Pun Nang Tsui, Gary Chi Wang Chan, Wing Fai Choi, Wai Han Yiu, Simon Chi Yuen Cheung, Michelle Man Ying Wong, Zhang Jin Zhang, Kathryn Choon Beng Tan, Lixing Lao, Kar Neng Lai, Sydney Chi Wai Tang*, READY and SCHEMATIC research group

*Corresponding author for this work

Research output: Contribution to journalJournal articlepeer-review

Abstract

Background: Diabetes leads to chronic kidney disease (CKD) and kidney failure, requiring dialysis or transplantation. Astragalus, a common herbal medicine and US pharmacopeia-registered food ingredient, is shown kidney protective by retrospective and preclinical data but with limited long-term prospective clinical evidence. This trial aimed to assess the effectiveness of astragalus on kidney function decline in macroalbuminuric diabetic CKD patients.

Methods: This randomized, assessor-blind, standard care-controlled, multi-center clinical trial randomly assigned 118 patients with estimated glomerular filtration rate (eGFR) of 30–90 ml/min/1.73m2 and urinary albumin-to-creatinine ratio (UACR) of 300–5000 mg/g from 7 public outpatient clinics and the community in Hong Kong between July 2018 and April 2022 to add-on oral astragalus granules (15 gs of raw herbs daily equivalent) or to continue standard care alone as control for 48 weeks. Primary outcomes were the slope of change of eGFR (used for sample size calculation) and UACR of the intention-to-treat population. Secondary outcomes included endpoint blood pressures, biochemistry, biomarkers, concomitant drug change and adverse events. (ClinicalTrials.gov: NCT03535935)

Results: During the 48-week period, the estimated difference in the slope of eGFR decline was 4.6 ml/min/1.73m2 per year (95 %CI: 1.5 to 7.6, p = 0.003) slower with astragalus. For UACR, the estimated inter-group proportional difference in the slope of change was insignificant (1.14, 95 %CI: 0.85 to 1.52, p = 0.392). 117 adverse events from 31 astragalus-treated patients and 41 standard care-controlled patients were documented. The 48-week endpoint systolic blood pressure was 7.9 mmHg lower (95 %CI: -12.9 to -2.8, p = 0.003) in the astragalus-treated patients. 113 (96 %) and 107 (91 %) patients had post-randomization and endpoint primary outcome measures, respectively.

Conclusion: In patients with type 2 diabetes, stage 2 to 3 CKD and macroalbuminuria, add-on astragalus for 48 weeks further stabilized kidney function on top of standard care.
Original languageEnglish
Article number155457
Number of pages11
JournalPhytomedicine
Volume130
Early online date28 Feb 2024
DOIs
Publication statusE-pub ahead of print - 28 Feb 2024

Scopus Subject Areas

  • Medicine(all)
  • Complementary and alternative medicine
  • Endocrinology, Diabetes and Metabolism
  • Nephrology

User-Defined Keywords

  • Diabetes
  • Chronic kidney disease
  • Integrative medicine
  • Clinical trial
  • Pragmatic
  • Astragalus
  • Chinese medicine

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