Semi-individualised Chinese Medicine Treatment as an Adjuvant Management for Diabetic Nephropathy: Interim analysis of an add-on, randomised, controlled, multi-centre, open-label pragmatic trial

Abstract

Introduction: Big data studies from Taiwan showed that Chinese medicine (CM) might reduce the risk of endstage kidney disease by 59% in a 6-year period. Nonetheless, clinical data to support the use of CM in diabetic kidney disease (DKD) management are limited, and the effect of combined Chinese and conventional medicine remains unclear. Method: This assessor-blind, add-on, randomised, controlled, multicentre pilot pragmatic trial evaluated the effect of an adjuvant semi-individualised CM treatment protocol based on expert consensus. 148 patients diagnosed with DKD were to be recruited and equally randomised to either the 48-week additional semiindividualised CM treatment programme or standard medical care. Primary end-points were the changes in estimated glomerular filtration rate (eGFR) and spot urine albumin-to-creatinine ratio (UACR) between baseline and treatment endpoint. Outcomes were analysed as intention-to-treat by regression models. The trial registration number was NCT02488252. Results: The first 40 patients have completed 24 weeks of treatment since July 2015. The two groups were similar in demographics. After adjusting for age, gender, baseline haemoglobin A1c, body mass index, blood pressures, eGFR, and UACR, the intervention group had higher mean (95% confidence interval [CI]) eGFR (53.4 [48.0-58.8] vs 50.1 [45.1-55.0] mL/min/1.73m2) and adjusted mean (95% CI) UACR (186 [100-273] vs 173 [93-252] mg/mmol) than the control group. The regression model explained 86% variability and remained robust when the 24-week UACR was adjusted in the sensitivity analysis. Intervention contributed to an increase of 3.3 mL/min/1.73m2 (P=0.18) in eGFR independent of UACR. The two groups were comparable in terms of fully adjusted 24-week mean UACR, glycated haemoglobin, blood pressures, aspartate transaminase and alanine transaminase levels, and severe adverse event rates. Conclusion: Our interim analysis suggests add-on semi-individualised CM treatment may stabilise eGFR among DKD patients independent of albuminuria, glycaemic, and blood pressure control. Acknowledgement This trial is supported by the Health and Medical Research Fund (Ref: 12133341).