Semi-individualised Chinese medicine treatment as an adjuvant management for diabetic nephropathy: a pilot add-on, randomised, controlled, multicentre, open-label pragmatic clinical trial

Kam Wa Chan, Tai Pang Ip, Alfred Siu Kei Kwong, Sing Leung Lui, Gary Chi Wang Chan, Benjamin John Cowling, Wai Han Yiu, Dickson Wai Leong Wong, Yang Liu, Yibin Feng, Kathryn Choon Beng Tan, Loretta Yuk Yee Chan, Joseph Chi Kam Leung, Kar Neng Lai, Sydney Chi Wai Tang, Kam Wa Chan, Tai Pang Ip, Alfred Siu Kei Kwong, Sing Leung Lui, Gary Chi Wang Chan, Benjamin John Cowling, Wai Han Yiu, Dickson Wai Leong Wong, Yang Liu, Yibin Feng, Kathryn Choon Beng Tan, Loretta Yuk Yee Chan, Joseph Chi Kam Leung, Kar Neng Lai, Sydney Chi Wai Tang

Abstract

Introduction: Diabetes mellitus and diabetic nephropathy (DN) are prevalent and costly to manage. DN is the leading cause of end-stage kidney disease. Conventional therapy blocking the renin-angiotensin system has only achieved limited effect in preserving renal function. Recent observational data show that the use of Chinese medicine (CM), a major form of traditional medicine used extensively in Asia, could reduce the risk of end-stage kidney disease. However, existing clinical practice guidelines are weakly evidence-based and the effect of CM remains unclear. This trial explores the effect of an existing integrative Chinese-Western medicine protocol for the management of DN.

Objective: To optimise parameters and assess the feasibility for a subsequent phase III randomised controlled trial through preliminary evaluation on the effect of an adjuvant semi-individualised CM treatment protocol on patients with type 2 diabetes with stages 2-3 chronic kidney disease and macroalbuminuria.

Methods and analysis: This is an assessor-blind, add-on, randomised, controlled, parallel, multicentre, open-label pilot pragmatic clinical trial. 148 patients diagnosed with DN will be recruited and randomised 1:1 to a 48-week additional semi-individualised CM treatment programme or standard medical care. Primary end points are the changes in estimated glomerular filtration rate and spot urine albumin-to-creatinine ratio between baseline and treatment end point. Secondary end points include fasting blood glucose, glycated haemoglobin, brain natriuretic peptide, fasting insulin, C peptide, fibroblast growth factor 23, urinary monocyte chemotactic protein-1, cystatin C, nephrin, transforming growth factor-β1 and vascular endothelial growth factor. Adverse events are monitored through self-completed questionnaire and clinical visits. Outcomes will be analysed by regression models. Enrolment started in July 2015.

Ethics and registration: This protocol is approved by the Institutional Review Board of the University of Hong Kong/Hospital Authority Hong Kong West Cluster (reference number UW 14-301).

Trial registration number: NCT02488252.

Keywords: Chinese medicine; albuminuria; clinical trial; glomerular filtration rate; pragmatic.

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Figures

Figure 1
Figure 1
Flow of study.

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