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

BMJ Open. 2016 Aug 5;6(8):e010741. doi: 10.1136/bmjopen-2015-010741.

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.

Publication types

  • Clinical Trial, Phase II
  • Clinical Trial, Phase III
  • Multicenter Study
  • Pragmatic Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Creatinine / analysis
  • Diabetes Mellitus, Type 2 / complications
  • Diabetic Nephropathies / drug therapy*
  • Drugs, Chinese Herbal / therapeutic use*
  • Female
  • Glomerular Filtration Rate / drug effects
  • Glycated Hemoglobin / analysis
  • Hong Kong
  • Humans
  • Integrative Medicine*
  • Male
  • Medicine, Chinese Traditional
  • Middle Aged
  • Patient Compliance
  • Pilot Projects
  • Precision Medicine*
  • Research Design
  • Treatment Outcome

Substances

  • Drugs, Chinese Herbal
  • Glycated Hemoglobin A
  • Creatinine

Associated data

  • ClinicalTrials.gov/NCT02488252