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

TitleSemi-individualised Chinese medicine treatment as an adjuvant management for diabetic nephropathy: a pilot add-on, randomised, controlled, multicentre, open-label pragmatic clinical trial
Authors
KeywordsAlbuminuria
Chinese medicine
Clinical trial
Glomerular filtration rate
Pragmatic
Issue Date2016
PublisherBMJ Publishing Group: BMJ Open. The Journal's web site is located at http://bmjopen.bmj.com
Citation
BMJ Open, 2016, v. 6 n. 8, article no. e010741 How to Cite?
AbstractIntroduction: 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.
Persistent Identifierhttp://hdl.handle.net/10722/232035
ISSN
2017 Impact Factor: 2.413
2015 SCImago Journal Rankings: 1.448
PubMed Central ID
ISI Accession Number ID

 

DC FieldValueLanguage
dc.contributor.authorChan, KW-
dc.contributor.authorIp, TP-
dc.contributor.authorKwong, ASK-
dc.contributor.authorLui, SL-
dc.contributor.authorChan, GCW-
dc.contributor.authorCowling, BJ-
dc.contributor.authorYiu, WH-
dc.contributor.authorWong, DWL-
dc.contributor.authorLiu, Y-
dc.contributor.authorFeng, Y-
dc.contributor.authorTan, KCB-
dc.contributor.authorChan, LYY-
dc.contributor.authorLeung, JCK-
dc.contributor.authorLai, KN-
dc.contributor.authorTang, SCW-
dc.date.accessioned2016-09-20T05:27:09Z-
dc.date.available2016-09-20T05:27:09Z-
dc.date.issued2016-
dc.identifier.citationBMJ Open, 2016, v. 6 n. 8, article no. e010741-
dc.identifier.issn2044-6055-
dc.identifier.urihttp://hdl.handle.net/10722/232035-
dc.description.abstractIntroduction: 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.-
dc.languageeng-
dc.publisherBMJ Publishing Group: BMJ Open. The Journal's web site is located at http://bmjopen.bmj.com-
dc.relation.ispartofBMJ Open-
dc.rightsThis work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.-
dc.subjectAlbuminuria-
dc.subjectChinese medicine-
dc.subjectClinical trial-
dc.subjectGlomerular filtration rate-
dc.subjectPragmatic-
dc.titleSemi-individualised Chinese medicine treatment as an adjuvant management for diabetic nephropathy: a pilot add-on, randomised, controlled, multicentre, open-label pragmatic clinical trial-
dc.typeArticle-
dc.identifier.emailIp, TP: iptp@hku.hk-
dc.identifier.emailLui, SL: sllui@hkucc.hku.hk-
dc.identifier.emailChan, GCW: gcwchan1@hku.hk-
dc.identifier.emailCowling, BJ: bcowling@hku.hk-
dc.identifier.emailYiu, WH: whyiu@hku.hk-
dc.identifier.emailLiu, Y: liuyang9@hku.hk-
dc.identifier.emailFeng, Y: yfeng@hku.hk-
dc.identifier.emailTan, KCB: kcbtan@hkucc.hku.hk-
dc.identifier.emailLeung, JCK: jckleung@hku.hk-
dc.identifier.emailLai, KN: knlai@hku.hk-
dc.identifier.emailTang, SCW: scwtang@hku.hk-
dc.identifier.authorityCowling, BJ=rp01326-
dc.identifier.authorityFeng, Y=rp00466-
dc.identifier.authorityTan, KCB=rp00402-
dc.identifier.authorityLeung, JCK=rp00448-
dc.identifier.authorityLai, KN=rp00324-
dc.identifier.authorityTang, SCW=rp00480-
dc.description.naturepublished_or_final_version-
dc.identifier.doi10.1136/bmjopen-2015-010741-
dc.identifier.pmid27496229-
dc.identifier.pmcidPMC4986085-
dc.identifier.scopuseid_2-s2.0-84981314180-
dc.identifier.hkuros264922-
dc.identifier.hkuros299529-
dc.identifier.volume6-
dc.identifier.issue8-
dc.identifier.spagearticle no. e010741-
dc.identifier.epagearticle no. e010741-
dc.identifier.isiWOS:000382336700025-
dc.publisher.placeUnited Kingdom-

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