The use of pattern differentiation in WHO-registered traditional Chinese medicine trials – A systematic review

Zhang, X; Tian, R; Zhao, C; Birch, S; Lee, JA; Alraek, T; Bovey, M; Zaslawski, C; Robinson, N; Kim, TH; Lee, MS; Bian, ZX

The use of pattern differentiation in WHO-registered traditional Chinese medicine trials – A systematic review

Zhang, X Tian, R Zhao, C Birch, S Lee, JA Alraek, T Bovey, M Zaslawski, C

Robinson, N Kim, TH Lee, MS Bian, ZX

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Publication Type:: Journal Article
Citation:: European Journal of Integrative Medicine, 2019, 30
Issue Date:: 2019-09-01

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Field	Value	Language
dc.contributor.author	Zhang, X	en_US
dc.contributor.author	Tian, R	en_US
dc.contributor.author	Zhao, C	en_US
dc.contributor.author	Birch, S	en_US
dc.contributor.author	Lee, JA	en_US
dc.contributor.author	Alraek, T	en_US
dc.contributor.author	Bovey, M	en_US
dc.contributor.author	Zaslawski, C https://orcid.org/0000-0001-5618-5161	en_US
dc.contributor.author	Robinson, N	en_US
dc.contributor.author	Kim, TH	en_US
dc.contributor.author	Lee, MS	en_US
dc.contributor.author	Bian, ZX	en_US
dc.date.issued	2019-09-01	en_US
dc.identifier.citation	European Journal of Integrative Medicine, 2019, 30	en_US
dc.identifier.issn	1876-3820	en_US
dc.identifier.uri	http://hdl.handle.net/10453/136579
dc.description.abstract	© 2019 Introduction: Pattern differentiation is a critical component for traditional Chinese medicine (TCM) diagnosis and treatment. However, the issue of whether pattern differentiation is appropriately applied in TCM interventional trials, including Chinese herbal medicine (CHM) interventions and non-herbal TCM interventions, is unclear. The aim of this study was to i) systematically review the current status of pattern differentiation used in WHO-registered clinical trials for different types of TCM interventions; and ii) provide suggestions for improving the use of pattern differentiation in future clinical trial design. Methods: The World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) database was searched for all TCM interventional trials registered up to 31 December 2017. In this systematic review trials with a TCM pattern differentiation in their design were included. Descriptive statistics were collated to demonstrate the characteristics of pattern differentiation applied for different TCM interventional trials. Results: Among 2955 TCM interventional trials registered during 1999–2017, 376 (12.7%) trials included pattern differentiation. Of 376 trials, the use of pattern differentiation was identified in; –the title (30.6%), objective (50.5%), participants inclusion (100%), outcomes (43.6%) and study background (12.5%). Further, 85.4% reported the specific name of the TCM intervention, 10.6% provided the intervention's targeted pattern, 83.8% reported the specific name of the TCM pattern, 7.2% presented diagnostic criteria for the pattern studied, and 19.1% adopted a pattern-related outcome as primary outcome for evaluation. Conclusion: The reporting and application of pattern differentiation in TCM trials were inadequate and confusing, which was mainly due to lack of clarity regarding study design, objectives, diagnostic criteria and outcomes.	en_US
dc.relation.ispartof	European Journal of Integrative Medicine	en_US
dc.relation.isbasedon	10.1016/j.eujim.2019.100945	en_US
dc.title	The use of pattern differentiation in WHO-registered traditional Chinese medicine trials – A systematic review	en_US
dc.type	Journal Article
utslib.citation.volume	30	en_US
utslib.for	1104 Complementary and Alternative Medicine	en_US
utslib.for	11 Medical and Health Sciences	en_US
pubs.embargo.period	Not known	en_US
pubs.organisational-group	/University of Technology Sydney
pubs.organisational-group	/University of Technology Sydney/Faculty of Science
pubs.organisational-group	/University of Technology Sydney/Faculty of Science/School of Life Sciences
utslib.copyright.status	closed_access
pubs.publication-status	Published	en_US
pubs.volume	30	en_US

Abstract:

© 2019 Introduction: Pattern differentiation is a critical component for traditional Chinese medicine (TCM) diagnosis and treatment. However, the issue of whether pattern differentiation is appropriately applied in TCM interventional trials, including Chinese herbal medicine (CHM) interventions and non-herbal TCM interventions, is unclear. The aim of this study was to i) systematically review the current status of pattern differentiation used in WHO-registered clinical trials for different types of TCM interventions; and ii) provide suggestions for improving the use of pattern differentiation in future clinical trial design. Methods: The World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) database was searched for all TCM interventional trials registered up to 31 December 2017. In this systematic review trials with a TCM pattern differentiation in their design were included. Descriptive statistics were collated to demonstrate the characteristics of pattern differentiation applied for different TCM interventional trials. Results: Among 2955 TCM interventional trials registered during 1999–2017, 376 (12.7%) trials included pattern differentiation. Of 376 trials, the use of pattern differentiation was identified in; –the title (30.6%), objective (50.5%), participants inclusion (100%), outcomes (43.6%) and study background (12.5%). Further, 85.4% reported the specific name of the TCM intervention, 10.6% provided the intervention's targeted pattern, 83.8% reported the specific name of the TCM pattern, 7.2% presented diagnostic criteria for the pattern studied, and 19.1% adopted a pattern-related outcome as primary outcome for evaluation. Conclusion: The reporting and application of pattern differentiation in TCM trials were inadequate and confusing, which was mainly due to lack of clarity regarding study design, objectives, diagnostic criteria and outcomes.

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http://hdl.handle.net/10453/136579