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

Xuan Zhang, Ran Tian, Chen Zhao, Stephen Birch, Ju Ah Lee, T. Alraek, Mark Bovey, Christopher Zaslawski, Nicola Robinson, Tae Hun Kim, Myeong Soo Lee, Zhaoxiang Bian*

*Corresponding author for this work

Research output: Contribution to journalJournal articlepeer-review

15 Citations (Scopus)


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.

Original languageEnglish
Article number100945
JournalEuropean Journal of Integrative Medicine
Publication statusPublished - Sept 2019

Scopus Subject Areas

  • Complementary and alternative medicine

User-Defined Keywords

  • Chinese medicine interventions
  • Clinical trial registration
  • Pattern differentiation
  • Systematic review
  • Traditional Chinese medicine
  • WHO registries


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