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Journal of Integrative Medicine ›› 2023, Vol. 21 ›› Issue (6): 528-536.doi: 10.1016/j.joim.2023.10.003

• Methodology • Previous Articles     Next Articles

Blinding assessment in clinical trials of traditional Chinese medicine: Exploratory principles and protocol

Xiao-cong Wang a, Xiao-yu Liu a, Kang-le Shi b, Qing-gang Meng a, Yue-fan Yu a, Shi-yao Wang a, Juan Wang a, Chang Qu a, Cong Lei c, Xin-ping Yu a   

  1. a. School of Traditional Chinese Medicine, Beijing University of Chinese Medicine, Beijing 100029, China
    b. School of Artificial Intelligence, University of Chinese Academy of Sciences, Beijing 100049, China
    c. School of Basic Medicine, Heilongjiang University of Chinese Medicine, Harbin 150040, Heilongjiang Province, China
  • Received:2023-02-02 Accepted:2023-09-11 Online:2023-12-08 Published:2023-12-08
  • Contact: Kang-le Shi; Qing-gang Meng;

As one of the key components of clinical trials, blinding, if successfully implemented, can help to mitigate the risks of implementation bias and measurement bias, consequently improving the validity and reliability of the trial results. However, successful blinding in clinical trials of traditional Chinese medicine (TCM) is hard to achieve, and the evaluation of blinding success through blinding assessment lacks established guidelines. Taking into account the challenges associated with blinding in the TCM field, here we present a framework for assessing blinding. Further, this study proposes a blinding assessment protocol for TCM clinical trials, building upon the framework and the existing methods. An assessment report checklist and an approach for evaluating the assessment results are presented based on the proposed protocol. It is anticipated that these improvements to blinding assessment will generate greater awareness among researchers, facilitate the standardization of blinding, and augment the blinding effectiveness. The use of this blinding assessment may further advance the quality and precision of TCM clinical trials and improve the accuracy of the trial results. The blinding assessment protocol will undergo continued optimization and refinement, drawing upon expert consensus and experience derived from clinical trials.

Key words: Traditional Chinese medicine, Blinding assessment, Evaluation protocol, Assessment report

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