Methodological Considerations in N-of-1 Trials of Traditional Chinese Medicine

Author:

Huang Haiyin1ORCID,An Jiaqi1ORCID,Lu Lizhi1ORCID,Wang Mingli1ORCID,Chen Huijia1ORCID,Chen Xinlin2ORCID,Shen Lihua1ORCID

Affiliation:

1. Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200437, China

2. Basic Medical College of Guangzhou University of Traditional Chinese Medicine, Guangzhou 510006, China

Abstract

More and more scholars choose N-of-1 trials for TCM clinical research. However, the quality of the experimental designs was uneven. Accumulating more than eight years of experience in exploring the N-of-1 trials of TCM, the authors and their team searched the related literature in main Chinese and English databases, referenced to relevant Chinese and international guidelines. The design, implementation, and data analysis of N-of-1 trials of TCM are still in in-depth exploration and practice. “Carryover effect” may affect the design and quality of the trials. Individualized treatment should be guided by the classic theories of TCM. It is expected to formulate reasonable observation periods and pairs and closely integrate individual and group statistical analysis.

Funder

National Natural Science Foundation of China

Publisher

Hindawi Limited

Subject

Complementary and alternative medicine

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