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Application progress of real-world study methodology in acupuncture clinical research
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DOI   10.11656/j.issn.1673-9043.2026.01.14
Key Words   acupuncture clinical research;real-world study;cohort study;efficacy evaluation;safety
Author NameAffiliationE-mail
LI Junlong First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China
National Clinical Research Center for Chinese Medicine, Tianjin 300381, China 		 
LI Guiping First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China
National Clinical Research Center for Chinese Medicine, Tianjin 300381, China
Tianjin Key Laboratory of Acupuncture and Moxibustion, Tianjin 300381, China 		 
LI Li First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China
National Clinical Research Center for Chinese Medicine, Tianjin 300381, China
Tianjin Key Laboratory of Acupuncture and Moxibustion, Tianjin 300381, China 		 
SHEN Yan First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China
National Clinical Research Center for Chinese Medicine, Tianjin 300381, China
Tianjin Key Laboratory of Acupuncture and Moxibustion, Tianjin 300381, China 		 
YANG Sha First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China
National Clinical Research Center for Chinese Medicine, Tianjin 300381, China
Tianjin Key Laboratory of Acupuncture and Moxibustion, Tianjin 300381, China 		 
WANG Jing Second Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300250, China  
XU Zhijie First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China
National Clinical Research Center for Chinese Medicine, Tianjin 300381, China 		 
XU Fan First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China  
LU Mengnan First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China
National Clinical Research Center for Chinese Medicine, Tianjin 300381, China 		 
WANG Xiaomei First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China
National Clinical Research Center for Chinese Medicine, Tianjin 300381, China 		 
ZHANG Jieying First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China
National Clinical Research Center for Chinese Medicine, Tianjin 300381, China 		 
WANG Shu Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital, Tianjin 300120, China
Key Laboratory of Acupuncture Therapy for Encephalopathy, National Administration of Traditional Chinese Medicine, Tianjin 300381, China 		wangs2008@163.com 
Abstract
    The article discusses the application status of real-world study（RWS） in the field of acupuncture and its significance for clinical efficacy evaluation. Chinese and English databases，including CNKI，Wanfang，VIP，PubMed，EMbase，and Web of Science，were searched for RWS literature in acupuncture published from January 2020 to December 2024. Based on the RECORD checklist and the STaRT-RWE tool framework，a summary analysis was conducted from the perspectives of study design，data sources，statistical methods，and clinical applications. Finally，57 RWS articles related to acupuncture were retrieved and screened. The research areas involved neurological diseases，cardiovascular diseases，pain management，perioperative care，and others. The results show that acupuncture therapy has significant efficacy and good safety in real-world clinical settings. RWS enhances the external validity and practical value of research through the integration of multi-source data and multi-factor analysis methods. RWS provides a new pathway for evaluating acupuncture efficacy that is closer to clinical practice. In the future，combining artificial intelligence and big data technologies can further promote the standardization and international development of acupuncture therapy.

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