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Analysis of current status of outcome indicators in a randomized controlled trial of acupuncture for Alzheimer’s disease
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DOI   10.11656/j.issn.1673-9043.2026.09.10
Key Words   Alzheimer's disease;acupuncture;randomized controlled trial;outcome indicator;core outcome set
Author NameAffiliationE-mail
SUN Shiyun The Third Clinical Medical College of Zhejiang Chinese Medical University, Hangzhou 310053, China  
CHEN Lingqian The Third Clinical Medical College of Zhejiang Chinese Medical University, Hangzhou 310053, China  
LI Zhuoyi The Third Clinical Medical College of Zhejiang Chinese Medical University, Hangzhou 310053, China  
FU Luyao The Third Clinical Medical College of Zhejiang Chinese Medical University, Hangzhou 310053, China  
HE Kelin Department of Acupuncture, The Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou 310005, China  
MA Ruijie The Third Clinical Medical College of Zhejiang Chinese Medical University, Hangzhou 310053, China
Department of Acupuncture, The Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou 310005, China 
20071028@zcmu.edu.cn 
Abstract
    [Objective] This study aims to analyze the current situation of outcome indicators in randomized controlled trials(RCTs) of acupuncture treatment for Alzheimer’s disease(AD),so as to provide a reference for constructing core outcome sets(COS),optimizing traditional Chinese medicine(TCM) clinical research protocols,and improving the quality of TCM clinical research. [Methods] The RCTs of acupuncture for the treatment of AD in 8 databases,including CNKI,Wanfang,VIP,SinoMed,Embase,PubMed,Web of Science,and Cochrane Library,which were searched from January 1,2014 to October 31,2024. The basic information and outcome indicators of the included studies were statistically collected. [Results] A total of 127 studies with a sample of 11 122 patients involving 38 diagnostic criteria were included,and a total of 124 outcome indicators were reported,with a total frequency of 625 uses. At present,the RCT studies of acupuncture in the treatment of AD have some problems,such as inconsistent diagnostic criteria,lack of rationality in the application of physical and chemical examination indicators,insufficient reporting of participants’ education level,lack of TCM characteristics in outcome indicators,and non-standard safety evaluation reports. [Conclusion] It is suggested that future investigators should jointly promote the construction of the COS of clinical trials for the treatment of AD with acupuncture,which is helpful to reduce the heterogeneity between clinical research protocol design,improve the application system of outcome indicators,and improve the rigor and reliability of research results.

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