Methodological challenges and recommendations for acupuncture clinical study:

A scoping review

针刺临床研究面临的方法学挑战与建议：概况性评价

Xiang-yu HU(胡翔昱), Wen-cui XIU(修文萃), Zi-yu TIAN(田紫煜), Rui-min JIAO(焦睿珉), Huan CHEN(陈欢), Xiao-yi HU(胡晓艺), Lan-jun SHI(施兰君), Tian-yu MING(明恬妤), Wei-juan GANG(岗卫娟)*, Xiang-hong JING (景向红)

Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing 100700, China (中国中医科学院针灸研究所，北京 100700，中国)

Abstract

Background: Methodological issues and challenges hinder the high-quality development of high-quality clinical acupuncture clinical studies.

Objective: To systematically summarize the methodological issues, challenges, and recommendations in acupuncture clinical research using the participant, intervention, comparison, outcome, and study design (PICOS) framework to generate a comprehensive list of methodological questions and recommendations.

Methods: We searched seven databases for articles on the methodological aspects of clinical acupuncture research from their inception to March 24, 2023. Two researchers independently screened the titles, abstracts, and full text of each article. Data extraction and analyses were performed for the eligible studies. Finally, the methodological challenges and recommendations for acupuncture clinical studies are listed, and the frequency of methodological challenges is displayed in a sunburst chart.

Results: A total of 226 studies were included in the review, most of which originated in China (173, 77%), followed by the United States (25, 11%) and the United Kingdom (12, 5%). Clinical research on acupuncture faces methodological challenges that span the five elements of the PICOS framework. The most frequently mentioned issues were related to comparison, followed by study design and interventions. If further categorized, the establishment of the control group is undoubtedly the most concerning issue for researchers.

Conclusion: This review provides a comprehensive overview of the challenges and recommendations for each aspect of the PICOS framework in clinical acupuncture research.

【摘要】

背景：针刺临床研究面临的方法学问题和挑战阻碍了其高质量发展。

目的：通过PICOS（participant, intervention, comparison, outcome, and study design）框架系统地总结针刺临床研究面临的方法学问题、挑战和建议，以生成一份全面的方法学问题和建议清单。

方法：我们在七个数据库中检索了与针刺临床研究方法学相关的文章，检索时间从建库开始到2023年3月24日。两名研究者独立筛选了每篇文章的标题、摘要和全文，并对符合纳入条件的研究进行了数据提取和分析。最后，我们通过表格列出了针刺临床研究的方法学挑战和建议，并在旭日图中显示了这些方法学挑战被关注的频率。

结果：共纳入226项研究，其中大部分来自中国（173，77%），其次是美国（25，11%）和英国（12，5%）。针刺临床研究面临的方法学挑战是全方位的，涉及PICOS框架的每个方面。最常被提及的问题与对照有关，其次是研究设计和干预。如果进一步分类，对照组的设置是研究人员最关心的问题。

结论：本范围综述全面概述了针刺临床研究在PICOS框架下每个方面存在的方法学挑战和建议。