近年来，针灸临床研究方法学有了显著进展，假针刺对照设置规范化、效应解析走向量化、盲法评价也日益受到重视，为区分针刺特异性与非特异性效应提供了关键支撑。同时，针刺临床研究专属报告指南体系逐步完善，针刺操作者效应、过程评价等实施性细节逐步被探索。这些进展共同推动了针灸临床研究的发展，为提升针灸临床研究质量提供了坚实的方法学支撑。然而，该体系仍面临合格假针刺对照设计困难、操作者效应管控缺失、过程评价工具不成熟等多重挑战，未来需针对性开展相关研究，持续完善针灸临床研究方法学体系基础。

In recent years, remarkable advances have been achieved in the methodology of acupuncture clinical research. The standardized design of sham acupuncture control groups, the shift toward quantitative analysis of therapeutic effects, and the growing emphasis on blinded assessment have jointly provided critical methodological support for distinguishing between the specific and non-specific effects of acupuncture. Meanwhile, the system of exclusive reporting guidelines for acupuncture clinical research has been gradually improved, and implementation details including acupuncturist-specific effects and process evaluation indicators have been increasingly explored and refined. These progresses have collectively propelled the development of acupuncture clinical research and laid a solid methodological foundation for enhancing the scientific quality and reliability of such studies. However, the current methodological system still confronts multiple challenges: the difficulty in designing qualified sham acupuncture controls with high credibility, the lack of effective strategies for regulating acupuncturist effects, and the immaturity of standardized tools for process evaluation. Moving forward, targeted research should be conducted to address these bottlenecks, continuously optimizing and improving the methodological framework of acupuncture clinical research to further elevate its academic recognition and clinical transformation value.