With the worldwide spread of acupuncture as a therapeutic modality and the rapid development of acupuncture clinical research, the number of acupuncture randomized controlled trial (RCT) studies is steadily increasing in China and around the world. However, the results of these studies seem to come from two different worlds indeed. Chinese RCT studies overwhelmingly demonstrate positive outcomes from acupuncture, whereas Western-based studies generally conclude that there is no discernible difference between acupuncture and a placebo. Why should there be such different outcomes when the same scientific method is being used? This paper analyzes factors that may be contributing to the different outcomes between China-based and Western-based RCT studies by considering and comparing starting points, purpose, study design, investigators, acupuncture treatment regimen, methodological quality, results, conclusions, and deficiencies in acupuncture RCT. Based on these comparisons, this paper examines the value of acupuncture RCT in general, and the methodological confusion which seems to have propagated from study to study. We propose the following suggestions to remediate the acupuncture clinical research paradigm: First, acupuncture clinical researches should be carried out step-by-step according to universal, agreed-upon research protocols. Second, norms for reporting outcome metrics need to be standardized for each stage of a study.
随着针灸的国际传播及针灸临床研究的迅速发展，中西方针刺随机对照试验（RCT）研究数量持续增长。然而，西方针刺RCT研究得出针刺效应相当于安慰剂的结果，与中国针刺RCT研究几乎全部是阳性结果形成鲜明对比。为什么同一种方法产生如此不同的结果？本文从针刺RCT研究的缘起与国内外针刺RCT研究现状出发，系统比较中西方针刺RCT在需求与起点、研究目的、研究设计、研究者、针刺治疗方案、研究的方法学质量、研究结果、研究结论及研究不足等方面的差异。在此基础上重新思考针刺RCT的价值及针刺临床研究中的方法学困惑，对针刺临床研究范式提出以下建议：根据研究方案成熟度，开展阶梯递进的临床研究；在不同研究阶段设置明确的实施指导和报告规范。.
Keywords: acupuncture; comparison; methodology of clinical research of acupuncture; randomized controlled trial (RCT).