Due to various constraints, such as clinical implementation conditions and unique characteristics of acupuncture-moxibustion, some randomized controlled trials (RCTs) of acupuncture-moxibustion still suffer from relatively low quality and limited applicability. The single-arm objective performance criteria/performance goal can be considered as an ideal supplementary and alternative research approach to RCTs. In this paper, the feasibility of applying the single-arm objective performance criteria/performance goal in acupuncture-moxibustion clinical research is explored from the limitations of conducting acupuncture-moxibustion RCTs, the principles, the essential design considerations and key statistical steps. In addition, illustrative examples are provided. The objective is to offer insights into resolving practical difficulties in acupuncture-moxibustion clinical research.
受临床实施条件及针灸自身特点等因素的限制，部分针灸随机对照试验（RCT）仍存在质量相对较低、应用受限等不足，单组目标值法可作为RCT较为理想的补充替代研究方法。本文从针灸临床RCT实施的局限性、单组目标值法的原理及其在针灸临床试验中的设计要点、关键统计学步骤及实例举证入手，分析单组目标值法在针灸临床研究中应用的可行性，以期为解决针灸临床研究中的实际困难提供思路。.
Keywords: acupuncture-moxibustion; clinical research; randomized controlled trial (RCT); single-arm objective performance criteria/performance goal.