严格设计的大样本针刺RCT不时得出针刺疗效相当于安慰剂的结论，作为高级别证据的针刺系统评价/meta分析结果显示针刺治疗很多疾病疗效不确定，这与越来越多民众寻求针灸治疗的临床实践不符。如何正确解读及应用针刺RCT证据成为当前急需解决的关键问题。国外学者提出对RCT针刺方案充分性进行评价并尝试制定评价方法，但因其研究方法或研究内容存在一定局限性，尚未达成共识。本研究将参考卫生研究报告指南和质量评价工具的制定方法，借鉴体现针刺/中医特点的报告指南的制定方法，构建体现针刺疗法特点的评价工具制定方法。应用该方法，将针刺类型及其治疗特点、治疗方案制定及其成熟度、针灸师资质及对照组合理性等针刺疗效及RCT结果影响因素融入RCT针刺方案充分性评价，制定基于针刺疗法特点的RCT针刺方案充分性评价工具，开展验证评价。本研究结果可用于针刺RCT解读、应用和设计，体现临床实践特点，解决当前研究与实践相悖的问题。

The rigorous large-scale randomized controlled trials of acupuncture often draw the conclusion that the efficacy of acupuncture is regarded as the placebo effect. As the highest-ranked evidence, systematic reviews and meta-analysis of acupuncture conclude that the therapeutic effects of acupuncture are uncertain in many diseases. Such results are not complied with the clinical practice of acupuncture that is increasingly accepted by people. Hence, how to correctly interpret and how to use the evidence of acupuncture RCT become the key issue needed to be immediately resolved at present. Some foreign researchers propose to assess the adequacy of RCT acupuncture regimen and attempt to develop the assessment method. However, due to the limitations of research method or research content, the consensus has not been made yet currently. In reference to the development method of reporting guidelines and quality evaluation tools of health research and of STRICTA and CONSORT CHM Forum , this study first is intended to establish the development method of the assessment tool reflecting the acupuncture characteristics. Then, using the above established method, this study aims to develop the assessment tool for the adequacy of acupuncture regimen based on the characteristic of acupuncture therapy. The factors affecting acupuncture effects such as acupuncture types and its features, the development of the acupuncture regimen and its maturity, the qualification of acupuncturists, and the influence factors of RCT results such as the appropriateness of control group will be adequately considered in the development. The purpose of this research is intended to guide the interpretation of acupuncture RCT and its application, provide the methodological reference to acupuncture RCT design so as to display the characteristics of acupuncture practice and avoid the divergence between research conclusion and clinical practice as far as possible.