The appropriate sample size estimation is very important in the design of clinical trials. However, insufficient or inappropriate sample size estimation is still a prominent problem in the currently published acupuncture and moxibustion clinical trials. At present, the superiority test, non-inferiority test and equivalence test have been widely used in acupuncture and moxibustion clinical trials. This article focuses on the application, calculation methods and PASS11 software using of these three hypothesis test types. In view of the problems in the estimation of sample size in acupuncture and moxibustion clinical trials, the particularity of sample size estimation in acupuncture and moxibustion is summarized from the aspects of parameter setting, ratio of intervention group and control group, and multi-group comparison, in order to guide acupuncture clinical researchers to correctly estimate sample size when conducting clinical trials.
确定合适的样本量是临床试验研究设计的关键步骤，而未报告样本量估计或估计不合理在目前发表的针灸临床试验中仍是一个比较突出的问题。目前临床试验假设检验类型的优效性试验、非劣效性试验和等效性试验已普遍应用于针灸临床试验中，本文针对这3种类型的适用情况、计算方法和PASS11软件的操作进行介绍。并针对针灸临床试验样本量估计时存在的问题，从参数设定、组间比例确定、多个比较组方面，对针灸领域样本量估计的特殊性进行总结，以期指导针灸临床研究者在进行临床试验时正确估计样本量。.
Keywords: acupuncture and moxibustion; equivalence trial; non-inferiority trial; sample size estimation; superiority trial.