ABSTRACT
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.
Subject(s)
Acupuncture , Acupuncture Therapy , Clinical Trials as Topic , Moxibustion , Sample SizeABSTRACT
Abstract Non-inferiority randomized clinical trials are indicated when it is intended to prove that an experimental group is not inferior to a control group by more than a margin of non-inferiority. However, this type of study differs from traditional randomized clinical trials (superiority studies) because they have particularities that impact on the formulation of hypothesis to be tested, experimental design (non-inferiority margin determination, adapted sample size calculation, sensitivity of the study and data final analysis) and also on the presentation of data when writing the manuscript. Therefore, this article aims to present and discuss the particularities of non-inferiority clinical studies, since these requirements are fundamental to guarantee the validity of the conclusions of this type of study.