[Application and reflection on pilot study in acupuncture clinical research].

Abstract

Pilot study is essential prerequisite for large-scale research. Acupuncture is a complex intervention measure. The factors of its clinical effect and effect mechanism are complicated. Hence, the resource waste is easily induced in research if the large-scale clinical research is rashly carried out before scientific verification. Currently, there is still a lack of high-quality evidence of clinical research, which affects the promotion and application of the curative effect of acupuncture. The pilot study of acupuncture can evaluate the feasibility and the process coordination of trial, optimize program and process and provide the basis of sample size calculation prior to launching a full-scale trial. Thereby, the methodological quality of acupuncture research and the reliability of trial results can be improved. In the paper, the arguments focus on the definition, design and report of pilot study so as to provide the approaches and references for the design and implementation of pilot study of clinical research of acupuncture.