A Guideline for Randomized Controlled Trials of Acupuncture.

Guidelines for clinical trials of acupuncture are scarce, particularly in their guidance on choosing an adequate control in an acupuncture trial. This guideline was developed to address the research methodology for clinical research in acupuncture which contains the essential elements to be considered in the design, preparation and reporting of an acupuncture RCT. Particularly, investigators focused on the control design because of the unique feature of acupuncture. As one size does not fit all, one single design cannot answer all research questions. Therefore, we recommend that the clinical questions be answered in different stages of trials by choosing the appropriate control or comparator. This concept is adapted from classical drug trials developed by the Food and Drug Administration (FDA) of USA in which trials are staged in four phages in order to address different research questions. From the points listed above, this guideline offers the specific recommendations in an acupuncture RCT.