Thinking and practice of designing a single-blind, double-dummy clinical trial for acupuncture: Taking “comparative study of manual acupuncture and electroacupuncture for menopausal hot flush” as an example

Abstract

Randomized controlled trial (RCT) is the golden standard for evaluation of clinical evidence. To assess the effect of acupuncture, due to the specificity of acupuncture intervention, the blinding and control methods are the difficulties in study design. It is not practical to blind investigators, participants and evaluators simultaneously. At present, blinding is generally conducted for the participants and evaluators in clinical trial. We took a comparative study of manual acupuncture and electroacupuncture for menopausal hot flush as an example to explore a new way with the reference of double-dummy design in new drug study. A single-blind and double-dummy clinical trial model of acupuncture was established. Based on individual acupuncture intervention in each group, the placebo intervention was combined to ensure the form consistency of two groups. Such a study design may eliminate non-specific effect of acupuncture, and can be conductive to comparing the specific effect of acupuncture and can provide the references and regimens for study design.