单盲双模拟针灸临床试验设计思路与实践——以“手针和电针治疗绝经烘热疗效比较”研究为例  

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

作　　者：石文英[1] 章薇[1] Wen-ying SHI;Wei ZHANG(The First Hospital of Hunan University of Chinese Medicine,Changsha 410007,Hunan Province China)

机构地区：[1]湖南中医药大学第一附属医院,中国长沙410007

出　　处：《World Journal of Acupuncture-Moxibustion》2023年第4期367-371,共5页世界针灸杂志（英文版）

基　　金：Supported by the program of "the 12^(th) Five-year" National Science and Technology Pillar Program:2012BAJ24B01;Scientific research project of Hunan Provincial Health Committee:20201633;Natural Science Foundation of Hunan Province:2020JJ5437;The fourth batch of academic experience inheritance of Hunan old TCM experts:[2020]No.37;The seventh batch of academic experience inheritance of national old TCM experts:[2022]No.76

摘　　要：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.

关 键 词：Single-blind Double dummy Clinical trial Randomized controlled trial(RCT) MENOPAUSAL Hot flush Acupuncture Electroacupuncture Manual acupuncture 

分 类 号：R245[医药卫生—针灸推拿学]