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

• Published in: World journal of acupuncture-moxibustion 2023-10, Vol.33 (4), p.367-371
• Main Authors: Shi, Wen-ying, Zhang, Wei
• Format: Article
• Language: English
• Subjects: Acupuncture; Clinical trial; Double dummy; Electroacupuncture; Hot flush; Manual acupuncture; Menopausal; Randomized controlled trial (RCT); Single-blind; 临床研究; 单盲; 双模拟; 围绝经期; 手针; 烘热; 电针; 针灸; 随机对照试验
• ISSN: 1003-5257
• DOI: 10.1016/j.wjam.2023.09.001

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. 随机对照试验是评价临床证据的“金标准”.在针灸临床疗效评价中, 因针灸治疗操作上的特殊性, 盲法和对照方法的选择是临床研究设计的难点, 对研究者,研究对象和评价者同时设盲是不切实际的, 目前临床研究普遍的做法是针对研究对象和评价者设盲.笔者以“手针和电针治疗绝经烘热疗效比较”为例, 探讨借助临床新药研究中双模拟的思路, 建立了单盲双模拟针灸临床研究模式, 在两组不同针刺干预基础上, 分别联合安慰干预, 使两组在治疗形式上保持一致.这样的研究设计可消除针刺非特异性治疗因素的影响, 有助于比较不同针刺特异性的治疗效果, 为针灸临床的设计提供了可参考的思路和方案.