“山幕针”——一种双盲安慰针装置的设计与实践

“Sham Needle”— Design and Application of A Double-blind Placebo Needle Assembly

为临床针刺双盲对照试验提供切实可行且科学的安慰针装置——"山幕针"。其特征是,真/假针具皆由毫针、针管及底座组成,假针具底座下端开口完全封闭,使毫针针尖无法与皮肤接触,从而不产生任何轻微刺激,而外形又与真针具完全相同。假针具内置的填充物可以模拟腧穴内软组织,同时结合试验前暗示诱导,起到降低破盲风险的作用,使针刺双盲试验成为可能。

The blind study design,particularly the double-blind study design is a very important method for diminishing placebo effect and reducing bias in clinical medical trial.Enlightened by Streitberger’s and Park’s sham needle design,the authors of the present paper introduce a newly designed sham needle device（Yan’s sham-needle）for controlled double-blind trials of acupuncture.This sham needle device consists of needle,tube and base.The bottom of the tube is completely sealed and it can never arouse any invasive stimulation on the subject’s skin when the sham needle is downward pressed on the body surface.Meanwhile,this sham device is filled with sponge which is able to simulate soft tissues of the acupoint area.By combining words suggestions or hints before trials and the same shape as verum device,this sham-needle device reduces the risk of blind-breaking and makes it possible to conduct controlled double-blind trials.Primary practice showed that this device may provide a new and practical tool for researching the placebo effect of acupuncture therapy.