A Visual Factor of Blinding of the Non-Penetrating Placebo Needle

비침습성 플라시보 침 맹검의 시각적 요소 평가

Objective : Acupuncture (from the Latin acus, "needle," and pungere, "to prick") is a technique of inserting and manipulating fine needles at specific points on the body. As a placebo acupuncture needle device was developed based on the visual impact of needling, it has been raised that it is useful only when acupuncture points and needling are visible to subjects. To examine the visual factor of the placebo acupuncture, the present study was aimed to compare the blinding index of the verum and placebo acupuncture between masked and unmasked situation. Methods : Thirty-six patients were randomly alloted to be stimulated with a verum or placebo acupuncture in a cross-over design. They were asked to guess a right answer whether they were stimulated with the verum or placebo acupuncture at LI4 in an unmasked or masked situation. The penetrating, pain, and deqi sensations were also measured after the stimulation using modified visual analogue scale. Results : The correct answer rate of the placebo acupuncture was 22.2% and 16.7% in an unmasked and masked situation, respectively (P>0.767). The blinding index of the placebo acupuncture was -0.56 (95%CI -0.84 to -0.27) and -0.67 (95%CI -0.91 to -0.42) in an unmasked and masked situation, respectively. The penetrating and deqi sensation of the verum acupuncture were significantly higher than those of the placebo acupuncture in both unmasked and masked situation. The pain sensation of the verum acupuncture was significantly higher than that of the placebo acupuncture in masked situation, but not in unmasked situation. Conclusion : Blinding of the placebo acupuncture was successful both in the unmasked and masked situation. These finding indicate that visual factor might not play a critical role in blinding of the placebo needle. We suggest that placebo needle would be also useful in a functional magnetic resonance imaging scan even when the subject could not see the placebo needle.