Objectives: To evaluate the blinding effectiveness of a modified blunt sham press needle on the basis of the ability of subjects to discriminate between real and sham acupuncture needles compared with their discrimination ability based on pure guessing, and to define differences between senses (touch and vision) in the rates of correctly identified needles.
Methods: Sixty-three healthy students and staff members were recruited through convenience sampling. First, real or sham acupuncture was randomly administered to the left LI4 point while subjects could not observe the needle tip. A real or sham needle tip was then shown to the subjects. Finally, a random combination of real or sham acupuncture needles were randomly administered to the left and right LI4 points, this time with the subjects observing the procedure. In all conditions the subjects gave their judgement as Yes or No in response to questions asking them to identify the needle type. The proportion of correct judgements (P(C)) was computed for the last part of the trial in left and right LI4 points, and the rates of correctly identified needles for each trial were obtained.
Results: The subjects' accuracy of discrimination between the real and sham acupuncture needles in left and right LI4 points was not significantly different from that based on pure guess (P(C)=0.50 (chance level)), which indicates complete inability to discriminate between needles. The rates of correctly identified needles using touch, vision and a combination of both senses were not significantly different (p=0.807).
Conclusions: The findings from this study show that this sham acupuncture device successfully blinded subjects to real and sham press needles, suggesting that it is effective for subject blinding in studies on acupuncture using press needles, and facilitating evaluation of the effects of acupuncture in placebo-controlled trials using a rigorous scientific research methodology.
Keywords: ACUPUNCTURE.
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