Objective:To research the differences of blinding assessment of practical placebo needle between male and female.Methods:In a single-blinded, cross-over trial, random allocation was taken to averagely divide sixty volunteers into two groups to acupuncture using two types of needle. In group A, practical placebo needles were using first, and then the real needle. And in group B, the real needles were the first, and then the placebo needle. Placebo acupuncture was performed by administering the practical placebo needle through an adhesive pad without skin penetration on the acupoint of RN12. Real acupuncture was performed by needling through the pad and penetrating the skin to 1 cun using a real needle on the same acupoints used with the placebo acupuncture. The acupuncture was administered every other day with three sessions for one type of needle and six sessions in total for each subject. After the third acupuncture of each two kinds of needle, the differences between the two needle types on the proportion of subjects’perception of needle penetration, the degree of needle acceptability were recorded.Results:(1) Difference of the proportion of subjects’perception of needle penetration between the two kinds of needles:In the acupuncture of RN12, the skin penetration were reported by 90.0%(54/60) subjects in placebo acupuncture, and by 96.0% (58/60) subjects in real acupuncture. In placebo acupuncture, the skin penetration were reported by 90.0% subjects in both male and female. There was no significant difference of blinding assessment of pragmatic placebo needle between male and female.(2) Needle acceptability:The placebo needle could be accepted or more easily accepted by 98.3% (59/60) subjects, in which there were 100%(30/30) males and 96.7%(29/30) females could accept the placebo needle. While the real needle could be accepted or more easily accepted by 93.3% (56/60) subjects, in which there were 96.7%(29/30) males and 90.% (27/30) females could accept the placebo needle.. Compared with the real needle, the pragmatic placebo needle was more easily accepted by subjects. While male would accept the acupuncture more easily than female. (p=0.641, p=0.0813).Conclusions: The pragmatic placebo needle is a valid control for acupuncture research. This approach produces a good subject blinding effect with a similar appearance to conventional acupuncture needles and no skin penetration when applied. |