To demonstrate efficacy of moxibustion, randomized controlled trials are required. But, clinical trials of moxibustion had limitations due to the absence of a sham moxibustion model for an appropriate placebo.
To develop a new sham moxibustion model based on the thermal characteristic of indirect moxibustion, and to evaluate whether it could be applied in clinical trials.
By applying heat insulation, we created a sham moxibustion. It radiated inert remedial heat(<40?). A clinical trial was performed on subjects to test double blinding. The subjects were randomly assigned into two groups(a real group / a sham group). Zusanli(ST36) was used in each group for 3 times. A sham acupuncture credibility questionnaire was modified into a moxibustion credibility questionnaire and was filled out after moxibustion.
Most subjects and practitioners could not distinguish the sham moxibustion from the real one. But subjects who had experienced moxibustion were more likely to distinguish the sham moxibustion from the real one. The real group showed significantly higher value in the Visual Analog Scale for intensity of heat during moxibustion than the sham group did.
The sham moxibustion in this study is proved credible to be applied in investigations of the effect of moxibustion. But it is more appropriate for the people who don’t have experienced moxibustion.