A novel sham moxibustion device: a randomized, placebo-controlled trial

Area of Science:

• Traditional Chinese Medicine
• Clinical Trial Methodology
• Acupuncture Research

Background:

• Moxibustion, a therapy involving burning mugwort, is used for various conditions, including common cold prevention.
• Conducting rigorous clinical trials for moxibustion is challenging due to the difficulty in creating effective placebos.
• A validated sham device is crucial for double-blinded, placebo-controlled studies in moxibustion research.

Purpose of the Study:

• To develop and validate a sham moxibustion device.
• To assess the ability of participants and practitioners to distinguish sham from real moxibustion.
• To evaluate the feasibility of using this device in larger clinical trials for common cold prevention.

Main Methods:

• A double-blinded, randomized, placebo-controlled trial was conducted with 71 volunteers aged 55-75.
• Sham and real moxibustion devices were designed to be visually and procedurally similar, with the sham device preventing heat and smoke transfer.
• Participants received treatment every two days for one month, with blinding effectiveness assessed via questionnaires.

Main Results:

• No significant differences were found in participants' or practitioners' ability to distinguish between real and sham moxibustion (P=1.000 for participants, P=0.811-0.840 for practitioners).
• A high percentage of participants in both groups were uncertain about the treatment received, indicating successful blinding.
• The sham device demonstrated effectiveness in maintaining the double-blind protocol.

Conclusions:

• The developed sham moxibustion device is validated and effective.
• This device enables robust placebo-controlled trials in moxibustion research.
• The findings support the use of this sham device for future double-blinded clinical trials in moxibustion.