Validating a new non-penetrating sham acupuncture device: two randomised controlled trials

Area of Science:

• Integrative and Complementary Medicine
• Clinical Trial Methodology
• Traditional Chinese Medicine

Background:

• Developing a credible sham control is crucial for rigorous acupuncture clinical trials.
• Existing sham devices require validation for their efficacy and indistinguishability from real acupuncture.
• The Park Sham Device offers an improved design for sham acupuncture procedures.

Purpose of the Study:

• To validate the Park Sham Device for acupuncture clinical trials.
• To assess if the sham procedure is indistinguishable from real acupuncture in naive subjects.
• To determine if the sham procedure is inactive, using the sensation of de qi as a measure.

Main Methods:

• Two randomized controlled trials (RCTs) were conducted: one with stroke patients (n=58) and one with healthy volunteers (n=63).
• Both studies employed subject and assessor blinding.
• Interventions included real or sham acupuncture using the Park Sham Device, with outcomes assessed by patient perception and expert judgment of de qi.

Main Results:

• No patients in either study believed they received the sham needle treatment, indicating indistinguishability.
• In healthy volunteers, the relative risk of experiencing de qi with real acupuncture versus sham was 15.38 (95% CI 2.26 to 104.86).
• Expert consensus on de qi showed a relative risk of 15.38 for real acupuncture, suggesting the sham is inactive.

Conclusions:

• The Park Sham Device provides a valid control for acupuncture trials, being indistinguishable from real acupuncture and inactive.
• The findings support the concept of de qi as a specific sensation in acupuncture.
• This validated sham device enhances the methodological rigor of acupuncture research.