TY - JOUR
T1 - Systematic review of acupuncture placebo devices with a focus on the credibility of blinding of healthy participants and/or acupuncturists
AU - Zhang, George Shengxi
AU - Zhang, Claire Shuiqing
AU - Tan, Hsiewe Ying
AU - Wang, Yanyi
AU - DaCosta, Cliff
AU - Zhang, Anthony Lin
AU - Xue, Charlie Changli
AU - Xie, Yi Min
PY - 2018
Y1 - 2018
N2 - Background: An ideal placebo design in clinical research should resemble the intervention under investigation to facilitate blinding, yet remain clinically inert. With regard to physical interventions such as acupuncture, a true placebo device has not been developed and validated. Since 1998, researchers have designed several placebo acupuncture devices (PADs). The three most widely used PADs are the Streitberger, the Park and the Takakura device. Aim: This review focuses on evaluating studies of these devices, in the context of credibility of blinding (COB), assessment of penetrating pain or sensation, and de qi sensation. Methods: Electronic database searches were conducted in four English and two Chinese databases from their inception until November 2016. All studies included in the review were conducted on healthy participants and compared verum manual acupuncture with any of the aforementioned PADs with respect to one or more of the above three outcomes related to blinding effect. Results: The synthesised analyses of the 15 included studies showed that the Streitberger and Park placebo devices may not blind participants successfully when tested at a sensitive acupuncture point (LI4). In terms of penetrating sensation, there were significant differences between these two placebo devices and verum acupuncture when applied at this point. The Takakura device was the only PAD that had the potential to blind the acupuncturist. However, the blinding analyses of all outcome measures were inconsistent. Conclusion: Overall, there were insufficient data to confirm the blinding effects of these skin-contact PADs as each device was associated with limitations that warrant further design improvements.
AB - Background: An ideal placebo design in clinical research should resemble the intervention under investigation to facilitate blinding, yet remain clinically inert. With regard to physical interventions such as acupuncture, a true placebo device has not been developed and validated. Since 1998, researchers have designed several placebo acupuncture devices (PADs). The three most widely used PADs are the Streitberger, the Park and the Takakura device. Aim: This review focuses on evaluating studies of these devices, in the context of credibility of blinding (COB), assessment of penetrating pain or sensation, and de qi sensation. Methods: Electronic database searches were conducted in four English and two Chinese databases from their inception until November 2016. All studies included in the review were conducted on healthy participants and compared verum manual acupuncture with any of the aforementioned PADs with respect to one or more of the above three outcomes related to blinding effect. Results: The synthesised analyses of the 15 included studies showed that the Streitberger and Park placebo devices may not blind participants successfully when tested at a sensitive acupuncture point (LI4). In terms of penetrating sensation, there were significant differences between these two placebo devices and verum acupuncture when applied at this point. The Takakura device was the only PAD that had the potential to blind the acupuncturist. However, the blinding analyses of all outcome measures were inconsistent. Conclusion: Overall, there were insufficient data to confirm the blinding effects of these skin-contact PADs as each device was associated with limitations that warrant further design improvements.
KW - acupuncture
KW - clinical trials
KW - systematic reviews (medical research)
UR - http://handle.westernsydney.edu.au:8081/1959.7/uws:49610
UR - https://journals.sagepub.com/doi/abs/10.1136/acupmed-2017-011484
U2 - 10.1136/acupmed-2017-011484
DO - 10.1136/acupmed-2017-011484
M3 - Article
SN - 0964-5284
VL - 36
SP - 204
EP - 214
JO - Acupuncture in medicine
JF - Acupuncture in medicine
IS - 4
ER -