Sham acupuncture devices--practical advice for researchers

Several validated sham acupuncture devices have recently become available. While some debate exists on whether such needles are the best placebo control for an RCT of acupuncture, practical advice based on research experience is missing from the literature. This paper shares our concrete experience using the most commonly used such sham needle (the 'Streitberger needle' and its paired verum needle) in a large RCT (n=135) which included a two-week run-in period. The placebo run-in gave us an opportunity to use the sham device on all participants, who were then re-randomised to receive genuine acupuncture or to continue treatment with the device. The blinding was successful both at the end of the run-in and at the conclusion of the trial despite the re-randomisation. We also report our experience with the sham needle in neuroimaging experiments where the magnetic machinery poses considerable challenges for acupuncture research.