The Methodology of Controlled Trials of Acupuncture

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Abstract
The double-blind controlled trial methodology cannot be straightforwardly applied to trials of acupuncture. The double-blind condition, where the clinician is ignorant of the treatment allocation, cannot be sensibly maintained in trials of acupuncture or other physical treatments. The definition of an appropriate control group is also a difficult matter. The great majority of controlled trials of acupuncture so far conducted are seriously flawed by the use of a placebo control that itself has therapeutic effects. Recently more appropriate control groups have been developed, notably mock TENS, which is inert, and minimal acupuncture, which has only a very slight specific effect. As trials can only be single blind, if is especially important to monitor the adequacy of the control procedure, to ensure that it is perceived as being as effective as the true treatment. It is suggested that this can be achieved by assessing the: credibility of the two treatment procedures. Controlled trials of acupuncture should therefore be single blind, and employ a control condition that has no more than minimal specific effects, but is nevertheless seen as a credible, bona fide treatment by patients.