Toward improving the reliability of clinical acupuncture trials: arguments against the validity of "sham acupuncture" as controls.

In refining the design of single-blind acupuncture research trials, "sham acupuncture" has been proposed and used in trials as a useful "inactive" control, yet the degree of inactivity with sham acupuncture points remains largely undetermined. With neural and dermal effects occurring whenever a needle is inserted into the skin, regardless of depth or location, the estimated effect upon Qi when needling sham acupuncture points remains a matter of conjecture. This paper examines the statistical consequences of utilizing sham acupuncture as a control when its energetic and biomedical effects are unknown. It argues the need for a more careful consideration of "assumptions" in clinical research design.