Methodological Advances Needed in Analysis and Interpretation of Sham Acupuncture Validation Studies

Abstract

Many challenges remain in the evaluation of the clinical efficacy of acupuncture: for example, how to define the particular form of acupuncture used, when there are so many varieties of practice that can be called ‘acupuncture’ and how to choose the control method appropriate to that particular form of acupuncture.1 Perhaps we are still some distance from closing the gap between the rigour of a study (internal validity) and its generalisability and real-world applicability (external validity). In this issue of Acupuncture in Medicine , two reports are presented on the validity of two sham acupuncture methods. In sincere appreciation of the efforts of Takakura et al 2 3 and Tan et al ,4 in this difficult area, we would like to offer a few general points concerning the validation of acupuncture sham control and to comment on the two studies. While it is established that the two main objectives of a validation study of a sham control procedure are to test whether it is indistinguishable from the real acupuncture, and to investigate its relative inertness, how much information needs to be disclosed during the informed consent process is crucial, but has not generally been agreed. Tan et al 4 told the study participants: ‘this study will investigate whether people can tell the difference between a real acupuncture needle and a fake acupuncture needle with a blunt tip, using a small device….’ This question seems to be inviting participants to look out for a fake needle with a blunt tip, and thus raises excessive suspicions …