Should systematic reviews assess the risk of bias from sham–placebo acupuncture control procedures?

Introduction Clinical guidelines depend on the analysis of randomised controlled trials in systematic reviews. How to interpret the results of acupuncture vs. sham–placebo procedures is a controversial aspect of the evidence base for acupuncture. Two inferences can be drawn from the acupuncture vs. sham–placebo randomised controlled trials. The first is whether acupuncture has a physiological basis. The second is whether there is any validity in traditional concepts of acupuncture practice. The degree to which sham acupuncture controls can physiologically be considered placebo controls has been challenged. However, whether these procedures should be considered ‘inert’ in terms of Chinese medicine theory has yet to be fully examined. This review aims to evaluate the extent to which sham–placebo procedures used in randomised controlled trials should be considered inert, with particular reference to traditional Chinese medicine theories. It also considers sham–placebo controls from a biomedical perspective. Methods Sham–placebo procedures were identified through reviews examining acupuncture controls. Results Four main types of sham–placebo control were identified. The procedures are heterogeneous and should not necessarily be considered as equivalent within systematic reviews. Conclusion These procedures cannot be considered as inert controls from either a Chinese medicine or biomedical perspective. There is a need to develop appropriate Acupuncture Control Assessment Guidelines to assess the risk of bias from sham–placebo controls when undertaking systematic reviews. The terminology used to describe control procedures needs to be developed and standardised. This article belongs to the Special Issue: Clinical Guidelines for Integrated Practice.