A Review and Analysis of Placebo Treatments, Placebo Effects, and Placebo Controls in Trials of Medical Procedures When Sham Is Not Inert

Stichting (Foundation) for the Study of Traditional East Asian Medicine (STEAM), Amsterdam, The Netherlands.
The Journal of Alternative and Complementary Medicine (Impact Factor: 1.59). 05/2006; 12(3):303-10. DOI: 10.1089/acm.2006.12.303
Source: PubMed


Researchers examining the efficacy of medical procedures make assumptions about the nature of placebo. From these assumptions they select the sham interventions to be used in their trials. However, placebo is not well defined. A number of definitions are contradictory and sometimes misleading. This leads to problems in sham-controlled studies of medical procedures and difficulties interpreting their results. The author explores some of the contradictory definitions of placebo and assumptions and consequences of these. Principal among these is the assumption that the placebo is inert when it is not, which introduces bias against the tested medical procedures and devices. To illustrate the problem, the author examines the use of sham procedures in clinical trials of the medical procedures surgery and acupuncture in which the sham was assumed to be inert but was not. Trials of surgery and acupuncture should be re-examined in light of this.

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Available from: Stephen Birch, Oct 29, 2015
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    • "Numerous acupuncture researches had focused on the placebo effect of acupuncture [15–18] and used minimal or sham acupuncture as control to real acupuncture [19–23]. Studies had questioned the accuracy of the definition of placebo [24]. Others also questioned whether minimal, superficial, or sham acupuncture procedures are acceptable as inert placebo controls [25, 26]. "
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    Evidence-based Complementary and Alternative Medicine 07/2014; 2014(2):871217. DOI:10.1155/2014/871217 · 1.88 Impact Factor
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    • "Ideally, an RCT should be blinded, but there is a problem with placebo controls in acupuncture research, since they possibly have similar physiological effects as acupuncture in the activation of the endogenous opioid system [22,23]. We therefore decided not to use a placebo control group and hence blinding was impossible. "
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    • "Firstly, from the biomedical point of view the needle applies pressure to the skin and as such produces a physiological response [5]. The pressure applied by the Streitberger needle can on occasions cause the needle to pierce the skin [9]. Secondly, from traditional practice point of view it is not true to say the penetration of the skin is always thought to be essential, for example in some forms of Japanese acupuncture non-penetrating techniques are used [28]. "
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    ABSTRACT: 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. Therefore 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.
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