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Placebo-Controlled Trials in Acupuncture: Problems and Solutions

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Evidence-based Research Methods for Chinese Medicine

Abstract

The objective of this chapter is to provide an overview of the problems and solutions of randomized placebo-controlled trials in acupuncture. Studies examining how acupuncture might work cover a broad range of physiological systems, ranging from a single biochemical pathway to the whole biological system. Needling, touch, and pressure occur before skin penetration and then surface receptors/structures are stimulated by both shallow and deeper insertions with additional receptors are further stimulated by deeper insertions. This process raises important questions about the use of penetrating and non-penetrating sham acupuncture techniques and placebo effects. In clinical research the placebo treatment must be inert, and only when the provided randomization and blinding are properly used, a trial comparing the test treatment to the placebo treatment can be said as placebo-controlled. A placebo-controlled trial is an explanatory trial since it tests the known mechanisms associated with the treatment. But in hands-on therapies like acupuncture what can constitute a valid placebo control treatment? Are there predictable mechanisms by which acupuncture works suggesting which valid placebo can be used? Are there any sham acupuncture interventions that can constitute placebo treatments? Are they credible to be sham treatments? If they are not inert or credible, then how can we perform placebo-controlled trials on acupuncture? Are such trials possible? Many forms of sham acupuncture have been tried out in efforts to control placebo effects. In the ‘real’ or ‘test’ acupuncture the ‘real’ technique is applied to the ‘real’ acupoints. Thus, sham acupuncture involves varying the techniques of treatment and the locations of treatment. Given these two variables, three basic variations of sham acupuncture are possible. One of these could possibly act as a placebo control research model, provided that the sham techniques are clinically inert and the sites of their application are clinically inert. The other two models act to compare either treatment sites or treatment techniques. In the latter two models placebo can be held equal between treatment groups, but these models are not capable of acting as placebo-controlled trials. The second and third sham models are often used inadvertently as though they were capable of answering the same question as the first or were placebo-controlled clinical trials like the first. This chapter will give an overview on the current status and problems of placebo-controlled trials in acupuncture trials and suggest possible solutions. We can summarize the evidence: so far no sham acupuncture techniques are inert; they are also clinically effective; and no placebo-controlled trials of acupuncture have ever been performed. Given the evidence, we propose to stop performing sham acupuncture studies since they cannot achieve control for placebo effects. We propose a two-pronged approach to address the issues of mechanisms of action and effectiveness.

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Authors and Affiliations

  1. Institute of Health Sciences, Kristiania University College, Oslo, Norway

    Stephen Birch & Terje Alraek

  2. Department of Community Medicine, Faculty of Health Sciences, National Research Center in Complementary and Alternative Medicine (NAFKAM), UiT The Arctic University of Norway, Tromsø, Norway

    Terje Alraek

  3. Department of Acupuncture and Moxibustion, Korean Medicine Hospital, Pusan National University, Yangsan, Korea

    Kun Hyung Kim

  4. Clinical Research Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea

    Myeong Soo Lee

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Correspondence to Stephen Birch or Myeong Soo Lee .

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  1. Institute of Chinese Medical Sciences, University of Macau, Macau, Macao

    Siu-wai Leung

  2. Institute of Chinese Medical Sciences, University of Macau, Macau, Macao

    Hao Hu

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Birch, S., Alraek, T., Kim, K.H., Lee, M.S. (2016). Placebo-Controlled Trials in Acupuncture: Problems and Solutions. In: Leung, Sw., Hu, H. (eds) Evidence-based Research Methods for Chinese Medicine. Springer, Singapore. https://doi.org/10.1007/978-981-10-2290-6_4

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