Is the use of sham acupuncture valid as a placebo-control in randomized controlled clinical trials? Iréne Lund, Jan Näslund, Thomas Lundeberg Department.

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Presentation transcript:

Is the use of sham acupuncture valid as a placebo-control in randomized controlled clinical trials? Iréne Lund, Jan Näslund, Thomas Lundeberg Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden Foundation for Acupuncture and Alternative Biological Treatment Methods, Sabbatsbergs Hospital, Stockholm, Sweden

An evidence based challenge Randomized, placebo-controlled clinical trials are recommended for evaluation of a treatment’s efficacy with the goal of separating the specific effects (verum) from the non-specific ones (placebo). In order to be able to carry out placebo-controlled randomized trials with acupuncture, a sham acupuncture needle was introduced. Clinical studies have reported that both verum acupuncture and sham/minimal acupuncture induce a significant alleviation of migraine headache, low back pain and knee osteoarthritis pain. Minimal and sham acupuncture sets up activity in afferent nerve fibers, as verum acupuncture does, and induces a modulation of the activity in many of the same brain structures as verum acupuncture.

Percentage responder rates migraine The figures are modified after a power point presentation of Dr M. Cummings and with the permission of Dr K. Linde.

Percentage responder rates knee osteoarthritic pain The figures are modified after a power point presentation of Dr M. Cummings and with the permission of Dr K. Linde.

Percentage responder rates low back pain The figures are modified after a power point presentation of Dr M. Cummings and with the permission of Dr K. Linde.

Conclusion Acupuncture is not a standardized treatment and there is no verum acupuncture. Sham acupuncture is not inert and should therefore not be used as a placebo-control in RCTs for the test of efficacy, i.e. the present research paradigm (verum vs sham acupuncture) may be questioned as not valid. Instead of reducing bias it introduces a bias against the findings of the tested treatment. The use of observational research design is a way to evaluate the clinical effectiveness of acupuncture effects.