“A placebo can only be assumed to be inert according to current
knowledge” [1]. The sham procedure used in Kaptchuk et al’s IBS placebo
study [2] is already known not to be inert. One cannot touch the body
without biological effects. Some of these effects may in theory be
attributable to placebo, others are normal reactions to touch and can have
many dimensions to them [3, 4]. Therefore the sham acupuncture which
necessarily involves touch and pressure is not an inert placebo (something
admitted by its proponents [5]) and cannot have effects solely
attributable to the ritual of therapy [6] as the authors claim [7]. Thus
placebo effects in both the sham treatment arms are necessarily
overstated. Additionally some aspects of the effects of touch are probably
specific to the acupuncture therapy [8], a possibility acknowledged by the
lead author in recent discussions about the role of touch in taiji chuan
[9, 10].
In these articles about taiji chuan the lead author also demonstrates
knowledge of complex interventions and the difficulties of doing research
on them. Among other things, the evidence he cites comes from acupuncture
related studies showing how many aspects of patient-practitioner psycho-
social-verbal interactions are specific aspects of acupuncture treatment
[11]. This and other supporting studies have demonstrated the complex
nature of acupuncture as an intervention [8, 12]. Unfortunately in the
third arm of the IBS placebo study since sham acupuncture was used to
investigate placebo effects, not only is there a problem with the sham not
being inert, but the study will have attributed to placebo some effects
due to these non-placebo related specific components of acupuncture
intervention. There is no discussion of this and no attempt to tease apart
placebo related treatment components from these acupuncture specific non-
placebo related patient-practitioner interactional components [12]. Thus
the study will necessarily have further overestimated placebo effects in
this third arm, due to this mislabeling of treatment components.
This placebo study chose to use sham acupuncture as its ‘placebo’
treatment. This was an unfortunate choice. No sham acupuncture treatment
has ever been demonstrated to be inert, raising questions about bias in
acupuncture studies [1] and thus the suitability of sham acupuncture in
trials of acupuncture [13]. Recently experts have raised the issue of
whether there should be a moratorium on sham acupuncture studies due in
part to these difficulties [14]. The authors of this study have chosen to
ignore the same evidence and arguments about complex interventions and the
inherent difficulty of separating their placebo effects that they have
used and cited elsewhere [8, 9, 10], raising other questions about this
placebo study.
It would have been much more interesting and relevant to answer the
questions about placebo that this study attempted to investigate if they
had chosen a sham (placebo) standard pharmaceutical intervention
administered in normal GP practice where the doctor usually does not have
time to talk much with the patient, and use as a third arm an extended
discussion treatment arm added to the placebo medication.
References
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the placebo in placebo controlled trials? Heart. 1997;77:95–96.
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Kirsch I, Schnyer RN, Nam BH, Nguyen LT, Park M, Rivers AL, McManus C,
Kokkotou E, Drossman DA, Goldman P, Lembo AJ. Components of placebo
effect: randomized controlled trial in patients with irritable bowel
syndrome. BMJ, 2008:336(7651):999-1003.
3. Fields T. Touch Therapy. London, Churchill Livingstone. 2000.
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Stephen Birch
Foundation (Stichting) for the Study of Traditional East Asian Medicine
(STEAM), Amsterdam, the Netherlands
Mark Bovey
Coordinator, Acupuncture Research Resource Centre, Thames Valley
University, London, UK
Competing interests:
None declared