Is the use of sham acupuncture valid as a placebo-control in randomized controlled clinical trials?

1
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

2
An evidence based challenge

• Randomized, placebo-controlled clinical trials
  are recommended for evaluation of a treatments
  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.

3
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.
4
Percentage responder ratesknee osteoarthritic
pain
The figures are modified after a power point
presentation of Dr M. Cummings and with the
permission of Dr K. Linde.
5
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.
6
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.