number of correspondents to the British Medical Journal criticised this
support, claiming that the evidence was not sufficient to reach a positive
conclusion.^36
There are problems with designing trials for acupuncture associated with
the control arm of an RCT.^37 The most usual placebo method is sham
acupuncture, when needles are inserted outside acupuncture points with
minimum interaction between practitioner and patient.^38 It is argued that
this is an incorrect method because it leads to a study of the importance of
the acupuncture point rather than of acupuncture itself.^39 Furthermore, as
stated above, there are doubts about whether acupuncture points and non-
acupuncture points can be identified. Even if they can, there is evidence that
acupuncture at non-classic points, the so-called trigger points, may have
analgesic effects.
Kaptchk et al. investigated whether a validated sham acupuncture device
had a greater placebo effect than an inert pill in people with persistent upper
extremity pain due to repetitive strain injury.^40 During the placebo run-in,
participants assigned to the acupuncture group received two treatments a
week with a sham acupuncture device that looked exactly like a real
acupuncture needle but had a blunt tip and retracted into a hollow shaft
handle. When the needle was ‘inserted into the skin’ participants saw and
felt the needle penetration. Both sham and genuine needles were held in
place with a plastic ring and surgical tape so the procedure looked identical.
After the run-in period, the acupuncturists followed identical protocols for
administering real or continued sham acupuncture. Participants in the pill
group were instructed to take one capsule each evening to minimise daytime
drowsiness. The placebo capsule contained cornstarch, and the amitripty-
line capsule contained cornstarch plus 25 mg amitriptyline. The primary
outcome was self-reported intensity of pain in the most severely affected
arm during the preceding week measured on a 10-point numerical rating
scale ranging from no pain (1) to the most severe pain imaginable (10). The
sham device had greater effects than the placebo pill on self-reported pain
and severity of symptoms over the entire course of treatment, but not during
the 2-week placebo run-in. It was concluded that placebo effects seem to
depend on the behaviours embedded in medical rituals.
Notwithstanding the difficulties highlighted above, a number of RCTs
have been conducted, providing results that, with a few notable exceptions,
are not conclusive.^41
Various methods of assessing clinically meaningful change associated
with a course of acupuncture treatment have been studied.^42 The most effec-
tive was the Measure Your Own Outcome Profile (MYMOP), in which
patients were initially invited to rank up to three symptoms for which they
were most interested in seeking treatment with acupuncture. This helped the
acupuncturists formulate a treatment plan for each patient. Subsequently
138 | Traditional medicine