What
is your interpretation?
You answered:
The study should be replicated with the two
treatment groups being Compound G or an active placebo, a
low dose of a benzodiazepine to mimic the sedative side effects
of Compound G.
CORRECT
(in my opinion)
Some
researchers favor the use of such "active placebos" (Greenberg
and Fisher, 1994), and I tend to agree. The finding
that a new drug relieves pain better than another drug that
produces similar side effects is quite convincing, particularly
when accompanied by evidence that the blinding has remained
effective and is a protection against false positives caused
by drug side effects. Others argue against the use of active
placebos. One argument is that it is unethical to expose
patients to the adverse effects of the active placebo without
expectation of benefit. That argument is largely countered
by using doses just large enough to produce mild side effects
in most patients. A more serious concern is that if the
active placebo has some unexpected effect of worsening pain,
this can again produce a false positive result for the putative
analgesic under evaluation. The investigator should examine
animal and human studies of pain to ascertain that the proposed
active placebo does not worsen or improve pain.
It
is not clear whether one needs to exactly match the magnitude
of the side effects of the two treatments to eliminate this
bias. The study illustrated in
Figure 2.2 suggested that most of the side-effect induced
placebo response occurs with the detection of the first
mild symptom, but further research is needed.
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