Clin Pharmacol Ther. 2001 Sep;70(3):287-91.
Gender and the placebo analgesic effect in acute pain.
Averbuch M, Katzper M.
Division of Analgesic, Anti-inflammatory and Ophthalmic Drug
Products, Center for Drug Evaluation and Research, Food and
Drug Administration, Rockville, MD 20857, USA.
OBJECTIVE: Our objective was to examine the placebo arms
from a series of clinical trials in which the post-third
molar extraction dental pain model was used to elucidate the
time course of the placebo effect and the proportion of the
population that are responders, as well as to evaluate
whether the placebo analgesic response of female subjects
may differ from that of male subjects. METHODS: We performed
a meta-analysis of 596 subjects included in the placebo
treatment arm of 16 double-blind, post-third molar
extraction dental pain (moderate to severe) studies
submitted to the Food and Drug Administration
electronically. The inclusion and exclusion criteria were
practically identical in all studies. Pain relief and pain
intensity measurements used the same metrics in all studies.
The measurements were recorded just before drug
administration and at least at postdose hours 0.5, 1, 1.5,
2, 3, 4, 5, and 6. RESULTS: There were 325 female subjects
and 271 male subjects. They were all otherwise healthy, with
a mean age of 21.6 years for female subjects and 22.3 years
for male subjects. The postoperative baseline pain was
greater in female subjects than in male subjects, and this
difference was statistically significant. Both pain
intensity and pain relief scores demonstrate the well-
established placebo effect in 10% of the pooled subjects, as
well as in all the individual studies. Over time, however,
the mean pain intensity and pain relief scores for the
female and male treatment groups were not noticeably
different at any time point after medication. Further
analysis of the data showed no gender difference in duration
of action of the placebo. CONCLUSIONS: The results
demonstrated no gender difference in response to placebo.
These results were obtained from the post-third molar
extraction situation, in which the least possible
confounding factors were present. To fully establish the
generality of this phenomenon, studies should be carried out
in other pain models.
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