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Comparison of amitriptyline, cyclobenzaprine, & placebo in the treatment of fibromyalgia (FM). A randomized, double-blind clinical trial

  [ 31 votes ]   [ Discuss This Article ] • January 2, 1994

OBJECTIVE. To compare the relative efficacy and tolerability
of amitriptyline, cyclobenzaprine, and placebo in the
treatment of fibromyalgia, and to identify predictors of
response to amitriptyline and cyclobenzaprine.

hundred eight patients who fulfilled the American College of
Rheumatology criteria for the classification of fibromyalgia
were entered into a 6-month prospective, double-blind,
multicenter trial and were randomized to 1 of 3 treatment
groups: amitriptyline, cyclobenzaprine, or placebo.

After 1 month, 21%, 12%, and 0% of the amitriptyline,
cyclobenzaprine, and placebo patients, respectively, had
significant clinical improvement (amitriptyline versus placebo
P = 0.002, cyclobenzaprine versus placebo P = 0.02,
amitriptyline versus cyclobenzaprine P not significant). These
percentages increased to 36%, 33%, and 19%, respectively, at
the 6-month assessment (P not significant). The nature and
frequency of side effects reported by patients treated with
amitriptyline and those reported by patients treated with
cyclobenzaprine were similar. A normal Minnesota Multiphasic
Personality Inventory (MMPI) profile at baseline was
predictive of clinical improvement at the 1-month evaluation
(odds ratio 3.3, 95% confidence interval 1.2-9.0). However,
neither the MMPI profile nor any of the demographic, clinical,
or functional parameters evaluated at baseline predicted
long-term response.

CONCLUSION. Our data confirm the short-term efficacy of
amitriptyline and cyclobenzaprine in a small percentage of
patients with fibromyalgia. Long-term efficacy could not be
demonstrated because of a higher-than-expected placebo
response. Predictors of response to these drugs could not be

Carette S, Bell MJ, Reynolds WJ, Haraoui B, McCain GA, Bykerk VP,
Edworthy SM, Baron M, Koehler BE, Fam AG, et al

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