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

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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.

METHODS. Two

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.

RESULTS.

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

determined.

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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