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A randomized placebo-controlled trial of sustained-release amitriptyline in primary fibromyalgia

par Ginsberg, Francis;Mancaux, André ;Joos, Erika;Vanhove, Philippe;Famaey, Jean Pierre
Référence Journal of musculoskeletal pain, 4, 3, page (37-47)
Publication Publié, 1996

Article révisé par les pairs

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Résumé :

Objectives: The objective of this study was to evaluate the efficacy and safety of a sustained-release preparation of amitriptyline, taken once daily, in patients with primary fibromyalgia [FS]. Methods: Forty-six patients were evaluated at one and two months in a double-blind placebo-controlled study. The primary evaluation of the outcome of therapy was based on the comparison of the 'clinically meaningful' response rate in the two treatment groups. Results: At four weeks, five of the 24 patients receiving amitriptyline [A] [21%, 95% CI 7.1-42.2%] and none of the 22 patients receiving placebo [P] [95% CI 0-15.4%] were responders [P = 0.050]; at eight weeks there were 14 [58%, 95% CI 36.6-77.9%] responders in group A and none in group P [95% CI 0- 15.4%] [P < 0.001]. Adverse events were observed in group A only and were minor. Conclusions: Sustained-release amitriptyline may be beneficial in the treatment of some FS patients.