A randomized, controlled trial of amitriptyline and naproxen in the treatment of patients with fibromyalgia

Authors

  • Don L. Goldenberg MD,

    Associate Professor of Medicine, Corresponding author
    1. Multipurpose Arthritis Center and the Department of Medicine, Boston University School of Medicine and the Department of Medicine and Thorndike Memorial Laboratory, Boston City Hospital, Boston, Massachusetts
    • Arthritis Center, K5, Boston University School of Medicine, 71 East Concord Street, Boston, MA 02118
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  • David T. Felson Md, Mph,

    Assistant Professor of Medicine
    1. Multipurpose Arthritis Center and the Department of Medicine, Boston University School of Medicine and the Department of Medicine and Thorndike Memorial Laboratory, Boston City Hospital, Boston, Massachusetts
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  • Hal Dinerman MD

    Arthritis Fellow
    1. Multipurpose Arthritis Center and the Department of Medicine, Boston University School of Medicine and the Department of Medicine and Thorndike Memorial Laboratory, Boston City Hospital, Boston, Massachusetts
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Abstract

Sixty-two patients with fibromyalgia were randomly assigned to receive 25 mg of amitriptyline at night, 500 mg of naproxen twice daily, both amitriptyline and naproxen, or placebo in a 6-week, double-blind trial. Amitriptyline was associated with significant improvement in all outcome parameters, including patient and physician global assessments, patient pain, sleep difficulties, fatigue on awakening, and tender point score. Patients taking the combined naproxen—amitriptyline regimen experienced minor, but not significant, improvement in pain when compared with patients who took amitriptyline alone. Amitriptyline, or amitriptyline and naproxen, is an effective therapeutic regimen for patients with fibromyalgia.

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