Efficacy of tramadol in treatment of pain in fibromyalgia

J. Russell, M. Kamin, R. M. Bennett, T. J. Schnitzer, J. A. Green, W. A. Katz

    Research output: Contribution to journalArticle

    159 Scopus citations

    Abstract

    An outpatient, randomized, double-blind, placebo-controlled clinical trial was conducted to evaluate the efficacy and safety of tramadol in the treatment of the pain of fibromyalgia syndrome. One hundred patients with fibromyalgia syndrome, (1990 American College of Rheumatology criteria), were enrolled into an open-label phase and treated with tramadol 50-400 mg/day. Patients who tolerated tramadol and perceived benefit were randomized to treatment with tramadol or placebo in the double-blind phase. The primary efficacy outcome measurement was the time (days) to exit from the double-blind phase because of inadequate pain relief, which was reported as the cumulative probability of discontinuing treatment because of inadequate pain relief. One hundred patients entered the open-label phase; 69% tolerated and achieved benefit with tramadol. These patients were then randomized to continue tramadol (n = 35) or convert to a placebo (n = 34) during a 6-week, double-blind treatment period. The Kaplan-Meier estimate of cumulative probability of discontinuing the double blind period because of inadequate pain relief was significantly lower in the tramadol group compared with the placebo group (p = 0.001). Twenty (57.1%) patients in the tramadol group successfully completed the entire double-blind phase compared with nine (27%) in the placebo group (p = .015). These results support the efficacy of tramadol over a period of 6 weeks in a double blind study for the treatment of the pain of fibromyalgia in a group of patients who had been determined to tolerate it and perceive a benefit.

    Original languageEnglish (US)
    Pages (from-to)250-257
    Number of pages8
    JournalJournal of Clinical Rheumatology
    Volume6
    Issue number5
    DOIs
    StatePublished - Jan 1 2000

      Fingerprint

    Keywords

    • Clinical trial
    • Fibromyalgia syndrome
    • Tramadol

    ASJC Scopus subject areas

    • Rheumatology

    Cite this

    Russell, J., Kamin, M., Bennett, R. M., Schnitzer, T. J., Green, J. A., & Katz, W. A. (2000). Efficacy of tramadol in treatment of pain in fibromyalgia. Journal of Clinical Rheumatology, 6(5), 250-257. https://doi.org/10.1097/00124743-200010000-00004