Pragmatic consideration of recent randomized, placebo-controlled clinical trials for treatment of fibromyalgia

Article

Abstract

A flurry of recent randomized, placebo-controlled trials assessing dissimilar pharmacotherapeutic treatment options for fibromyalgia (FM) have been presented in the past few years. This review evaluates these trials in light of recent pathophysiological concepts germane to FM, including mood disorders, autonomic dysregulation, altered sleep stage architecture, and the diagnostic tender point controversy. Studies with gabapentin, pregabalin, duloxetine, milnacipran, sodium oxybate, and pramipexole for treatment of FM are discussed.

Keywords

Gabapentin Pregabalin Duloxetine Pramipexole Ropinirole 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

References and Recommended Reading

  1. 1.
    Inanici F, Yunus MB: History of fibromyalgia: past to present. Curr Pain Headache Rep 2004, 8:369–378.PubMedCrossRefGoogle Scholar
  2. 2.
    Gowers WR: Lumbago: its lessons and analogues. BMJ 1904, i:117–121.CrossRefGoogle Scholar
  3. 3.
    Yunus MB: Primary fibromyalgia syndrome: current concepts. Compr Ther 1984, 10:21–28.PubMedGoogle Scholar
  4. 4.
    Wolfe F, Smythe HA, Yunus MB, et al.: The American College of Rheumatology 1990 criteria for the classification of fibromyalgia: report of the multicenter criteria committee. Arthritis Rheum 1990, 33:160–172.PubMedCrossRefGoogle Scholar
  5. 5.
    Harth M, Nielson WR: The fibromyalgia tender points: use them or lose them? A brief review of the controversy. J Rheumatol 2007, 34:914–922.PubMedGoogle Scholar
  6. 6.
    Fietta P, Fietta P, Manganelli P: Fibromyalgia and psychiatric disorders. Acta Biomed 2007, 78:88–95.PubMedGoogle Scholar
  7. 7.
    Carta MG, Cardia C, Mannu F, et al.: The high frequency of manic symptoms in fibromyalgia does influence the choice of treatment? Clin Pract Epidemol Ment Health 2006, 2:36.PubMedCrossRefGoogle Scholar
  8. 8.
    Cohen H, Neumann L, Haiman Y, et al.: Prevalence of post-traumatic stress disorder in fibromyalgia patients: overlapping syndromes or post-traumatic fibromyalgia syndrome? Semin Arthritis Rheum 2002, 32:38–50.PubMedCrossRefGoogle Scholar
  9. 9.
    Moldofsky H, Scarisbrick P: Induction of neurasthenic musculoskeletal pain syndrome by selective sleep stage deprivation. Psychosom Med 1976, 38:35–44.PubMedGoogle Scholar
  10. 10.
    Lentz MJ, Landis CA, Rothermel J, Shaver JL: Effects of selective slow wave sleep disruption on musculoskeletal pain and fatigue in middle aged women. J Rheumatol 1999, 26:1586–1592.PubMedGoogle Scholar
  11. 11.
    Harding SM: Sleep in fibromyalgia patients: subjective and objective findings. Am J Med Sci 1998, 315:367–376.PubMedCrossRefGoogle Scholar
  12. 12.
    Martinez-Lavin M, Hermosillo AG, Rosas M, Soto M: Circadian studies of autonomic nervous balance in patients with fibromyalgia: a heart variability analysis. Arthritis Rheum 1998, 41:1966–1971.PubMedCrossRefGoogle Scholar
  13. 13.
    Rosner I, Rozenbaum M, Naschitz JE, et al.: Dysautonomia in chronic fatigue syndrome vs. fibromyalgia. Isr Med Assoc J 2000, 2(Suppl):23–24.PubMedGoogle Scholar
  14. 14.
    Cohen H, Neumann L, Shore M, et al.: Abnormal sympathovagal balance in men with fibromyalgia. J Rheumatol 2001, 28:581–589.PubMedGoogle Scholar
  15. 15.
    Raj SR, Brouillard D, Simpson CS, et al.: Dysautonomia among patients with fibromyalgia: a noninvasive assessment. J Rheumatol 2000, 27:2660–2665.PubMedGoogle Scholar
  16. 16.
    Vaeroy H, Qiao ZG, Morkrid L, Forre O: Altered sympathetic nervous system response in patients with fibromyalgia (fibrositis syndrome). J Rheumatol 1998, 16:1460–1465.Google Scholar
  17. 17.
    Endresen GK: Fibromyalgia: a rheumatologic diagnosis? Rheumatol Int 2007, 27:999–1004.PubMedCrossRefGoogle Scholar
  18. 18.
    Holman AJ: Positional cervical spinal cord compression and fibromyalgia: a novel comorbidity with important diagnostic and treatment implications. J Pain 2008, 9:613–622.PubMedCrossRefGoogle Scholar
  19. 19.
    Baillie JK, Power I: The mechanism of action of gabapentin in neuropathic pain. Curr Opin Investig Drugs 2006, 7:33–39.PubMedGoogle Scholar
  20. 20.
    Arnold LM, Goldenberg DL, Stanford SB, et al.: Gabapentin in the treatment of fibromyalgia: a randomized, double-blind, placebo-controlled, multicenter trial. Arthritis Rheum 2007, 56:1336–1344.PubMedCrossRefGoogle Scholar
  21. 21.
    Crofford LJ, Rowbotham MC, Mease PJ, et al.: Pregabalin for the treatment of fibromyalgia syndrome: results of a randomized, double-blind, placebo-controlled trial. Arthritis Rheum 2005, 52:1264–1273.PubMedCrossRefGoogle Scholar
  22. 22.
    Mease PJ, Russell IJ, Arnold LM, et al.: A randomized, double-blind, placebo-controlled, phase III trial of pregabalin in the treatment of patients with fibromyalgia. J Rheumatol 2008, 35:502–514.PubMedGoogle Scholar
  23. 23.
    Arnold LM, Lu Y, Crofford LJ, et al.: A double-blind multicenter trial comparing duloxetine to placebo in the treatment of fibromyalgia with and without major depressive disorder. Arthritis Rheum 2004, 50:2974–2984.PubMedCrossRefGoogle Scholar
  24. 24.
    Iyengar S, Ahmad L, Simmons RM: Efficacy of the selective serotonin and norepinephrine reuptake inhibitor duloxetine in the formalin model of persistent pain. Biol Psychiatry 2002, 51(Suppl 8):75S–76S.Google Scholar
  25. 25.
    Millian MJ: Descending control of pain. Prog Neurobiol 2002, 66:355–474.CrossRefGoogle Scholar
  26. 26.
    Arnold LM, Rosen A, Pritchett YL, et al.: A randomized, double-blind, placebo-controlled trial of duloxetine in the treatment of women with fibromyalgia with and without major depressive disorder. Pain 2005, 119:5–15.PubMedCrossRefGoogle Scholar
  27. 27.
    Russell IJ, Mease PJ, Smith TR, et al.: Efficacy and safety of duloxetine for treatment of fibromyalgia in patients with and without major depressive disorder: results from a 6-month, randomized, double-blind, placebo-controlled, fixed-dose trial. Pain 2008, 136:432–444.PubMedCrossRefGoogle Scholar
  28. 28.
    Chappell A, Bradley L, Wiltse C, et al.: Duloxetine 60–120 mg versus placebo in the treatment of fibromyalgia syndrome [abstract]. Arthritis Rheum 2007, 56:S609.Google Scholar
  29. 29.
    Chappell AS, Littlejohn G, Kajdasz D, et al.: A 1-year safety and efficacy study of duloxetine in patients with fibromyalgia [abstract THU0370]. Presented at the European League Against Rheumatism: Annual European Congress of Rheumatology. Paris, France; 2008.Google Scholar
  30. 30.
    Mease P, Russell IJ, Kajdasz D, et al.: Long-term safety, tolerability, and effectiveness of duloxetine in treatment of fibromyalgia [abstract THU0401]. Presented at the European League Against Rheumatism: Annual European Congress of Rheumatology. Paris, France; 2008.Google Scholar
  31. 31.
    Anonymous: Cymbalta (duloxetine HC1): concomitant opioid analgesic use. Eli Lilly & Co., Inc. Indianapolis, IN. 2008.Google Scholar
  32. 32.
    Eli Lilly & Co., Inc.: Cymbata (duloxetine) package insert. Available at http://pi.lilly.com/us/cymbalta-pi.pdf. Accessed June 2008.
  33. 33.
    Gendreau RM, Thorn MD, Gendreau JF, et al.: Efficacy of milnacipran in patients with fibromyalgia. J Rheumatol 2005, 32:1975–1985.PubMedGoogle Scholar
  34. 34.
    Mease P, Clauw DJ, Palmer RH, et al.: Milnacipran efficacy and safety in the treatment of fibromyalgia syndrome [abstract THU0379]. Presented at the European League Against Rheumatism: Annual European Congress of Rheumatology. Paris, France; 2008.Google Scholar
  35. 35.
    Clauw DJ, Mease P, Palmer RH, et al.: Milnacipran for the treatment of fibromyalgia syndrome: a 15-week, randomized, double-blind, placebo-controlled trial [abstract THU0366]. Presented at the European League Against Rheumatism: Annual European Congress of Rheumatology. Paris, France; 2008.Google Scholar
  36. 36.
    Branco JC, Perrot S, Bragee G, et al.: Milnacipran for the treatment of fibromyalgia syndrome: a European multi-center, randomized, double-blind, placebo-controlled trial [abstract THU0365]. Presented at the European League Against Rheumatism: Annual European Congress of Rheumatology. Paris, France; 2008.Google Scholar
  37. 37.
    Scharf MB, Hauck M, Stover R, et al.: Effect of gamma-hydroxybutyrate on pain, fatigue, and the alpha sleep anomaly in patients with fibromyalgia: preliminary report. J Rheumatol 1998, 25:1986–1990.PubMedGoogle Scholar
  38. 38.
    Scharf MB, Baumann M, Berkowitz DV: The effects of sodium oxybate on clinical symptoms and sleep patterns in patients with fibromyalgia. J Rheumatol 2003, 30:1070–1074.PubMedGoogle Scholar
  39. 39.
    Russell IJ, Bennett RM, Michalek JE: Sodium oxybate relieves pain and improves sleep in fibromyalgia syndrome [FMS]: a randomized, double-blind, placebo-controlled, multi-center clinical trial [abstract]. Arthritis Rheum 2005, 52:L30.Google Scholar
  40. 40.
    Moldofsky H, Alvarez-Horine S: Effects of sodium oxybate on sleep physiology and sleep-related symptoms in fibromyalgia [abstract THU0381]. Presented at the European League Against Rheumatism: Annual European Congress of Rheumatology. Paris, France; 2008.Google Scholar
  41. 41.
    Russell IJ, Vaeroy H, Javors M, Nyberg F: Cerebrospinal fluid biogenic amine metabolites in fibromyalgia/fibrositis syndrome and rheumatoid arthritis. Arthritis Rheum 1992, 35:550–556.PubMedCrossRefGoogle Scholar
  42. 42.
    Wood PB, Patterson JC, Sunderland JJ, et al.: Reduced presynaptic dopamine activity in fibromyalgia syndrome demonstrated with positron emission tomography: a pilot study. Pain 2007, 8:51–58.CrossRefGoogle Scholar
  43. 43.
    Holman AJ, Myers RR: A randomized, double-blind, placebo-controlled trial of pramipexole, a dopamine agonist, in patients with fibromyalgia receiving concomitant medications. Arthritis Rheum 2005, 52:2495–2505.PubMedCrossRefGoogle Scholar
  44. 44.
    Dodd ML, Klos KJ, Bower JH, et al.: Pathological gambling caused by drugs used to treat Parkinson disease. Arch Neurol 2005, 62:1377–1381.PubMedCrossRefGoogle Scholar
  45. 45.
    Holman AJ: Pathological compulsive behavior associated with dopamine agonists used to treat fibromyalgia [abstract]. Arthritis Rheum 2008, in press.Google Scholar
  46. 46.
    Holman AJ: Treatment of fibromyalgia with the dopamine agonist ropinirole: a 14-week double-blind, pilot, randomized controlled trial with 14-week blinded extension [abstract]. Arthritis Rheum 2004, 50:S698.Google Scholar
  47. 47.
    Carville SF, Arendt-Nielsen S, Bliddal H, et al.: EULAR evidenced-based recommendations for the management of fibromyalgia syndrome. Ann Rheum Dis 2008, 67:536–541.PubMedCrossRefGoogle Scholar

Copyright information

© Current Medicine Group LLC 2008

Authors and Affiliations

  1. 1.Pacific Rheumatology ResearchRentonUSA

Personalised recommendations