PAIN
Volume 145, Issue 1 , Pages 69-81 , September 2009

Treatment of fibromyalgia syndrome with gabapentin and pregabalin – A meta-analysis of randomized controlled trials

  • Winfried Häuser

      Affiliations

    • Department of Internal Medicine I, Klinikum Saarbrücken gGmbH, Winterberg 1, D-66119 Saarbrücken, Germany
    • Department of Psychosomatic Medicine, Technische Universität München, Langerstr. 3, D-81675 München, Germany
    • Corresponding Author InformationCorresponding author. Address: Department of Psychosomatic Medicine, Technische Universität München, Langerstr. 3, D-81675 München, Germany. Tel.: +49 681 9632020; fax: +49 681 9632022.
    web address
  • ,
  • Kathrin Bernardy

      Affiliations

    • Department of Psychosomatic Medicine, MediClin Bliestal Clinics, D-66440 Blieskastel, Germany
    • Department of Anaesthesiology, Intensive Care and Pain Therapy, Saarland University Hospital, D-66421 Hamburg/Saar, Germany
  • ,
  • Nurcan Üçeyler

      Affiliations

    • Department of Neurology, University of Würzburg, Josef-Schneider-Str. 11, D-97080 Würzburg, Germany
  • ,
  • Claudia Sommer

      Affiliations

    • Department of Neurology, University of Würzburg, Josef-Schneider-Str. 11, D-97080 Würzburg, Germany

Received 21 November 2008 ,Revised 15 April 2009 ,Accepted 12 May 2009.

References 

  1. Administration UFaD. FDA approves first drug for treating fibromyalgia. Available from: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01656.html.
  2. Arnold LM, Goldenberg DL, Stanford SB, Lalonde JK, Sandhu HS, Keck PE, et al. Gabapentin in the treatment of fibromyalgia: a randomized, double-blind, placebo-controlled, multicenter trial. Arthritis Rheum. 2007;56:1336–1344
  3. Arnold LM, Russell IJ, Diri EW, Duan WR, Young JP, Sharma U, et al. A 14-week, randomized, double-blinded, placebo-controlled monotherapy trial of pregabalin in patients with fibromyalgia. J Pain. 2008;9:792–805
  4. Burckhardt CS, Goldenberg D, Crofford L, Gerwin R, Gowans S, Kackson K. APS clinical practice guideline series no. 4. Glenview: American Pain Society; 2005;
  5. Busch AJ, Barber KA, Overend TJ, Peloso PM, Schachter CL. Exercise for treating fibromyalgia syndrome. Cochrane Database Syst Rev. 2007;CD003786
  6. Carville SF, Arendt-Nielsen S, Bliddal H, Blotman F, Branco JC, Buskila D, et al. EULAR evidence-based recommendations for the management of fibromyalgia syndrome. Ann Rheum Dis. 2008;67:536–541
  7. Cohen J. Statistical power analysis for the behavioral sciences Hillsdale. OK: Lawrence Erlbaum Associates; 1988;
  8. Collaboration TC. Review Manager (RevMan). T.C. Collaboration 2008. 5.0. The Nordic Cochrane Centre. 2008.
  9. Crofford LJ, Mease PJ, Simpson SL, Young JP, Martin SA, Haig GM, et al. Fibromyalgia relapse evaluation and efficacy for durability of meaningful relief (FREEDOM): a 6-month, double-blind, placebo-controlled trial with pregabalin. Pain. 2008;136:419–431
  10. Crofford LJ, Rowbotham MC, Mease PJ, Russell IJ, Dworkin RH, Corbin AE, et al. Pregabalin for the treatment of fibromyalgia syndrome: results of a randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2005;52:1264–1273
  11. Dworkin RH, Turk DC, Wyrwich KW, Beaton D, Cleeland CS, Farrar JT, et al. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain. 2008;9:105–121
  12. Egger M, Davey Smith G, Schneider M, Minder C. Bias in meta-analysis detected by a simple, graphical test. BMJ. 1997;315:629–634
  13. Fietta P, Fietta P, Manganelli P. Fibromyalgia and psychiatric disorders. Acta Biomed. 2007;78:88–95
  14. Guyatt GH, Sackett DL, Cook DJ. Users’ guides to the medical literature. II. How to use an article about therapy or prevention. B. What were the results and will they help me in caring for my patients? Evidence-Based Medicine Working Group. JAMA. 1994;271:59–63
  15. Häuser W, Bernardy K, Offenbächer M, Arnold B, Schiltenwolf M. Efficacy of multicomponent treatment in fibromyalgia syndrome – a meta-analysis of randomized controlled clinical trials. Arthritis Rheum. 2009;61:216–224
  16. Häuser W, Bernardy K, Üçeyler N, Sommer C. Treatment of fibromyalgia syndrome with antidepressants – a meta-analysis of randomized controlled trials. JAMA. 2009;301:198–209
  17. Henningsen P, Zimmermann T, Sattel H. Medically unexplained physical symptoms, anxiety, and depression: a meta-analytic review. Psychosom Med. 2003;65:528–533
  18. Katz RS, Heard AR, Mills M, Leavitt F. The prevalence and clinical impact of reported cognitive difficulties (Fibrofog) in patients with rheumatic disease with and without fibromyalgia. J Clin Rheumatol. 2004;10:53–58
  19. Klement A, Häuser W, Brückle W, Eidmann U, Felde E, Herrmann M, et al. Principles of treatment, coordination of medical care and patient education in fibromyalgia syndrome and chronic widespread pain. Schmerz. 2008;22:283–294
  20. Knapp G, Biggerstaff BJ, Hartung J. Assessing the amount of heterogeneity in random-effects meta-analysis. Biom J. 2006;48:271–285
  21. Laird NM, Mosteller F. Some statistical methods for combining experimental results. Int J Technol Assess Health Care. 1990;6:5–30
  22. Lyseng-Williamson KA, Siddiqui MA. Pregabalin: a review of its use in fibromyalgia. Drugs. 2008;68:2205–2223
  23. Mease PJ, Arnold LM, Crofford LJ, Williams DA, Russell IJ, Humphrey L, et al. Identifying the clinical domains of fibromyalgia: contributions from clinician and patient Delphi exercises. Arthritis Rheum. 2008;59:952–960
  24. Mease PJ, Russell IJ, Arnold LM, Florian H, Young JP, Martin SA, 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
  25. Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. Ann Intern Med. 2001;134:657–662
  26. Moore RA, Gavaghan D, Tramer MR, Collins SL, McQuay HJ. Size is everything–large amounts of information are needed to overcome random effects in estimating direction and magnitude of treatment effects. Pain. 1998;78:209–216
  27. Orwin GR. A fail-safe N for effect size in meta-analysis. J Educat Statistics. 1983;8:157–159
  28. Pauer L. Pregabalin for management of fibromyalgia (FM): a 14-week, randomized, double-blind, placebo-controlled monotherapy trial (study A0081100). 2008. Available from: http://www.clinicaltrials.org.
  29. Sackett DL. Rules of evidence and clinical recommendations on the use of antithrombotic agents. Chest. 1986;89:2S–3S
  30. Staud R, Price DD. Long-term trials of pregabalin and duloxetine for fibromyalgia symptoms: How study designs can effect placebo factors. Pain. 2008;232–234
  31. Serra E. Duloxetine and pregabalin: safe and effective for the long-term treatment of fibromyalgia?. Nat Clin Pract Neurol. 2008;4:594–595
  32. Sommer C, Häuser W, Gerhold K, Joraschky P, Petzke F, Tölle T, et al. Etiology and pathophysiology of fibromyalgia syndrome and chronic widespread pain. Schmerz. 2008;22:267–282
  33. Spaeth M. Is pregabalin a safe and effective treatment for patients with fibromyalgia?. Nat Clin Pract Rheumatol. 2008;4:514–515
  34. Staud R, Price DD. Letters to the editor. Importance of measuring placebo factors in complex clinical trials. Pain. 2008;138:473–474
  35. Straube S, Derry S, McQuay HJ, Moore RA. Enriched enrollment: definition and effects of enrichment and dose in trials of pregabalin and gabapentin in neuropathic pain. A systematic review. Br J Clin Pharmacol. 2008;66:266–275
  36. Turk DC, Vierck CJ, Scarbrough E, Crofford LJ, Rudin NJ. Fibromyalgia: combining pharmacological and nonpharmacological approaches to treating the person, not just the pain. J Pain. 2008;9:99–104
  37. Üçeyler N, Häuser W, Sommer C. A systematic review on the effectiveness of treatment with antidepressants in fibromyalgia syndrome. Arthritis Rheum. 2008;59:1279–1298
  38. van Tulder M, Furlan A, Bombardier C, Bouter L. Updated method guidelines for systematic reviews in the cochrane collaboration back review group. Spine. 2003;28:1290–1299
  39. Weir PT, Harlan GA, Nkoy FL, Jones SS, Hegmann KT, Gren LH, et al. The incidence of fibromyalgia and its associated comorbidities: a population-based retrospective cohort study based on International Classification of Diseases, 9th Revision codes. J Clin Rheumatol. 2006;12:124–128
  40. Wolfe F, Smythe HA, Yunus MB, Bennett RM, Bombardier C, Goldenberg DL, 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

PII: S0304-3959(09)00277-2

doi: 10.1016/j.pain.2009.05.014

PAIN
Volume 145, Issue 1 , Pages 69-81 , September 2009