Anticonvulsants for fibromyalgia

Cochrane Database of Systematic Reviews

Volumn 2013, Issue 10, 2013, Pages

  Üçeyler, Nurcan ^a   Sommer, Claudia ^a   Walitt, Brian ^b   Häuser, Winfried ^c  

^a UNIVERSITY OF WÜRZBURG   (Germany)

^b GEORGETOWN UNIVERSITY MEDICAL CENTER   (United States)

^c TECHNICAL UNIVERSITY OF MUNICH   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

ANTICONVULSIVE AGENT; GABAPENTIN; LACOSAMIDE; LEVETIRACETAM; PLACEBO; PREGABALIN; 4 AMINOBUTYRIC ACID; ACETAMIDE DERIVATIVE; AMINE; CYCLOHEXANECARBOXYLIC ACID DERIVATIVE; ETIRACETAM; HARKOSERIDE; PIRACETAM;

ANALGESIC ACTIVITY; ANGIONEUROTIC EDEMA; ANXIETY DISORDER; BECK ANXIETY INVENTORY; BLURRED VISION; CLINICAL PRACTICE; CLINICAL PROTOCOL; COORDINATION DISORDER; DEPRESSION; DISEASE SEVERITY; DIZZINESS; DOSE RESPONSE; DROWSINESS; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FATIGUE; FATIGUE SEVERITY SCALE; FIBROMYALGIA; HEALTH CARE QUALITY; HUMAN; LEG SWELLING; MENTAL STRESS; MONTGOMERY ASBERG DEPRESSION RATING SCALE; OUTCOME ASSESSMENT; PAIN; PRIORITY JOURNAL; QUALITY OF LIFE; REVIEW; SHORT FORM 36; SKIN SWELLING; SLEEP DISORDER; STATE TRAIT ANXIETY INVENTORY; SYSTEMATIC REVIEW; VISUAL ANALOG SCALE; ANALOGS AND DERIVATIVES; META ANALYSIS;

ACETAMIDES; AMINES; ANTICONVULSANTS; CYCLOHEXANECARBOXYLIC ACIDS; FIBROMYALGIA; GAMMA-AMINOBUTYRIC ACID; HUMANS; PIRACETAM;

EID: 84888382223     PISSN: None     EISSN: 1469493X     Source Type: Journal    
DOI: 10.1002/14651858.CD010782     Document Type: Review

References (89)

1. Arnold LM, Goldenberg DL, Stanford SB, Lalonde JK, Sandhu HS, Keck PE Jr, et al.Gabapentin in the treatment of fibromyalgia: a randomized, double-blind, placebo-controlled, multicenter trial. Arthritis and Rheumatism 2007;56(4):1336-44.
2. Arnold LM, Russell IJ, Diri EW, Duan WR, Young JP Jr, Sharma U, et al.A 14-week, randomized, double-blinded, placebo-controlled monotherapy trial of pregabalin in patients with fibromyalgia. Pain 2008;9(9):792-805.
3. Crofford LJ, Rowbotham MC, Mease PJ, Russell IJ, Dworkin RH, Corbin AE, et al.Pregabalin 1008-105 Study Group. Pregabalin for the treatment of fibromyalgia syndrome: results of a randomized, double-blind, placebo-controlled trial. Arthritis and Rheumatism 2005;52(4):264-73.
4. Mease PJ, Russell IJ, Arnold LM, Florian H, Young JP Jr, Martin SA, et al.A randomized, double-blind, placebo-controlled, phase III trial of pregabalin in the treatment of patients with fibromyalgia. Journal of Rheumatology 2008;35(3):502-14.
5. Ohta H, Oka H, Usui C, Ohkura M, Suzuki M, Nishioka K. A randomized, double-blind, multicenter, placebo-controlled phase III trial to evaluate the efficacy and safety of pregabalin in Japanese patients with fibromyalgia. Arthritis Research and Therapy 2012;14:R217.
6. Pauer L, Winkelmann A, Arsenault P, Jespersen A, Whelan L, Atkinson G, et al.A0081100 Investigators. An international, randomized, double-blind, placebo-controlled, phase III trial of pregabalin monotherapy in treatment of patients with fibromyalgia. Journal of Rheumatology 2011;38(12):2643-52.
7. Rowbotham M. Levetiracetam for treatment of pain associated with fibromyalgia. First received on 15 November 2005; last updated on 12 April 2011. www.clinicaltrials.gov/ct2/show/NCT00254657 (accessed 4 October 2013).
8. UCB. Assessing efficacy and safety of lacosamide compared to placebo in reducing signs and symptoms of fibromyalgia syndrome. First received on 9 November 2006; last updated 30 August 2011. clinicaltrials.gov/ct2/show/NCT00401830 (accessed 4 October 2013).
9. Crofford LJ, Mease PJ, Simpson SL, Young JP Jr, 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(3):419-31.
10. Roth T, Lankford DA, Bhadra P, Whalen E, Resnick EM. Effect of pregabalin on sleep in patients with fibromyalgia and sleep maintenance disturbance: a randomized, placebo-controlled, 2-way crossover polysomnography study. Arthritis Care and Research (Hoboken) 2012;64:597-606.
11. Arnold LM, Leon T, Whalen E, Barrett J. Relationships among pain and depressive and anxiety symptoms in clinical trials of pregabalin in fibromyalgia. Psychosomatics 2010;51:489-57.
12. Arnold LM, Emir B, Murphy TK, Zeiher BG, Pauer L, Scott G, et al.Safety profile and tolerability of up to 1 year of pregabalin treatment in 3 open-label extension studies in patients with fibromyalgia. Clinical Therapeutics 2012;34:1092-102.
13. Attal N, Cruccu G, Baron R, Haanpää M, Hansson P, Jensen TS, et al.European Federation of Neurological Societies. EFNS guidelines on the pharmacological treatment of neuropathic pain: 2010 revision. European Journal of Neurology 2010;17:1117-e88.
14. Begg CB, Mazumdar M. Operating characteristics of a rank correlation test for publication bias. Biometrics 1994;50(4):1088-101.
15. Bennett RM, Jones J, Turk DC, Russell IJ, Matallana L. An internet survey of 2, 596 people with fibromyalgia. BMC Musculoskeletal Disorders 2007;8:27.
16. Bernardy K, Füber N, Köllner V, Häuser W. Efficacy of cognitive-behavioral therapies in fibromyalgia syndrome - a systematic review and metaanalysis of randomized controlled trials. Journal of Rheumatology 2010;37(10):1991-2005.
17. Bernardy K, Klose P, Busch AJ, Choy EHS, Häuser W. Cognitive behavioural therapies for fibromyalgia. Cochrane Database of Systematic Reviews 2013, Issue 9. [DOI: 10.1002/14651858.CD009796]
18. Beydoun A, D'Souza J, Hebert D, Doty P. Lacosamide: pharmacology, mechanisms of action and pooled efficacy and safety data in partial-onset seizures. Expert Review of Neurotherapeutics 2009;9(1):33-42.
19. Birse F, Derry S, Moore RA. Phenytoin for neuropathic pain and fibromyalgia in adults. Cochrane Database of Systematic Reviews 2012, Issue 5. [DOI: 10.1002/14651858.CD009485.pub2]
20. Bockbrader HN, Wesche D, Miller R, Chapel S, Janiczek N, Burger P. A comparison of the pharmacokinetics and pharmacodynamics of pregabalin and gabapentin. Clinical Pharmacokinetics 2010;49:661-9.
21. Boomershine CS. Pregabalin for the management of fibromyalgia syndrome. Journal of Pain Research 2010;22:81-8.
22. Bradley LA. Pathophysiology of fibromyalgia. American Journal of Medicine 2009;122:S22-S30.
23. Branco JC, Bannwarth B, Failde I, Abello Carbonell J, Blotman F, Spaeth M, et al.Prevalence of fibromyalgia: a survey in five European countries. Seminars in Arthritis and Rheumatism 2010;39(6):448-53.
24. Briley M. Drugs to treat fibromyalgia - the transatlantic difference. Current Opinion in Investigational Drugs 2010;11(1):16-8.
25. Buskila D. Developments in the scientific and clinical understanding of fibromyalgia. Arthritis Research Therapy 2009;11:242.
26. Centers for Disease Control and Prevention, 2012. Fibromyalgia. www.cdc.gov/arthritis/basics/fibromyalgia.htm (accessed 4 October 2013).
27. Cohen J. Statistical Power Analysis for the Behavioral Sciences. Hillsdale: Lawrence Erlbaum Associates, 1988.
28. Corrigan R, Derry S, Wiffen PJ, Moore RA. Clonazepam for neuropathic pain and fibromyalgia in adults. Cochrane Database of Systematic Reviews 2012, Issue 5. [DOI: 10.1002/14651858.CD009486.pub2]
29. Deare JC, Zheng Z, Xue CCL, Liu JP, Shang J, Scott SW, et al.Acupuncture for treating fibromyalgia. Cochrane Database of Systematic Reviews 2013, Issue 5. [DOI: 10.1002/14651858.CD007070.pub2]
30. Derry S, Gill D, Phillips T, Moore RA. Milnacipran for neuropathic pain and fibromyalgia in adults. Cochrane Database of Systematic Reviews 2012, Issue 3. [DOI: 10.1002/14651858.CD008244.pub2]
31. Dooley DJ, Taylor CP, Donevan S, Feltner D. Ca2+ channel alpha2delta ligands: novel modulators of neurotransmission. Trends in Pharmacological Sciences 2007;28(2):151.
32. Dworkin RH, Turk DC, McDermott MP, Peirce-Sandner S, Burke LB, Cowan P, et al.Interpreting the clinical importance of group differences in chronic pain clinical trials: IMMPACT recommendations. Pain 2009;146(3):238-44.
33. Eccleston C, Palermo TM, Williams ACDC, Lewandowski A, Morley S, Fisher E, et al.Psychological therapies for the management of chronic and recurrent pain in children and adolescents. Cochrane Database of Systematic Reviews 2012, Issue 12. [DOI: 10.1002/14651858.CD003968]
34. Egger M, Smith GD, Schneider M, Minder C. Bias in meta-analysis detected by a simple, graphical test. BMJ 1997;315:629-34.
35. Eich W, Häuser W, Arnold B, Bernardy K, Brückle W, Eidmann U, et al.Fibromyalgia syndrome: general principles and coordination of clinical care and patient education. Schmerz 2012;26:268-75.
36. Eich W, Häuser W, Arnold B, Jäckel W, Offenbächer M, Petzke F, et al.Fibromyalgia syndrome: definition, classification, clinical diagnosis and prognosis. Schmerz 2012;26:247-58.
37. European Medicines Agency. Refusal assessment report for Lyrica, 2009. www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Assessment_Report_-_Variation/human/000546/WC500076177.pdf (accessed 5 October 2013).
38. FDA. FDA approves first drug for treating fibromyalgia, 2007. www.fda.gov/newsevents/newsroom/pressAnnouncements/2007/ucm108936.htm (accessed 4 October 2013).
39. Fitzcharles MA, Ste-Marie PA, Goldenberg DL, Pereira JX, Abbey S, Choinière M, et al.Canadian Pain Society and Canadian Rheumatology Association recommendations for rational care of persons with fibromyalgia. A summary report. Journal of Rheumatology 2013;40:1388-93.
40. Furukawa TA, Cipriani A, Barbui C, Brambilla P, Watanabe N. Imputing response rates from means and standard deviations in meta-analyses. International Clinical Psychopharmacology 2005;20:49-52.
41. Furukawa TA, Barbui C, Cipriani A, Brambilla P, Watanabe N. Imputing missing standard deviations in meta-analyses can provide accurate results. Journal of Clinical Epidemiology 2006;59:7-10.
42. Gahr M, Freudenmann RW, Hiemke C, Kölle MA, Schönfeldt-Lecuona C. Pregabalin abuse and dependence in Germany: results from a database query. European Journal of Clinical Pharmacology 2013;69(6):1335-42.
43. Gracely RH, Ambrose KR. Neuroimaging of fibromyalgia. Best Practice and Research Clinical Rheumatology 2011;25(2):271-84.
44. Guyatt G, Oxman AD, Akl EA, Kunz R, Vist G, Brozek J, et al.GRADE guidelines: 1. Introduction-GRADE evidence profiles and summary of findings tables. Journal of Clinical Epidemiology 2011;64(4):383-94.
45. Hearn L, Derry S, Moore RA. Lacosamide for neuropathic pain and fibromyalgia in adults. Cochrane Database of Systematic Reviews 2012, Issue 2. [DOI: 10.1002/14651858.CD009318.pub2]
46. Higgins JPT, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta-analyses. BMJ 2003;327(7414):557-60.
47. Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. Available from www.cochrane-handbook.org.
48. Häuser W, Zimmer C, Felde E, Köllner V. What are the key symptoms of fibromyalgia? Results of a survey of the German Fibromyalgia Association [Was sind die Kernsymptome des Fibromyalgiesyndroms? Umfrageergebnisse der Deutschen Fibromyalgievereinigung]. Schmerz 2008;22(2):176-83.
49. Häuser W, Hayo S, Biewer W, Gesmann M, Kühn-Becker H, Petzke F, et al.Diagnosis of fibromyalgia syndrome - a comparison of Association of the Medical Scientific Societies in Germany, survey, and American College of Rheumatology criteria. Clinical Journal of Pain 2010;26:505-11.
50. Häuser W, Klose P, Langhorst J, Moradi B, Steinbach M, Schiltenwolf M, et al.Efficacy of different types of aerobic exercise in fibromyalgia syndrome: a systematic review and meta-analysis of randomised controlled trials. Arthritis Research Therapy 2010;12:R79.
51. Häuser W, Kosseva M, Uceyler N, Klose P, Sommer C. Emotional, physical and sexual abuse in fibromyalgia syndrome - a systematic review with meta-analysis. Arthritis Care and Research (Hoboken) 2011;63(8):808-20.
52. Häuser W, Jung E, Erbslöh-Möller B, Gesmann M, Kühn-Becker H, Petermann F, et al.German fibromyalgia consumer reports. Benefits and harms of fibromyalgia syndrome therapies [in German]. Schmerz 2012;26:150-9.
53. Häuser W, Sarzi-Puttini P, Tölle TR, Wolfe F. Placebo and nocebo responses in randomised controlled trials of drugs applying for approval for fibromyalgia syndrome treatment: systematic review and meta-analysis. Clinical and Experimental Rheumatology 2012;30(6 Suppl 74):78-87.
54. Häuser W, Urrútia G, Tort S, Üçeyler N, Walitt B. Serotonin and noradrenaline reuptake inhibitors (SNRIs) for fibromyalgia syndrome. Cochrane Database of Systematic Reviews 2013, Issue 1. [DOI: 10.1002/14651858.CD010292]
55. Lange M, Petermann F. Influence of depression on fibromyalgia: a systematic review. Schmerz 2010;24:326-33.
56. Lawrence RC, Felson DT, Helmick CG, Arnold LM, Choi H, Deyo RA, et al.Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part II. Arthritis and Rheumatism 2008;58(1):26-35.
57. Marschall U, Arnold B, Häuser W. Treatment and healthcare costs of fibromyalgia syndrome in Germany: analysis of the data of the Barmer health insurance (BEK) from 2008-2009 [Behandlung und Krankheitskosten des Fibromyalgie Syndroms in Deutschland]. Schmerz 2011;25(4):402-10.
58. Mease P, Arnold LM, Choy EH, Clauw DJ, Crofford LJ, Glass JM, et al: OMERACT Fibromyalgia Working Group. Fibromyalgia syndrome module at OMERACT 9: domain construct. Journal of Rheumatology 2009;36(10):2318-29.
59. Moore RA, Straube S, Wiffen PJ, Derry S, McQuay HJ. Pregabalin for acute and chronic pain in adults. Cochrane Database of Systematic Reviews 2009, Issue 3. [DOI: 10.1002/14651858.CD007076.pub2]
60. Moore AR, Eccleston C, Derry S, Wiffen P, Bell RF, Straube S. "Evidence" in chronic pain - establishing best practice in the reporting of systematic reviews. Pain 2010;150(3):386-9.
61. Moore RA, Derry S, McQuay HJ, Straube S, Aldington D, Wiffen P, et al.Clinical effectiveness: an approach to clinical trial design more relevant to clinical practice, acknowledging the importance of individual differences. Pain 2010;149(2):173-6.
62. Moore RA, Wiffen PJ, Derry S, McQuay HJ. Gabapentin for chronic neuropathic pain and fibromyalgia in adults. Cochrane Database of Systematic Reviews 2011, Issue 3. [DOI: 10.1002/14651858.CD007938.pub2]
63. Moore RA, Derry S, Aldington D, Cole P, Wiffen PJ. Amitriptyline for neuropathic pain and fibromyalgia in adults. Cochrane Database of Systematic Reviews 2012, Issue 12. [DOI: 10.1002/14651858.CD008242.pub2]
64. Moore RA, Straube S, Eccleston C, Derry S, Aldington D, Wiffen P, et al.Estimate at your peril: imputation methods for patient withdrawal can bias efficacy outcomes in chronic pain trials using responder analyses. Pain 2012;153:265-8.
65. Mutschler J, Grosshans M, Herwig U, Heekeren K, Kawohl W, Brühl A. Pregabalin-induced suicidal ideations. Pharmacopsychiatry 2011;44:119.
66. Nishishinya MB, Walitt B, Urrútia G, Mease P, Rodríguez A, Lizardo RJR, et al.Anti-depressants and centrally active agents for fibromyalgia syndrome. Cochrane Database of Systematic Reviews 2006, Issue 4. [DOI: 10.1002/14651858.CD006192]
67. Norman GR, Sridhar FG, Guyatt GH, Walter SD. Relation of distribution- and anchor-based approaches in interpretation of changes in health-related quality of life. Medical Care 2001;39(10):1039-47.
68. Olaizola I, Ellger T, Young P, Bösebeck F, Evers S, Kellinghaus C. Pregabalin-associated acute psychosis and epileptiform EEG-changes. Seizure 2006;15:208-10.
69. Page RL 2nd, Cantu M, Lindenfeld J, Hergott LJ, Lowes BD. Possible heart failure exacerbation associated with pregabalin: case discussion and literature review. Journal of Cardiovascular Medicine (Hagerstown) 2008;9:922-5.
70. Phillips K, Clauw DJ. Central pain mechanisms in chronic pain states - maybe it is all in their head. Best Practice and Research Clinical Rheumatology 2011;25:141-54.
71. Nordic Cochrane Centre, The Cochrane Collaboration. Review Manager (RevMan). 5.2. Copenhagen: Nordic Cochrane Centre, The Cochrane Collaboration, 2012.
72. Routman JS, Willig JH, Westfall AO, Abroms SR, Varshney M, Adusumilli S. Comparative efficacy versus effectiveness of initial antiretroviral therapy in clinical trials versus routine care. Clinical Infectious Diseases 2010;15(4):574-84.
73. Seidel S, Aigner M, Ossege M, Pernicka E, Wildner B, Sycha T. Antipsychotics for acute and chronic pain in adults. Cochrane Database of Systematic Reviews 2013, Issue 8. [DOI: 10.1002/14651858.CD004844.pub3]
74. Sommer C, Häuser W, Burgmer M, Engelhardt R, Gerhold K, Petzke F, et al.Etiology and pathophysiology of fibromyalgia syndrome. Schmerz 2012;26:259-67.
75. Straube S, Derry S, Moore RA, McQuay HJ. Pregabalin in fibromyalgia: meta-analysis of efficacy and safety from company clinical trial reports. Rheumatology 2010;49:706-15.
76. Tort S, Urrútia G, Nishishinya MB, Walitt B. Monoamine oxidase inhibitors (MAOIs) for fibromyalgia syndrome. Cochrane Database of Systematic Reviews 2012, Issue 4. [DOI: 10.1002/14651858.CD009807]
77. Tzellos TG, Toulis KA, Goulis DG, Papazisis G, Zampeli VA, Vakfari A, et al.Gabapentin and pregabalin in the treatment of fibromyalgia: a systematic review and a meta-analysis. Journal of Clinical Pharmacology and Therapeutics 2010;35:639-56.
78. Ulloa CM, Towfigh A, Safdieh J. Review of levetiracetam, with a focus on the extended release formulation, as adjuvant therapy in controlling partial-onset seizures. Neuropsychiatric Disease and Treatment 2009;5:467-76.
79. Wiffen PJ, Derry S, Moore R, Aldington D, Cole P, Rice ASC, et al.Antiepileptic drugs for neuropathic pain and fibromyalgia. Cochrane Database of Systematic Reviews 2013, Issue 6. [DOI: 10.1002/14651858.CD010567]
80. Wiffen PJ, Derry S, Lunn MPT, Moore RA. Topiramate for neuropathic pain and fibromyalgia in adults. Cochrane Database of Systematic Reviews 2013, Issue 8. [DOI: 10.1002/14651858.CD008314.pub3]
81. Winkelmann A, Perrot S, Schaefer C, Ryan K, Chandran A, Sadosky A, et al.Impact of fibromyalgia severity on health economic costs: results from a European cross-sectional study. Applied Health Economics and Health Policy 2011;9(2):125-36.
82. 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 and Rheumatism 1990;33(12):1863-4.
83. Wolfe F, Anderson J, Harkness D, Bennett RM, Caro XJ, Goldenberg DL, et al.A prospective, longitudinal, multicenter study of service utilization and costs in fibromyalgia. Arthritis and Rheumatism 1997;40(9):1553-5.
84. Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Katz RS, Mease P, et al.The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis and Rheumatism 2010;62(5):600-10.
85. Wolfe F, Häuser W, Hassett AL, Katz RS, Walitt BT. The development of fibromyalgia - I: examination of rates and predictors in patients with rheumatoid arthritis (RA). Pain 2011;152(2):291-9.
86. Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Häuser W, Katz RS, et al.Fibromyalgia criteria and severity scales for clinical and epidemiological studies: a modification of the ACR Preliminary Diagnostic Criteria for Fibromyalgia. Journal of Rheumatology 2011;38(6):1113-22.
87. Wolfe F, Brähler E, Hinz A, Häuser W. Fibromyalgia prevalence, somatic symptom reporting, and the dimensionality of polysymptomatic distress: results from a survey of the general population. Arthritis Care and Research (Hoboken) 2013;65:777-85.
88. Wolfe F, Walitt BT, Katz RS, Lee YC, Michaud KD, Häuser W. Longitudinal patterns of analgesic and central acting drug use and associated effectiveness in fibromyalgia. European Journal Pain 2013;17:581-6.
89. Üçeyler N, Zeller D, Kahn AK, Kewenig S, Kittel-Schneider S, Schmid A, et al.Small fibre pathology in patients with fibromyalgia syndrome. Brain 2013;136:1857-67.