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Duloxetine for treating painful neuropathy, chronic pain or fibromyalgia

  1. Michael PT Lunn1,*,
  2. Richard AC Hughes2,
  3. Philip J Wiffen3

Editorial Group: Cochrane Neuromuscular Disease Group

Published Online: 3 JAN 2014

Assessed as up-to-date: 19 NOV 2013

DOI: 10.1002/14651858.CD007115.pub3


How to Cite

Lunn MPT, Hughes RAC, Wiffen PJ. Duloxetine for treating painful neuropathy, chronic pain or fibromyalgia. Cochrane Database of Systematic Reviews 2014, Issue 1. Art. No.: CD007115. DOI: 10.1002/14651858.CD007115.pub3.

Author Information

  1. 1

    National Hospital for Neurology and Neurosurgery, Department of Neurology and MRC Centre for Neuromuscular Diseases, London, UK

  2. 2

    National Hospital for Neurology and Neurosurgery, MRC Centre for Neuromuscular Diseases, London, UK

  3. 3

    University of Oxford, Pain Research and Nuffield Department of Clinical Neurosciences, Oxford, Oxfordshire, UK

*Michael PT Lunn, Department of Neurology and MRC Centre for Neuromuscular Diseases, National Hospital for Neurology and Neurosurgery, Queen Square, London, WC1N 3BG, UK. michael.lunn@uclh.nhs.uk.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 3 JAN 2014

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References

References to studies included in this review

  1. References to studies included in this review
  2. References to studies excluded from this review
  3. References to studies awaiting assessment
  4. References to ongoing studies
  5. Additional references
  6. References to other published versions of this review
Arnold 2004 {published data only}
Arnold 2005 {published data only}
  • Arnold LM, Rosen A, Pritchett YL, D'Souza DN, Goldstein DJ, Iyengar S, et al. A randomized double-blind, placebo-controlled trial of duloxetine in the treatment of women with fibromyalgia with or without major depressive disorder. Pain 2005;119(1-3):5-15. [PUBMED: 16298061]
Arnold 2010 {published data only}
  • Arnold LM, Clauw D, Wang F, Ahl J, Gaynor PJ, Wohlreich MM. Flexible dosed duloxetine in the treatment of fibromyalgia: a randomized double-blind placebo-controlled trial [A study comparing duloxetine and placebo in the treatment of fibromyalgia]. Journal of Rheumatology 2010;37(12):2578-86. [PUBMED: 20843911]
Arnold 2012 {published data only}
  • Arnold LM, Zhang S, Pangallo BA. Efficacy and safety of duloxetine 30 mg/d in patients with fibromyalgia: a randomized, double-blind, placebo-controlled study. Clinical Journal of Pain 2012;28(9):775-81. [PUBMED: 22971669]
Brecht 2007 {published data only}
  • Brecht S, Courtecuisse C, Debieuvre C, Croenlein J, Desaiah D, Raskin J, et al. Efficacy and safety of duloxetine 60 mg once daily in the treatment of pain in patients with major depressive disorder and at least moderate pain of unknown etiology: a randomized controlled trial. Journal of Clinical Psychiatry 2007;68(11):1707-16. [PUBMED: 18052564]
Chappell 2008 {published data only}
  • Chappell AS, Bradley LA, Wiltse C, Detke MJ, D'Souza DN, Spaeth M. A six-month double-blind, placebo-controlled, randomized clinical trial of duloxetine for the treatment of fibromyalgia. International Journal of General Medicine 2009;30(1):91-102. [PUBMED: 20428412]
Gao 2010 {published data only}
  • Gao Y, Ning G, Jia WP, Zhou ZG, Xu ZR, Liu ZM, et al. Duloxetine versus placebo in the treatment of patients with diabetic peripheral neuropathic pain in China. Chinese Medical Journal 2010;123(22):3184-92. [CTG: NCT00408993; PUBMED: 21163113]
Gaynor 2011a {published data only}
  • Gaynor PJ, Gopal M, Zheng W, Martinez JM, Robinson MJ, Hann D, Marangell LB. Duloxetine versus placebo in the treatment of major depressive disorder and associated painful physical symptoms: a replication study. Current Medical Research and Opinion 2011;27(10):1859-67. [PUBMED: 21838410]
Gaynor 2011b {published data only}
  • Gaynor PJ, Gopal M, Zheng W, Martinez JM, Robinson MJ, Marangell LB. A randomized placebo-controlled trial of duloxetine in patients with major depressive disorder and associated painful physical symptoms. Current Medical Research and Opinion 2011;27(10):1849-58. [PUBMED: 21838411]
Goldstein 2005 {published data only}
Kaur 2011 {published data only}
  • Kaur H, Hota D, Bhansali A, Dutta P, Bansal D, Chakrabarti A. A comparative evaluation of amitriptyline and duloxetine in painful diabetic neuropathy: a randomized, double-blind, cross-over clinical trial. Diabetes Care 2011;34(4):818-22. [PUBMED: 21355098]
Raskin 2005 {published data only}
Rowbotham 2012 {published data only}
  • Rowbotham MC, Arslanian A, Nothaft W, Duan WR, Best AE, Pritchett Y, et al. Efficacy and safety of the α4β2 neuronal nicotinic receptor agonist ABT-894 in patients with diabetic peripheral neuropathic pain [Safety and efficacy study in subjects with diabetic neuropathic pain]. Pain 2012;153(4):862-8. [CTG: NCT00507936; PUBMED: 22386472]
Russell 2008 {published data only}
  • Russell IJ, Mease PJ, Smith TR, Kajdasz DK, Wohlreich MM, Detke MJ, et al. Efficacy and safety of duloxetine for the treatment of fibromyalgia in patients with or without major depressive disorder: results from a 6-month randomized double-blind, placebo-controlled, fixed-dose trial. Pain 2008;136(3):432-44. [PUBMED: 18395345]
Tesfaye 2013 {published and unpublished data}
  • Tesfaye S, Wilhelm S, Lledo A, Schacht A, Tölle T, Bouhassira D, et al. Duloxetine and pregabalin: high-dose monotherapy or their combination? The “COMBO-DN study” – a multinational, randomized, double-blind, parallel-group study in patients with diabetic peripheral neuropathic pain [Use of duloxetine or pregabalin in monotherapy versus combination therapy of both drugs in patients with painful diabetic neuropathy "The COMBO - DN (COmbination vs Monotherapy of pregaBalin and dulOxetine in Diabetic Neuropathy) Study"]. Pain 2013 May 31 [Epub ahead of print]. [CTG: NCT01089556; PUBMED: 23732189]
Vranken 2011 {published data only}
  • Vranken JH, Hollmann MW, van der Vegt MH, Kruis MR, Heesen M, Vos K, et al. Duloxetine in patients with central neuropathic pain caused by spinal cord injury or stroke: a randomized, double-blind, placebo-controlled trial. Pain 2011;152(2):267-73.
Wernicke 2006 {published data only}
  • Wernicke JF, Pritchett YL, D'Souza DN, Waninger A, Tran P, Iyengar S, et al. A randomized controlled trial of duloxetine in diabetic peripheral neuropathic pain. Neurology 2006;67(8):1411-20. [PUBMED: 17060567]
Yasuda 2010 {published and unpublished data}
  • Yasuda H, Hotta N, Nakao K, Kasuga M, Kashiwagi A, Kawamori R. Superiority of duloxetine to placebo in improving painful diabetic neuropathic pain: results of a randomized controlled trial in Japan [A superiority study of LY248686 versus placebo in the treatment of patients with diabetic peripheral neuropathic pain]. Journal of Diabetes Investigation 2011;2(2):132-9.

References to studies excluded from this review

  1. References to studies included in this review
  2. References to studies excluded from this review
  3. References to studies awaiting assessment
  4. References to ongoing studies
  5. Additional references
  6. References to other published versions of this review
Boyle 2012 {published data only}
  • Boyle J, Eriksson ME, Gribble L, Gouni R, Johnsen S, Coppini DV, Kerr D. Randomized, placebo-controlled comparison of amitriptyline, duloxetine, and pregabalin in patients with chronic diabetic peripheral neuropathic pain: impact on pain, polysomnographic sleep, daytime functioning, and quality of life. [Effects of pregabalin, duloxetine & amitriptyline on pain & sleep (NCT00370656)]. Diabetes Care. 2012;35(12):2451-8. [DOI: 10.2337/dc12-0656]
Brannan 2005 {published data only}
  • Brannan SK, Mallinckrodt CH, Brown EB, Wohlreich MM, Watkin JG, Schatzberg AF. Duloxetine 60mg once daily in the treatment of painful physical symptoms in patients with major depressive disorder. Journal of Psychiatric Research 2005;39(1):43-53. [PUBMED: 15504423]
Canovas 2007 {published data only}
  • Cánovas L, Illodo G, Castro M, Mouriz L, Vázquez-Martínez A, Centeno J, et al. Effects of duloxetin and amitriptilin in neuropathic pain: study in 180 patients [Efectos de duloxetina y amitriptilina en el dolor neuropatico: estudio en 180 casos]. Revista de la Sociedad Espanola del Dolor 2007;14(8):568-73.
Chappell 2009 {published data only}
  • Chappell AS, Ossanna MJ, Liu-Seifert H, Iyengar S, Skljarevski V, Li LC, et al. Duloxetine, a centrally acting analgesic, in the treatment of patients with osteoarthritis knee pain: a 13-week, randomized, placebo-controlled trial. Pain 2009;146(3):253-60. [PUBMED: 19625125]
Chappell 2011 {published data only}
Goldstein 2004 {published data only}
  • Goldstein DJ, Lu Y, Detke MJ, Wiltse C, Mallinckrodt C, Demitrack MA. Duloxetine in the treatment of depression: a double-blind placebo-controlled comparison with paroxetine. Journal of Clinical Psychopharmacology 2004;24(4):389-99. [PUBMED: 15232330]
Harrison 2013 {published data only}
Lavoie Smith 2012 {published data only}
  • Lavoie Smith EM, Pang H, Cirrincione C, Fleishman SB, Paskett ED, Fadul CE, et al. CALGB 170601: A phase III double blind trial of duloxetine to treat painful chemotherapy-induced peripheral neuropathy (CIPN). Journal of clinical oncology 2012;Conference:32676.
NCT00125892 {published data only}
  • NCT00125892. A study of duloxetine in the treatment of fibromyalgia - [A 1-year safety study of duloxetine in patients with fibromyalgia; www.lillytrials.com/results/Cymbalta.pdf]. clinicaltrials.gov/show/NCT00125892; (Accessed 7 November 2013). [Lilly Clinical Trials Register Reference Summary #: 9075]
NCT00266643 {published data only}
  • NCT00266643. Tolerability of switching to duloxetine for the management of diabetic nerve pain (NCT00266643) [A comparison of strategies for switching patients from amitriptyline to duloxetine for the management of diabetic peripheral neuropathic pain (Lilly trial reference Summary ID# 8952).]. clinicaltrials.gov/show/NCT00266643; www.lillytrials.com/results/Cymbalta.pdf (accessed 7 November 2013). [Lilly trial reference Summary ID#: 8952]
NCT00385671 {published data only}
  • NCT00385671. An open-label comparison of duloxetine to other alternatives for the management of diabetic peripheral neuropathic pain. www.clinicaltrials.gov/show/NCT00385671 (Accessed 7 November 2013).
NCT00425230 {published data only}
  • NCT00425230. Open label study of duloxetine for the treatment of phantom limb pain [Pilot study of use of duloxetine for the treatment of phantom limb pain]. www.clinicaltrials.org/show/NCT00425230 (accessed 7 November 2013).
NCT00552682 {unpublished data only}
  • NCT00552682. Pilot, opened, randomized clinical trial to assess the efficacy of duloxetine in the treatment of fibromyalgia in patients with infection by HIV 1+. www.clinicaltrials.gov\show\NCT00552682 (Accessed 7 November).
NCT00641719 {published data only}
  • NCT00641719. A long-term study for the treatment of painful diabetic neuropathy. www.clinicaltrials.gov/show/NCT00641719 (Accessed 7 November 2013).
NCT01451606 {unpublished data only}
  • NCT01451606. Duloxetine for the treatment of chronic pelvic pain. http://clinicaltrials.gov/ct2/show/NCT01451606 (Accessed 7 November 2013). [CTG: NCT01451606]
Raskin 2005a {published data only}
  • Raskin J, Pritchett YL, Chappell AS, D-Souza DN, Wong CK, Ferdinand SJ, et al. Duloxetine in the treatment of diabetic peripheral neuropathic pain - results from three clinical trials. European Journal of Neurology 2005;12(s2):221.
Raskin 2006a {published data only}
  • Raskin J, Smith TR, Wong K, Pritchett YL, D'Souza DN, Iyengar S, et al. Duloxetine versus routine care in the long-term management of diabetic neuropathic pain. Journal of Palliative Medicine 2006;9(1):29-40. [PUBMED: 16430342]
Raskin 2006b {published data only}
Russell 2006 {published data only}
  • Russell JW. Does duloxetine safely and effectively reduce the severity of diabetic peripheral neuropathic pain?. Nature Clinical Practice Neurology 2006;2(1):18-9. [PUBMED: 16932514]
Skljarevski 2008 {published data only}
  • Skljarevski V, Desaiah D, Liu-Siefert H, Zhang Q, Chappell AS, Detke MJ, et al. Efficacy of duloxetine in low back pain. European Journal of Neurology 2008;15(Suppl 3):320.
Skljarevski 2009 {published data only}
Skljarevski 2009a {published data only}
  • Skljarevski V, Desaiah D, Zhang Q, Chappell AS, Detke MJ, Gross JL, et al. Evaluating the maintenance of effect of duloxetine in patients with diabetic peripheral neuropathic pain [Maintenance of effect of duloxetine in patients with diabetic peripheral neuropathic pain]. Diabetes/Metabolism Research and Reviews 2009;25(7):623-31. [CTG: NCT00322621; PUBMED: 19637208]
Skljarevski 2010 {published data only}
  • Skljarevski V, Desaiah D, Liu-Seifert H, Zhang Q, Chappell AS, Detke MJ, et al. Efficacy and safety of duloxetine in patients with chronic low back pain. Spine 2010;35(13):E578-85. [PUBMED: 20461028]
Skljarevski 2010b {published data only}
  • Skljarevski V, Zhang S, Desaiah D, Alaka KJ, Palacios S, Miazgowski T, et al. Duloxetine versus placebo in patients with chronic low back pain: a 12-week, fixed-dose, randomized, double-blind trial. Journal of Pain 2010;11(12):1282-90.
Smith 2013 {published data only}
  • Smith EML, Pang H, Cirrincione C, Fleishman S, Paskett ED, Ahles T, et al. Effect of duloxetine on pain, function, and quality of life among patients with chemotherapy-induced painful peripheral neuropathy: a randomized clinical trial. JAMA 2013;309(13):1359-67.
Tanenberg 2011 {published data only}
  • Tanenberg RJ, Irving GA, Risser RC, Ahl J, Robinson MJ, Skljarevski V, et al. Duloxetine, pregabalin, and duloxetine plus gabapentin for diabetic peripheral neuropathic pain management in patients with inadequate pain response to gabapentin: an open-label, randomized, noninferiority comparison. Mayo Clinic Proceedings 2011;86(7):615-26.
Vollmer 2011 {published data only}
  • Vollmer T, Robinson M, Risser R, Malcolm SK, Carlson J. A randomised, double-blind, placebo-controlled trial of duloxetine for the treatment of central neuropathic pain associated with multiple sclerosis. Multiple Sclerosis Journal 2011;17 (10 suppl):P1044.
Wernicke 2006b {published data only}
  • Wernicke JF, Raskin J, Rosen A, Pritchett YL, D'Souza DN, Iyengar S, et al. Duloxetine in the long-term management of diabetic neuropathic pain: an open-label, 52-week extension of a randomized controlled clinical trial. Current Therapeutic Research 2006;67(5):283-304.
Wu 2006 {published data only}
  • Wu EQ, Birnbaum HJ, Mareva MN, Le TK, Robinson RL, Rosen A, et al. Cost-effectiveness of duloxetine versus routine treatment for U.S. patients with diabetic peripheral neuropathic pain. The Journal of Pain 2006;7(6):399-407.

References to studies awaiting assessment

  1. References to studies included in this review
  2. References to studies excluded from this review
  3. References to studies awaiting assessment
  4. References to ongoing studies
  5. Additional references
  6. References to other published versions of this review
NCT00603265 {published data only}
  • NCT00603265. A phase 2a, randomized, double-blind, placebo- and active-controlled, parallel-group, multicenter study to assess the safety and efficacy of ADL5859 100 mg BID in subjects with neuropathic pain associated with diabetic peripheral neuropathy [Safety and efficacy study of ADL5859 in subjects with neuropathic pain associated with diabetic peripheral neuropathy]. www.clinicaltrials.gov/show/NCT00603265 (Accessed 7 November 2013). [CTG: NCT00603265]

References to ongoing studies

  1. References to studies included in this review
  2. References to studies excluded from this review
  3. References to studies awaiting assessment
  4. References to ongoing studies
  5. Additional references
  6. References to other published versions of this review
NCT00457730 {unpublished data only}
  • NCT00457730. A randomized placebo controlled trial of duloxetine for central pain in multiple sclerosis [A study to test the use of duloxetine for pain in MS]. http://clinicaltrials.gov/show/NCT00457730 Accessed 19 December 2013.
NCT00619983 {published data only}
  • NCT00619983. Three way interaction between gabapentin, duloxetine, and donepezil in patients with diabetic neuropathy. http://clinicaltrials.gov/show/NCT00619983 Accessed 19 December 2013.
NCT01179672 {unpublished data only}
  • NCT01179672. A study in patients with diabetic peripheral neuropathic pain in China. http://clinicaltrials.gov/show/NCT01179672 (Accessed 19 December 2013).
NCT01237587 {unpublished data only}
  • NCT01237587. Effect of duloxetine 30/60 mg once daily versus placebo in adolescents with juvenile primary fibromyalgia syndrome [A study of duloxetine in adolescents with juvenile primary fibromyalgia syndrome]. http://clinicaltrials.gov/show/NCT01237587 Accessed 19 December 2013.
NCT01552057 {unpublished data only}
  • NCT01552057. A phase III clinical trial of duloxetine in participants with fibromyalgia [A study of duloxetine in fibromyalgia]. http://clinicaltrials.gov/show/NCT01552057 Accessed 19 December 2013.

Additional references

  1. References to studies included in this review
  2. References to studies excluded from this review
  3. References to studies awaiting assessment
  4. References to ongoing studies
  5. Additional references
  6. References to other published versions of this review
Aronson 2007
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Attal 2006
Beard 2008
  • Beard SM, McCrink L, Le TK, Garcia-Cebrian A, Monz B, Malik RA. Cost effectiveness of duloxetine in the treatment of diabetic peripheral neuropathic pain in the UK. Current Medical Research and Opinion 2008;24(2):385-99.
Bellows 2012
  • Bellows BK, Dahal A, Jiao T, Biskupiak J. A cost-utility analysis of pregabalin versus duloxetine for the treatment of painful diabetic neuropathy. Journal of Pain & Palliative Care Pharmacotherapy 2012;26(2):153–64.
Breivik 2006
Burckhardt 1991
Bymaster 2001
  • Bymaster FP, Dreshfield-Ahmad LJ, Threlkeld PG, Shaw JL, Thompson L, Nelson DL, et al. Comparative affinity of duloxetine and venlafaxine for serotonin and norepinephrine transporters in vitro and in vivo, human serotonin receptor subtypes, and other neuronal receptors. Neuropsychopharmacology 2001;25(6):871-80.
Bymaster 2005
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Dadabhoy 2006
Daousi 2004
Dworkin 2008
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Elbourne 2002
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Fava 2004
  • Fava M, Mallinckrodt CH, Detke MJ, Watkin JG, Wohlreich MM. The effect of duloxetine on painful physical symptoms in depressed patients: do improvements in these symptoms result in higher remission rates?. Journal of Clinical Psychiatry 2004;65(4):521-30.
Gahimer 2007
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GRADEpro 2008
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Hall 2006
Higgins 2008
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  • 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.
Kajdasz 2007
  • Kajdasz DK, Iyengar S, Desaiah D, Backonja MM, Farrar JT, Fishbain DA, et al. Duloxetine for the management of diabetic peripheral neuropathic pain: evidence-based findings from post hoc analysis of three multicenter, randomized, double-blind, placebo-controlled, parallel-group studies. Clinical Therapeutics 2007;29(Supplement):2536-46.
Mariappan 2009
Mease 2011
Moore 2009
Moore 2012
Nagda 2004
  • Nagda J, Bajwa ZH. Definitions and Classification of Pain. Principles and practice of pain management. New York: McGraw Hill, 2004:51-4.
Nose 2007
  • Nose M, Cipriani A, Furukawa TA, Omori I, Churchill R, McGuire H et al for the Meta-Analysis of New Generation Antidepressants (MANGA) Study Group. Duloxetine versus other anti-depressive agents for depression. Cochrane Database of Systematic Reviews 2007, Issue 2. [DOI: 10.1002/14651858.CD005454.pub2]
O'Connor 2008
Perahia 2006
  • Perahia DG, Pritchett YL, Desaiah D, Raskin J. Efficacy of duloxetine in painful symptoms: analgesic or antidepressant effect?. International Clinical Psychopharmacology 2006;21(6):311-7.
Saarto 2007
Salaffi 2004
Schuessler 2006
Thorlund 2011
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Wernicke 2007
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References to other published versions of this review

  1. References to studies included in this review
  2. References to studies excluded from this review
  3. References to studies awaiting assessment
  4. References to ongoing studies
  5. Additional references
  6. References to other published versions of this review
Lunn 2008
  • Lunn MPT, Hughes RAC, Wiffen PJ. Duloxetine for treating painful neuropathy or chronic pain. Cochrane Database of Systematic Reviews 2008, Issue 2. [DOI: 10.1002/14651858.CD007115]
Lunn 2009