Current Diabetes Reports

, Volume 12, Issue 4, pp 403–413 | Cite as

Management of Painful Diabetic Neuropathy: Guideline Guidance or Jungle?

Microvascular Complications—Neuropathy (D Ziegler, Section Editor)

Abstract

The treatment of painful diabetic polyneuropathy (PDPN) remains a major challenge. A number of reasons have made the guidelines on PDPN management of particular interest, including its high prevalence, health and socioeconomic impact, interdisciplinary nature and the need for updated evidence-based information to refine patient-tailored treatment by weighing up the risks of each treatment against its proven benefits, as well as optimizing the use of all available resources. The various guidelines on the management of neuropathic pain developed so far contain some differences in their work methodology and results. Some variations in the recommendations are to be expected but could be disorienting and confusing for stakeholders. In this review, a critical evaluation of the more recent guidelines on the management of PDPN is provided together with highlights on points of agreement and disagreement as well as insights into their clinical aspects.

Keywords

Painful neuropathy Neuropathic pain Diabetic neuropathy Guidelines Antidepressants SNRI Opioids Venlafaxine Duloxetine Pregabalin Gabapentin Tramadol Oxycodone Treatment 

Notes

Disclosure

Conflicts of interest: V. Spallone: has board membership with Wörwag Pharma, TRIGOcare International, Daiichi Sankyo Europe; has received grant support from Biocure SrL; has received payment for lectures including service on speakers bureaus from Eli-Lilly, Pfizer, Boehringer Ingelheim, Sanofi-Aventis; and has received payment for development of educational presentations from Eli-Lilly.

References

Papers of particular interest, published recently, have been highlighted as: • Of importance •• Of major importance

  1. 1.
    Davies M, Brophy S, Williams R, et al. The prevalence, severity and impact of painful diabetic peripheral neuropathy in type 2 diabetes. Diabetes Care. 2006;29:1518–22.PubMedCrossRefGoogle Scholar
  2. 2.
    Van Acker K, Bouhassira D, De Bacquer D, et al. Prevalence and impact on quality of life of peripheral neuropathy with or without neuropathic pain in type 1 and type 2 diabetic patients attending hospital outpatients clinics. Diabetes Metab. 2009;35:206–13.PubMedCrossRefGoogle Scholar
  3. 3.
    • Tesfaye S, Vileikyte L, Rayman G, et al. Painful diabetic peripheral neuropathy: consensus recommendations on diagnosis, assessment and management. Diabetes Metab Res Rev. 2011;27:629–38. This paper is a detailed report of the sub-committee on Painful Diabetic Neuropathy of the Toronto Expert Panel. The International Consensus Workshop in Toronto in 2009 produced evidence-based guidelines on different aspects of diabetic neuropathy.CrossRefGoogle Scholar
  4. 4.
    • Ziegler D. Current concepts in the management of diabetic polyneuropathy. Curr Diabetes Rev. 2011;7:208–20. This paper is a comprehensive review on contemporary issues in diabetic polyneuropathy.PubMedCrossRefGoogle Scholar
  5. 5.
    • Spallone V, Lacerenza M, Rossi A, et al. Painful diabetic polyneuropathy: approach to diagnosis and management. Clin J Pain 2011 Dec 30. [Epub ahead of print] This paper provides a current practical overview of the diagnostic workup and management of PDPN. Google Scholar
  6. 6.
    Gore M, Dukes E, Rowbotham DJ, Tai KS, Leslie D. Clinical characteristics and pain management among patients with painful peripheral neuropathic disorders in general practice settings. Eur J Pain. 2007;11:652–64.PubMedCrossRefGoogle Scholar
  7. 7.
    O’Connor AB. Neuropathic pain. Quality of life impact, costs and cost effectiveness of therapy. Pharmacoeconomics. 2009;27:95–112.PubMedCrossRefGoogle Scholar
  8. 8.
    • Grol R. Has guideline development gone astray? Yes. BMJ. 2010;340:c306. This is the first interesting part of a brief debate on the value of guidelines in clinical practice.PubMedCrossRefGoogle Scholar
  9. 9.
    • Gibbons RJ, Antman EM, Smith SC. Has guideline development gone astray? No. BMJ. 2010;340:c343. This is the second interesting part of a brief debate on the value of guidelines in clinical practice.PubMedCrossRefGoogle Scholar
  10. 10.
    Getchius TS, Moses LK, French J, et al. AAN guidelines: a benefit to the neurologist. Neurology. 2010;75:1126–7.PubMedCrossRefGoogle Scholar
  11. 11.
    International Diabetes Federation Clinical Guidelines Task Force. Guide for Guidelines. A guide for clinical guideline development. Available at www.idf.org. Accessed April 2012
  12. 12.
    Atkins D, Best D, Briss PA, et al. Grading quality of evidence and strength of recommendations. BMJ. 2004;328:1490.PubMedCrossRefGoogle Scholar
  13. 13.
    Dworkin RH, O’Connor AB, Backonja M, et al. Pharmacologic management of neuropathic pain: evidence-based recommendations. Pain. 2007;132:237–51.PubMedCrossRefGoogle Scholar
  14. 14.
    • Dworkin RH, O’Connor AB, Audette J, et al. Recommendations for the pharmacological management of neuropathic pain: an overview and literature update. Mayo Clin Proc. 2010;85(3 Suppl):S3–S14. This paper reviews and updates the 2007 NeuPSIG guidelines on the management of neuropathic pain of different etiology. It provides both brief overview of recent studies and practical advice for a stepwise approach to the patient with neuropathic pain.PubMedCrossRefGoogle Scholar
  15. 15.
    CEBM Centre for Evidence-based Medicine. CEBM Web site. Levels of evidence and grades of recommendation. Available at http://www.cebm.net/index.aspx?o=1025. Accessed April 2012
  16. 16.
    Attal N, Cruccu G, Haanpaa M, et al. EFNS guidelines on pharmacological treatment of neuropathic pain. Eur J Neurol. 2006;13:1153–69.PubMedCrossRefGoogle Scholar
  17. 17.
    • Attal N, Cruccu G, Baron R, et al. EFNS guidelines on the pharmacological treatment of neuropathic pain: 2010 revision. Eur J Neurol. 2010;17:1113–e88. This paper updates the 2006 EFNS guidelines on pharmacological treatment of neuropathic pain. Appendix 1 contains summary data of the studies published from 2005 and included in the systematic review.PubMedCrossRefGoogle Scholar
  18. 18.
    Cruccu G, Aziz TZ, Garcia-Larrea L, et al. EFNS guidelines on neurostimulation therapy for neuropathic pain. Eur J Neurol. 2007;14:952–70.PubMedCrossRefGoogle Scholar
  19. 19.
    Brainin M, Barnes M, Baron JC, et al. Guidance for the preparation of neurological management guidelines by EFNS scientific task forces—revised recommendations 2004. Eur J Neurol. 2004;11:577–81.PubMedCrossRefGoogle Scholar
  20. 20.
    Gilron I, Bailey JM, Tu D. Holden RRet al: Nortriptyline and gabapentin, alone and in combination for neuropathic pain: a double-blind, randomised controlled crossover trial. Lancet. 2009;374:1252–61.PubMedCrossRefGoogle Scholar
  21. 21.
    Jensen MP, Chodroff MJ, Dworkin RH. The impact of neuropathic pain on health-related quality of life: review and implications. Neurology. 2007;68:1178–82.PubMedCrossRefGoogle Scholar
  22. 22.
    AAN (American Academy of Neurology). Clinical Practice Guideline Process Manual. 2004th ed. St. Paul: The American Academy of Neurology; 2004.Google Scholar
  23. 23.
    AAN (American Academy of Neurology). Clinical Practice Guideline Process Manual. 2011th ed. St. Paul: The American Academy of Neurology; 2011.Google Scholar
  24. 24.
    Moore RA, Straube S, Wiffen PJ, et al. Pregabalin for acute and chronic pain in adults. Cochrane Database Syst Rev. 2009;3:CD007076.PubMedGoogle Scholar
  25. 25.
    Landefeld CS, Steinman MA. The Neurontin legacy—marketing through misinformation and manipulation. N Engl J Med. 2009;360:103–6.PubMedCrossRefGoogle Scholar
  26. 26.
    •• National Institute for Health and Clinical Excellence. Neuropathic pain. The pharmacological management of neuropathic pain in adults in non-specialist settings. NICE clinical guideline 96. Issued: March 2010. Available at: www.nice.org.uk/guidance/CG96. Accessed April 2012. This NICE guideline on the pharmacological management of neuropathic pain provides evidence-based data on efficacy, safety and cost-effectiveness of the available drugs for neuropathic pain. It gives a thorough stepwise care pathway for clinicians and patients.
  27. 27.
    National Institute for Health and Clinical Excellence. Type 1 diabetes: diagnosis and management of type 1 diabetes in children, young people and adults (NICE clinical guideline 15). Issued: July 2004. Available at http://www.nice.org.uk/guidance/index.jsp?action=byID&o=10944. Accessed April 2012
  28. 28.
    National Institute for Health and Clinical Excellence. Type 2 diabetes: the management of type 2 diabetes (NICE clinical guideline 87). Issued: May 2009. Available at http://www.nice.org.uk/guidance/index.jsp?action=byID&o=12165. Accessed April 2012
  29. 29.
    Dworkin RH, Turk DC, Wyrwich KW, et al. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain. 2008;9:105–21.PubMedCrossRefGoogle Scholar
  30. 30.
    Fox-Rushby JA, GL Griffith, JR Ross et al. The clinical and cost-effectiveness of different treatment pathways for neuropathic pain [NP]. NIHR Health Technology Assessment (HTA) programme, ref. 05/30/03. In press. Project abstract available from www.hta.ac.uk/1527. Accessed April 2012
  31. 31.
    • Bril V, England J, Franklin GM, et al. Evidence-based guideline: Treatment of painful diabetic neuropathy: report of the American Academy of Neurology, the American Association of Neuromuscular and Electrodiagnostic Medicine, and the American Academy of Physical Medicine and Rehabilitation. Neurology. 2011;76:1758–65. This paper is the AAN guideline on the pharmacological treatment of PDPN prepared according to AAN guideline rules. It contains evidence-based recommendations on the efficacy on pain and quality of life of available treatments.PubMedCrossRefGoogle Scholar
  32. 32.
    • Tesfaye S, Boulton AJ, Dyck PJ, et al. Toronto Diabetic Neuropathy Expert Group. Diabetic neuropathies: update on definitions, diagnostic criteria, estimation of severity, and treatments. Diabetes Care. 2010;33:2285–93. This paper is the preliminary summary report of the Toronto consensus meeting on diabetic neuropathy. It provides novel insights into definition and diagnosis of different forms of diabetic neuropathy.PubMedCrossRefGoogle Scholar
  33. 33.
    Gibbons CH, Freeman R. Treatment-induced diabetic neuropathy: a reversible painful autonomic neuropathy. Ann Neurol. 2010;67:534–41.Google Scholar
  34. 34.
    • Hartemann A, Attal N, Bouhassira D, et al. Painful diabetic neuropathy: diagnosis and management. Diabetes Metab. 2011;37:377–88. This paper is the result of a consensus work developed under the auspices of the French-speaking Society of Diabetology. It gives a practical and lucid approach to both diagnosis and treatment of PDPN.PubMedCrossRefGoogle Scholar
  35. 35.
    Saarto T, Wiffen PJ. Antidepressants for neuropathic pain. Cochrane Database Syst Rev. 2007; (4):CD005454.Google Scholar
  36. 36.
    Moore RA, Wiffen PJ, Derry S, McQuay HJ. Gabapentin for chronic neuropathic pain and fibromyalgia in adults. Cochrane Database Syst Rev. 2011; (3):CD007938.Google Scholar
  37. 37.
    Lunn MP, Hughes RA, Wiffen PJ. Duloxetine for treating painful neuropathy or chronic pain. Cochrane Database Syst Rev. 2009; (4):CD007115.Google Scholar
  38. 38.
    Duehmke RM, Hollingshead J, Cornblath DR. Tramadol for neuropathic pain. Cochrane Database Syst Rev. 2006; (3):CD003726.Google Scholar
  39. 39.
    Gill D, Derry S, Wiffen PJ, Moore RA. Valproic acid and sodium valproate for neuropathic pain and fibromyalgia in adults. Cochrane Database Syst Rev. 2011; (10):CD009183.Google Scholar
  40. 40.
    Derry S, Lloyd R, Moore RA, McQuay HJ. Topical capsaicin for chronic neuropathic pain in adults. Cochrane Database Syst Rev 2009; (4):CD007393.Google Scholar
  41. 41.
    Jadad AR, Moore RA, Carroll D, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials. 1996;17:1–12.PubMedCrossRefGoogle Scholar
  42. 42.
    Argoff CE, Backonja MM, Belgrade MJ, et al. Consensus guidelines: treatment planning and options. Diabetic peripheral neuropathic pain. Mayo Clin Proc. 2006;81(4 Suppl):S12–25.PubMedCrossRefGoogle Scholar
  43. 43.
    Moulin DE, Clark AJ, Gilron I, et al. Pharmacological management of chronic neuropathic pain - consensus statement and guidelines from the Canadian Pain Society. Pain Res Manag. 2007;12:13–21.PubMedGoogle Scholar
  44. 44.
    • Bohlega S, Alsaadi T, Amir A, et al. Guidelines for the pharmacological treatment of peripheral neuropathic pain: expert panel recommendations for the middle East region. J Int Med Res. 2010;38:295–317. This paper contains guidelines on diagnosis and managenement of neuropathic pain developed by an expert panel of Middle East region. It has a clinical perspective and pays attention to the needs of that region.PubMedGoogle Scholar
  45. 45.
    Scottish Intercollegiate Guidelines Network (SIGN). Management of Diabetes. Edinburgh: SIGN; 2010. (SIGN publication no.116). Available at http://www.sign.ac.uk/guidelines/fulltext/116/index.html Accessed April 2012
  46. 46.
    Handelsman Y, Mechanick JI, Blonde L, et al. American Association of clinical endocrinologists medical guidelines for clinical practice for developing a diabetes mellitus comprehensive care plan. End Pract. 2011;17:1–51.CrossRefGoogle Scholar
  47. 47.
    Harati Y, Gooch C, Swenson M, et al. Double-blind randomized trial of tramadol for the treatment of the pain of diabetic neuropathy. Neurology. 1998;50:1842–6.PubMedCrossRefGoogle Scholar
  48. 48.
    Kadiroglu AK, Sit D, Kayabasi H, et al. The effect of venlafaxine HCl on painful peripheral diabetic neuropathy in patients with type 2 diabetes mellitus. J Diabetes Complications. 2008;22:241–5.PubMedCrossRefGoogle Scholar
  49. 49.
    Watson CP, Moulin D, Watt-Watson J, et al. Controlled-release oxycodone relieves neuropathic pain: a randomized controlled trial in painful diabetic neuropathy. Pain. 2003;105:71–8.PubMedCrossRefGoogle Scholar
  50. 50.
    Katz J, Finnerup NB, Dworkin RH. Clinical trial outcome in neuropathic pain: relationship to study characteristics. Neurology. 2008;70:263–72.PubMedCrossRefGoogle Scholar
  51. 51.
    French J, Gronseth G. Lost in a jungle of evidence: we need a compass. Neurology. 2008;71:1634–8.PubMedCrossRefGoogle Scholar
  52. 52.
    Lesser H, Sharma U, LaMoreaux L, et al. Pregabalin relieves symptoms of painful diabetic neuropathy: a randomized controlled trial. Neurology. 2004;63:2104–10.PubMedCrossRefGoogle Scholar
  53. 53.
    Richter RW, Portenoy R, Sharma U, et al. Relief of painful diabetic peripheral neuropathy with pregabalin: a randomized, placebo-controlled trial. J Pain. 2005;6:253–60.PubMedCrossRefGoogle Scholar
  54. 54.
    Rosenstock J, Tuchman M, LaMoreaux L, et al. Pregabalin for the treatment of painful diabetic peripheral neuropathy: a double-blind, placebo-controlled trial. Pain. 2004;110:628–38.PubMedCrossRefGoogle Scholar
  55. 55.
    Freynhagen R, Strojek K, Griesing T, et al. Efficacy of pregabalin in neuropathic pain evaluated in a 12-week, randomised, double-blind, multicentre, placebo-controlled trial of flexible- and fixed-dose regimens. Pain. 2005;115:254–63.PubMedCrossRefGoogle Scholar
  56. 56.
    Arezzo JC, Rosenstock J, Lamoreaux L, et al. Efficacy and safety of pregabalin 600 mg/d for treating painful diabetic peripheral neuropathy: a double-blind placebo-controlled trial. BMC Neurol. 2008;8:33.PubMedCrossRefGoogle Scholar
  57. 57.
    Tölle T, Freynhagen R, Versavel M, et al. Pregabalin for relief of neuropathic pain associated with diabetic neuropathy: a randomized, double-blind study. Eur J Pain. 2008;12:203–13.PubMedCrossRefGoogle Scholar
  58. 58.
    Freeman R, Durso-Decruz E, Emir B. Efficacy, safety and tolerability of pregabalin treatment for painful diabetic peripheral neuropathy: findings from seven randomized, controlled trials across a range of doses. Diabetes Care. 2008;31:1448–54.PubMedCrossRefGoogle Scholar
  59. 59.
    Backonja M, Beydoun A. Edwards KRet al.: Gabapentin for the symptomatic treatment of painful neuropathy in patients with diabetes mellitus: a randomized controlled trial. JAMA. 1998;280:1831–6.PubMedCrossRefGoogle Scholar
  60. 60.
    Gorson KC, Schott C, Herman R, et al. Gabapentin in the treatment of painful diabetic neuropathy: a placebo controlled, double blind, crossover trial. J Neurol Neurosurg Psychiatry. 1999;66:251–2.PubMedCrossRefGoogle Scholar
  61. 61.
    Wiffen PJ, McQuay HJ, Edwards J, Moore RA. WITHDRAWN: Gabapentin for acute and chronic pain. Cochrane Database Syst Rev. 2011, Issue 3. Art. No. CD005452.Google Scholar
  62. 62.
    Kochar DK, Jain N, Agarwal RP, et al. Sodium valproate in the management of painful neuropathy in type 2 diabetes: a randomized placebo controlled study. Acta Neurol Scand. 2002;106:248–52.PubMedCrossRefGoogle Scholar
  63. 63.
    Kochar DK, Rawat N, Agrawal RP, et al. Sodium valproate for painful diabetic neuropathy: a randomized double-blind placebo-controlled study. QJM. 2004;97:33–8.PubMedCrossRefGoogle Scholar
  64. 64.
    Vrethem M, Boivie J, Arnqvist H, et al. A comparison of amitriptyline and maprotiline in the treatment of painful diabetic neuropathy in diabetics and nondiabetics. Clin J Pain. 1997;13:313–23.PubMedCrossRefGoogle Scholar
  65. 65.
    Max MB. Endogenous monoamine analgesic systems: amitriptyline in painful diabetic neuropathy. Anesth Prog. 1987;34:123–7.PubMedGoogle Scholar
  66. 66.
    Max MB, Culnane M, Schafer SC, et al. Amitriptyline relieves diabetic neuropathy pain in patients with normal or depressed mood. Neurology. 1987;37:589–96.PubMedCrossRefGoogle Scholar
  67. 67.
    Mendel CM, Klein RF, Chappell DA, et al. A trial of amitriptyline and fluphenazine in the treatment of painful diabetic neuropathy. JAMA. 1986;255:637–9.PubMedCrossRefGoogle Scholar
  68. 68.
    Kvinesdal B, Molin J, Froland A, Gram LF. Imipramine treatment of painful diabetic neuropathy. JAMA. 1984;251:1727–30.PubMedCrossRefGoogle Scholar
  69. 69.
    Gomez-Perez FJ, Rull JA, Dies H, Rodriquez-Rivera JG, Gonzalez-Barranco J, Lozano-Castaneda O. Nortriptyline and fluphenazine in the symptomatic treatment of diabetic neuropathy: a double-blind cross-over study. Pain. 1985;23:395–400.PubMedCrossRefGoogle Scholar
  70. 70.
    Max MB, Lynch SA, Muir J, Shoaf SE, Smoller B, Dubner R. Effects of desipramine, amitriptyline, and fluoxetine on pain in diabetic neuropathy. N Engl J Med. 1992;326:1250–6.PubMedCrossRefGoogle Scholar
  71. 71.
    Max MB, Kishore-Kumar R, Schafer SC, et al. Efficacy of desipramine in painful diabetic neuropathy: a placebo-controlled trial. Pain. 1991;45:3–9.PubMedCrossRefGoogle Scholar
  72. 72.
    Sindrup SH, Gram LF. Skjold Tet al.: Clomipramine vs desipramine vs placebo in the treatment of diabetic neuropathy symptoms. A double-blind cross-over study. Br J Clin Pharmacol. 1990;30:683–91.PubMedGoogle Scholar
  73. 73.
    Raskin J, Pritchett L, Wang F, et al. A double-blind, randomized multicenter trial comparing duloxetine with placebo in the management of diabetic peripheral neuropathic pain. Pain Med. 2005;6:346–56.PubMedCrossRefGoogle Scholar
  74. 74.
    Goldstein DJ, Lu Y, Detke MJ, et al. Duloxetine vs. placebo in patients with painful diabetic neuropathy. Pain. 2005;116:109–18.PubMedCrossRefGoogle Scholar
  75. 75.
    Wernicke JF, Pritchett YL, D’Souza DN, et al. A randomized controlled trial of duloxetine in diabetic peripheral neuropathic pain. Neurology. 2006;67:1411–20.PubMedCrossRefGoogle Scholar
  76. 76.
    Kajdasz DK, Iyengar S, Desaiah D, 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. Clin Ther. 2007;29(Suppl):2536–46.PubMedCrossRefGoogle Scholar
  77. 77.
    Rowbotham MC, Goli V, Kunz NR, Lei D. Venlafaxine extended release in the treatment of painful diabetic neuropathy: a double-blind, placebo-controlled study. Pain. 2004;110:697–706.PubMedCrossRefGoogle Scholar
  78. 78.
    Simpson DA. Gabapentin and venlafaxine for the treatment of painful diabetic neuropathy. J Clin Neuromuscul Dis. 2001;3:53–62.PubMedCrossRefGoogle Scholar
  79. 79.
    Sindrup SH, Bach FW, Madsen C, et al. Venlafaxine versus imipramine in painful polyneuropathy: a randomized, controlled trial. Neurology. 2003;60:1284–9.PubMedCrossRefGoogle Scholar
  80. 80.
    Sindrup SH, Andersen G, Madsen C, et al. Tramadol relieves pain and allodynia in polyneuropathy: a randomised, double-blind, controlled trial. Pain. 1999;83:85–90.PubMedCrossRefGoogle Scholar
  81. 81.
    Freeman R, Raskin P, Hewitt D, et al. Randomized study of tramadol/acetaminophen versus placebo in painful diabetic neuropathy. Curr Med Res Opin. 2007;23:147–61.PubMedCrossRefGoogle Scholar
  82. 82.
    Gimbel JS, Richards P, Portenoy RK. Controlled-release oxycodone for pain in diabetic neuropathy: a randomized controlled trial. Neurology. 2003;60:927–34.PubMedCrossRefGoogle Scholar
  83. 83.
    Hanna M, O’Brien C, Wilson MC. Prolonged-release oxycodone enhances the effects of existing gabapentin therapy in painful diabetic neuropathy patients. Eur J Pain. 2008;12:804–13.PubMedCrossRefGoogle Scholar
  84. 84.
    Tandan R, Lewis GA, Krusinski PB, et al. Topical capsaicin in painful diabetic neuropathy. Controlled study with long-term follow-up. Diabetes Care. 1992;15:8–14.PubMedCrossRefGoogle Scholar
  85. 85.
    The Capsaicin Study Group. Treatment of painful diabetic neuropathy with topical capsaicin. A multicenter, double-blind, vehicle-controlled study. Arch Intern Med. 1991;151:2225–9.CrossRefGoogle Scholar
  86. 86.
    Scheffler N, Sheitel P, Lipton M. Treatment of painful diabetic neuropathy with capsaicin 0.075 %. J Am Podiatr Med Assoc. 1991;81:288–93.PubMedGoogle Scholar

Copyright information

© Springer Science+Business Media, LLC 2012

Authors and Affiliations

  1. 1.Endocrinology, Department of Internal MedicineTor Vergata UniversityRomeItaly

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