Skip to content
EvidenceHelixEvidenceLib · Scientific Encyclopedia
⌘ K

Scientific library

EvidenceLib encyclopediaAll articles A–Z2,835Open textbooks209Open-access articles1,406Cancer study catalog458How it is made

My workspace this browser

Saved pages0Notes & annotations0

Recently viewed

Explore by field

Cancer and Oncology182Genetics and Genomics170Neuroscience185Cardiovascular Medicine180Immunology142Pharmacology173Molecular Biology161Infectious Diseases150Rare and Inherited Diseases181Clinical Research173Anatomy and Physiology613Drugs and Chemicals621Psychiatry and Psychology185Public Health and Nutrition178Diagnostics and Medical Technology125Respiratory Medicine113Digestive System and Liver91Metabolism and Endocrine Disease177Bones, Joints, Muscles and Skin213Kidney, Urology and Women's Health173Eye, Ear, Nose and Throat55
Plans & pricingCompare EvidenceHelix workspace plans
Library›Open textbooks›Optimal pharmacotherapy pathway in adults with diabetic peripheral neuropathic pain: the OPTION-DM RCT›References

Continue where you left off ()

Explore more with EvidenceHelix Workspace

Compare studies, analyze evidence and create research reports with premium tools.

Explore Researcher plans

Optimal pharmacotherapy pathway in adults with diabetic peripheral neuropathic pain: the OPTION-DM RCT · References

References

CC BY 4.0 · National Institute for Health and Care Research · approximately 10 min read

  1. Tesfaye S, Sloan G, Petrie J, White D, Bradburn M, Julious S, et al. Comparison of amitriptyline supplemented with pregabalin, pregabalin supplemented with amitriptyline, and duloxetine supplemented with pregabalin for the treatment of diabetic peripheral neuropathic pain (OPTION-DM): a multicentre, double-blind, randomised crossover trial. Lancet 2022;400:680–90. 10.1016/S0140-6736(22)01472-636007534
  2. Selvarajah D, Petrie J, White D, Julious S, Bortolami O, Cooper C, et al. Multicentre, double-blind, crossover trial to identify the Optimal Pathway for TreatIng neurOpathic paiN in Diabetes Mellitus (OPTION-DM): study protocol for a randomised controlled trial. Trials 2018;19:578. 10.1186/s13063-018-2959-y30348206
  3. Creative Commons. Attribution 4.0 International (CC BY 4.0). URL: https://creativecommons.org/licenses/by/4.0/ (accessed 9 December 2021).
  4. Diabetes UK. Number of People with Diabetes Reaches 4.8 Million. 2020. URL: www.diabetes.org.uk/about_us/news/diabetes-prevalence-2019 (accessed 9 December 2021).
  5. Abbott CA, Malik RA, van Ross ER, Kulkarni J, Boulton AJ. Prevalence and characteristics of painful diabetic neuropathy in a large community-based diabetic population in the U.K. Diabetes Care 2011;34:2220–4. 10.2337/dc11-110821852677
  6. Davies M, Brophy S, Williams R, Taylor A. The prevalence, severity, and impact of painful diabetic peripheral neuropathy in type 2 diabetes. Diabetes Care 2006;29:1518–22. 10.2337/dc05-222816801572
  7. Veves A, Backonja M, Malik RA. Painful diabetic neuropathy: epidemiology, natural history, early diagnosis, and treatment options. Pain Med 2008;9:660–74. 10.1111/j.1526-4637.2007.00347.x18828198
  8. Boulton AJ, Vinik AI, Arezzo JC, Bril V, Feldman EL, Freeman R, et al. Diabetic neuropathies: a statement by the American Diabetes Association. Diabetes Care 2005;28:956–62. 10.2337/diacare.28.4.95615793206
  9. Galer BS, Gianas A, Jensen MP. Painful diabetic polyneuropathy: epidemiology, pain description, and quality of life. Diabetes Res Clin Pract 2000;47:123–8. 10.1016/S0168-8227(99)00112-610670912
  10. Zelman DC, Brandenburg NA, Gore M. Sleep impairment in patients with painful diabetic peripheral neuropathy. Clin J Pain 2006;22:681–5. 10.1097/01.ajp.0000210910.49923.0916988563
  11. Gore M, Brandenburg NA, Dukes E, Hoffman DL, Tai KS, Stacey B. Pain severity in diabetic peripheral neuropathy is associated with patient functioning, symptom levels of anxiety and depression, and sleep. J Pain Symptom Manage 2005;30:374–85. 10.1016/j.jpainsymman.2005.04.00916256902
  12. Gore M, Brandenburg NA, Hoffman DL, Tai KS, Stacey B. Burden of illness in painful diabetic peripheral neuropathy: the patients’ perspectives. J Pain 2006;7:892–900. 10.1016/j.jpain.2006.04.01317157775
  13. Tölle T, Xu X, Sadosky AB. Painful diabetic neuropathy: a cross-sectional survey of health state impairment and treatment patterns. J Diabetes Complications 2006;20:26–33. 10.1016/j.jdiacomp.2005.09.00716389164
  14. National Institute for Health and Care Excellence (NICE). Neuropathic Pain in Adults: Pharmacological Management in Non-Specialist Settings. Clinical Guideline [CG173]. London: NICE; 2013.
  15. Moore RA, Derry S, Aldington D, Cole P, Wiffen PJ. Amitriptyline for neuropathic pain in adults. Cochrane Database Syst Rev 2015;7:CD008242. 10.1002/14651858.CD008242.pub3
  16. Lunn M, Hughes R, Wiffen P. Duloxetine for treating painful neuropathy, chronic pain or fibromyalgia (review). Cochrane Database Syst Rev 2014;3:CD007115. 10.1002/14651858.CD007115.pub3
  17. Moore RA, Straube S, Wiffen PJ, Derry S, McQuay HJ. Pregabalin for acute and chronic pain in adults. Cochrane Database Syst Rev 2009;3:CD007076. 10.1002/14651858.CD007076.pub2
  18. Moore R, Wiffen P, Derry S, Mcquay H. Gabapentin for chronic neuropathic pain and fibromyalgia in adults (review). Cochrane Database Syst Rev 2011;3:CD007938. 10.1002/14651858.CD007938.pub2
  19. 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. 10.2337/dc07-210518356405
  20. Sultan A, Gaskell H, Derry S, Moore RA. Duloxetine for painful diabetic neuropathy and fibromyalgia pain: systematic review of randomised trials. BMC Neurol 2008;8:29. 10.1186/1471-2377-8-2918673529
  21. Wong MC, Chung JW, Wong TK. Effects of treatments for symptoms of painful diabetic neuropathy: systematic review. BMJ 2007;335:87. 10.1136/bmj.39213.565972.AE17562735
  22. Tesfaye S, Vileikyte L, Rayman G, Sindrup SH, Perkins BA, Baconja M, et al. Painful diabetic peripheral neuropathy: consensus recommendations on diagnosis, assessment and management. Diabetes Metab Res Rev 2011;27:629–38. 10.1002/dmrr.122521695762
  23. Dworkin RH, O’Connor AB, Audette J, Baron R, Gourlay GK, Haanpää ML, et al. Recommendations for the pharmacological management of neuropathic pain: an overview and literature update. Mayo Clin Proc 2010;85:3–14. 10.4065/mcp.2009.0649
  24. Attal N, Cruccu G, Baron R, Haanpää M, Hansson P, Jensen TS, Nurmikko T. EFNS guidelines on the pharmacological treatment of neuropathic pain: 2010 revision [published online ahead of print]. Eur J Neurol 2010. 10.1111/j.1468-1331.2010.02999.x
  25. Bansal D, Bhansali A, Hota D, Chakrabarti A, Dutta P. Amitriptyline vs. pregabalin in painful diabetic neuropathy: a randomized double blind clinical trial. Diabet Med 2009;26:1019–26. 10.1111/j.1464-5491.2009.02806.x19900234
  26. 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;34:818–22. 10.2337/dc10-179321355098
  27. 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. Diabetes Care 2012;35:2451–8. 10.2337/dc12-065622991449
  28. Quilici S, Chancellor J, Löthgren M, Simon D, Said G, Le TK, et al. Meta-analysis of duloxetine vs. pregabalin and gabapentin in the treatment of diabetic peripheral neuropathic pain. BMC Neurol 2009;9:6. 10.1186/1471-2377-9-619208243
  29. Gilron I, Bailey JM, Tu D, Holden RR, Weaver DF, Houlden RL. Morphine, gabapentin, or their combination for neuropathic pain. N Engl J Med 2005;352:1324–34. 10.1056/NEJMoa04258015800228
  30. Tesfaye S, Selvarajah D. Morphine, gabapentin, or their combination for neuropathic pain. N Engl J Med 2005;352:2650–1. 10.1056/NEJM200506233522520
  31. 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. Pain 2013;154:2616–25. 10.1016/j.pain.2013.05.04323732189
  32. Wu EQ, Birnbaum HG, Mareva MN, Le TK, Robinson RL, Rosen A, Gelwicks S. Cost-effectiveness of duloxetine versus routine treatment for U.S. patients with diabetic peripheral neuropathic pain. J Pain 2006;7:399–407. 10.1016/j.jpain.2006.01.44316750796
  33. 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. Curr Med Res Opin 2008;24:385–99. 10.1185/030079908x25385218157921
  34. O’Connor A, Noyes K, Holloway R. A cost–utility comparison of four first-line medications in painful diabetic neuropathy. PharmacoEconomics 2008;26:1045–64. 19014205
  35. de Salas-Cansado M, Pérez C, Saldaña MT, Navarro A, González-Gómez FJ, Ruiz L, Rejas J. An economic evaluation of pregabalin versus usual care in the management of community-treated patients with refractory painful diabetic peripheral neuropathy in primary care settings. Prim Care Diabetes 2012;6:303–12. 10.1016/j.pcd.2012.03.00122595032
  36. Backonja M, Beydoun A, Edwards KR, Schwartz SL, Fonseca V, Hes M, et al. Gabapentin for the symptomatic treatment of painful neuropathy in patients with diabetes mellitus: a randomized controlled trial. JAMA 1998;280:1831–6. 10.1001/jama.280.21.18319846777
  37. Dworkin RH, Turk DC, Peirce-Sandner S, Burke LB, Farrar JT, Gilron I, et al. Considerations for improving assay sensitivity in chronic pain clinical trials: IMMPACT recommendations. Pain 2012;153:1148–58. 10.1016/j.pain.2012.03.00322494920
  38. Bouhassira D, Attal N, Alchaar H, Boureau F, Brochet B, Bruxelle J, et al. Comparison of pain syndromes associated with nervous or somatic lesions and development of a new neuropathic pain diagnostic questionnaire (DN4). Pain 2005;114:29–36. 10.1016/j.pain.2004.12.01015733628
  39. Bril V, Tomioka S, Buchanan RA, Perkins BA, mTCNS Study Group. Reliability and validity of the modified Toronto Clinical Neuropathy Score in diabetic sensorimotor polyneuropathy. Diabet Med 2009;26:240–6. 10.1111/j.1464-5491.2009.02667.x19317818
  40. Great Britain. Data Protection Act 2018. London: The Stationery Office; 2018.
  41. Ware JE, Gandek B. Overview of the SF-36 Health Survey and the International Quality of Life Assessment (IQOLA) Project. J Clin Epidemiol 1998;51:903–12. 10.1016/S0895-4356(98)00081-X9817107
  42. Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand 1983;67:361–70. 10.1111/j.1600-0447.1983.tb09716.x6880820
  43. Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap 1994;23:129–38.8080219
  44. Bastien CH, Valliéres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med 2001;2:297–307. 10.1016/S1389-9457(00)00065-411438246
  45. Guy W. ECDEU Assessment Manual for Psychopharmacology. Rockville, MD: U.S. Department of Health, Education, and Welfare; 1976. 10.1037/e591322011-001
  46. Devlin N, Shah K, Feng Y, Mulhern B, Van Hout B. Valuing health-related quality of life: an EQ-5D-5L value set for England. Health Econ 2018;27:7–22. 10.1002/hec.356428833869
  47. Beecham J, Knapp M. Costing Psychiatric Interventions. In Thornicroft J, editor. Measuring Mental Health Needs. Cambridge: Cambridge University Press; 2001. pp. 200–24.
  48. Bouhassira D, Attal N, Fermanian J, Alchaar H, Gautron M, Masquelier E, et al. Development and validation of the Neuropathic Pain Symptom Inventory. Pain 2004;108:248–57. 10.1016/j.pain.2003.12.02415030944
  49. Demant DT, Lund K, Vollert J, Maier C, Segerdahl M, Finnerup NB, et al. The effect of oxcarbazepine in peripheral neuropathic pain depends on pain phenotype: a randomised, double-blind, placebo-controlled phenotype-stratified study. Pain 2014;155:2263–73. 10.1016/j.pain.2014.08.01425139589
  50. Bouhassira D, Wilhelm S, Schacht A, Perrot S, Kosek E, Cruccu G, et al. Neuropathic pain phenotyping as a predictor of treatment response in painful diabetic neuropathy: data from the randomized, double-blind, COMBO-DN study. Pain 2014;155:2171–9. 10.1016/j.pain.2014.08.02025168665
  51. Marchettini P, Wilhelm S, Petto H, Tesfaye S, Tölle T, Bouhassira D, et al. Are there different predictors of analgesic response between antidepressants and anticonvulsants in painful diabetic neuropathy? Eur J Pain 2016;20:472–82. 10.1002/ejp.76326311228
  52. Bouhassira D, Branders S, Attal N, Fernandes AM, Demolle D, Barbour J, et al. Stratification of patients based on the Neuropathic Pain Symptom Inventory: development and validation of a new algorithm. Pain 2021;162:1038–46. 10.1097/j.pain.000000000000213033136982
  53. Joint Formulary Committee. British National Formulary (online). London: BMJ Group and Pharmaceutical Press. URL: www.medicinescomplete.com/mc/bnf/current/PHP5799-degarelix.htm (accessed 9 December 2021).
  54. Julious SA, Walters SJ. Estimating effect sizes for health-related quality of life outcomes. Stat Methods Med Res 2014;23:430–9. 10.1177/096228021347637923427222
  55. 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;9:105–21. 10.1016/j.jpain.2007.09.00518055266
  56. Julious S. A tutorial in biostatistics: sample sizes for clinical trials with normal data. Stat Med 2004;23:1921–86. 10.1002/sim.178315195324
  57. Gilron I, Bailey JM, Tu D, Holden RR, Jackson AC, Houlden RL. Nortriptyline and gabapentin, alone and in combination for neuropathic pain: a double-blind, randomised controlled crossover trial. Lancet 2009;374:1252–61. 10.1016/S0140-6736(09)61081-319796802
  58. Kenward MG, Molenberghs G. Last observation carried forward: a crystal ball? J Biopharm Stat 2009;19:872–88. 10.1080/1054340090310540620183449
  59. European Medicines Agency. Guideline on Missing Data in Confirmatory Clinical Trials. 2010. URL: www.ema.europa.eu/en/documents/scientific-guideline/guideline-missing-data-confirmatory-clinical-trials_en.pdf (accessed 6 August 2021).
  60. Little RRD. Statistical Analysis with Missing Data. 3rd edn. Chichester: Wiley; 2019. 10.1002/9781119482260
  61. Cro S, Morris TP, Kenward MG, Carpenter JR. Sensitivity analysis for clinical trials with missing continuous outcome data using controlled multiple imputation: a practical guide. Stat Med 2020;39:2815–42. 10.1002/sim.856932419182
  62. National Institute for Health and Care Excellence. Guide to the Methods of Technology Appraisal. 2018. URL: www.nice.org.uk/Media/Default/About/what-we-do/NICE-guidance/NICE-technology-appraisals/technology-appraisal-processes-guide-apr-2018.pdf (accessed 9 December 2021).
  63. Husereau D, Drummond M, Petrou S, Carswell C, Moher D, Greenberg D, et al. Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement. Cost Eff Resour Alloc 2013;11:6. 10.1186/1478-7547-11-623531194
  64. Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, et al. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res 2011;20:1727–36. 10.1007/s11136-011-9903-x21479777
  65. National Institute for Health and Care Excellence. Position Statement on Use of the EQ-5D5L Value Set for England (Updated October 2019). URL: www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/technology-appraisal-guidance/eq-5d-5l (accessed 17 August 2021).
  66. van Hout B, Janssen MF, Feng YS, Kohlmann T, Busschbach J, Golicki D, et al. Interim scoring for the EQ-5D-5L: mapping the EQ-5D-5L to EQ-5D-3L value sets. Value Health 2012;15:708–15. 10.1016/j.jval.2012.02.00822867780
  67. NHS. National Cost Collection for the NHS 2018/19. URL: www.england.nhs.uk/national-cost-collection/ (accessed 9 December).
  68. Curtis L, Burns A. Unit Costs of Health and Social Care 2019. Canterbury: PSSRU, University of Kent; 2019.
  69. The Podiatry Clinic. Podiatry Clinic Tariff. URL: www.thepodiatry-clinic.co.uk/prices/ (accessed 16 May 2022).
  70. A&A Podiatrists. Podiatry Service Prices. URL: www.painfreefeet.co.uk/servicespodiatry/chiropody-cost/ (accessed 16 May 2022).
  71. The Footcare Centre. Treatments and Prices. URL: www.thefootcarecentre.co.uk/treatments-and-prices/ (accessed 16 May 2022).
  72. NHS Employers. NHS TCS 2018 (AfC). URL: www.nhsemployers.org/sites/default/files/media/NHS-terms-and-conditions-pay-poster-201819_0.pdf (accessed 20 December 2021).
  73. Escape Holistic Therapies. Price List. URL: www.escapeholistictherapies.co.uk/price-list/ (accessed 16 May 2022).
  74. Holly’s Holistics. Home Massage and Aromatherapy Treatments Price Guide. URL: https://hollysholistics.co.uk/price-guide/ (accessed 16 May 2022).
  75. Natural at Heart. Treatments and Prices. URL: www.naturalatheart.co.uk/price-list.html (accessed 16 May 2022).
  76. Curtis L, Burns A. Unit Costs of Health and Social Care 2020. Canterbury: PSSRU, University of Kent; 2020.
  77. Office for National Statistics. Earnings and Hours Worked, All Employees: ASHE Table 1. 2020. URL: www.ons.gov.uk/employmentandlabourmarket/peopleinwork/earningsandworkinghours/datasets/allemployeesashetable1 (accessed 2 July 2021).
  78. Mulhern B, Feng Y, Shah K, Janssen MF, Herdman M, van Hout B, Devlin N. Comparing the UK EQ-5D-3L and English EQ-5D-5L value sets. PharmacoEconomics 2018;36:699–713. 10.1007/s40273-018-0628-329476363
  79. Bril V, England J, Franklin GM, Backonja M, Cohen J, Del Toro D, et al. Evidence-based guideline: treatment of painful diabetic neuropathy. Neurology 2011;76:1758–65. 10.1212/WNL.0b013e3182166ebe21482920
  80. Holbech JV, Bach FW, Finnerup NB, Brøsen K, Jensen TS, Sindrup SH. Imipramine and pregabalin combination for painful polyneuropathy: a randomized controlled trial. Pain 2015;156:958–66. 10.1097/j.pain.000000000000014325719617
  81. Finnerup NB, Attal N, Haroutounian S, McNicol E, Baron R, Dworkin RH, et al. Pharmacotherapy for neuropathic pain in adults: a systematic review and meta-analysis. Lancet Neurol 2015;14:162–73. 10.1016/S1474-4422(14)70251-025575710
  82. National Institute for Health and Care Excellence. Neuropathic Pain in Adults: Pharmacological Management in Non-Specialist Settings. Clinical Guideline [CG173]. 2020. URL: www.nice.org.uk/guidance/cg173 (accessed 9 December 2021).
  83. Chaparro LE, Wiffen PJ, Moore RA, Gilron I. Combination pharmacotherapy for the treatment of neuropathic pain in adults. Cochrane Database Syst Rev 2012;7:CD008943. 10.1002/14651858.CD008943.pub2
  84. Collado Mateo D, García Gordillo MA, Olivares PR, Adsuar JC. Normative values of EQ-5D-5L for diabetes patients from Spain. Nutr Hosp 2015;32:1595–602. 10.3305/nh.2015.32.4.960526545523
  85. Wang P, Luo N, Tai ES, Thumboo J. The EQ-5D-5L is more discriminative than the EQ-5D-3L in patients with diabetes in Singapore. Value Health Reg Issues 2016;9:57–62. 10.1016/j.vhri.2015.11.00327881260
  86. Pan CW, Sun HP, Wang X, Ma Q, Xu Y, Luo N, Wang P. The EQ-5D-5L index score is more discriminative than the EQ-5D-3L index score in diabetes patients. Qual Life Res 2015;24:1767–74. 10.1007/s11136-014-0902-625540029
  87. Moisset X, Bouhassira D, Avez Couturier J, Alchaar H, Conradi S, Delmotte MH, et al. Pharmacological and non-pharmacological treatments for neuropathic pain: systematic review and French recommendations. Rev Neurol 2020;176:325–52. 10.1016/j.neurol.2020.01.36132276788
  88. Smith CT, Hopkins C, Sydes M, Woolfall K, Clarke M, Murray G, et al. Good practice principles for sharing individual participant data from publicly funded clinical trials. Trials 2015;16. 10.1186/1745-6215-16-S2-O1
← ConclusionsAcknowledgements →

Attribution. Solomon Tesfaye; Gordon Sloan; Jennifer Petrie; David White; Mike Bradburn; Tracey Young et al. (2022). Optimal pharmacotherapy pathway in adults with diabetic peripheral neuropathic pain: the OPTION-DM RCT. National Institute for Health and Care Research. Copyright © 2022 Tesfaye et al. This work was produced by Tesfaye et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This is an Open Access publication distributed under the terms of the Creative Commons Attribution CC BY 4.0 licence, which permits unrestricted use, distribution, reproduction and adaption in any medium and for any purpose provided that it is properly attributed. See: https://creativecommons.org/licenses/by/4.0/. For attribution the title, original author(s), the publication source – NIHR Journals Library, and the DOI of the publication must be cited. Licensed under CC BY 4.0. NCBI Bookshelf NBK585245. CC BY 4.0. Original source ↗. Text reproduced from the Bookshelf XML without changing wording; figures, images and supplements are not reproduced.

In this chapter Contents

  • References

Source

OpenStax source file ↗

Source record ↗

EvidenceLib is a research-education resource, not medical advice. It does not diagnose, prescribe or recommend starting, stopping or changing any treatment. Talk to a qualified clinician about your own situation. Methods, sources and licences · Rights and removal requests · Legal · Support