PAIN
Volume 150, Issue 1 , Pages 12-16 , July 2010

Placebo and treatment group responses in postherpetic neuralgia vs. painful diabetic peripheral neuropathy clinical trials in the REPORT database

  • Robert H. Dworkin

      Affiliations

    • Departments of Anesthesiology and Neurology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA
    • Corresponding Author InformationCorresponding author. Tel.: +1 585 275 3524; fax: +1 585 473 5007.
    • ,
  • Dennis C. Turk

      Affiliations

    • Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, WA, USA
    • ,
  • Sarah Peirce-Sandner

      Affiliations

    • Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA
    • ,
  • Michael P. McDermott

      Affiliations

    • Departments of Biostatistics and Computational Biology and Neurology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA
    • ,
  • John T. Farrar

      Affiliations

    • Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, PA, USA
    • ,
  • Sharon Hertz

      Affiliations

    • United States Food and Drug Administration, Bethesda, MD, USA
    • ,
  • Nathaniel P. Katz

      Affiliations

    • Analgesic Research, Needham, MA, and Tufts University, Boston, MA, USA
    • ,
  • Srinivasa N. Raja

      Affiliations

    • Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University, Baltimore, MD, USA
    • ,
  • Bob A. Rappaport

      Affiliations

    • United States Food and Drug Administration, Bethesda, MD, USA

Received 4 October 2009 ,Revised 14 January 2010 ,Accepted 1 February 2010.

References 

  1. Attal N, Cruccu G, Haanpää M, Hansson P, Jensen TS, Nurmikko T, et al. EFNS guidelines on pharmacological treatment of neuropathic pain. Eur J Neurol. 2006;13:1153–1169
  2. Baron R. Mechanisms of disease: neuropathic pain – a clinical perspective. Nat Clin Pract Neurol. 2006;2:95–106
  3. Baron R, Tölle TR, Gockel U, Brosz M, Freynhagen R. A cross-sectional cohort survey in 2100 patients with painful diabetic neuropathy and postherpetic neuralgia: differences in demographic data and sensory symptoms. Pain. 2009;146:34–40
  4. Beydoun A, Shaibani A, Hopwood M, Wan Y. Oxcarbazepine in painful diabetic neuropathy: results of a dose-ranging study. Acta Neurol Scand. 2006;113:395–404
  5. Dworkin RH, Katz J, Gitlin MJ. Placebo response in clinical trials of depression and its implications for research on chronic neuropathic pain. Neurology. 2005;65:S7–S19
  6. Dworkin RH, O’Connor AB, Backonja M, Farrar JT, Finnerup NB, Jensen TS, et al. Pharmacologic management of neuropathic pain: evidence-based recommendations. Pain. 2007;132:237–251
  7. Dworkin RH, Turk DC, Farrar JT, Haythornthwaite JA, Jensen MP, Katz NP, et al. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005;113:9–19
  8. 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;146:238–244
  9. 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
  10. Ellenberg SS, Temple R. Placebo-controlled trials and active-control trials in the evaluation of new treatments, part 2: practical issues and specific cases. Ann Intern Med. 2000;133:464–470
  11. European Medicines Agency. Guideline on clinical and medicinal products intended for the treatment of neuropathic pain; 2007. Available from: www.emea.europa.eu.
  12. Finnerup NB, Otto M, Jensen TS, Sindrup SH. Algorithm for neuropathic pain treatment: an evidence based proposal. Pain. 2005;118:289–305
  13. International Conference on Harmonization. Choice of control group and related issues in clinical trials: E10; 2001. Available from: ww.fda.gov/cder/guidance/index.htm#ICH_efficacy.
  14. Katz J, Finnerup NB, Dworkin RH. Clinical trial outcome in neuropathic pain: relationship to study characteristics. Neurology. 2008;70:263–272
  15. Katz N. Methodological issues in clinical trials of opioids for chronic pain. Neurology. 2005;65:S32–S49
  16. McQuay HJ, Derry S, Moore RA, Poulain P, Legout V. Enriched enrolment with randomised withdrawal (EERW): time for a new look at clinical trial design in chronic pain. Pain. 2008;135:217–220
  17. Moulin DE, Clark AJ, Gilron I, Ware MA, Watson CP, Sessle BJ, et al. Pharmacological management of chronic neuropathic pain: consensus statement and guidelines from the Canadian Pain Society. Pain Res Manage. 2007;12:13–21
  18. Oaklander AL. Mechanisms of pain and itch caused by herpes zoster (shingles). J Pain. 2008;9:S8–S10
  19. O’Connor AB. The need for improved access to FDA reviews. JAMA. 2009;302:191–193
  20. Pfizer, Inc. PhRMA web synopsis (Protocol A0081007): a randomized placebo-controlled trial of the efficacy and safety of pregabalin in the treatment of subjects with neuropathic pain associated with lumbo-sacral radiculopathy; 2008. Available from: http://pdf.clinicalstudyresults.org/documents/company-study_4268_0.pdf.
  21. Quessy SN, Rowbotham MC. Placebo response in neuropathic pain trials. Pain. 2008;138:479–483
  22. Raskin P, Donofrio PD, Rosenthal NR, Hewitt DJ, Jordan DM, Xiang J, et al. Topiramate vs placebo in painful diabetic neuropathy: analgesic and metabolic effects. Neurology. 2004;63:865–873
  23. Rowbotham MC. Mechanisms of neuropathic pain and their implications for the design of clinical trials. Neurology. 2005;65:S66–S73
  24. Rowbotham MC. The impact of selective publication on clinical research in pain. Pain. 2008;140:401–404
  25. Rowbotham MC. The case for publishing ‘negative’ clinical trials. Pain. 2009;146:225–226
  26. Silver M, Blum D, Grainger J, Hammer AE, Quessy S. Double-blind, placebo-controlled trial of lamotrigine in combination with other medications for neuropathic pain. J Pain Symptom Manage. 2007;34:446–454
  27. Simpson DM, Clifford D, Schiffito G. Pregabalin in the treatment of painful HIV neuropathy: a randomized, double-blind, placebo-controlled trial. Seattle, WA: American Academy of Neurology; 2009;
  28. Temple R, Ellenberg SS. Placebo-controlled trials and active-control trials in the evaluation of new treatments, part 1: ethical and scientific issues. Ann Intern Med. 2000;133:455–463
  29. Thienel U, Neto W, Schwabe SK, Vijapurkar U. Topiramate in painful diabetic polyneuropathy: findings from three double-blind placebo-controlled trials. Acta Neurol Scand. 2004;110:221–231
  30. Turk DC, Dworkin RH, Allen RR, Bellamy N, Brandenburg N, Carr DB, et al. Core outcome domains for chronic pain clinical trials: IMMPACT recommendations. Pain. 2003;106:337–345
  31. Turk DC, Dworkin RH, Burke LB, Gershon R, Rothman M, Scott J, et al. Developing outcome measures for pain clinical trials: IMMPACT recommendations. Pain. 2006;125:208–215
  32. Turk DC, Dworkin RH, McDermott MP, Bellamy N, Burke LB, Chandler JM, et al. Analyzing multiple endpoints in clinical trials of pain treatments: IMMPACT recommendations. Pain. 2008;139:485–493
  33. Vedula SS, Bero L, Scherer RW, Dickersin K. Outcome reporting in industry-sponsored trials of gabapentin for off-label use. N Engl J Med. 2009;361:1963–1971
  34. Vinik AI, Tuchman M, Safirstein B, Corder C, Kirby L, Wilks K, et al. Lamotrigine for treatment of pain associated with diabetic neuropathy: results of two randomized double-blind, placebo-controlled studies. Pain. 2007;128:169–179
  35. Woolf CJ. Pain: moving from symptom control toward mechanism-specific pharmacologic management. Ann Intern Med. 2004;140:441–451
  36. XenoPort, Inc. Phase II results for GSK1838262 (XP13512) reported for neuropathic pain associated with diabetic peripheral neuropathy; 2009. Available from: http://phx.corporate-ir.net/phoenix.zhtml?c=187883&p=irol-newsArticle&ID=1280577&highlight=.
  37. Zhang W, Robertson J, Jones AC, Dieppe PA, Doherty M. The placebo effect and its determinants in osteoarthritis: meta-analysis of randomized controlled trials. Ann Rheum Dis. 2008;67:1716–1723

PII: S0304-3959(10)00067-9

doi: 10.1016/j.pain.2010.02.002

PAIN
Volume 150, Issue 1 , Pages 12-16 , July 2010

Article Tools