Clinical trial outcome in neuropathic pain: Relationship to study characteristics

Neurology

Volumn 70, Issue 4, 2008, Pages 263-272

  Katz, Jennifer ^a,b   Finnerup, Nanna B ^c   Dworkin, Robert H ^b  

^a STATE UNIVERSITY OF NEW YORK   (United States)

^b UNIVERSITY OF ROCHESTER SCHOOL OF MEDICINE AND DENTISTRY   (United States)

^c AARHUS UNIVERSITY HOSPITAL   (Denmark)

Author keywords

[No Author keywords available]

Indexed keywords

ANTICONVULSIVE AGENT; ANTIDEPRESSANT AGENT; CANNABINOID; CAPSAICIN; GLYCINE RECEPTOR ANTAGONIST; LAMOTRIGINE; LIDOCAINE; MEXILETINE; N METHYL DEXTRO ASPARTIC ACID RECEPTOR BLOCKING AGENT; OPIATE; OXCARBAZEPINE; PLACEBO; TOPIRAMATE; TRAMADOL;

ARTICLE; CLINICAL TRIAL; COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; HUMAN; MAJOR CLINICAL STUDY; MULTIVARIATE ANALYSIS; NEUROPATHIC PAIN; OUTCOME ASSESSMENT; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; TREATMENT RESPONSE; UNIVARIATE ANALYSIS;

EID: 38549120670     PISSN: 00283878     EISSN: None     Source Type: Journal    
DOI: 10.1212/01.wnl.0000275528.01263.6c     Document Type: Article

References (47)

1. Kieburtz K, Simpson D, Yiannoutsos C, et al. A randomized trial of amitriptyline and mexiletine for painful neuropathy in HIV infection. Neurology 1998;51:1682-1688.
2. Shlay JC, Chaloner K, Max MB, et al. Acupuncture and amitriptyline for pain due to HIV-related peripheral neuropathy: a randomized controlled trial. JAMA 1998;280:1590-1595.
3. Thienel U, Neto W, Schwabe SK, Vijapurkur U. Topiramate in painful diabetic polyneuropathy: findings from three double-blind placebo-controlled trials. Acta Neurol Scand 2004;110:221-231.
4. Neurobiological technologies. Memantine. Available at: www.ntii.com/products/memantine.shtml. Accessed June 20, 2005.
5. 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.
6. Grainger J, Hammer A, Blum D, Silver M, Quessy S. Double-blind, placebo-controlled trial of add-on lamotrigine in patients with neuropathic pain and inadequate relief with gabapentin, TCAs or non-narcotic analgesics. J Pain 2006;7(suppl 2):S34.
7. Grosskopf J, Mazzola J, Wan Y, Hopwood M. A randomized, placebo-controlled study of oxcarbazepine in painful diabetic neuropathy. Acta Neurol Scand 2006;114:177-180.
8. Vinik AI, Tuchman M, Safirstein B, 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.
9. Max MB. Neuropathic pain syndromes. In: Max MB, Portenoy RK, Laska EM, eds. The design of analgesic clinical trials. New York: Raven Press; 1991:193-219.
10. Max MB. Small clinical trials. In: Gallin JI, Ognibene F, eds. Principles and practice of clinical research, 2nd edition. New York: Elsevier; 2007:219-235.
11. Raskin P, Donofrio PD, Rosenthal NR, et al. Topiramate vs placebo in painful diabetic neuropathy: analgesic and metabolic effects. Neurology 2004;63:865-873.
12. 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(suppl 4):S7-S19.
13. Katz N. Methodological issues in clinical trials of opioids for chronic pain. Neurology 2005;65(suppl 4):S32-S49.
14. Ernst E, Resch KL. Concept of true and perceived placebo effects. BMJ 1995;311:551-553.
15. Turner JA, Deyo RA, Loeser JD, Von Korff M, Fordyce WE. The importance of placebo effects in pain treatment and research. JAMA 1994;271:1609-1614.
16. Vase L, Riley JLIII, Price DD. A comparison of placebo effects in clinical analgesic trials versus studies of placebo analgesia. Pain 2002;99:443-452.
17. Finnerup NB, Otto M, Jensen TS, Sindrup SH. Algorithm for neuropathic pain treatment: an evidence based proposal. Pain 2005;118:289-305.
18. McQuay HJ, Carroll D, Jadad AR, et al. Dextromethorphan for the treatment of neuropathic pain: a double-blind randomized controlled crossover trial with an integral n-of-1 design. Pain 1994;59:127-133.
19. McCleane G. 200 mg daily of lamotrigine has no analgesic effect in neuropathic pain: a randomized, double-blind, placebo controlled trial. Pain 1999;83:105-107.
20. McCleane G. Topical application of doxepin hydrochloride, capsaicin and a combination of both produces analgesia in chronic neuropathic pain: a randomized, double-blind, placebo-controlled study. Br J Clin Pharmacol 2000;49:574-579.
21. Hosmer DW, Lemeshow S. Applied logistic regression, 2nd ed. New York: John Wiley; 2000.
22. McQuay H, Carroll D, Moore A. Variation in the placebo effect in randomised controlled trials of analgesics: all is as blind as it seems. Pain 1995;64:331-335.
23. Dworkin RH, Backonja M, Rowbotham MC, et al. Advances in neuropathic pain: diagnosis, mechanisms, and treatment recommendations. Arch Neurol 2003;60:1524-1534.
24. Dubinsky RM, Kabbani H, El-Chami Z, Boutwell C, Ali H. Practice parameter: treatment of postherpetic neuralgia: an evidence-based report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology 2004;63:959-965.
25. Walsh BT, Seidman SN, Sysko R, Gould M. Placebo response in studies of major depression: variable, substantial, and growing. JAMA 2002;287:1840-1847.
26. Khan A, Detke M, Khan SRF, Mallinckrodt C. Placebo response and antidepressant clinical trial outcome. J Nerv Ment Dis 2003;191:211-218.
27. Khan A, Khan SR, Walens G, Kolts R, Giller EL. Frequency of positive studies among fixed and flexible dose antidepressant clinical trials: an analysis of the Food and Drug Administration summary basis of approval reports. Neuropsychopharmacology 2003;28:552-557.
28. Khan A, Kolts RL, Thase ME, Krishnan KRR, Brown W. Research design features and patient characteristics associated with the outcome of antidepressant clinical trials. Am J Psychiatry 2004;161:2045-2049.
29. Khan A, Schwartz K, Kolts RL, Ridgway D, Lineberry C. Relationship between depression severity entry criteria and antidepressant trial outcomes. Biol Psychiatry 2007;62:65-71.
30. Khan A, Leventhal RM, Khan SR, Brown WA. Severity of depression and response to antidepressants and placebo; an analysis of the Food and Drug Administration database. J Clin Psychopharmacol 2002;22:40-45.
31. Schatzberg AF, Kraemer HC. Use of placebo control groups in evaluating efficacy of treatment of unipolar major depression. Biol Psychiatry 2000;47:736-744.
32. Fava M, Evins AE, Dorer DJ, Schoenfeld DA. The problem of the placebo response in clinical trials for psychiatric disorders: culprits, possible remedies, and a novel study design approach. Psychother Psychosom 2003;72:115-127.
33. Zimbroff DL. Patient and rater education of expectations in clinical trials (PREECT). J Clin Psychiatry 2001;21:251-252.
34. Greist JH, Mundt JC, Kobak K. Factors contributing to failed trials of new agents: can technology prevent some problems? J Clin Psychiatry 2002;63(suppl 2):8-13.
35. Yang H, Cusin C, Fava M. Is there a placebo problem in antidepressant trials? Curr Top Med Chem 2005;5:1077-1086.
36. Moore RA, Gavaghan D, Tramèr MR, Collins SL, McQuay HJ. Size is everything: large amounts of information are needed to overcome random effects in estimating direction and magnitude of treatment effects. Pain 1998;78:209-216.
37. McQuay HJ, Moore RA. Placebo. Postgrad Med J 2005;81:155-160.
38. Shetty N, Friedman JH, Kieburtz K, Marshall FJ, Oakes D. The placebo response in Parkinson's disease. Clin Neuropharmacol 1999;22:207-212.
39. Moerman DE. "The loaves and the fishes:" a comment on "The emperor's new drugs: an analysis of antidepressant medication data submitted to the U.S. Food and Drug Administration." Prevention Treatment 2002;5:article 29.
40. Kleijnen J, de Craen AJM, van Everdingen J, Krol L. Placebo effect in double-blind clinical trials: a review of interactions with medications. Lancet 1994;344:1347-1349.
41. de la Fuente-Fernandez R, Ruth TJ, Sossi V, Schulzer M, Calne DB, Stoessl AJ. Expectation and dopamine release: mechanism of the placebo effect in Parkinson's disease. Science 2001;293:1164-1166.
42. de la Fuente-Fernandez R, Schulzer M, Stoessl AJ. The placebo effect in neurological disorders. Lancet Neurology 2002;1:85-91.
43. Ziegler D, Pritchett YL, Wang F, et al. Impact of disease characteristics on the efficacy of duloxetine in diabetic peripheral neuropathic pain. Diabetes Care 2007;30:664-669.
44. Wasan AD, Davar G, Jamison R. The association between negative affect and opioid analgesia in patients with discogenic low back pain. Pain 2005;117:450-461.
45. Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole RM. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain 2001;94:149-158.
46. Rush AJ. The use of placebos in unipolar major depression: the current status. Biol Psychiatry 2000;47:745-747.
47. Otto MW, Nierenberg AA. Assay sensitivity, failed clinical trials, and the conduct of science. Psychother Psychosom 2002;71:241-243.