The placebo response: Relationship to outcomes in trials of postherpetic neuralgia

Clinical Drug Investigation

Volumn 30, Issue 11, 2010, Pages 739-748

  Irving, Gordon ^a  

^a Swedish Medical Center   (United States)

Author keywords

Clinical trial design; Neuropathic pain; Placebo response; Postherpetic neuralgia

Indexed keywords

AMITRIPTYLINE; CAPSAICIN; CHOLECYSTOKININ; CHOLECYSTOKININ RECEPTOR BLOCKING AGENT; DESIPRAMINE; DEXTROMETHORPHAN; DULOXETINE; FLUPHENAZINE; GABAPENTIN; GW 406381; LAMOTRIGINE; LIDOCAINE; LORAZEPAM; MAGNESIUM; MEMANTINE; METHADONE; MORPHINE; NEUROTRANSMITTER; NORTRIPTYLINE; OPIATE; OPIATE ANTAGONIST; PREGABALIN; TRAMADOL; VALPROATE SEMISODIUM; VARICELLA ZOSTER VACCINE; VINCRISTINE;

ANALGESIA; BRAIN REGION; CLINICAL TRIAL; EMOTION; FIBROMYALGIA; HUMAN; NEUROPATHIC PAIN; NONHUMAN; OUTCOME ASSESSMENT; PLACEBO EFFECT; POSTHERPETIC NEURALGIA; PRIORITY JOURNAL; REMISSION; REVIEW; REWARD; SYSTEMATIC REVIEW; TREATMENT DURATION; TREATMENT RESPONSE;

CONTROLLED CLINICAL TRIALS AS TOPIC; HUMANS; NEURALGIA, POSTHERPETIC; PAIN MEASUREMENT; PATIENT SELECTION; PLACEBO EFFECT; REMISSION, SPONTANEOUS; RESEARCH DESIGN; TIME FACTORS; TREATMENT OUTCOME;

EID: 77956453757     PISSN: 11732563     EISSN: 11791918     Source Type: Journal    
DOI: 10.2165/11584300-000000000-00000     Document Type: Review

References (61)

1. Katz J, Finnerup NB, Dworkin RH. Clinical trial outcome in neuropathic pain: relationship to study characteristics. Neurology 2008 Jan 22; 70 (4): 263-72
2. Enck P, Benedetti F, Schedlowski M. New insights into the placebo and nocebo responses. Neuron 2008 Jul 31; 59 (2): 195-206
3. Quessy SN, Rowbotham MC. Placebo response in neuropathic pain trials. Pain 2008 Sep 15; 138 (3): 479-83
4. Dworkin RH. An overview of neuropathic pain: syndromes, symptoms, signs, and several mechanisms. Clin J Pain 2002 Nov-Dec; 18 (6): 343-9
5. Price DD, Finniss DG, Benedetti F. A comprehensive review of the placebo effect: recent advances and current thought. Annu Rev Psychol 2008; 59: 565-90
6. Petrovic P, Kalso E, Petersson KM, et al. Placebo and opioid analgesia: imaging a shared neuronal network. Science 2002 Mar 1; 295 (5560): 1737-40
7. Wager TD, Rilling JK, Smith EE, et al. Placebo-induced changes in FMRI in the anticipation and experience of pain. Science 2004 Feb 20; 303 (5661): 1162-7
8. Watson A, El-Deredy W, Iannetti GD, et al. Placebo conditioning and placebo analgesia modulate a common brain network during pain anticipation and perception. Pain 2009 Sep; 145 (1-2): 24-30
9. Krummenacher P, Candia V, Folkers G, et al. Prefrontal cortex modulates placebo analgesia. Pain 2010 Mar; 148 (3): 368-74
10. Benedetti F. Mechanisms of placebo and placebo-related effects across diseases and treatments. Annu Rev Pharmacol Toxicol 2008; 48: 33-60
11. Cesselin F. Opioid and anti-opioid peptides. Fundam Clin Pharmacol 1995; 9 (5): 409-33
12. Price DD, Craggs J, Verne GN, et al. Placebo analgesia is accompanied by large reductions in pain-related brain activity in irritable bowel syndrome patients. Pain 2007 Jan; 127 (1-2): 63-72
13. Scott DJ, Stohler CS, Egnatuk CM, et al. Individual differences in reward responding explain placebo-induced expectations and effects. Neuron 2007 Jul 19; 55 (2): 325-36
14. Linde K, Witt CM, Streng A, et al. The impact of patient expectations on outcomes in four randomized controlled trials of acupuncture in patients with chronic pain. Pain 2007 Apr; 128 (3): 264-71
15. Vase L, Robinson ME, Verne GN, et al. Increased placebo analgesia over time in irritable bowel syndrome (IBS) patients is associated with desire and expectation but not endogenous opioid mechanisms. Pain 2005 Jun; 115 (3): 338-47
16. Amanzio M, Corazzini LL, Vase L, et al. A systematic review of adverse events in placebo groups of anti-migraine clinical trials. Pain 2009 Dec; 146 (3): 261-9
17. Benedetti F, Amanzio M, Vighetti S, et al. The biochemical and neuroendocrine bases of the hyperalgesic nocebo effect. J Neurosci 2006 Nov 15; 26 (46): 12014-22
18. Rhudy JL,Meagher MW. Fear and anxiety: divergent effects on human pain thresholds. Pain 2000 Jan; 84 (1): 65-75
19. Hebb AL, Poulin JF, Roach SP, et al. Cholecystokinin and endogenous opioid peptides: interactive influence on pain, cognition, and emotion. Prog Neuropsychopharmacol Biol Psychiatry 2005 Dec; 29 (8): 1225-38
20. Al Absi M, Rokke PD. Can anxiety help us tolerate pain? Pain 1991 Jul; 46 (1): 43-51
21. Morton DL, Watson A, El-DeredyW, et al. Reproducibility of placebo analgesia: effect of dispositional optimism. Pain 2009 Nov; 146 (1-2): 194-8
22. Petrovic P, Dietrich T, Fransson P, et al. Placebo in emotional processing: induced expectations of anxiety relief activate a generalized modulatory network. Neuron 2005 Jun 16; 46 (6): 957-69
23. Vase L, Petersen GL, Riley III JL, et al. Factors contributing to large analgesic effects in placebomechanism studies conducted between 2002 and 2007. Pain 2009 Sep; 145 (1-2): 36-44
24. Vase L, Riley III JL, Price DD. A comparison of placebo effects in clinical analgesic trials versus studies of placebo analgesia. Pain 2002 Oct; 99 (3): 443-52
25. Rowbotham MC, Reisner-Keller LA, Fields HL. Both intravenous lidocaine and morphine reduce the pain of postherpetic neuralgia. Neurology 1991 Jul; 41 (7): 1024-8
26. De Benedittis G, Lorenzetti A. Topical aspirin/diethyl ether mixture versus indomethacin and diclofenac/diethyl ether mixtures for acute herpetic neuralgia and postherpetic neuralgia: a double-blind crossover placebo-controlled study. Pain 1996 Apr; 65 (1): 45-51
27. Baranowski AP, De Courcey J, Bonello E. A trial of intravenous lidocaine on the pain and allodynia of postherpetic neuralgia. J Pain Symptom Manage 1999 Jun; 17 (6): 429-33
28. Brill S, Sedgwick PM, Hamann W, et al. Efficacy of intravenous magnesium in neuropathic pain. Br J Anaesth 2002 Nov; 89 (5): 711-4
29. Wallace MS, Moulin D, Clark AJ, et al. A Phase II, multicenter, randomized, double-blind, placebo-controlled crossover study of CJC-1008 - a long-acting, parenteral opioid analgesic - in the treatment of postherpetic neuralgia. JOpioid Manag 2006 May-Jun; 2 (3): 167-73
30. Max MB, Schafer SC, Culnane M, et al. Amitriptyline, but not lorazepam, relieves postherpetic neuralgia. Neurology 1988 Sep; 38 (9): 1427-32
31. Kishore-Kumar R,Max MB, Schafer SC, et al. Desipramine relieves postherpetic neuralgia. Clin Pharmacol Ther 1990 Mar; 47 (3): 305-12
32. Watson CP, Tyler KL, Bickers DR, et al. A randomized vehicle-controlled trial of topical capsaicin in the treatment of postherpetic neuralgia. Clin Ther 1993 May-Jun; 15 (3): 510-26
33. Rowbotham M, Harden N, Stacey B, et al. Gabapentin for the treatment of postherpetic neuralgia: a randomized controlled trial. JAMA 1998 Dec 2; 280 (21): 1837-42
34. Dowd NP, Day F, Timon D, et al. Iontophoretic vincristine in the treatment of postherpetic neuralgia: a double-blind, randomized, controlled trial. J Pain Symptom Manage 1999 Mar; 17 (3): 175-80
35. Graff-Radford SB, Shaw LR, Naliboff BN. Amitriptyline and fluphenazine in the treatment of postherpetic neuralgia. Clin J Pain 2000 Sep; 16 (3): 188-92
36. Rice AS, Maton S, Postherpetic Neuralgia Study Group. Gabapentin in postherpetic neuralgia: a randomised, double blind, placebo controlled study. Pain 2001 Nov; 94 (2): 215-24
37. Sang CN, Booher S, Gilron I, et al. Dextromethorphan and memantine in painful diabetic neuropathy and postherpetic neuralgia: efficacy and dose-response trials. Anesthesiology 2002 May; 96 (5): 1053-61
38. Galer BS, Jensen MP, Ma T, et al. The lidocaine patch 5% effectively treats all neuropathic pain qualities: results of a randomized, double-blind, vehicle-controlled, 3-week efficacy study with use of the neuropathic pain scale. Clin J Pain 2002 Sep-Oct; 18 (5): 297-301
39. Raja SN, Haythornthwaite JA, Pappagallo M, et al. Opioids versus antidepressants in postherpetic neuralgia: a randomized, placebo-controlled trial. Neurology 2002 Oct 8; 59 (7): 1015-21
40. Dworkin RH, Corbin AE, Young Jr JP, et al. Pregabalin for the treatment of postherpetic neuralgia: a randomized, placebo-controlled trial. Neurology 2003 Apr 22; 60 (8): 1274-83
41. Boureau F, Legallicier P, Kabir-Ahmadi M. Tramadol in post-herpetic neuralgia: a randomized, double-blind, placebocontrolled trial. Pain 2003 Jul; 104 (1-2): 323-31
42. Kochar DK, Garg P, Bumb RA, et al. Divalproex sodium in the management of post-herpetic neuralgia: a randomized double-blind placebo-controlled study. Q J Med 2005 Jan; 98 (1): 29-34
43. Van Seventer R, Feister HA, Young Jr JP, et al. Efficacy and tolerability of twice-daily pregabalin for treating pain and related sleep interference in postherpetic neuralgia: a 13-week, randomized trial. Curr Med Res Opin 2006 Feb; 22 (2): 375-84
44. Stacey BR, Barrett JA, Whalen E, et al. Pregabalin for postherpetic neuralgia: placebo-controlled trial of fixed and flexible dosing regimens on allodynia and time to onset of pain relief. J Pain 2008 Nov; 9 (11): 1006-17
45. Irving G, Jensen M, Cramer M, et al. Efficacy and tolerability of gastric-retentive gabapentin for the treatment of postherpetic neuralgia: results of a double-blind, randomized, placebo-controlled clinical trial. Clin J Pain 2009 Mar-Apr; 25 (3): 185-92
46. Shackelford S, Rauck R, Quessy S, et al. A randomized, double-blind, placebo-controlled trial of a selective COX-2 inhibitor, GW406381, in patients with postherpetic neuralgia. J Pain 2009 Jun; 10 (6): 654-60
47. Wallace MS, Irving G, Cowles VE. Gabapentin extendedrelease tablets for the treatment of patients with postherpetic neuralgia: a randomized, double-blind, placebo-controlled, multicentre study. Clin Drug Investig 2010; 30 (11): 765-76
48. Irizarry MC, Webb DJ, Ali Z, et al. Predictors of placebo response in pooled lamotrigine neuropathic pain clinical trials. Clin J Pain 2009 Jul-Aug; 25 (6): 469-76
49. Fisher JA. Ready-to-recruit or ready-to-consent populations? Informed consent and the limits of subject autonomy. Qualitative Inquiry 2007; 13 (6): 875-94
50. Kost RG, Straus SE. Postherpetic neuralgia: pathogenesis, treatment, and prevention. N Engl J Med 1996 Jul 4; 335 (1): 32-42
51. Whitley RJ, Shukla S, Crooks RJ. The identification of risk factors associated with persistent pain following herpes zoster. J Infect Dis 1998 Nov; 178 Suppl. 1: S71-5
52. Oxman MN, Levin MJ, Johnson GR, et al., Shingles Prevention Study Group. A vaccine to prevent herpes zoster and postherpetic neuralgia in older adults. N Engl J Med 2005 Jun 2; 352 (22): 2271-84
53. Backonja M, Wallace MS, Blonsky ER, et al. NGX-4010, a high-concentration capsaicin patch, for the treatment of postherpetic neuralgia: a randomised, double-blind study. Lancet Neurol 2008 Dec; 7 (12): 1106-12
54. Dworkin RH, Katz J, Gitlin MJ. Placebo response in clinical trials of depression and its implications for research on chronic neuropathic pain. Neurology 2005 Dec 29; 65 (12 Suppl. 4): S7-19
55. Johnson RW. Herpes zoster and postherpetic neuralgia: a review of the effects of vaccination. Aging Clin Exp Res 2009 Jun; 21 (3): 236-43
56. Straube S, Derry S, McQuay HJ, et al. Enriched enrollment: definition and effects of enrichment and dose in trials of pregabalin and gabapentin in neuropathic pain - a systematic review. Br J Clin Pharmacol 2008 Aug; 66 (2): 266-75
57. McQuay HJ, Derry S, Moore RA, et al. Enriched enrolment with randomised withdrawal (EERW): time for a new look at clinical trial design in chronic pain. Pain 2008 Apr; 135 (3): 217-20
58. Crofford LJ, Mease PJ, Simpson SL, et al. Fibromyalgia relapse evaluation and efficacy for durability ofmeaningful relief (FREEDOM): a 6-month, double-blind, placebocontrolled trial with pregabalin. Pain 2008 Jun; 136 (3): 419-31
59. Chappell AS, Littlejohn G, Kajdasz DK, et al. A 1-year safety and efficacy study of duloxetine in patients with fibromyalgia. Clin J Pain 2009 Jun; 25 (5): 365-75
60. Staud R, Price DD. Long-term trials of pregabalin and duloxetine for fibromyalgia symptoms: how study designs can affect placebo factors. Pain 2008 Jun; 136 (3): 232-4
61. Cherkin DC, Deyo RA, Street JH, et al. Pitfalls of patient education: limited success of a program for back pain in primary care. Spine 1996 Feb 1; 21 (3): 345-55