Serum correlates of the placebo effect in irritable bowel syndrome

Neurogastroenterology and Motility

Volumn 22, Issue 3, 2010, Pages

  Kokkotou, E ^a   Conboy, L A ^a   Ziogas, D C ^a   Quilty, M T ^a   Kelley, J M ^b,c   Davis, R B ^a   Lembo, A J ^a   Kaptchuk, T J ^a  

^a HARVARD MEDICAL SCHOOL   (United States)

^b MASSACHUSETTS GENERAL HOSPITAL   (United States)

^c ENDICOTT COLLEGE   (United States)

Author keywords

Biomarkers; Irritable bowel syndrome; Placebo effect; Randomized controlled trials; Serum

Indexed keywords

BIOLOGICAL MARKER; BRAIN DERIVED GROWTH FACTOR; GELATINASE B; GROWTH REGULATED ONCOGENE ALPHA; INTERLEUKIN 1BETA; MACROPHAGE INFLAMMATORY PROTEIN 3BETA; MELANOMA GROWTH STIMULATORY ACTIVITY FACTOR; NEUTROPHIL GELATINASE ASSOCIATED LIPOCALIN; OSTEOPROTEGERIN; PLACEBO; TISSUE INHIBITOR OF METALLOPROTEINASE 1; TUMOR NECROSIS FACTOR; TUMOR NECROSIS FACTOR RELATED WEAK INDUCER OF APOPTOSIS; UNCLASSIFIED DRUG; VASCULOTROPIN;

ACUPUNCTURE; ADULT; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; FEMALE; HUMAN; IMMUNOASSAY; IRRITABLE COLON; MAJOR CLINICAL STUDY; MALE; MULTIPLEX ELECTROCHEMILUMINESCENT IMMUNOASSAY; PLACEBO EFFECT; PRIORITY JOURNAL; PROTEIN BLOOD LEVEL; RANDOMIZED CONTROLLED TRIAL; SELF REPORT; SHAM PROCEDURE; SINGLE BLIND PROCEDURE; TREATMENT RESPONSE;

ACUPUNCTURE THERAPY; ADULT; BIOLOGICAL MARKERS; FEMALE; HUMANS; IRRITABLE BOWEL SYNDROME; MALE; MIDDLE AGED; OSTEOPROTEGERIN; PATIENT SELECTION; PLACEBO EFFECT; QUESTIONNAIRES; STATISTICS, NONPARAMETRIC; TREATMENT OUTCOME; TUMOR NECROSIS FACTORS;

EID: 76349096467     PISSN: 13501925     EISSN: 13652982     Source Type: Journal    
DOI: 10.1111/j.1365-2982.2009.01440.x     Document Type: Article

References (60)

1. Kaptchuk TJ. Powerful placebo: the dark side of the randomised controlled trial. Lancet 1998 351 : 1722 1725.
2. 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.
3. Zarin DA, Ide NC, Tse T, Harlan WR, West JC, Lindberg DA. Issues in the registration of clinical trials. JAMA 2007 297 : 2112 2120.
4. 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.
5. Petrovic P, Kalso E, Petersson KM, Ingvar M. Placebo and opioid analgesia - imaging a shared neuronal network. Science 2002 295 : 1737 1740.
6. Benedetti F. Mechanisms of placebo and placebo-related effects across diseases and treatments. Annu Rev Pharmacol Toxicol 2008 48 : 33 60.
7. Zubieta JK, Stohler CS. Neurobiological mechanisms of placebo responses. Ann N Y Acad Sci 2009 1156 : 198 210.
8. Klosterhalfen S, Enck P. Neurophysiology and psychobiology of the placebo response. Curr Opin Psychiatry 2008 21 : 189 195.
9. Price DD, Finniss DG, Benedetti F. A comprehensive review of the placebo effect: recent advances and current thought. Annu Rev Psychol 2008 59 : 565 590.
10. Enck P, Benedetti F, Schedlowski M. New insights into the placebo and nocebo responses. Neuron 2008 59 : 195 206.
11. Wager TD, Rilling JK, Smith EE et al. Placebo-induced changes in FMRI in the anticipation and experience of pain. Science 2004 303 : 1162 1167.
12. Dorn SD, Kaptchuk TJ, Park JB et al. A meta-analysis of the placebo response in complementary and alternative medicine trials of irritable bowel syndrome. Neurogastroenterol Motil 2007 19 : 630 637.
13. Bernstein CN. The placebo effect for gastroenterology: tool or torment. Clin Gastroenterol Hepatol 2006 4 : 1302 1308.
14. Price DD, Craggs J, Verne GN, Perlstein WM, Robinson ME. Placebo analgesia is accompanied by large reductions in pain-related brain activity in irritable bowel syndrome patients. Pain 2007 127 : 63 72.
15. Vase L, Robinson ME, Verne GN, Price DD. The contributions of suggestion, desire, and expectation to placebo effects in irritable bowel syndrome patients. An empirical investigation. Pain 2003 105 : 17 25.
16. Mayer EA, Naliboff BD, Chang L. Basic pathophysiologic mechanisms in irritable bowel syndrome. Dig Dis 2001 19 : 212 218. (Pubitemid 34045213)
17. Hrobjartsson A, Gotzsche PC. Is the placebo powerless? An analysis of clinical trials comparing placebo with no treatment. N Engl J Med 2001 344 : 1594 1602.
18. Pitz M, Cheang M, Bernstein CN. Defining the predictors of the placebo response in irritable bowel syndrome. Clin Gastroenterol Hepatol 2005 3 : 237 247.
19. Arebi N, Gurmany S, Bullas D, Hobson A, Stagg A, Kamm M. Review article: the psychoneuroimmunology of irritable bowel syndrome - an exploration of interactions between psychological, neurological and immunological observations. Aliment Pharmacol Ther 2008 28 : 830 840.
20. Talley NJ, Weaver AL, Zinsmeister AR, Melton LJ 3rd. Onset and disappearance of gastrointestinal symptoms and functional gastrointestinal disorders. Am J Epidemiol 1992 136 : 165 177.
21. Mayer EA. The neurobiology of stress and gastrointestinal disease. Gut 2000 47 : 861 869.
22. Nicholl BI, Halder SL, Macfarlane GJ et al. Psychosocial risk markers for new onset irritable bowel syndrome - results of a large prospective population-based study. Pain 2008 137 : 147 155.
23. Jarcho JM, Chang L, Berman SM et al. Neural and psychological predictors of treatment response in irritable bowel syndrome patients with a 5-HT(3) receptor antagonist - a pilot study. Aliment Pharmacol Ther 2008 28 : 344 352.
24. Tache Y, Martinez V, Million M, Rivier J. Corticotropin-releasing factor and the brain-gut motor response to stress. Can J Gastroenterol 1999 13 (Suppl A 18A 25A.
25. Dinan TG, Quigley EM, Ahmed SM et al. Hypothalamic-pituitary-gut axis dysregulation in irritable bowel syndrome: plasma cytokines as a potential biomarker? Gastroenterology 2006 130 : 304 311.
26. Fukudo S. Role of corticotropin-releasing hormone in irritable bowel syndrome and intestinal inflammation. J Gastroenterol 2007 42 (Suppl 17 48 51.
27. Kaptchuk TJ, Kelley JM, Conboy LA et al. Components of placebo effect: randomised controlled trial in patients with irritable bowel syndrome. BMJ 2008 336 : 999 1003.
28. Lembo AJ, Neri B, Tolley J, Barken D, Carroll S, Pan H. Use of serum biomarkers in a diagnostic test for irritable bowel syndrome. Aliment Pharmacol Ther 2009 29 : 834 842.
29. Conboy LA, Wasserman RH, Jacobson EE et al. Investigating placebo effects in irritable bowel syndrome: a novel research design. Contemp Clin Trials 2006 27 : 123 134.
30. Camilleri M, Mangel AW, Fehnel SE, Drossman DA, Mayer EA, Talley NJ. Primary endpoints for irritable bowel syndrome trials: a review of performance of endpoints. Clin Gastroenterol Hepatol 2007 5 : 534 540.
31. Passos MC, Lembo AJ, Conboy LA et al. Adequate relief in a treatment trial with IBS patients: a prospective assessment. Am J Gastroenterol 2009 104 : 912 919.
32. Berman SM, Naliboff BD, Suyenobu B et al. Reduced brainstem inhibition during anticipated pelvic visceral pain correlates with enhanced brain response to the visceral stimulus in women with irritable bowel syndrome. J Neurosci 2008 28 : 349 359.
33. Franchimont N, Reenaers C, Lambert C et al. Increased expression of receptor activator of NF-kappaB ligand (RANKL), its receptor RANK and its decoy receptor osteoprotegerin in the colon of Crohn's disease patients. Clin Exp Immunol 2004 138 : 491 498.
34. Bernstein CN, Sargent M, Leslie WD. Serum osteoprotegerin is increased in Crohn's disease: a population-based case control study. Inflamm Bowel Dis 2005 11 : 325 330.
35. Winkles JA. The TWEAK-Fn14 cytokine-receptor axis: discovery, biology and therapeutic targeting. Nat Rev Drug Discov 2008 7 : 411 425.
36. Maecker H, Varfolomeev E, Kischkel F et al. TWEAK attenuates the transition from innate to adaptive immunity. Cell 2005 123 : 931 944.
37. Dohi T, Borodovsky A, Wu P et al. TWEAK/Fn14 pathway: a nonredundant role in intestinal damage in mice through a TWEAK/intestinal epithelial cell axis. Gastroenterology 2009 136 : 912 923.
38. Spiller R, Campbell E. Post-infectious irritable bowel syndrome. Curr Opin Gastroenterol 2006 22 : 13 7.
39. van der Veek PP, van den Berg M, de Kroon YE, Verspaget HW, Masclee AA. Role of tumor necrosis factor-alpha and interleukin-10 gene polymorphisms in irritable bowel syndrome. Am J Gastroenterol 2005 100 : 2510 2516.
40. O'Mahony L, McCarthy J, Kelly P et al. Lactobacillus and bifidobacterium in irritable bowel syndrome: symptom responses and relationship to cytokine profiles. Gastroenterology 2005 128 : 541 551.
41. Liebregts T, Adam B, Bredack C et al. Immune activation in patients with irritable bowel syndrome. Gastroenterology 2007 132 : 913 920.
42. Drossman DA, Camilleri M, Mayer EA, Whitehead WE. AGA technical review on irritable bowel syndrome. Gastroenterology 2002 123 : 2108 2131. (Pubitemid 35408332)
43. Jones MP, Dilley JB, Drossman D, Crowell MD. Brain-gut connections in functional GI disorders: anatomic and physiologic relationships. Neurogastroenterol Motil 2006 18 : 91 103.
44. Mayer EA, Derbyshire S, Naliboff BD. Cerebral activation in irritable bowel syndrome. Gastroenterology 2000 119 : 1418 1420.
45. Colloca L, Benedetti F. Placebos and painkillers: is mind as real as matter? Nat Rev Neurosci 2005 6 : 545 552.
46. Ader R. On the development of psychoneuroimmunology. Eur J Pharmacol 2000 405 : 167 176.
47. Blalock JE. The immune system as the sixth sense. J Intern Med 2005 257 : 126 138.
48. Besedovsky HO, Rey AD. Physiology of psychoneuroimmunology: a personal view. Brain Behav Immun 2007 21 : 34 44.
49. Barbara G, De Giorgio R, Stanghellini V, Cremon C, Salvioli B, Corinaldesi R. New pathophysiological mechanisms in irritable bowel syndrome. Aliment Pharmacol Ther 2004 20 (Suppl 2 1 9. (Pubitemid 39237523)
50. Barbara G, Stanghellini V, De Giorgio R et al. Activated mast cells in proximity to colonic nerves correlate with abdominal pain in irritable bowel syndrome. Gastroenterology 2004 126 : 693 702.
51. Tornblom H, Lindberg G, Nyberg B, Veress B. Full-thickness biopsy of the jejunum reveals inflammation and enteric neuropathy in irritable bowel syndrome. Gastroenterology 2002 123 : 1972 1979.
52. Kindt S, Van Oudenhove L, Broekaert D et al. Immune dysfunction in patients with functional gastrointestinal disorders. Neurogastroenterol Motil 2009 21 : 389 398.
53. Ohman L, Lindmark AC, Isaksson S et al. B-cell activation in patients with irritable bowel syndrome (IBS). Neurogastroenterol Motil 2009 21 : 644 650, e27.
54. Evans D. Suppression of the acute-phase response as a biological mechanism for the placebo effect. Med Hypotheses 2005 64 : 1 7.
55. Hashish I, Harvey W, Harris M. Anti-inflammatory effects of ultrasound therapy: evidence for a major placebo effect. Br J Rheumatol 1986 25 : 77 81.
56. Carlson LE, Speca M, Faris P, Patel KD. One year pre-post intervention follow-up of psychological, immune, endocrine and blood pressure outcomes of mindfulness-based stress reduction (MBSR) in breast and prostate cancer outpatients. Brain Behav Immun 2007 21 : 1038 1049.
57. Furmark T, Appel L, Henningsson S et al. A link between serotonin-related gene polymorphisms, amygdala activity, and placebo-induced relief from social anxiety. J Neurosci 2008 28 : 13066 13074.
58. Maxion-Bergemann S, Thielecke F, Abel F, Bergemann R. Costs of irritable bowel syndrome in the UK and US. Pharmacoeconomics 2006 24 : 21 37.
59. Kaptchuk TJ, Stason WB, Davis RB et al. Sham device v inert pill: randomised controlled trial of two placebo treatments. BMJ 2006 332 : 391 397.
60. Zubieta JK, Bueller JA, Jackson LR et al. Placebo effects mediated by endogenous opioid activity on mu-opioid receptors. J Neurosci 2005 25 : 7754 7762.