Placebo and Nocebo. Ethical Challenges and Solutions

Placebo and Pain: From Bench to Bedside

Volumn , Issue , 2013, Pages 277-286

  Colloca, Luana ^a,b   Miller, Franklin G ^a  

^a NATIONAL INSTITUTES OF HEALTH   (United States)

^b NATIONAL INSTITUTE OF MENTAL HEALTH   (United States)

Author keywords

Deception; Decision making processes; Ethics; Nocebo; Placebo

Indexed keywords

EID: 84902419730     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1016/B978-0-12-397928-5.00027-1     Document Type: Chapter

References (72)

1. Colloca L., Benedetti F. Placebos and painkillers: is mind as real as matter?. Nat Rev Neurosci 2005, 6(7):545-552.
2. Wolf S., Doering C.R., Clark M.L., Hagans J.A. Chance distribution and placebo reactor. J Lab Clin Med 1957, 49(6):837-841.
3. Wolf S., Pinsky R.H. Effects of placebo administration and occurrence of toxic reactions. J Am Med Assoc 1954, 155(4):339-341.
4. Beecher H.K. The placebo effect and sound planning in surgery. Surg Gynecol Obstet 1962, 114:507-509.
5. Beecher H.K. Surgery as placebo. A quantitative study of bias. JAMA 1961, 176:1102-1107.
6. Beecher H.K. The powerful placebo. J Am Med Assoc 1955, 159(17):1602-1606.
7. Lasagna L., Mosteller F., Von Felsinger J.M., Beecher H.K. A study of the placebo response. Am J Med 1954, 16(6):770-779.
8. Beecher H.K., Keats A.S., Mosteller F., Lasagna L. The effectiveness of oral analgesics (morphine, codeine, acetylsalicylic acid) and the problem of placebo 'reactors' and 'non-reactors'. J Pharmacol Exp Ther 1953, 109(4):393-400.
9. Benedetti F., Amanzio M., Rosato R., Blanchard C. Nonopioid placebo analgesia is mediated by CB1 cannabinoid receptors. Nat Med 2011, 17(10):1228-1230.
10. Colloca L., Benedetti F. Placebo analgesia induced by social observational learning. Pain 2009, 144(1-2):28-34.
11. Colloca L., Miller F.G. How placebo responses are formed: a learning perspective. Philos Trans R Soc Lond B Biol Sci 2011, 366(1572):1859-1869.
12. Miller F.G., Colloca L. The legitimacy of placebo treatments in clinical practice: evidence and ethics. Am J Bioeth 2009, 9(12):39-47.
13. Miller F.G., Colloca L. The placebo phenomenon and medical ethics: rethinking the relationship between informed consent and risk-benefit assessment. Theor Med Bioeth 2011, 32(4):229-243.
14. Meissner K., Bingel U., Colloca L., et al. The placebo effect: advances from different methodological approaches. J Neurosci 2011, 31(45):16117-16124.
15. Hrobjartsson A., Gotzsche P.C. Is the placebo powerless? An analysis of clinical trials comparing placebo with no treatment. N Engl J Med 2001, 344(21):1594-1602.
16. Hrobjartsson A., Gotzsche P.C. Is the placebo powerless? Update of a systematic review with 52 new randomized trials comparing placebo with no treatment. J Intern Med 2004, 256(2):91-100.
17. Hrobjartsson A., Gotzsche P.C. Placebo interventions for all clinical conditions. Cochrane Database Syst Rev 2010, (1):CD003974.
18. Tracey I. Getting the pain you expect: mechanisms of placebo, nocebo and reappraisal effects in humans. Nat Med 2010, 16(11):1277-1283.
19. Vase L., Riley J.L., Price D.D. A comparison of placebo effects in clinical analgesic trials versus studies of placebo analgesia. Pain 2002, 99(3):443-452.
20. Vase L., Petersen G.L., Riley J.L., Price D.D. Factors contributing to large analgesic effects in placebo mechanism studies conducted between 2002 and 2007. Pain 2009, 145(1-2):36-44.
21. Hrobjartsson A., Norup M. The use of placebo interventions in medical practice-a national questionnaire survey of Danish clinicians. Eval Health Prof 2003, 26(2):153-165.
22. Tilburt J.C., Emanuel E.J., Kaptchuk T.J., et al. Prescribing 'placebo treatments': results of national survey of US internists and rheumatologists. BMJ 2008, 337. a1938.
23. Meissner K., Hofner L., Fassler M., Linde K. Widespread use of pure and impure placebo interventions by GPs in Germany. Fam Pract 2012, 29(1):79-85.
24. Fassler M., Meissner K., Schneider A., Linde K. Frequency and circumstances of placebo use in clinical practice - a systematic review of empirical studies. BMC Med 2010, 8:15.
25. Lynoe N., Mattsson B., Sandlund M. The attitudes of patients and physicians towards placebo treatment - a comparative study. Soc Sci Med 1993, 36(6):767-774.
26. Fassler M., Gnadinger M., Rosemann T., Biller-Andorno N. Placebo interventions in practice: a questionnaire survey on the attitudes of patients and physicians. Br J Gen Pract 2011, 61(583):101-107.
27. American Medical Association American Medical Association Code of Medical Ethics, Opinion 8.083: Placebo Use in Clinical Practice 2007, Available at. http://www.ama-assn.org/ama/pub/physician-resources/medical-ethics/code-medical-ethics/opinion8083.shtml.
28. Helsinki D.O. World Medical Association 53rd WMA General Assembly 2002, Washington, (Note of Clarification on paragraph 29 added). http://www.wma.net/en/30publications/10policies/b3/.
29. Helsinki D.O. World Medical Association 59th WMA General Assembly October 2008, Seoul. http://www.wma.net/en/30publications/10policies/b3/.
30. Moseley J.B., O'Malley K., Petersen N.J., et al. A controlled trial of arthroscopic surgery for osteoarthritis of the knee. N Engl J Med 2002, 347(2):81-88.
31. Buchbinder R., Osborne R.H., Ebeling P.R., et al. A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures. N Engl J Med 2009, 361(6):557-568.
32. Miller F.G., Kallmes D.F. The case of vertebroplasty trials: promoting a culture of evidence-based procedural medicine. Spine (Phila Pa 1976) 2010, 35(23):2023-2026.
33. Miller F.G., Kallmes D.F., Buchbinder R. Vertebroplasty and the placebo response. Radiology 2011, 259(3):621-625.
34. Wulff K.C., Miller F.G., Pearson S.D. Can coverage be rescinded when negative trial results threaten a popular procedure? The ongoing saga of vertebroplasty. Health Aff (Millwood) 2011, 30(12):2269-2276.
35. Colloca L., Benedetti F., Porro C.A. Experimental designs and brain mapping approaches for studying the placebo analgesic effect. Eur J Appl Physiol 2008, 102(4):371-380.
36. American Psychological Association A 2010, par. 8.07 ref. 39. http://www.apa.org/ethics/code/index.aspx.
37. Miller F.G., Kaptchuk T.J. Deception of subjects in neuroscience: an ethical analysis. J Neurosci 2008, 28(19):4841-4843.
38. Miller F.G., Wendler D., Swartzman L.C. Deception in research on the placebo effect. PLoS Med 2005, 2(9):e262.
39. Martin A.L., Katz J. Inclusion of authorized deception in the informed consent process does not affect the magnitude of the placebo effect for experimentally induced pain. Pain 2010, 149(2):208-215.
40. Foddy B. A duty to deceive: placebos in clinical practice. Am J Bioeth 2009, 9(12):4-12.
41. Lichtenberg P., Heresco-Levy U., Nitzan U. The ethics of the placebo in clinical practice. J Med Ethics 2004, 30(6):551-554.
42. Bok S. The ethics of giving placebos. Sci Am 1974, 231(5):17-23.
43. Asai A., Kadooka Y. Reexamination of the ethics of placebo use in clinical practice. Bioethics 2013, 27(4):186-193.
44. Touwen D.P., Engberts D.P. Those famous red pills-Deliberations and hesitations. Ethics of placebo use in therapeutic and research settings. Eur Neuropsychopharmacol 2012, 22(11):775-781.
45. Dobrila-Dintinjana R., Nacinovic-Duletic A. Placebo in the treatment of pain. Coll Antropol 2011, 35(suppl 2):319-323.
46. Raz A., Harris C.S., de Jong V., Braude H. Is there a place for (deceptive) placebos within clinical practice?. Am J Bioeth 2009, 9(12):52-54.
47. Miller F.G., Colloca L., Kaptchuk T.J. The placebo effect: illness and interpersonal healing. Perspect Biol Med 2009, 52(4):518-539.
48. Lui F., Colloca L., Duzzi D., et al. Neural bases of conditioned placebo analgesia. Pain 2010, 151(3):816-824.
49. Benedetti F., Lanotte M., Colloca L., et al. Electrophysiological properties of thalamic, subthalamic and nigral neurons during the anti-parkinsonian placebo response. J Physiol 2009, 587(Pt 15):3869-3883.
50. Thomas K.B. Time and the consultation in general practice. Br Med J 1978, 2(6143):1000.
51. Colloca L., Lopiano L., Lanotte M., Benedetti F. Overt versus covert treatment for pain, anxiety, and Parkinson's disease. Lancet Neurol 2004, 3(11):679-684.
52. Kaptchuk T.J., Kelley J.M., Conboy L.A., et al. Components of placebo effect: randomised controlled trial in patients with irritable bowel syndrome. BMJ 2008, 336(7651):999-1003.
53. Brody H., Colloca L., Miller F.G. The placebo phenomenon: implications for the ethics of shared decision-making. J Gen Intern Med 2012, 27(6):739-742.
54. Colloca L., Miller F.G. The nocebo effect and its relevance for clinical practice. Psychosom Med 2011, 73(7):598-603.
55. Colloca L., Finniss D. Nocebo effects, patient-clinician communication, and therapeutic outcomes. JAMA 2012, 307(6):567-568.
56. Amanzio M., Corazzini L.L., Vase L., Benedetti F. A systematic review of adverse events in placebo groups of anti-migraine clinical trials. Pain 2009, 146(3):261-269.
57. Reuter U., Sanchez del Rio M., Carpay J.A., et al. Placebo adverse events in headache trials: headache as an adverse event of placebo. Cephalalgia 2003, 23(7):496-503.
58. Wells R.E., Kaptchuk T.J. To tell the truth, the whole truth, may do patients harm: the problem of the nocebo effect for informed consent. Am J Bioeth 2012, 12(3):22-29.
59. Miller F.G. Clarifying the nocebo effect and its ethical implications. Am J Bioeth 2012, 12(3):30-31.
60. Varelmann D., Pancaro C., Cappiello E.C., Camann W.R. Nocebo-induced hyperalgesia during local anesthetic injection. Anesth Analg 2010, 110(3):868-870.
61. Colloca L., Miller F.G. Harnessing the placebo effect: the need for translational research. Philos Trans R Soc Lond B Biol Sci 2011, 366(1572):1922-1930.
62. Cohen N., Ader R., Bovbjerg D. Conditioned effects of cyclophosphamide. Enhancement of delayed-type hypersensitivity in the mouse. Ann N Y Acad Sci 1987, 496:553-560.
63. Ader R., Cohen N. Behaviorally conditioned immunosuppression and murine systemic lupus erythematosus. Science 1982, 215(4539):1534-1536.
64. Nolan T.A., Price D.D., Caudle R.M., et al. Placebo-induced analgesia in an operant pain model in rats. Pain 2012, 153(10):2009-2016.
65. Guo J.Y., Wang J.Y., Luo F. Dissection of placebo analgesia in mice: the conditions for activation of opioid and non-opioid systems. J Psychopharmacol 2010, 24(10):1561-1567.
66. Zhang R.R., Zhang W.C., Wang J.Y., Guo J.Y. The opioid placebo analgesia is mediated exclusively through mu-opioid receptor in rat. Int J Neuropsychopharmacol 2013, 16(4):849-856.
67. Ader R., Mercurio M.G., Walton J., et al. Conditioned pharmacotherapeutic effects: a preliminary study. Psychosom Med 2010, 72(2):192-197.
68. Sandler A.D., Bodfish J.W. Open-label use of placebos in the treatment of ADHD: a pilot study. Child Care Health Dev 2008, 34(1):104-110.
69. Sandler A.D., Glesne C.E., Bodfish J.W. Conditioned placebo dose reduction: a new treatment in attention-deficit hyperactivity disorder?. J Dev Behav Pediatr 2010, 31(5):369-375.
70. Mayer D.J. Acupuncture: an evidence-based review of the clinical literature. Annu Rev Med 2000, 51:49-63.
71. Egbert L.D., Battit G.E., Welch C.E., Bartlett M.K. Reduction of postoperative pain by encouragement and instruction of patients. a study of doctor-patient rapport. N Engl J Med 1964, 270:825-827.
72. Hull S.C., Colloca L., Avins A., et al. A survey of patients' attitudes about the use of placebo treatments. BMJ 2013, 346:f3757.