Deception in research on the placebo effect

PLoS Medicine

Volumn 2, Issue 9, 2005, Pages 0853-0859

  Miller, Franklin G ^a   Wendler, David ^a   Swartzman, Leora C ^b  

^a NATIONAL INSTITUTES OF HEALTH   (United States)

^b UNIVERSITY OF WESTERN ONTARIO   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

ANESTHETIC AGENT; BRONCHOCONSTRICTING AGENT; BRONCHODILATING AGENT; LIDOCAINE; PLACEBO;

ANALGESIA; ASTHMA; AUTHORITY; CLINICAL PRACTICE; CLINICAL RESEARCH; DRUG APPROVAL; DRUG DESIGN; DRUG EFFECT; DRUG MECHANISM; DRUG POTENCY; DRUG RESEARCH; HEALTH CARE PERSONNEL; HUMAN; INFORMED CONSENT; INTESTINE DISTENSION; IRRITABLE COLON; MEDICAL DECISION MAKING; MEDICAL ETHICS; MEDICAL EXPERT; MEDICAL SPECIALIST; NEUROBIOLOGY; PHARMACODYNAMICS; PRACTICE GUIDELINE; PSYCHOBIOLOGY; PSYCHOLOGIST; RATING SCALE; REVIEW; TREATMENT INDICATION; UNIVERSITY HOSPITAL; VALIDATION PROCESS; ARTICLE; CLINICAL TRIAL (TOPIC); DECEPTION; ETHICS; INTERPERSONAL COMMUNICATION; METHODOLOGY; PLACEBO EFFECT; RESEARCH ETHICS;

CLINICAL TRIALS AS TOPIC; DECEPTION; DISCLOSURE; ETHICS, RESEARCH; HUMANS; INFORMED CONSENT; PLACEBO EFFECT; RESEARCH DESIGN;

EID: 25644455193     PISSN: 15491277     EISSN: None     Source Type: Journal    
DOI: 10.1371/journal.pmed.0020262     Document Type: Review

References (46)

1. Kleinman A, Guess HA, Wilentz JS (2002) An overview. In: Guess HA, Kleinman A, Kusek JW, Engel LW, editors. The science of the placebo: Towards an interdisciplinary research agenda. London: BMJ. pp. 1-32.
2. Harrington A, editor (1997) The placebo effect: An interdisciplinary exploration. Cambridge (Massachusetts): Harvard University Press. 272 p.
3. Kirsch I (1985) Response expectancy as a determinant of experience and behavior. Am Psychol 40: 1189-1202.
4. Pollo A, Amanzio M, Arslanian A, Casadio C, Maggi G, et al. (2001) Response expectancies in placebo analgesia and their clinical relevance. Pain 93: 77-84.
5. Stewart-Williams S, Podd J (2004) The placebo effect: Dissolving the expectancy versus conditioning debate. Psychol Bull 130: 324-340.
6. Wager TD, Rilling JK, Smith EE, Sokolik A, Casey KL, et al. (2004) Placebo-induced changes in fMRI in the anticipation and experience of pain. Science 303: 1162-1167.
7. Mayberg HS, Silva JA, Brannan SK, Tekell JL, Mahurin RK, et al. (2002) The functional neuroanatomy of the placebo effect. Am J Psychiatry 159: 728-737.
8. de la Fuente-Fernandez R, Schulzer M, Stoessl AJ (2004) Placebo mechanisms and reward circuitry: Clues from Parkinson's disease. Biol Psychiatry 56: 67-71.
9. National Institutes of Health (2001) Elucidation of the underlying mechanisms of placebo effect. Bethesda: National Institute of Health. Available: http://grants1.nih.gov/ grants/guide/rfa-. les/RFA-AT-02-002.html. Accessed 11 July 2005.
10. Benedetti F, Maggi G, Lopiano L, Lanotte M, Rainero I, et al. (2003) Open versus hidden medical treatments: The patient's knowledge about a therapy affects the therapy outcome. Prev Treat 6: article 1. Available: http://journals.apa.org/prevention/volume6/ toc-jun-03.html. Accessed 21 July 2005.
11. Benedetti F, Pollo A, Lopiano L, Lanotte M, Vighetti S, et al. (2003) Conscious expectation and unconscious conditioning in analgesic, motor, and hormonal placebo/nocebo responses. J Neurosci 23: 4315-4323.
12. Leigh R, MacQueen G, Tougas G, Hargreave FE, Bienstock J (2003) Change in forced expiratory volume in 1 second after sham bronchoconstrictor in suggestible but not suggestion-resistant asthmatic subjects: A pilot study. Psychosom Med 65: 791-795.
13. Vase L, Robinson ME, Verne GN, Price DD (2003) The contributions of suggestion, desire, and expectation to placebo effects in irritable bowel syndrome patients. An empirical investigation. Pain 105: 17-25.
14. Swartzman LC, Burkell J (1998) Expectations and the placebo effect in clinical drug trials: Why we should not turn a blind eye to unblinding, and other cautionary notes. Clin Pharmacol Ther 64: 1-7.
15. Mitchell SH, Laurent CL, de Wit H (1996) Interaction of expectancy and the phenomenological effects of d-amphetamine: Subjective effects and self-administration. Psychopharmacology (Berl) 125: 371-378.
16. McKay D, Schare ML (1999) The effects of alcohol and alcohol expectancies on subjective reports and physiological reactivity: A metaanalysis. Addict Behav 24: 633-647.
17. Kirsch I, Weixel LJ (1988) Double-blind versus deceptive administration of placebo. Behav Neurosci 102: 319-323.
18. Perkins K, Sayette M, Conklin C, Caggiula A (2003) Placebo effects of tobacco smoking and other nicotine intake. Nicotine Tob Res 5: 695-709.
19. Curran HV, Brignell C, Fletcher S, Middleton P, Henry J (2002) Cognitive and subjective dose-response effects of acute oral delt 9-tetrahydrocannabinol (THC) in infrequent cannabis users. Psychopharmacology (Berl) 164: 61-70.
20. Kirsch I (2003) Hidden administration as ethical alternatives to the balanced placebo design. Washington (DC): American Psychological Association. Available: http://journals.apa.org/ prevention/volume6/pre0060005c.html. Accessed 11 July 2005.
21. Caspi O (2002) When are placebo medication side effects due to the placebo phenomenon? JAMA 287: 2502.
22. Rohsenow DJ, Marlatt GA (1981) The balanced placebo design: Methodological considerations. Addict Behav 6: 107-122.
23. Milgram S (1977) Subject reaction: The neglected factor in the ethics of experimentation. Hastings Cent Rep 7: 19-23.
24. Vedantum S (2004 June 7) Human responses to technology scrutinized: Emotional interactions draw interest of psychologists and marketers. Washington Post; Sect A: 14.
25. Wendler D (1996) Deception in medical and behavioral research: Is it ever acceptable? Milbank Q 74: 87-114.
26. Wendler D, Miller FG (2004) Deception in the pursuit of science. Arch Intern Med 164: 597-600.
27. Fleming M, Bruno M, Barry K, Fost N (1989) Informed consent, deception, and the use of disguised alcohol questionnaires. Am J Drug Alcohol Abuse 15: 309-319.
28. Broder A (1998) Deception can be acceptable. Am Psychol 53: 805-806.
29. Kimmel AJ (1988) In defense of deception. Am Psychol 53: 803-805.
30. Ortman A, Hertwig R (1997) Is deception acceptable? Am Psychol 52: 746-747.
31. Ortman A, Hertwig R (1998) The question remains: Is deception acceptable? Am Psychol 53: 806-807.
32. Gallo PS, Smith S, Mumford S (1973) Effects of deceiving subjects on experimental results. J Soc Psychol 89: 99-107.
33. Aristotle (2004) Nichomachean ethics. Thomson JAK, translator; Tredennick H, Barnes J, editors. London: Penguin Books. 400 p.
34. American Psychological Association (2002) Ethical principles of psychologists and code of conduct. Am Psychol 57: 1060-1073. Available: http://www.apa.org/ethics/code2002.pdf. Accessed 21 July 2005.
35. Holmes DS, Bennett DH (1974) Experiments to answer questions raised by the use of deception in psychological research. I. Role playing as an alternative to deception. II. Effectiveness of debriefing after a deception. III. Effect of informed consent on deception. J Pers Soc Psychol 29: 358-367.
36. Bok S (1978) Lying: Moral choice in public and private life. New York: Random House. 368 p.
37. Wiener RL, Erker PV (1986) The effects of prebriefing misinformed research participants on their attributions of responsibility. J Psychol 120: 397-410.
38. Sieber JE, Iannuzzo R, Rodriguez B (1995) Deception methods in psychology: Have they changed in 23 years? Ethics Behav 5: 67-85.
39. Boter H, van Delden JJM, de Haan RJ, Rinkel GJE (2004) Patients' evaluation of informed consent to postponed information: Cohort study. BMJ 329: 86-87.
40. Colloca L, Benedetti F (2004) The placebo in clinical studies and in medical practice. In: Price DD, Bushnell MC, editors. Psychological methods of pain control: Basic science and clinical perspectives. Seattle: IASP Press. pp. 187-205.
41. Price D (2001) Assessing placebo effects without placebo groups: An untapped possibility? Pain 90: 201-203.
42. Amanzio M, Pollo A, Maggi G, Benedetti F (2001) Response variability to analgesics: A role for non-specific activation of endongenous opioids. Pain 90: 205-215.
43. Miller FG, Rosenstein DL (2003) The therapeutic orientation to clinical trials. N Engl J Med 348: 1383-1386.
44. Miller FG (2004) Research ethics and misguided moral intuition. J Law Med Ethics 32: 111-116.
45. Pittinger DJ (2002) Deception in research: Distinctions and solutions from the perspective of utilitarianism. Ethics Behav 12: 117-142.
46. Miller FG, Rosenstein DL (2002) Reporting of ethical issues in publications of medical research. Lancet 360: 1326-1328.