Effects of placebos without deception compared with no treatment: protocol for a systematic review and meta-analysis

BMJ Open

Volumn 5, Issue 11, 2015, Pages

  Petkovic, Grace ^a   Charlesworth, James E G ^a   Kelley, John ^b,c   Miller, Franklin ^d   Roberts, Nia ^a   Howick, Jeremy ^a  

^a UNIVERSITY OF OXFORD   (United Kingdom)

^b HARVARD MEDICAL SCHOOL   (United States)

^c ENDICOTT COLLEGE   (United States)

^d NATIONAL INSTITUTES OF HEALTH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

PLACEBO;

CLINICAL PROTOCOL; COMPARATIVE STUDY; DECEPTION; HUMAN; META ANALYSIS; METHODOLOGY; OUTCOME ASSESSMENT; PLACEBO EFFECT;

CLINICAL PROTOCOLS; DECEPTION; HUMANS; OUTCOME ASSESSMENT (HEALTH CARE); PLACEBO EFFECT; PLACEBOS; RESEARCH DESIGN;

EID: 84985001990     PISSN: None     EISSN: 20446055     Source Type: Journal    
DOI: 10.1136/BMJOPEN-2015-009428     Document Type: Review

References (47)

1. Howick J, Bishop FL, Heneghan C, et al. Placebo use in the United Kingdom: results from a National Survey of Primary Care Practitioners. PLoS One 2013;8:e58247.
2. GMC. Good Medical Practice (2006). The duties of a doctor registered with the General Medical Council. London: GMC, 2006.
3. Bostick NA, Sade R, Levine MA, et al. Placebo use in clinical practice: report of the American Medical Association Council on Ethical and Judicial Affairs. J Clin Ethics 2008;19:58-61.
4. Aulas JJ, Rosner I. [Efficacy of a non blind placebo prescription]. Encephale 2003;29:68-71.
5. Bergmann JF, Chassany O, Gandiol J, et al. A randomised clinical trial of the effect of informed consent on the analgesic activity of placebo and naproxen in cancer pain. Clin Trials Metaanal 1994;29:41-7.
6. Dahan R, Caulin C, Figea L, et al. Does informed consent influence therapeutic outcome? A clinical trial of the hypnotic activity of placebo in patients admitted to hospital. BMJ 1986;293:363-4.
7. Kirsch I, Weixel LJ. Double-blind versus deceptive administration of a placebo. Behav Neurosci 1988;102:319-23.
8. Park LC, Covi L. Nonblind placebo trial: an exploration of neurotic patients' responses to placebo when its inert content is disclosed. Arch Gen Psychiatry 1965;12:36-45.
9. Pollo A, Amanzio M, Casadio C, et al. Response expectancies in placebo analgesia and their clinical relevance. Pain 2001;93:77-84.
10. Sandler AD, Bodfish JW. Open-label use of placebos in the treatment of ADHD: a pilot study. Child Care Health Dev 2008;34:104-10.
11. Chalmers I. The lethal consequences of failing to make full use of all relevant evidence about the effects of medical treatments: the importance of systematic reviews. In: Rothwell PM, ed. Treating individuals: from randomised trials to personalized medicine. London: The Lancet, 2007:37-58.
12. Everly GS, Lating JM. A clinical guide to the treatment of the human stress response. 2nd edn..New York, London: Kluwer Academic/Plenum Publishers, 2002.
13. Hróbjartsson A, Gøtzsche P. Placebo interventions for all clinical conditions. Cochrane Database Syst Rev 2010;(1):CD003974.
14. Kaptchuk TJ, Friedlander E, Kelley JM, et al. Placebos without deception: a randomized controlled trial in irritable bowel syndrome. PLoS One 2010;5:e15591.
15. Foddy B. A duty to deceive: placebos in clinical practice. Am J Bioeth 2009;9:4-12.
16. Benedetti F. Placebo effects: understanding the mechanisms in health and disease. Oxford: Oxford University Press, 2009.
17. Schafer SM, Colloca L, Wager TD. Conditioned placebo analgesia persists when subjects know they are receiving a placebo. J Pain 2015;16:412-20.
18. Jensen KB, Kaptchuk TJ, Chen X, et al. A neural mechanism for nonconscious activation of conditioned placebo and nocebo responses. Cereb Cortex 2015;25:3903-10.
19. Jensen KB, Kaptchuk TJ, Kirsch I, et al. Nonconscious activation of placebo and nocebo pain responses. Proc Natl Acad Sci USA 2012;109:15959-64.
20. Fuchs T, Schlimme JE. Embodiment and psychopathology: a phenomenological perspective. Curr Opin Psychiatry 2009;22:570-5.
21. 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.
22. Bingel U, Wanigasekera V, Wiech K, et al. The effect of treatment expectation on drug efficacy: imaging the analgesic benefit of the opioid remifentanil. Sci Transl Med 2011;3:70ra14.
23. Cohen S, Janicki-Deverts D. Can we improve our physical health by altering our social networks? Perspect Psychol Sci 2009;4:375-8.
24. Ozbay F, Johnson DC, Dimoulas E, et al. Social support and resilience to stress: from neurobiology to clinical practice. Psychiatry (Edgmont) 2007;4:35-40.
25. Fässler M, Meissner K, Schneider A, et al. Frequency and circumstances of placebo use in clinical practice-a systematic review of empirical studies. BMC Med 2010;8:15.
26. Bok S. The ethics of giving placebos. Sci Am 1974;231:17-23.
27. Boozang KM. The therapeutic placebo: the case for patient deception. Fla Law Rev 2002;54:687-746.
28. Brody H. The lie that heals: the ethics of giving placebos. Ann Intern Med 1982;97:112-8.
29. Cheyne C. Exploiting placebo effects for therapeutic benefit. Health Care Anal 2005;13:177-88.
30. Foddy B. Response to open peer commentaries on “A duty to deceive: placebos in clinical practice”. Am J Bioeth 2009;9:W1-2.
31. Kolber AJ. A limited defense of clinical placebo deception. Yale Law Policy Rev 2007;26:75-134.
32. Miller FG, Colloca L. The legitimacy of placebo treatments in clinical practice: evidence and ethics. Am J Bioeth 2009;9:39-47.
33. Miller FG, Emanuel EJ, Rosenstein DL, et al. Ethical issues concerning research in complementary and alternative medicine. JAMA 2004;291:599-604.
34. Miller FG, Wendler D, Swartzman LC. Deception in research on the placebo effect. PLoS Med 2005;2:e262.
35. Wendler D, Miller FG. Deception in the pursuit of science. Arch Intern Med 2004;164:597-600.
36. Beecher HK. The powerful placebo. J Am Med Assoc 1955;159:1602-6.
37. Kienle GS, Kiene H. The powerful placebo effect: fact or fiction? J Clin Epidemiol 1997;50:1311-8.
38. Hróbjartsson A, Gøtzsche P. Is the placebo powerless? An analysis of clinical trials comparing placebo with no treatment. N Engl J Med 2001;344:1594-602.
39. Hróbjartsson A, Gøtzsche PC. Is the placebo powerless? Update of a systematic review with 52 new randomized trials comparing placebo with no treatment. J Intern Med 2004;256:91-100.
40. Kelley JM, Kaptchuk T, Cusin C, et al. Open-label placebo for major depressive disorder: a pilot randomized controlled trial. Psychother Psychosom 2012;81:312-4.
41. Research Training in the Biomedical, Behavioral, and Clinical Research Sciences. Research Training in the Biomedical, Behavioral, and Clinical Research Sciences. Washington DC, 2011.
42. Di Blasi Z, Harkness E, Ernst E, et al. Influence of context effects on health outcomes: a systematic review. Lancet 2001;357:757-62.
43. Moher D, Liberati A, Tetzlaff J, et al. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. BMJ 2009;339:b2535.
44. Mistiaen P, van Osch M, van Vliet L, et al. The effect of patient-practitioner communication on pain: a systematic review. Eur J Pain 2015. [Epub ahead of print 22 Oct 2015].
45. Higgins JJ, Green S. The Cochrane handbook for systematic reviews of interventions. Version 5.1.0 [updated March 2011] ed. Chichester: The Cochrane Collaboration, 2011.
46. Schünemann H, Brozek J, Oxman A, eds. GRADE handbook for grading quality of evidence and strength of recommendation. Asia Pac J Public Health, 2008.
47. Chan SP, Chui WC, Lo KW, et al. Consensus statement: appropriate consumer education and communication programs for weight-loss agents in Asia. Asia Pac J Public Health 2012;24:641-9.