The potential benefit of the placebo effect in sham-controlled trials: Implications for risk-benefit assessments and informed consent

Journal of Medical Ethics

Volumn 39, Issue 11, 2013, Pages 703-707

  Brim, Remy L ^a   Miller, Franklin G ^a  

^a NATIONAL INSTITUTES OF HEALTH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CONTROLLED CLINICAL TRIAL (TOPIC); ETHICS; HUMAN; INFORMED CONSENT; PLACEBO EFFECT; PROFESSIONAL STANDARD; RESEARCH ETHICS; RISK ASSESSMENT; STANDARDS;

CONSENT FORMS; CONTROLLED CLINICAL TRIALS AS TOPIC; ETHICS COMMITTEES, RESEARCH; ETHICS, RESEARCH; HUMANS; INFORMED CONSENT; PLACEBO EFFECT; RISK ASSESSMENT;

EID: 84886748805     PISSN: 03066800     EISSN: 14734257     Source Type: Journal    
DOI: 10.1136/medethics-2012-101045     Document Type: Article

References (27)

1. Miller FG, Kaptchuk TJ. Sham procedures and the ethics of clinical trials. J R Soc Med 2004;97:576-8.
2. Miller FG, Wendler D. The ethics of sham invasive intervention trials. Clin Trials 2009;6:401-2.
3. London AJ, Kadane JB. Placebos that harm: sham surgery controls in clinical trials. Stat Methods Med Res 2002;11:413-27.
4. Macklin R. The ethical problems with sham surgery in clinical research. N Engl J Med 1999;341:992-96.
5. Hróbjartsson A, Gøtzsche P. Placebo interventions for all clinical conditions. Cochrane Database of Systematic Reviews 2010;1:CD003974.
6. Bishop FL, Adams AE, Kaptchuk TJ, et al. Informed consent and placebo effects: a content analysis of information leaflets to identify what clinical trial participants are told about placebos. PLoS One 2012;7:e39661.
7. Miller FG, Brody H. Understanding and harnessing placebo effects: clearing away the underbrush. Journal Med Philos 2011;36:69-78.
8. Lidstone SC, Schulzer M, Dinelle K, et al. Effects of expectation on placebo-induced dopamine release in Parkinson disease. Arch Gen Psychiatry 2010;67:857-65.
9. McRae C, Cherin E, Yamazaki TG, et al. Effects of perceived treatment on quality of life and medical outcomes in a double-blind placebo surgery trial. Arch Gen Psychiatry 2004;61:412-20.
10. Wager TD, Rilling JK, Smith EE, et al. Placebo-induced changes in FMRI in the anticipation and experience of pain. Science 2004;303:1162-7.
11. Amanzio M, Benedetti F. Neuropharmacological dissection of placebo analgesia: expectation-activated opioid systems versus conditioning-activated specific subsystems. J Neurosci 1999;19:484-94.
12. Benedetti F, Amanzio M, Rosato R, et al. Nonopioid placebo analgesia is mediated by CB1 cannabinoid receptors. Nat Med 2011;17:1228-30.
13. Scott DJ, Stohler CS, Egnatuk CM, et al. Individual differences in reward responding explain placebo-induced expectations and effects. Neuron 2007;55(2):325-36.
14. de la Fuente-Fernandez R, Ruth TJ, Sossi V, et al. Expectation and dopamine release: mechanism of the placebo effect in Parkinson's disease. Science 2001;293:1164-6.
15. Goetz CG, Leurgans S, Raman R. Placebo-associated improvements in motor function: comparison of subjective and objective sections of the UPDRS in early Parkinson's disease. Mov Disord 2002;17:283-8.
16. 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;128:264-71.
17. Beecher HK. Surgery as placebo. A quantitative study of bias. JAMA 1961;176:1102-7.
18. Dimond EG, Kittle CF, Crockett JE. Comparison of internal mammary artery ligation and sham operation for angina pectoris. Am J Cardiol 1960;5:483-6.
19. Kallmes DF, Comstock BA, Heagerty PJ, et al. A randomized trial of vertebroplasty for osteoporotic spinal fractures. N Engl J Med 2009;361:569-79.
20. Moseley JB, O'Malley K, Petersen NJ, et al. A controlled trial of arthroscopic surgery for osteoarthritis of the knee. N Engl J Med 2002;347:81-8.
21. Haake M, Muller HH, Schade-Brittinger C, et al. German Acupuncture Trials (GERAC) for chronic low back pain: randomized, multicenter, blinded, parallel-group trial with 3 groups. Arch Intern Med 2007;167:1892-8.
22. Wise RA, Bartlett SJ, Brown ED, et al. Randomized trial of the effect of drug presentation on asthma outcomes: the American Lung Association Asthma Clinical Research Centers. J Allergy Clin Immunol 2009;124:436-44.
23. Katsnelson A. Experimental therapies for Parkinson's disease: why fake it? Nature 2011;476(7359):142-4.
24. Bishop FL, Jacobson EE, Shaw J, et al. Participants' experiences of being debriefed to placebo allocation in a clinical trial. Qual Health Res 2012;22:1138-49.
25. Kaptchuk TJ, Friedlander E, Kelley JM, et al. Placebos without deception: a randomized controlled trial in irritable bowel syndrome. PLoS One 2010;5(12): e15591.
26. Chung SK, Price DD, Verne GN, et al. Revelation of a personal placebo response: its effects on mood, attitudes and future placebo responding. Pain 2007;132:281-8.
27. Miller FG, Colloca L. The legitimacy of placebo treatments in clinical practice: evidence and ethics. Am J Bioeth 2009;9:39-47.