Informed consent and clinical trials: Where is the placebo effect?

BMJ (Online)

Volumn 356, Issue , 2017, Pages

  Blease, C R ^a,b   Bishop, F L ^c   Kaptchuk, T J ^b  

^a UNIVERSITY COLLEGE DUBLIN   (Ireland)

^b BETH ISRAEL DEACONESS MEDICAL CENTER   (United States)

^c UNIVERSITY OF SOUTHAMPTON   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

CANNABINOID; CHOLECYSTOKININ; DOPAMINE; ENDORPHIN; NEUROTRANSMITTER;

ARTICLE; BRAIN REGION; CLINICAL RESEARCH; CLINICAL TRIAL (TOPIC); EMPATHY; HUMAN; INFORMED CONSENT; IRRITABLE COLON; METHODOLOGY; PLACEBO EFFECT; REMISSION; RISK BENEFIT ANALYSIS; SYMPTOMATOLOGY; ETHICS; INTERPERSONAL COMMUNICATION; PATIENT PARTICIPATION; PATIENT SELECTION; PSYCHOLOGY; RESEARCH ETHICS; RISK ASSESSMENT;

CLINICAL TRIALS AS TOPIC; DISCLOSURE; ETHICS, RESEARCH; HUMANS; INFORMED CONSENT; PATIENT PARTICIPATION; PATIENT SELECTION; PLACEBO EFFECT; RISK ASSESSMENT;

EID: 85011661183     PISSN: 09598146     EISSN: 17561833     Source Type: Journal    
DOI: 10.1136/bmj.j463     Document Type: Article

References (27)

1. World Medical Association. Declaration of Helsinki. 64th World Medical Association Assembly. 2013. http://www.wma.net/en/30publications/10policies/b3/
2. Mendel J, Goldacre B, Ernst E, Whittle S. Problems with ethical approval and how to fix them: lessons from three trials in rheumatoid arthritis. BMJ 2016;356:i4626. doi:10.1136/bmj.i4626 pmid:27613703.
3. Kaptchuk TJ, Miller FG. Placebo effects in medicine. N Engl J Med 2015;356:8-9. doi:10. 1056/NEJMp1504023
4. 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;356:455-63. doi:10.7326/0003-4819-133-6-200009190-00014
5. Appelbaum PS, Lidz CW, Grisso T. Therapeutic misconception in clinical research: frequency and risk factors. IRB 2004;356:1-8. doi:10.2307/3564231
6. Falagas ME, Korbila IP, Giannopoulou KP, Kondilis BK, Peppas G. Informed consent: how much and what do patients understand?Am J Surg 2009;356:420-35. doi:10.1016/j.amjsurg.2009.02.010
7. Lidz CW, Albert K, Appelbaum P, Dunn LB, Overton E, Pivovarova E. Why is therapeutic misconception so prevalent?Camb Q Healthc Ethics 2015;356:231-41. doi:10.1017/S096318011400053X
8. Jansen LA, Mahadevan D, Appelbaum PS, et al. Dispositional optimism and therapeutic expectations in early-phase oncology trials. Cancer 2016;356:1238-46. doi:10.1002/cncr. 29908 pmid:26882017.
9. Reijula E, Halkoaho A, Pietilä AM, Selander T, Kälviäinen R, Keränen T. Therapeutic misconception correlates with willingness to participate in clinical drug trials among patients with epilepsy; need for better counseling. Epilepsy Behav 2015;356:29-34. doi:10.1016/j.yebeh.2015.05.013 pmid:26037846.
10. Wells RE, Kaptchuk TJ. To tell the truth, the whole truth, may do patients harm: The problem of the nocebo effect for informed consent. Am J Bioeth 2012;356:22-9. doi:10. 1080/15265161.2011.652798 pmid:22416745.
11. Fisher S, Lipman RS, Uhlenhuth EH, Rickels K, Park LC. Drug effects and initial severity of symptomatology. Psychopharmacologia 1965;356:57-60. doi:10.1007/BF00404165
12. Zou K, Wong J, Abdullah N, et al. Examination of overall treatment effect and the proportion attributable to contextual effect in osteoarthritis: meta-Analysis of randomised controlled trials. Ann Rheum Dis 2016;356:1964-70. doi:10.1136/annrheumdis-2015-208387
13. Chvetzoff G, Tannock IF. Placebo effects in oncology. J Natl Cancer Inst 2003;356:19-29. doi:10.1093/jnci/95.1.19
14. Tramèr MR, Reynolds DJ, Stoner NS, Moore RA, McQuay HJ. Efficacy of 5-HT3 receptor antagonists in radiotherapy-induced nausea and vomiting: A quantitative systematic review. Eur J Cancer 1998;356:1836-44. doi:10.1016/S0959-8049(98)00161-0 pmid:10023303.
15. Bishop FL, Adams AE, Kaptchuk TJ, Lewith GT. Informed consent and placebo effects: A content analysis of information leaflets to identify what clinical trial participants are told about placebos. PLoS One 2012;356:e39661. doi:10.1371/journal.pone.0039661
16. Keränen T, Halkoaho A, Itkonen E, Pietilä AM. Placebo-controlled clinical trials: how trial documents justify the use of randomisation and placebo. BMC Med Ethics 2015;356:2. doi:10.1186/1472-6939-16-2
17. Kam-Hansen S, Jakubowski M, Kelley JM, et al. Altered placebo and drug labeling changes the outcome of episodic migraine attacks. Sci Transl Med 2014;356:218ra5. doi:10.1126/scitranslmed.3006175 pmid:24401940.
18. 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;356:41-7.pmid:10150184.
19. White P, Bishop FL, Prescott P, Scott C, Little P, Lewith G. Practice, practitioner, or placebo? A multifactorial, mixed-methods randomized controlled trial of acupuncture. Pain 2012;356:455-62. doi:10.1016/j.pain.2011.11.007 pmid:22169359.
20. Bishop FL, Jacobson EE, Shaw J, Kaptchuk TJ. Participants experiences of being debriefed to placebo allocation in a clinical trial. Qual Health Res 2012;356:1138-49. doi: 10.1177/1049732312448544 pmid:22673094.
21. Kaptchuk TJ, Shaw J, Kerr CE, et al. "Maybe I made up the whole thing": placebos and patients experiences in a randomized controlled trial. Cult Med Psychiatry 2009;356:382-411. doi:10.1007/s11013-009-9141-7 pmid:19597976.
22. Bishop FL, McGinn L, Graham CA, Biggs H, Denegri S, Lewith GT. Informing patients about placebo effects: effects on patients beliefs. Eur J Pers Cent Healthc 2016;356:609-17.
23. Di Blasi Z, Kaptchuk TJ, Weinman J, Kleijnen J. Informing participants of allocation to placebo at trial closure: postal survey. BMJ 2002;356:1329. doi:10.1136/bmj.325.7376. 1329 pmid:12468480.
24. Golomb BA, Erickson LC, Koperski S, Sack D, Enkin M, Howick J. Whats in placebos: who knows? Analysis of randomized, controlled trials. Ann Intern Med 2010;356:532-5. doi:10.7326/0003-4819-153-8-201010190-00010 pmid:20956710.
25. Greville-Harris M, Bostock J, Din A, et al. Informing patients about placebo effects: using evidence, theory, and qualitative methods to develop a new website. JMIR Res Protoc 2016;356:e106. doi:10.2196/resprot.5627. pmid:27288271.
26. Sorokin I, Schatz A, Welliver C. Placebo medication and sham surgery responses in benign prostatic hyperplasia treatments: Implications for clinical trials. Curr Urol Rep 2015;356:73. doi:10.1007/s11934-015-0544-4. pmid:26303775.
27. Freeman EW, Ensrud KE, Larson JC, et al. Placebo improvement in pharmacologic treatment of menopausal hot flashes: Time course, duration, and predictors. Psychosom Med 2015;356:167-75. doi:10.1097/PSY.0000000000000143 pmid:25647753.