To tell the truth, the whole truth, may do patients harm: the problem of the nocebo effect for informed consent - PubMed (original) (raw)

To tell the truth, the whole truth, may do patients harm: the problem of the nocebo effect for informed consent

Rebecca Erwin Wells et al. Am J Bioeth. 2012.

Abstract

The principle of informed consent obligates physicians to explain possible side effects when prescribing medications. This disclosure may itself induce adverse effects through expectancy mechanisms known as nocebo effects, contradicting the principle of nonmaleficence. Rigorous research suggests that providing patients with a detailed enumeration of every possible adverse event-especially subjective self-appraised symptoms-can actually increase side effects. Describing one version of what might happen (clinical "facts") may actually create outcomes that are different from what would have happened without this information (another version of "facts"). This essay argues that the perceived tension between balancing informed consent with nonmaleficence might be resolved by recognizing that adverse effects have no clear black or white "truth." This essay suggests a pragmatic approach for providers to minimize nocebo responses while still maintaining patient autonomy through "contextualized informed consent," which takes into account possible side effects, the patient being treated, and the particular diagnosis involved.

PubMed Disclaimer

Comment in

• Clarifying the nocebo effect and its ethical implications.
  Miller FG. Miller FG. Am J Bioeth. 2012;12(3):30-1. doi: 10.1080/15265161.2011.652799. Am J Bioeth. 2012. PMID: 22416746 No abstract available.
• Nocebo and informed consent in the internet era.
  Meynen G, Swaab DF, Widdershoven G. Meynen G, et al. Am J Bioeth. 2012;12(3):31-3. doi: 10.1080/15265161.2011.652801. Am J Bioeth. 2012. PMID: 22416747 No abstract available.
• Saying things the "right" way: avoiding "nocebo" effects and providing full informed consent.
  Howick J. Howick J. Am J Bioeth. 2012;12(3):33-4. doi: 10.1080/15265161.2012.656799. Am J Bioeth. 2012. PMID: 22416748 No abstract available.
• Plenty to worry about: consent, control, and anxiety.
  Bromwich D. Bromwich D. Am J Bioeth. 2012;12(3):35-6. doi: 10.1080/15265161.2012.656810. Am J Bioeth. 2012. PMID: 22416749 No abstract available.
• Ulysses contracts and the nocebo effect.
  Barilan YM. Barilan YM. Am J Bioeth. 2012;12(3):37-9. doi: 10.1080/15265161.2011.652800. Am J Bioeth. 2012. PMID: 22416750 No abstract available.

Similar articles

• Nocebo and informed consent in the internet era.
  Meynen G, Swaab DF, Widdershoven G. Meynen G, et al. Am J Bioeth. 2012;12(3):31-3. doi: 10.1080/15265161.2011.652801. Am J Bioeth. 2012. PMID: 22416747 No abstract available.
• Saying things the "right" way: avoiding "nocebo" effects and providing full informed consent.
  Howick J. Howick J. Am J Bioeth. 2012;12(3):33-4. doi: 10.1080/15265161.2012.656799. Am J Bioeth. 2012. PMID: 22416748 No abstract available.
• Ulysses contracts and the nocebo effect.
  Barilan YM. Barilan YM. Am J Bioeth. 2012;12(3):37-9. doi: 10.1080/15265161.2011.652800. Am J Bioeth. 2012. PMID: 22416750 No abstract available.
• Principles of Clinical Ethics and Their Application to Practice.
  Varkey B. Varkey B. Med Princ Pract. 2021;30(1):17-28. doi: 10.1159/000509119. Epub 2020 Jun 4. Med Princ Pract. 2021. PMID: 32498071 Free PMC article. Review.
• Nocebo phenomena in medicine: their relevance in everyday clinical practice.
  Häuser W, Hansen E, Enck P. Häuser W, et al. Dtsch Arztebl Int. 2012 Jun;109(26):459-65. doi: 10.3238/arztebl.2012.0459. Epub 2012 Jun 29. Dtsch Arztebl Int. 2012. PMID: 22833756 Free PMC article. Review.

Cited by

• Drug trials are more likely to disclose full placebo control information than non-drug trials: A cross-sectional study of participant information leaflets of placebo-controlled trials.
  Won J, Han JY, Ji YJ, Ha D, Han BJ, Lee H. Won J, et al. Integr Med Res. 2024 Jun;13(2):101043. doi: 10.1016/j.imr.2024.101043. Epub 2024 Apr 17. Integr Med Res. 2024. PMID: 38779540 Free PMC article.
• Unheard and unseen: The hidden impact of nocebo communication in the Intensive Care Unit.
  Huynh KN, Rouse-Watson S, Chu J, Lane AS, Cyna AM. Huynh KN, et al. J Intensive Care Soc. 2023 Nov 29;25(2):128-130. doi: 10.1177/17511437231214148. eCollection 2024 May. J Intensive Care Soc. 2023. PMID: 38737306 Free PMC article. No abstract available.
• Negative expectations (nocebo phenomenon) in clinical interventions: A scoping review.
  Nasiri-Dehsorkhi H, Vaziri S, Esmaillzadeh A, Adibi P. Nasiri-Dehsorkhi H, et al. J Educ Health Promot. 2024 Mar 28;13:106. doi: 10.4103/jehp.jehp_269_23. eCollection 2024. J Educ Health Promot. 2024. PMID: 38726093 Free PMC article. Review.
• Translating knowledge on placebo and nocebo effects into clinical practice.
  Caliskan EB, Bingel U, Kunkel A. Caliskan EB, et al. Pain Rep. 2024 Mar 25;9(2):e1142. doi: 10.1097/PR9.0000000000001142. eCollection 2024 Apr. Pain Rep. 2024. PMID: 38533458 Free PMC article.
• Confirmation of COVID-19 infection status and reporting of Long COVID symptoms in a population-based birth cohort: No evidence of a nocebo effect.
  Macleod-Hall CI, Munafò MR, Dyer ML. Macleod-Hall CI, et al. J Health Psychol. 2024 May;29(6):581-594. doi: 10.1177/13591053241228711. Epub 2024 Jan 25. J Health Psychol. 2024. PMID: 38269448 Free PMC article.

References

1. 1. Ainslie G. Breakdown of Will. Cambridge University Press; Cambridge: 2001.
2. 1. Amanzio M, Corazzini LL, Vase L, Benedetti F. A systematic review of adverse events in placebo groups of anti-migraine clinical trials. Pain. 2009 - PubMed
3. 1. Barilan YM. Informed consent: between waiver and excellence in responsible deliberation. Med Health Care and Philos. 2010;13:89–95.
4. 1. Barsky AJ, Borus JF. Functional somatic syndromes. Annals of Internal Medicine. 1999;130(11):910–21. - PubMed
5. 1. Barsky AJ, Saintfort R, Rogers MP, Borus JF. Nonspecific medication side effects and the nocebo phenomenon. Journal of American Medical Association. 2002;287(5):622–7. - PubMed

Publication types

MeSH terms

Grants and funding

• K24 AT004095-07/AT/NCCIH NIH HHS/United States
• K24 AT004095/AT/NCCIH NIH HHS/United States
• T32 AT000051/AT/NCCIH NIH HHS/United States
• T32 AT000051-12/AT/NCCIH NIH HHS/United States
• T32AT000051/AT/NCCIH NIH HHS/United States

LinkOut - more resources

• Full Text Sources

  • Europe PubMed Central
  • PubMed Central
  • Taylor & Francis

• Medical

  • MedlinePlus Health Information