Wednesday, September 28, 2016

Placebo as Therapy: Context, Ethics, and Recommendations

By Somnath Das

This post was written as part of a class assignment from students who took a neuroethics course with Dr. Rommelfanger in Paris of Summer 2016.

I am a Senior at Emory University and am currently pursuing a double major in Neuroscience and Chemistry. Currently, I am applying to medical school. My interest in healthcare lies primarily in understanding the behavioral motivations of patients as they navigate through various healthcare systems. I also wish to study how to effectively translate innovations powered by biomedical research into accurate health information for patients and optimized healthcare delivery. Neuroethics allows me to focus these interests onto patient dignity and rights when considering the role novel therapeutics and interventions in treatment. Studying this fascinating field has given me a perspective on the role deontological considerations play in both neuroscience and medicine as a whole. It is with this perspective that I hope to approach my patients with a balanced worldview, taking into account both individual rights as well as stakeholders and developers participating in a rapidly changing field. 

Placebo therapy is broadly characterized as the administration of an agent that possesses a physiologically inert effect. However, current research suggests that placebo in fact has observable therapeutic outcomes across a wide spectrum of disorders. Thus, placebo’s efficacy should be investigated thoroughly by researchers, ethicists, and physicians in order to evaluate and develop protocols to implement placebo therapy in an effective manner. It is necessary that researchers communicate to physicians and clinicians about the efficacy and rigor by which research has quantified placebo’s effect. In addition, training protocols must be developed such that physicians can safely implement placebo therapy in practice. Finally, the ethics of placebo should be carefully considered; a calculation of placebo ethics is presented in tandem with policy recommendations in this document.

Image courtesy of Wikicommons.
A robust body of recent literature has connected placebo administration to treatment of neurological and psychiatric disorders. Placebo therapy has been shown to modulate the rostral anterior cingulate cortex (rACC), whose connectivity with the periaquiductual gray (PAG) is important for endogenous opioid production and thus modulation of pain [1]. Administration of saline injection has been shown to modulate dopamine release in the dorsal striatum, which has important implications for patients with Parkinson’s disease [2]. A review by Irving Kirsch found that placebo demonstrated a significant confounding effect in many studies involving antidepressants suggesting placebo therapy’s efficacy for treating depression [3]. Karen Rommelfanger in an opinion article for Nature Neuroscience discussed placebo’s potential as a treatment for conditions that lack a standard of care, such as psychogenic movement disorders, highlighting both clinical evidence about its efficacy as well as ethical considerations [4]. It is thus important that research on the placebo effect continue to supplement what is a growing field in order to accurately and rigorously document its efficacy for clinical application.

Studies on placebo utilization by family medicine physicians have shown that this therapy is commonly recruited in practice. A study by Kermen et al. (2010) found that among their respondents, 56% had used placebo in clinical practice. The most common reason for doing so was “unjustified demand for medication,” and the majority of their respondents recommended prescribing placebo to patients over no treatment [5]. Educators seeking to implement novel therapies, particularly for neurological and psychiatric disorders, should investigate the feasibility of placebo training education. Not only should clinical data be emphasized, but also doctor-patient communication. Patient belief in therapy, and thus cognitive salience of placebo, has been shown to modulate therapeutic efficacy in PD patients [6]. Therefore, physicians seeking to implement placebo therapy must be trained in effective doctor-patient communication specific to how to best reassure their patients about placebo’s safety and effectiveness.

That said, there are various ethical considerations when deciding to use placebo. The role of deception presents a significant issue. However, research has shown that models of authorized deception do not affect the efficacy of placebo therapy [7]. Physicians prescribing placebo could also be accused of giving patients therapies which they know are inert, violating the physician-patient relationship. However, the study by Kermen et al. presented above in addition to a continuous volume of studies suggest that physicians do believe in the efficacy of placebo. In addition, as education about placebo therapy and development of guidelines increases over time, so will updates to professional understanding of mechanism of placebo as therapy.

There is a significant need to develop standardized guidelines for ethical and appropriate usage of placebo therapy. Studies have shown for example that genes may modulate the effectiveness of placebo [8]. Literature has documented placebo’s effectiveness in mental disorders where the patient’s ability to consent may be variable, such as schizophrenia [9]. As placebo is being explored in the context of various psychiatric disorders, the ability of patients to consent to placebo treatment should be actively explored. Finally, guidelines should include which types of placebos are appropriate for usage. Studies have quantified physician prescription of multivitamins, antibiotics, and titrated medications in order to administer placebo therapy. Prescription of impure placebo remains to be fully studied, as many studies assume pure placebo [10, 11]. Alternative therapies, such as medical marijuana and acupuncture, must also be considered under these guidelines. As usage of this therapy grows, so should guidelines pertaining to how to responsibly prescribe placebo without potential treatment side effects.

As researchers continue to test various principles of placebos, physicians and ethicists too must begin a dialogue about the future of its therapeutic implementation. Training guidelines for physicians, disseminated either through medical education curricula or physician seminars, should be created in order to safely implement placebo in clinical practice. These guidelines should include elements relevant to placebo research and also physician-patient communication. Alternative therapies and the use of impure placebo should also be considered. Ethical studies have shown that issues pertaining to deception may not necessarily be as significant as once thought and thus legal precedent for authorized deception may need to precede implementation of placebo in practice. As novel applications of placebo are being developed, the rights of the patient to consent must be explored. Consent models for placebo must be updated in order to account for the growing number of disorders, particularly psychiatric, that it is used to treat. The future of placebo therapy largely depends on a multi-faceted conversation between multiple scientific, legal, and ethical fields. However, this discussion is necessary in order to implement what is a novel and effective therapy for many patients across multiple spectrums of illness.

References

1. Bingel, U., J. Lorenz, E. Schoell, C. Weiller, and C. Buchel. "Mechanisms of Placebo Analgesia: Racc Recruitment of a Subcortical Antinociceptive Network." [In eng]. Pain 120, no. 1-2 (Jan 2006): 8-15.

2. de la Fuente-Fernandez, R., and A. J. Stoessl. "The Placebo Effect in Parkinson's Disease." [In eng]. Trends Neurosci 25, no. 6 (Jun 2002): 302-6.

3. Kirsch, Irving. "Antidepressants and the Placebo Effect." Zeitschrift Fur Psychologie 222, no. 3 (2014): 128-34.

4. Rommelfanger, Karen S. "Opinion: A Role for Placebo Therapy in Psychogenic Movement Disorders." Nat Rev Neurol 9, no. 6 (06//print 2013): 351-56.

5. Kermen, R., J. Hickner, H. Brody, and I. Hasham. "Family Physicians Believe the Placebo Effect Is Therapeutic but Often Use Real Drugs as Placebos." [In eng]. Fam Med 42, no. 9 (Oct 2010): 636-42.

6. Lidstone, S. C., M. Schulzer, K. Dinelle, E. Mak, V. Sossi, T. J. Ruth, R. de la Fuente-Fernandez, A. G. Phillips, and A. J. Stoessl. "Effects of Expectation on Placebo-Induced Dopamine Release in Parkinson Disease." [In eng]. Arch Gen Psychiatry 67, no. 8 (Aug 2010): 857-65.

7. Martin, A.L., Katz, J.. " Inclusion of authorized deception in the informed consent process does not affect the magnitude of the placebo effect for experimentally induced pain. Pain 2010 May;149(2):208-15. doi: 10.1016/

8. Hall, K. T., A. J. Lembo, I. Kirsch, D. C. Ziogas, J. Douaiher, K. B. Jensen, L. A. Conboy, et al. "Catechol-O-Methyltransferase Val158met Polymorphism Predicts Placebo Effect in Irritable Bowel Syndrome." [In eng]. PLoS One 7, no. 10 (2012): e48135.

9. Kinon, B. J., A. J. Potts, and S. B. Watson. "Placebo Response in Clinical Trials with Schizophrenia Patients." [In eng]. Curr Opin Psychiatry 24, no. 2 (Mar 2011): 107-13.

10. Harris, Cory S, and Amir Raz. "Deliberate Use of Placebos in Clinical Practice: What We Really Know." Journal of Medical Ethics (May 28, 2012 2012).

11. Louhiala, Pekka. "What Do We Really Know About the Deliberate Use of Placebos in Clinical Practice?". Journal of Medical Ethics 38, no. 7 (July 1, 2012 2012): 403-05.

Want to cite this post?

Das, S. (2016). Placebo as Therapy: Context, Ethics, and Recommendations. The Neuroethics Blog. Retrieved on , from http://www.theneuroethicsblog.com/2016/09/placebo-as-therapy-context-ethics-and.html

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