Friday, October 7, 2016

Prescribing the Placebo Effect

By Sarika Sachdeva

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. 

Sarika Sachdeva is an undergraduate junior at Emory studying Neuroscience and Behavioral Biology and Economics. She is involved with research on stimulant abuse and addiction under Dr. Leonard Howell at Yerkes National Primate Research Center. 

In 2006, Dr. Ted Kaptchuk designed a clinical drug trial to evaluate a new pain pill in patients with severe arm pain. Participants in the study were assigned to receive either the pill or an acupuncture treatment for several weeks. Dr. Kaptchuk found that the people who received acupuncture ended up with more pain relief than those who had taken the pain pill. This difference was surprising, not because the pain pill was expected to be more effective, but because neither treatment was real- the pain pills contained cornstarch and the acupuncture was done with false needles that never pierced the skin.

Placebos are often considered baseline measurements, used as the standard scientific method to determine if a drug is actually making a biological difference or if its effects are just ‘inside the head’ and no better than a sugar pill (Anderson 2013). Utilizing the placebo effect as a form of treatment carries a stigma: only 0.3% of physicians admit to regularly prescribing them, in contrast with data that indicates around 50% of physicians actually do (Rommelfanger 2013).

Image courtesy of Pixabay
Recently, however, there has been a growing body of evidence that placebos produce real physiological changes, making them an active treatment not unlike ibuprofen, aspirin, or other traditional pharmaceuticals. This would explain why Dr. Kaptchuk’s study resulted in two separate outcomes for two different placebos. The first evidence of the idea that placebos are not inert came from a study on coronary heart disease that compared the mortality rates of a fat-lowering drug against a placebo. The results were insignificant; there was less than a 1% difference in mortality between the drug and the placebo, but a closer examination of the results revealed an interesting trend. In both the drug and the placebo groups, the participants who occasionally missed doses had a much higher mortality rate than the group that fully complied with the schedule by about 10% (Speers 2011). In other words, how often the placebo, or inactive pill was taken had a significant impact on mortality. This challenged the assumption that placebos have no physical impact on the body. Other studies using functional brain imaging scans have provided further evidence of the physiological changes produced by mere placebos. One of these studies compared fMRI scans in the brains of depressed men who had either taken a placebo or an antidepressant and found that both led to similar increases in activity in areas associated with pain in the prefrontal cortex and decreases in areas associated with anxiety in the amygdala, a clear indication of the validity of a placebo (Benedetti et al. 2005).

The physiological effects of a placebo treatment have important implications when considering treatment options for patients. This is of special importance for conditions that have no known treatment, or for when many treatment options have been exhausted with no success. Because placebos are not accepted as an active form of treatment, they are often not considered or taken seriously (Hernandez et al. 2014). In light of the fact that placebos have proven physiological effects and success no different from other medications and treatments, not using their benefits in a mainstream way may actually be prolonging the pain and afflictions of people with conditions that could be treated with a placebo (Rommelfanger 2012).

Use of the placebo as a treatment must be done with caution and within ethical limitations (Lichtenberg et al. 2004). The most polarizing aspect of the placebo is if the patient is being deceived because they think they are being given an effective medication when instead they are being treated with an inert pill seemingly unrelated to their condition. This does not qualify as deception: firstly, the placebo pill is not inert and has been shown to have physiological effects as mentioned previously. Secondly, if the physician informs the patient that they are being given a treatment that has proven to be effective, they are not lying. The physician does not have to pretend the placebo is a miracle cure or that he or she knows how it works in order to prescribe it to a patient that could benefit. Deception is believed to be necessary for the placebo effect to take place, but this is not necessarily the case (Blease et al. 2016). A physician could simply tell their patient that they are being given a placebo that has been shown to work for no apparent reason, eliminating all concerns about deception while still benefiting from the placebo’s effects.

Based on research into the efficacy of placebos and evidence that indicates they are not inert, I advise that the placebo be recognized as a valid form of treatment which physicians may choose to prescribe at their discretion with patient consent. I recommend medical practice regarding placebos be refined in order to accommodate recent research and account for potential ethical concerns through a three-fold approach:

1) Educating patients about the known and unknowns of placebo as a treatment, thereby allowing patients to make an informed decision when deciding to consent to a treatment that may be a placebo, or that they know is a placebo.
If a placebo is a viable treatment, physicians should present it as an option along with any other treatments being considered. The physician should detail the advantages of a placebo treatment, ideally in person, and clarify the word ‘inert’ as it inaccurately defines the placebo as a fake treatment whose effects are ‘all in the head’. Patients should also be informed of the difference between not knowing they are taking a placebo and knowing that they are, and physicians who use placebos should respect a patient’s decision if they would or would not like to be told if they are being given a placebo.

2) Training healthcare professionals with a standardized protocol in order to avoid misconceptions and ensure that the latest research is accounted for in their practice.
This will help avoid patients being given contradictory information by different physicians, pharmacists, or nurses and keep them up to date with the latest research on the efficacy of placebos so that they can incorporate details of optimal conditions into their practice. This training can be implemented as part of their license renewal.
The standardized protocol should include guidelines on how to treat consent for placebo treatments. Physicians can choose not to disclose that the medication they are given is a placebo; however, if asked about the drug specifically by a patient, the physician must disclose that the medication is a placebo. Physicians must honor a patient’s decision to choose not to be treated with a placebo after presenting them with that option.

3) Encouraging and funding further research into the physiology, efficacy, and optimal conditions of placebos.
Further research into placebos, especially into the potential negative effects, is needed to determine the conditions and subset of patients under which it is most effective. The method through which a placebo is administered is important to its outcome, so even factors such as the prescribed dosage and color of the pill can impact the results. This information can also be used to make non-placebo medication more effective, similar to how dosage curves are established in clinical drug trials. Research is also needed into the mechanisms behind which placebos work, which can provide valuable insight towards several diseases.
The above approach will help destigmatize placebo treatments in medicine and open up viable treatment options to people unable to be treated through other medication. Placebo treatments expand the potentials of modern medicine by creating real physiological results through nonspecific treatment. The placebo effect is seen even when knowledge that a placebo is being given is known and informed consent can allow patients to be comfortable that the medicine they are receiving is legitimate, even if it is a ‘just’ a sugar pill.

References: 

Anderson, L. 2013. What is a Placebo. Drugs. Available here

Benedetti, F., H. S. Mayberg, T. D. Wager, C. S. Stohler, and J. Zubieta. 2005. Neurobiological Mechanisms of the Placebo Effect. The Journal of Neuroscience. Available here.

Blease, C., L. Colloca, and T. J. Kaptchuk. 2016. Are open-label placebos ethical? Informed consent and ethical equivocations. Bioethics. Available here.

Hernandez, A., J. Banos, C. Llop, and M. Farre. 2014. The definition of placebo in the informed consent forms of clinical trials. PloS One. Available here.

Kaptchuk, T. J., W. B. Stason, R. B. Davis, et al. 2006. Sham device versus inert pill: randomized controlled trial of two placebo treatments. BMJ. Available here.

Lichtenberg, P., U. Hereseco-Levy, U. Nitzan. 2004. The ethics of the placebo in clinical practice. Journal of Medical Ethics. Available here.

Rommelfanger, K. S. 2012. Take two placebo pills and call me in the morning. Huffpost Science. Available here.

Speers, R. 2011. The power of drug compliance: Active ingredient or placebo. Modern Medicine Network. Available here.

Want to cite this post?

Sachdeva, S. (2016). Prescribing the Placebo Effect. The Neuroethics Blog. Retrieved on , from http://www.theneuroethicsblog.com/2016/10/prescribing-placebo-effect.html

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