Placebos and Placebo Treatments: What Is the Difference?
Article Outline
I noticed an article in the most recent issue of Physician's News Digest that really grabbed my attention. The title was “Placebos in clinical practice” (Guadagnino, 2008). As pain management nurses, we know that the only role for placebos is in controlled clinical trials that mandate informed consent. The term placebo is literally translated from Latin as “I will please” (American Pain Society [APS], 2005). Before the 1960s, the administration of inert substances to promote a placebo effect or to satisfy a patient's expectation of receiving a prescribed treatment was not considered to be a problem (Tilburt, Emanuel, Kaptchuk, Crulin, & Miller, 2008). The Nuremberg Code was developed after Nazi physicians had performed painful and often lethal experiments on prisoners (Markman & Markman, 2007). After the Nuremberg Code was published in 1947, investigators believed it was irrelevant for modern research. A few events proved that belief to be false.
The most notable was the Tuskegee Syphilis Study, in which African-American men with syphilis were denied treatment after it was known that penicillin was an effective treatment (Markman & Markman, 2007). The study began in 1930 when there was no treatment available, but by 1947 penicillin was considered to be the standard treatment. Unethical research continued in the 1960s, when patients were injected with live cancer cells to study cancer immunity and the subjects were not aware that the transfusions contained cancer cells. This is when Institutional Review Boards and the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research were developed (National Institutes of Health, 1974).
This explains the current position statements held by the APS (2005) and the American Society for Pain Management Nursing (ASPMN) (2004). Both define a placebo as a medication or treatment thought to produce an effect in patients resulting from its implicit or explicit intent and not from its specific physical or chemical properties. The placebo effect is thus a positive clinical outcome caused by a treatment that is not attributed to its known physical properties or mechanism of action (Markman & Markman, 2007). The placebo effect may be improved symptom control or improvements in physiologic parameters and is believed to be the result of the mind-body connection.
In the past, pain was erroneously assessed by the administration of a placebo without the patient's knowledge or consent. Often, they were intended to discredit a report of pain or discomfort. If the placebo “worked” it was thought that there was no pain or that the patient was seeking opioids. The placebo is effective in placebo responders and is not an indication of the presence or absence of pain.
And so the title “Placebos in clinical practice” (Guadagnino, 2008) caught my eye. This article was reporting research by Tilburt, Emanuel, Kaptchuk, Curlin, and Miller (2008). Those researchers investigated the attitudes and behaviors regarding placebo treatments. Placebo treatments were defined as a treatment whose benefits (in the opinion of the clinician) derive from positive patient expectations and not from the physiologic mechanism of the treatment itself. Using the American Medical Association's master file, the authors randomly selected physicians with the primary specialty of internal medicine or rheumatology, a group of physicians who commonly treat patients with debilitating clinical conditions.
A survey instrument was developed using questions on the use of placebo treatment incorporated into questions that covered other topics related to complementary and alternative medicine. They devised a series of nonjudgemental questions that avoided use of the word placebo. Hypothetic scenarios were used, and clinicians were asked for the likelihood of their personally recommending a dextrose pill that was shown in clinical trials to be superior to a no-treatment control group. The subjects were asked how often they recommend a therapy “primarily because you believe it will enhance the patient's expectation of getting better” (Tilburt, et al., 2008).
Fifty-eight percent of the respondents indicated that they would be very likely or moderately likely to recommend a dextrose tablet for a patient with fibromyalgia if trials had shown such treatment to be superior to no treatment. Furthermore, 62% of the respondents said that recommending treatments in this manner was ethically obligatory and permissible. Fifty-five percent of respondents agreed that they had recommended a placebo treatment and that they usually describe it as “a medicine not typically used for your condition but might benefit you.”
After reading the article, I began to wonder: How many times have I suggested to my spouse, sister, or friend to try X treatment—it may not work but it won't harm you? I would love to hear your thoughts about the ethical nature of placebo treatments. Where do you stand?
References
- . APS position statement on the use of placebos in pain management. The Journal of Pain. 2005;6(4):215–217
- . Position statement on use of placebos in pain management. Lenexas, KS: American Society for Pain Management Nursing; 2004;
- . Placebos in clinical practice. Physician's News Digest—Philadelphia Metro Edition. 2008;22(3):1–7
- . Running an ethical trial 60 years after the Nuremberg Code. The Lancet Oncology. 2007;8:1139–1146
- . The Belmont report: Ethical principles and guidelines for the protection of human subjects of research. http://ohsr.od.nih.gov/guidleines/belmont.html1979;Retrieved December 16, 2008
- . Prescribing “placebo treatments”: results of national survey of US internists and rheumatologists. British Medical Journal. 2008;337:1938–1942
PII: S1524-9042(08)00235-X
doi:10.1016/j.pmn.2008.12.001
© 2009 American Society for Pain Management Nursing. Published by Elsevier Inc. All rights reserved.
