CASE
The patient (Mr. K) presented to the clinic for treatment of his allergies and allergy-induced asthma. He had had problems related to these conditions for many years and had tried various treatments, none of which provided adequate relief. The clinic started him on immunotherapy, and shortly after he received his first dose, he reported “shortness of breath” and “chest discomfort.” The dose was reduced to almost undetectable levels of allergen, but after his next three injections, the patient continued to report shortness of breath (SOB) and chest discomfort.
During these symptoms, Mr. K's vitals signs remained stable except for mild tachycardia. Pulmonary function and oxygen saturation remained within normal limits. Accordingly, the PA, with the concurrence and encouragement of the supervising physician, injected the patient with normal saline to determine if his symptoms were a physiologic response to immunotherapy or psychosomatic. Shortly after the saline injection, Mr. K again reported SOB and chest discomfort. The PA and physician discontinued immunotherapy and prescribed an oral antihistamine with nasal, inhaled, and oral corticosteroids. The patient's response to these new medications was minimal.
THE ETHICAL QUANDARY
The PA now wonders if it was ethical to give a placebo (the saline solution) to the patient without his knowledge. Whether to disclose the placebo use to the patient after the fact is also a question. Should the PA explain to the patient that he still had symptoms even after receiving the saline solution, or should he tell the patient only that he is having enough of a reaction to warrant discontinuation of immunotherapy?
DISCUSSION
This case raises questions regarding the ethics of using a placebo, truthtelling to patients, the PA-patient relationship, trust, and the medical goals consistent with prescribing a placebo.
How often are placebos used in clinical practice? A number of studies have tried to answer this question. In 2008, Sherman and colleagues reported that 45% of 231 physicians at three medical schools in Chicago utilized placebos.1 In 2004, Nitzin and colleagues reported that 60% of 90 Israeli physicians and nurses in tertiary and primary care used placebos;2 and in 2003, Hrobjartsson and colleagues reported that of 500 physicians surveyed in Denmark, 54% of hospital physicians, 86% of general practice physicians, and 45% of specialists used placebos in their practices.3
Is it defensible to use placebos in clinical practice? Placebos are used regular regularly in clinical trials—where they often have a therapeutic effect, even though this effect is not intended. In a clinical setting, however, the placebo is intended to provide a therapeutic benefit. Despite their obviously widespread use, the use of placebos continues to be debated.
In 2000, the National Institutes of Health held a conference, “The Science of the Placebo: Toward an Interdisciplinary Research Agenda,” to discuss the use of placebo in clinical trials and clinical medicine (http://placebo.nih.gov/). The conference included a session on the ethics of using a placebo as treatment. Straus and colleagues observed, “The fruits of … basic research are needed to help engender new strategies to exploit placebo mechanisms as therapeutic allies…. As clinicians and researchers, we eagerly await the fruits of the interdisciplinary research efforts we at the NIH are now soliciting in pursuit of the science of the placebo.”4 In April 2003, “Placebo: Its Action and Place in Health Research Today,” a conference, was held in Warsaw, Poland (http://www.iitd.pan.wroc.pl/events/Placebo.html). This conference considered the use of placebos as an essential tool in clinical research and supported their use while upholding the highest ethical principles.
Both conferences noted that the goal of research is to advance medical knowledge and that in achieving that goal, the best interests of the patient may be compromised. The goal of clinical care, however, is to provide the patient with best current treatment.
Shortly after the NIH conference, Hrobjartsson and colleagues published a meta-analysis of 114 studies. They concluded, “We found little evidence that placebos had powerful clinical effects….5 In 2008, Hrobjartsson wrote in opposition to the American Medical Association's Council on Judicial Af fairs support of placebos that “Clinical placebo interventions are unethical, unnecessary and unprofessional.”6 Another writer criticized these conclusions, however, saying that “… the uncompromising condemnation of placebos … seems … just a bit too sweeping.”7 Yet this same author admits that “I would not want to prescribe or receive a placebo without some reason that was far more specific than the weak evidence of some general ‘placebo' effect.”7