Thursday, August 8, 2013

Ethics of Placebo Treatments

Excerpted from “Patients’ attitudes about the use of placebo treatments: telephone survey,” British Medical Journal. July 2, 2013 -- Several recent surveys of physicians have documented their use of placebo treatments in clinical practice. In a recent U.S. survey of internists and rheumatologists, half reported that they have prescribed placebo treatments, defined as treatments “whose benefits derive from positive patient expectations rather than from the physiologic or pharmacologic mechanism of the treatment itself.” These placebo treatments included active agents such as vitamins or analgesics that a physician prescribed to promote positive placebo effects rather than specific pharmacologic or physiologic effects.
The prescription of placebo treatments as part of medical care is ethically controversial. Their use has been criticized because the practice is thought to involve deception, thereby violating patient autonomy, because of concerns about the compatibility of placebo treatments with evidence-based medicine, and because the risks introduced by some placebo treatments outweigh the possible benefits of their use, as in the case of prescribing antibiotics for viral infection. U.S. clinical practice guidelines prohibit the use of placebo treatments without a patient’s knowledge, citing concerns about undermining trust and compromising the patient-physician relationship. Despite these concerns, some have argued that use of placebo treatments can be justified when they are effective, at least in certain cases.

The perspectives of U.S. patients have been missing in the debate over the use of placebo treatments in clinical practice. To probe the attitudes of U.S. patients regarding placebo treatments, a survey was conducted of adult members of a large Northern California health plan. The survey utilized a carefully constructed definition of “placebo treatments,” used a combination of general questions and detailed scenarios, and included a large and demographically diverse sample of patients. The data shows that patients are open to the idea of placebo treatments. Most (50 to 84 percent) judged it acceptable for doctors to recommend placebo treatments under conditions that varied according to the doctor’s level of certainty about the benefits of the treatment, the purpose of the treatment (for example, to address a patient’s need to receive a treatment) and the transparency with which the treatment was described to patients. Fewer than a quarter stated that it was never acceptable for doctors to recommend placebo treatments. In addition, many respondents indicated a willingness to try placebo treatments in different scenarios. This is generally compatible with trends reported in previous patient surveys in other countries regarding willingness to try placebo treatments.

Commentary


Dr. Dónal P. O’MathúnaCMDA Member and Ethics Lecturer at Dublin City University, Ireland Dónal P. O’Mathúna, PhD: “The placebo effect is often viewed negatively, as something to be eliminated in medical research or as a way to explain how ‘inert’ interventions have effects. More recently, placebos have been declared unethical, a deceptive violation of patient autonomy. The American Medical Association holds that placebos should be prescribed only if patients agree to their use.
“The BMJ study defined the placebo effect as patients getting better after a treatment because they expected improvement, not because of the treatment itself. It found that most patients are open to placebos, but concerned about the deceptive element. The findings highlight the importance of honesty and trust in medical practice.

Many believe placebos only work if patients do not know they are taking them. In the BMJ survey, two-thirds would try a placebo for moderate stomach pain or chronic abdominal pain, if told they were given a placebo. A recent randomized controlled trial found that irritable bowel syndrome patients, fully informed about being given an inert placebo, had significantly better outcomes than those given no treatment (Kaptchuk et al. PLoS ONE 2010;5(12):e15591). The placebo included a supportive interaction with patients given a clear rationale for how placebos might be beneficial.

Research into the placebo effect provides evidence that ethics matter, and that patients want open and honest interactions with their physicians. These studies support the non-deceptive use of placebos. Our mind, body and spirit are intricately interwoven. How we relate to others makes a difference.

Resources
Alternative Medicine: The Christian Handbook by Dónal O’Mathúna, PhD and Walt Larimore, MD
CMDA Ethics Statement on Human Research Ethics
Bioethics Ireland

2 comments:

  1. It will be a great day when "prescription pads" (or whatever they're called in the EMR) come with a checkbox "May prescribe placebo."

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  2. I believe that there are a number of issues here. First is what are the cultural expectations. For example, in Asian cultures typically, patient autonomy is NOT the highest ethical or moral imperative and a paternalistic approach is dominant. People have an expectation that the doctor do what's best to make the patient feel better and that is the doctor's duty. If that is the a priori assumption, then giving a placebo without consent is fine. From the point of view of a Christian, I have no problem with that for several reasons. One, God does not always explain things to us so understanding why/how things work does not seem to be a moral imperative to me. Secondly, what we believe about mechanism/physiology/pathophysiology, etc may not be correct so I don't expect a certain scientific certainty to every explanation I give. For example, there is strong evidence that certain medications don't really work (eg, loratadine OTC for allergies, flexeril for muscle relaxation, etc), yet I still prescribe them. I do so either because my anecdotal experience is that they do help some or because of theoretical benefit that they might help. Just because it's a "sugar pill" which I can't fully describe does not mean that it doesn't do something to help. Ironically, even sugar pills have been shown to help (eg, kids getting IV's). Third, we have to decide how much someone needs to know before they decide to follow a treatment. I find that some patients just want to know that I've thought about them as individuals, have listened to their symptoms and story, and have prescribed something that I think could help them. Most do not care how I made that decision and whether or not I based that on my experience or one particular trial or a Cochrane review, etc. -Timothy Jang, Christian physician, practice in LA

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