by Jeffrey P. Kahn, Ph.D., M.P.H. Director, Center for Bioethics University of Minnesota

The National Institutes of Health held a conference last week to discuss one of the oldest aspects of medicine: the use of placebos. There is no doubt that placebos -- inert substances given in place of active drugs -- have a beneficial effect on patients who take them. So what's wrong with using placebos?

When a doctor gives patients a placebo, patients have to be deceived into thinking they are getting an effective therapy for it to "work." In research, subjects have to be blind as to whether they are receiving the new drug being tested or are in the placebo control group. The problem then is that placebos rely on deception as part of medical care or on the possibility of withholding effective therapy in order to answer a research question. So how far should we be willing to go for potential health benefits or to answer a research question?

What's your opinion?

Why deny the placebo effect?

We know that placebos actually work, that is, that they have a positive effect. But to get the placebo effect requires that patients be deceived into thinking they are taking actual medicine. When they find out that they were actually taking sugar pills, two things happen. First, symptoms can quickly return and second, they begin to mistrust their doctor. Neither outcome is welcome, and can have much greater and long-lasting negative effects than any beneficial placebo effect. Honesty in research

The case for placebos is somewhat easier to make in research. Placebo controls have long been a part of the research enterprise, used as the best way of assessing whether new drugs actually have an effect on the disease or illness they are intended to treat. Under the rules of informed consent, subjects must be told if placebos will be used in research, and that they may be among those who receive it. Whether a subject goes into the active agent or placebo group depends on chance, much like the roll of dice, and only after the research ends will anyone know who was in each group.

The only problem with this approach is that prospective subjects often don't appreciate the fact that they may be in the placebo group. Studies have shown that the vast majority of subjects believe that they will be put into the research group that is best for their treatment. But researchers don't prejudge what's best for subjects, and if every subject received what was perceived to be in his or her best medical interests, research would be very difficult to conduct.

Of course it may be the case that those in the placebo group do better -- not because the placebo has more therapeutic effect, but because it has fewer side effects than the drug being tested. Whatever the outcome, such misunderstanding undermines the trust from subjects on which research depends.

Should we test with placebos when effective therapies exist?

Recent debate has focused on whether it is ever acceptable to use placebo controls in research when it means withholding effective therapy. The problem arises in parts of the developing world where effective therapies are either unavailable or unaffordable. Research may lead to the development of more affordable treatments, but the most effective way to do so is to test the new therapy against a placebo rather than against existing (but locally unavailable) therapy.

A recent meeting of the World Medical Association concluded that new treatments should be tested against the best current treatments and that placebos should be used only when no treatment exists, based largely on the argument that such a policy is the only way to protect research subjects from exploitation. But such a policy will also deprive the same subjects -- and the groups from which they come -- of the benefits they could realize from proscribed research.

This tension is far from resolved, and points to the need for greater efforts to balance the world community's important concern for subjects with a tendency toward exporting moral judgment along with research projects.

So should we rethink the use of placebos? If patients understand their use by physicians, and if their use offers real benefits to willing research subjects, then there may be a place for them yet. Or maybe we're just deceiving ourselves.

NIH Conference, March 2001

Gender & Placebo Analgesic Effect/Acute Pain

Clin Pharmacol Ther, 10/01

The Connection

LINK to site with many articles on placebos

Nonspecific Meds Side Effects:Nocebo Phenomon

JAMA, 2/02

Letters to the Editor
Placebo & Opioid Activate Same Neuronal Network

J Science, 2/07/02

Statement by the World Medical Association

2002 World Medical Association

Placebo Effect - Endorphins, 9/05

Placebo Power

LA Times, December 12. 2005

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