Wednesday, January 12, 2011

The Ethics of Using Placebos in Clinical Practice

The most interesting research study you may ever read about was published last month in PLoS - "Placebos without Deception: A Randomized Control Trial in Irritable Bowel Syndrome."

Placebos have been the focus of much attention in medical ethics. We know that placebos can produce positive effects in many conditions, but it has been believed that deceiving the patient was necessary for a placebo to be effective. Clinicians (and students in ethics classes) confronted what appeared to be a choice between helping patients feel, and be, healthier, and truthfulness in the clinical relationship.

Many years ago I was referred an elderly Russian woman who, after a severe stroke, was left with a severe anxiety state. None of the "conventional" interventions I tried helped her at all. At that point her daughter asked me to give her a placebo and to tell her that the placebo would help her. In as non-judgmental a way as I could muster I said "In the U.S. we believe we should be truthful with our patients and don't like to deceive them." The daughter replied - "You're being self-centered. That's your way. I'm recommending what we would do in Russia!"

I thought she had a point. I checked with a colleague who treated many Russian immigrants. He confirmed that his Russian patients saw benign deception as something good doctors would, and should, do.

I decided to do what the daughter had requested. The pharmacy my practice used was surprised to be asked about placebos, but could make one available. But at this point the family moved, so I didn't get to see if we could alleviate her symptoms with an impressive looking sugar pill.

Still longer ago, as a 25 year old medical intern I was, alas, much more cavalier. In my clinic I had a patient who was chronically agitated by what I thought were trivial matters. When my most likely inept efforts at counselling produced no results I gave her a bottle of brightly colored placebos I'd gotten from the pharmacy and told her they would calm her nerves. (I wish I could say I conducted a deep ethical analysis before going ahead, but that would be a deceptive claim.)

My patient did indeed experience reduced anxiety. To my surprise, her diabetes also came into better control. I've never doubted the power of the placebo effect since then.

In the project reported in PLoS, patients with IBS were invited to join a study in which they would receive "either placebo pills, which were like sugar pills which had been shown to have self-healing properties" or no treatment. Those who were randomized to the placebo group were told (1) the placebo effect is powerful, (2) the body can automatically respond to taking placebo pills like Pavlov's dogs who salivated when they heard a bell, (3) a positive attitude helps but is not necessary, and (4) taking the pills faithfully was critical.

You can guess where this is heading. Over the three week trial, symptoms and overall quality of life improved substantially more in the placebo group than in the control group. In the context of the study, deception wasn't necessary.

However well the findings hold up in the efforts at replication that are sure to follow, the study points in a clear clinical and ethical direction. Clinicians who (a) believe that placebos could help their patients, but (b) also believe that deliberate deception is to be avoided except in unusual circumstances, can (c) prescribe a placebo with a clear explanation of the kind given in the study.

I've always thought it was shortsighted to use the word "just" before the words "placebo effect." The placebo effect is powerful and real, whether it is mediated by mental state, endorphin secretion, or some other set of mechanisms. We don't say "it was just the surgery" when a patient's life has improved post-operatively. The word "just" suggests our dis-ease and ambivalence about use of placebos.

If we can harness the power of suggestion and the power of truthfulness at the same time, it will make for a real advance in clinical practice!

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