Placebo Effects: A Double Edged Sword
Yesterday I described some of the advantages and risks of using Zyprexa, a powerful medication with great value in treating our sickest patients.
I would add that Zyprexa, and the other Atypical Anti-psychotics, have tremendous utility in other cases, as well. There are many people who have a tendency to develop disorganized thinking when stressed. Some develop a "Brief Reactive Psychosis"; others are diagnosed with "Borderline Personality Disorder." I do not want to go into any detail on these diagnostic entities at this point, but for people who have these diagnoses, they can develop psychotic states that can appear indistinguishable from a Schizophrenic decompensation (but tend to be short lived states and they have full recoveries without any inter-episode residual symptoms.) Further, there are many people (and there is significant overlap) who have affective (emotional) instability. That is, their moods are highly reactive; when pleased, they may be nearly manic in response, and when sad, they may become profoundly depressed, without meeting criteria for a major depression.
Clinical experience with these patients has shown that effective treatments often require long term psychotherapy and the ability of all concerned to weather "affect storms" which can severely disrupt lives. Past attempts to regulate their affective lives with medications have been disappointing. For many of these people, Zyprexa has been a life saver, keeping them on an emotional "even keel" (often in conjunction with an anti-depressant).
So, what is the problem? There are two main problems, beyond the obvious risk of developing diabetes.
First, using Zyprexa to manage the thinking and affective problems in patients with a Personality Disorder is an "off label" use, which means it has not been approved by the FDA. Since one can be sued for untoward effects even for approved uses of a drug, this is problematic.
Second, how one presents the option is often instrumental in how the patient responds to the drug.
In the olden days of medicine, when Doctors were unquestioned and unquestionable authority figures, it was enough to tell a patient to take a medicine and they would get better. This was never a particularly wise approach, IMHO, but it was accepted practice.
Nowadays, with all the concerns about side effects (any effect that is not intended) and in accord w2ith the Hippocratic oath's imprecation to "first, do no harm" a wise Doctor will take the time and energy to enable the patient to understand the benefits expected and the risks inherent in taking medication.
This leads to issues relating to the Placebo effect. In Technology Review this month there is an article describing two new books from Medical Specialists that relate to how people heal, with some specific interest in the Placebo effect. From the article, Wishful Medicine, comes this description of the Placebo:
... the placebo effect is not a figment of a patient's imagination. And there are now technology and studies to prove it.
Latin for "I shall please," the placebo takes many forms, the most common of which are the sugar pill, the saline injection, and distilled water. There are even placebo surgeries wherein patients are anesthetized, cut open, and stitched up to look as if they have had surgical interventions, even though they haven't. The belief and expectation that a treatment will heal produces in many patients genuine feelings of relief. In some patients, there is even physical evidence of a benefit.
Doctors and researchers first discovered in 1931 that the placebo effect was a useful prop for better understanding the safety and efficacy of medicines in development. It was well known that some patients would say that they felt better at the very suggestion that they were being given a remedy. Researchers trying to measure the effects of a drug called sanocrysin on patients with tuberculosis wanted to control for this anomaly. Their solution was to give patients a glass of distilled water and tell them they were drinking sanocrysin. Ever since, placebo-controlled, double-blind studies have been embraced by the medical profession as a standard way of evaluating drugs in clinical trials.
But what has long puzzled researchers is whether the sense of healing that some patients feel when given a sugar pill is a function of human biology or psychology. It turns out that it's both. New research indicates that in cases of maladies like chronic pain, asthma, and depression, a person's expectation of healing sets off a chain reaction of neurochemical changes in the body that can alleviate physical symptoms.
As Groopman writes of Ted Kaptchuk's placebo work at Harvard Medical School, "a change in mind-set can alter neurochemistry, both in a laboratory setting and in the clinic. When we are patients, suffering from pain and debility, we look to our doctors and nurses for the words and gestures that reinforce our belief in medicine's power and solidify our expectation that we may benefit from an intervention. Recent research shows just how catalytic those neurochemical changes can be."
An understanding of basic psychology can allow a Doctor to take advantage of these effects and help the patient recover more quickly. As an example, anti-depressants take an average of 6 weeks to have a full effect, yet many patients will feel some relief within the first few days. Typically, the medications have a mild calming effect (the SSRI's tend to diminish the activity of the entire emotional circuitry of the brain; some complain of psychic numbing for just that reason, but others find it a relief) and some have mild sedating effects; by telling the patient that he might be lucky and feel some relief more quickly, it is often possible to harness the early effects of a drug and compound it by the patient's sense that they are, indeed, a lucky person. The combination of a relatively non specific effect of the drug and the mental state brings the person relief he would not have felt if you instead warned him that he might feel some numbing but it would have nothing to do with any efficacy of the drug.
This leads to the opposite issue with Placebo effects. Obviously, the Placebo effect is a result of a patient's expectations. If a patient expects side effects, it increase exponentially the odds of them developing side effects. If I tell a patient he is likely to feel sedated by a drug, it will make some more likely to feel sedated. (Alternately some patients who have unconscious resistance to authority and, especially an intolerance of their own dependency needs, will often respond with agitation to the mild sedation; this is a very complicated area and informs how one should present a medication to the person.)
To return to Zyprexa, and summarize: we now are in the position of offering a medication at the "intersection of a unique drug with uniquely effective action, some serious potential side effects, and defensive medicine" (from Part II of this series) complicated by our still limited understanding of how the patient's conscious and unconscious expectations will effect their ability to tolerate and benefit from the medication.
To Be Continued...
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