Off-label Antipsychotic Prescriptions May be Inappropriate for Aggression
> 1/4/2008 12:12:58 PM

The overworked staff of clinics and nursing homes often struggle to deal with outbursts from troubled patients. In addition to psychosis, a whole range of problems such as emotional disturbances, intellectual impairment, and confusion, can lead to outbursts. While antipsychotic medications are only approved for treating psychotic symptoms, they are now commonly used off-label to deal with aggression. Despite anecdotal reports that they are effective at calming patients, there are no conclusive studies to back up this claim. In fact, a study in the most recent issue of the Lancet makes a strong case that antipsychotics have no calming effect, and perhaps even increase aggression.

British researchers, led by Dr. Peter Tyrer, set up a trial with 86 non-psychotic patients from 10 different clinics. These patients were first evaluated for aggressiveness and then enrolled in a group given one of three treatments: the typical antipsychotic haloperidol, the atypical antipsychotic risperidone, and a placebo. The patients were observed for four weeks to evaluate levels of aggression. The risperidone group showed a 58% drop in aggression, and the haloperidol group showed a 65% reduction. This is an incredible benefit, one large enough that caretakers noticed and appreciated the drop in disturbances. However, this drop is also incredibly misleading.

The placebo group showed a 79% reduction in aggression. A pill made of sugar significantly outperformed two trusted antipsychotics. Not only is sugar less expensive than these other medications, but it is also much less dangerous; antipsychotics can have a number of terrible side-effects such as weight-gain and long-lasting, unbearable muscle twitches. The extra attention that patients received by participating in this study was enough to subdue much of their anger, and it appears as if medication only reduced this benefit by disturbing patients by giving them additional symptoms to deal with.

Off-label treatments are controversial, but they do often give doctors the flexibility they need to follow their intuition. Sometimes, doctors will see a good use for a drug years before the FDA approves it. Sometimes, doctors think they see a good use but are deceived by dramatic but non-representative anecdotes or placebo effects. This seems to be a case of the latter, and Dr. Tyrerís study is a clear sign that doctors should be wary about using antipsychotics as a panacea. It should also serve as a clear warning that they must be more cautious with all off-label uses that lack extensive evidence.


1. I'd like to direct your readers to this discussion at Autism Vox the Medication Question2. Readers should be aware of a difference in British and American usage. In the U.K., "learning disabilities" = developmental delays or mental retardation. In the U.S., "learning disabilities" = persons without developmental delays who have otherwise unexplained difficulties with learning.3. As I understand it, this study concerns people who were more-or-less institutionalized -- that is, not in family settings.
Posted by: Liz Ditz 1/5/2008 9:14:32 AM

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