Dr. David Rabiner
* MEDICATION TREATMENT FOR CHILD AND ADOLESCENT PSYCHIATRIC DISORDERS: WHAT IS THE EVIDENCE?
There was a very important paper that appeared in the May, 1999 issue of the Journal of the American Academy of Child and Adolescent Psychiatry on the use of medication for treating psychiatric disorders in children and adolescents (Jensen, P.J., Bhatara, V.S., Vitiello, B., Hoagwood, K., Feil, M., & Burke, L.B. (1999). Psychoactive medication prescribing practices for U.S. children: Gaps between research and clinical practice). In this paper, the authors examine the frequency with which different medications are prescribed in relation to what research data exists for the safety and efficacy of the different meds. Although this encompasses disorders other than ADHD, I think this is quite an interesting and important paper to include in ADHD RESEARCH UPDATE. This is because I know that many of you have children who receive medications other than stimulants, and knowing something about the research support for these medications would be important. In addition, many professionals who receive the newsletter may be involved in prescribing these medications to the children they treat.
There are 8 classes of medications that were looked at in this paper. Each class of medication, examples of brand name meds from each class, and the type of disorder it is typically prescribed for are presented in the table below. (Note: The medications listed in the Selected Examples column are just examples of medications from the general category.)
Category Selected Examples Problem prescribed for
Stimulants Ritalin, Adderall ADHD
SSRIs (Selective Fluoxetine (Prozac) Major Depression serotonin reuptake sertraline Obsessive compulsive inhibitors) disorder (OCD) Anxiety disorders
Central adrenergic Clonodine Tourette's disorder agonists guanafacine ADHD
Anticonvulsant mood Valproate and Bipolar disorder stabilizers carbamazepine
TCAs (tricyclic Elavil Major depression antidepressants) imiprimine ADHD
Benzodiazepines alprazolam Anxiety disorders
Antipsychotics Risperidone Childhood schizophrenia Haloperidal Tourette's disorder
Lithium Bipolar disorder Aggression
In terms of the frequency with which these different classes of medication are prescribed, the numbers differed somewhat depending on which national data base the estimates are based on. Not surprisingly, stimulant medications are far and away the most frequently prescribed medication in child psychiatry. The best estimates available are that stimulant medications were prescribed in nearly 2 million visits for patients under the age of 18 during 1995. This is between 5 and 10 times the next most-frequently prescribed class of medications, the SSRIs. Even the least-frequently prescribed medication in this listing was estimated to have been dispensed to thousands of children, however.
One clear conclusion made by the authors is that it is really quite difficult to obtain accurate estimates of just how often psychoactive medications are being prescribed to children and teens in this country. In fact, the best data that exists is probably on the prescription of stimulant medications for ADHD. Clearly, having more accurate data on the use of such medication for children and teens would be very useful to have.
What about the evidence supporting the efficacy and safety for the use of such medications in youth? The authors examine this in relation to what is known about both short- and long- term efficacy, and short- and long-term safety. The grading scale they used, and the criteria for the different grades are shown below:
A - Efficacy supported in at least 2 or more randomized, controlled trials. These would be studies in which children's response to medication was compared to how they responded to a placebo;
B - Efficacy supported in at least 1 randomized controlled trial;
C - Efficacy supported by "informed" clinical opinion, case reports, or non-placebo controlled trials. This would generally be considered only an initial stage in documenting the efficacy of a pharmacologic treatment;
A - Low incidence of adverse event reports to the FDA. That is, adverse effects that could be attributed to the medication have been infrequently reported.
Note: This is not the same as having safety data established based on long-term randomized and controlled clinical trials. As the authors note, however, conducting such trials for for long-term safety data may be neither ethical nor feasible.
B - Clinically significant adverse event reports restricted to case reports and/or anecdotal reports, suggesting possible rare side effects.
C - No data or minimal data supporting long-term adversity or safety. In other words, little about the long-term impacts are really know, one way or the other.
Using these criterion, the grades assigned by the authors based on their review of the literature are shown below. The conditions under the general class of medicaqtion indicate the disorder for which the ratings in that row apply. For example, stimulant medications for treating ADHD receive grades of A and B for short- and long-term efficacy respectively, and grades of A for short- and long-term safety. As you can see, when the same type of medication is used to treat different conditions, and the grades are not always the same. (Sorry, but I was not able to get things to line up exactly.)
Category Short-term E. Long-term E Short-term S Long-term S
for ADHD A B A A
for major dep. B C A C
for OCD A C A C
for other anxiety C C C C
for Tourettes B C B B
for ADHD C C C C
for bipolar disorder C C A A
for major depression C C B B
for ADHD B C B B
for anxiety disorders C C C C
for schizophrenia B C B C
for Tourettes A C B B
for bipolar disorder B C B C
for aggression B C C C
Please note that these grades are based on the authors' review, and other experts in the field might conceivably come to somewhat different conclusions. Overall, however, the ratings indicate important gaps in current knowledge. As you can see, not a single of the most frequently used medications for treating child and adolescent disorders received grades of A across the board. Stimulant medications for treating ADHD came closest, and I think that soon-to-be-published studies on long-term efficacy will turn this into an A grade quite shortly. In contrast, the long-term efficacy grade for every other medication was a C. Remember, this does not mean that these compounds are not effective for the designated use. Instead, it means that solid scientific data that documents long-term efficacy is not yet available. Of course, this is not that different from the situation that exists with many medications that are used to treat a variety of physical ailments. Even when it comes to short-term efficacy, however, only two other classes of medication received A grades for treating a particular disorder.
There are several important points that can be taken from this excellent review paper. First, one could certainly make a case that these medications are being over prescribed, given the efficacy and safety data that is available to support their use. For example, given the frequency with which antidepressant medications are prescribed for children and teens, the relative lack of scientific support for this is quite surprising. To date, there has been but a single study in which an antidepressant produced significantly better effects than a placebo in younger depressed patients (this was for fluoxetine - the generic form of Prozac - and where the results were 56% improved on fluoxetine vs. 33% on placebo). Clearly, there is a pressing need for more scientific study of these medications for treating children and teens.
Second, when one looks at the data above, it is surprising how much controversy there continues to be about the use of stimulant medications for treating ADHD relative to the use of the other medications listed. Clearly, stimulant medications have the best established efficacy and safety data available, even though more work in this area is also called for. If as much supportive data was available for these other medications as is currently available for stimulants, however, we would be much further along in our knowledge than we currently are.
Finally, I think these data suggest that one should be cautious about using medications to treat most psychiatric conditions in children and teens. With certain exceptions, the data to support the use of medications is not so compelling that one would not want to carefully explore other treatment options.
The authors - 3 of whom are child psychiatrists heavily involved in research - close their paper with the following statement:
"The lack of safety and efficacy data for psychotropic medications is of general concern, not just for parents of children with mental illness and their physicians, but for all with a stake in the future of the nation's children."
They lay out a set of recommendations for helping to close these important gaps in knowledge that will hopefully be heeded by researchers and pharmaceutical companies in the years ahead.
Source: David Rabiner, PhD
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