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To the Editor: In interpreting the TADS results,¹ the central issue is the benefit-to-risk ratio, which can be determined by considering the number needed to treat (NNT), the number needed to harm (NNH), and the number needed to prevent.² In this study, a categorical positive response was achieved in 71.0% of participants treated with fluoxetine in combination with CBT; in 60.6% with fluoxetine alone; in 43.2% with CBT alone; and in 34.8% with placebo. Based on these outcomes, the NNT is 3.9 for fluoxetine alone compared with placebo and 3.7 for drug vs no drug. I believe that these represent low NNTs (high benefit) that are clinically meaningful.

The TADS Team reported suicide-related adverse events in 6.9% of children taking fluoxetine and in 4.0% of children who did not take fluoxetine; this corresponds to a NNH of 34. Likewise, TADS reported suicide attempts in 6 (2.78%) of 216 adolescents . . . [Full Text of this Article]

Bernard J. Carroll, MB, BS, PhD
bcarroll@redshift.com
Pacific Behavioral Research Foundation
Carmel, Calif

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