control conditions.3 Combined treatment could be tested within study designs like those that have been applied in large studies for other psychiatric conditions.
A final issue identified in the process of assessing the evidence pertains to what may be perceived as a surprising divergence between the committee’s conclusion in regard to the body of evidence on SSRIs and FDA’s approval of the SSRIs sertraline and paroxetine (in 1999 and 2001, respectively), previously approved for treating depression, for treating PTSD. FDA’s determination was of a regulatory nature, and its focus was risk-benefit analysis. The committee considered the published RCTs available on SSRIs and made its conclusion on the basis of what emerged as a very mixed picture on efficacy. Further, at present, FDA generally does not reconsider its regulatory decisions except in cases where new safety data emerges. Reviews of the empirical evidence such as the one contained in this report take into consideration studies and data emerging over years and even decades.
In addition to assessing the quality and direction of the empirical evidence on various PTSD treatment modalities, the committee discussed the following issues, as requested by the sponsor:
What are the goals of PTSD treatment?
What is the definition of “recovery”?
For what proportion of patients is recovery possible?
Besides recovery, what other outcomes would benefit patients?
Does evidence support the value of early intervention?
How long should treatment continue?
What is the impact of a hiatus in treatment?
What is the impact of periodic reexamination for asymptomatic patients?