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Brady
reports PTSD treatment in JAMA
Patients with posttraumatic stress disorder (PTSD) taking sertraline
(Zoloft) drug treatment reported significant improvement in symptoms and
functioning, according to an article in the April 12 issue of The Journal
of the American Medical Association (JAMA).
Kathleen
Brady, M.D., Ph.D., professor
of psychiatry and behavioral sciences, and colleagues conducted a placebo-controlled
study from May 1996 to June 1997 to examine the efficacy of sertraline
(a selective serotonin reuptake inhibitor antidepressant drug) with 187
patients from outpatient psychiatric clinics in eight academic medical
centers and six clinical research centers. The 12-week study was done to
determine if treatment with sertraline effectively diminishes symptoms
of PSTD of moderate to marked severity.
The researchers found sertraline to be significantly more effective
than placebo (inactive medication) in the treatment of PTSD across a spectrum
of illness-specific global and functioning outcome measures. In the efficacy
analysis, 53 percent of patients receiving sertraline were much or very
much improved at treatment end point, compared to 32 percent of patients
receiving placebo, with benefit from sertraline often present within the
first four weeks of treatment.
“Despite the high prevalence of PTSD and its physical and emotional
impact on patients, few placebo-controlled studies have evaluated the efficacy
of treatment for the disorder in the general population,” said Brady. “This
study is the largest done with any treatment to date, and it showed that
sertraline treatment had significant effect not only on the symptoms of
PTSD, but on quality of life as well.”
This study is one of the two pivotal studies used to support the new
FDA indication for sertraline in PTSD and the first of the two to be published.
The clinical presence of PTSD is characterized by moderate-to-severe
symptoms in three separate domains, including reexperiencing (intrusive
thoughts, nightmares, flashbacks, images or memories); emotional numbing
and avoidance (flattened affect or detachment, loss of interest and motivation
and avoidance of any activity, place, person or topic associated with the
trauma); and increased arousal (startle reactions, poor concentration,
irritability and jumpiness, insomnia or hypervigilance).
According to background information in the study, traumatic stress
is a significant public health problem that frequently results in a distinctive
pattern of persistent and disabling psychological and physiological symptoms.
Once thought to be primarily limited to soldiers in combat, PTSD is now
recognized in civilians, including those who have experienced natural disasters,
physical and sexual assault, fire, motor vehicle and other serious trauma,
as well as those who have witnessed inflicted injury or death.
The authors add that “with a minimum symptom duration of one month
at a level of severity necessary to impair an individual’s functioning,
PTSD has been estimated to have a lifetime prevalence in the range of 5
percent to 12 percent, based on epidemiological surveys, with women having
twice the prevalence rate of men. Frequently, PTSD is a chronic illness
with a median time to recovery in the range of three to five years.”
For patients who completed the study, sertraline treatment was also
associated with significant improvement in measures of social and occupational
functioning, as well as perception of improved quality of life. “A potential
therapeutic advantage of sertraline as a treatment for PTSD is its established
efficacy in treating disorders commonly comorbid with PTSD, such as depression
and panic disorder.”
The researchers suggest that “Additional research is needed to determine
whether subgroups of PTSD patients might respond preferentially to drug
or behavioral treatments or might optimally benefit from combination therapy.
Finally what constitutes an adequate therapeutic trial and whether or when
patients with PTSD might benefit from long-term treatment are also issues
that await further research.”
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