Background: The prevalence of trauma-related psychiatric
disorders is high among refugees. Despite this, little is known about the
effect of pharmacological treatment for this patient group. The objective of
the present study was therefore to examine differences in the effects of
venlafaxine and sertraline on Post-Traumatic Stress Disorder (PTSD), depression
and functional impairment in trauma-affected refugees.
Methods: The study was a randomised pragmatic trial
comparing venlafaxine and sertraline in combination with psychotherapy and
social counselling. PTSD symptoms were measured on the Harvard Trauma
Questionnaire – part IV, which was the primary outcome measure. Other outcome
measures included: Hopkins Symptom Check List-25 (depression and anxiety),
Social Adjustment Scale – short version (social functioning), WHO-5 Well-being
Index (quality of life), Crisis Support Scale (support from social network),
Sheehan Disability Scale (disability in three areas of functioning), Hamilton
Depression and Anxiety scale, the somatisation items of the Symptoms
Checklist-90, Global Assessment of Functioning scales and the summarised score
of pain in four body areas rated on visual analogue scales.
Results: Two hundred seven adult refugee patients were
included in the trial (98 in the venlafaxine and 109 in the sertraline group).
Of these, 195 patients were eligible for intention-to-treat analyses. Small but
significant pre-treatment to post-treatment differences were found on the
Harvard Trauma Questionnaire and a number of other ratings in both groups. On
the primary outcome measure, no difference was found in treatment effect
between the sertraline and venlafaxine group. A significant group difference
was found in favour of sertraline on the Sheehan Disability Scale.
Conclusion: Sertraline had a slightly better outcome than
venlafaxine on some of the secondary outcome measures, but not on the primary
outcome measure. Furthermore, a higher percentage of dropouts was found in the
venlafaxine group compared to the sertraline group. Although this could
indicate that sertraline was better tolerated, which is supported by other
studies, a final conclusion on tolerability cannot be drawn from the current
study due to lack of systematic reporting of side effects.
Trial Registration: ClinicalTrials.gov NCT01569685.
Registration date: 28/2/12
Keywords: Refugee, Trauma, Venlafaxine, Sertraline, Stress
disorders, Post-traumatic stress disorders, Depression