Abstract
BackgroundThe 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.MethodsThe 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.ResultsTwo 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.ConclusionSertraline 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 RegistrationClinicalTrials.gov NCT01569685. Registration date: 28/2/12Electronic supplementary materialThe online version of this article (doi:10.1186/s12888-016-1081-5) contains supplementary material, which is available to authorized users.
Highlights
The prevalence of trauma-related psychiatric disorders is high among refugees
Aim of the study As stated above, venlafaxine has shown promising results in non-refugee Post-Traumatic Stress Disorder (PTSD) populations, but has only been compared to selective serotonin reuptake inhibitors (SSRI) in one small refugee study of limited quality. We found it appropriate to test the effects of venlafaxine versus an SSRI in a larger randomised trial in order to determine its effect in trauma-affected refugees
SE = Robust standard error Effect size: The effect size calculated as the pre-post score difference/the baseline standard deviation * = statistically significant (p = 0.05 or below), ** = higly statistical significant (p = 0.01 or below) Bold = Improvement, Italic = Deterioration was even clearer on the Sheehan Disability Scale, where we found a significant improvement in the sertraline group, but a non-significant deterioration in the venlafaxine group
Summary
The prevalence of trauma-related psychiatric disorders is high among refugees. The objective of the present study was to examine differences in the effects of venlafaxine and sertraline on Post-Traumatic Stress Disorder (PTSD), depression and functional impairment in trauma-affected refugees. The prevalence of trauma-related psychiatric disorders such as Post-Traumatic Stress Disorder (PTSD) and depression is high among refugees [1]. Trauma-affected refugees often present with a complex mixture of psychiatric symptoms that goes beyond merely PTSD in combination with psychosocial problems. They are often described among clinicians as a hard-to-treat patient group compared to other groups of PTSD patients [10]
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