Treatment of trauma-affected refugees with venlafaxine versus sertraline combined with psychotherapy - a randomised study.
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.


CONCLUSIONS
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.


BACKGROUND
ClinicalTrials.gov NCT01569685 . Registration date: 28/2/12.
Competence Centre for Transcultural Psychiatry, Maglevaenget 2, 2750, Ballerup, Denmark. charlotte.sonne@regionh.dk.|National Center for Psychotraumatology, University of Southern Denmark, Campusvej 55, 5230, Odense, Denmark. charlotte.sonne@regionh.dk.
Charlotte
http://orcid.org/0000-0003-4001-7790
C
Sonne
Competence Centre for Transcultural Psychiatry, Maglevaenget 2, 2750, Ballerup, Denmark.
Jessica
J
Carlsson
Mental Health Centre North Zealand, University of Copenhagen, Dyrehavevej 48, 3400, Hillerød, Denmark.
Per
P
Bech
National Center for Psychotraumatology, University of Southern Denmark, Campusvej 55, 5230, Odense, Denmark.
Ask
A
Elklit
Institute of Public Health and Center for Healthy Aging, University of Copenhagen, Øster Farimagsgade 5, 1353, København K, Denmark.
Erik Lykke
EL
Mortensen
D000328:Adult; D018687:Antidepressive Agents, Second-Generation / Q000627:therapeutic use*; D001007:Anxiety / Q000188:drug therapy; D003718:Denmark; D003863:Depression / Q000188:drug therapy; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011569:Psychiatric Status Rating Scales; D011788:Quality of Life / Q000523:psychology; D012036:Refugees / Q000523:psychology*; D012107:Research Design; D020280:Sertraline / Q000627:therapeutic use*; D013313:Stress Disorders, Post-Traumatic / Q000188:drug therapy* / Q000523:psychology; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D000069470:Venlafaxine Hydrochloride / Q000627:therapeutic use*
D018687:Antidepressive Agents, Second-Generation; D000069470:Venlafaxine Hydrochloride; D020280:Sertraline
Depression; Refugee; Sertraline; Stress disorders, Post-traumatic stress disorders; Trauma; Venlafaxine