Cargando…

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 ser...

Descripción completa

Detalles Bibliográficos
Autores principales: Sonne, Charlotte, Carlsson, Jessica, Bech, Per, Elklit, Ask, Mortensen, Erik Lykke
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5101827/
https://www.ncbi.nlm.nih.gov/pubmed/27825327
http://dx.doi.org/10.1186/s12888-016-1081-5
_version_ 1782466359338205184
author Sonne, Charlotte
Carlsson, Jessica
Bech, Per
Elklit, Ask
Mortensen, Erik Lykke
author_facet Sonne, Charlotte
Carlsson, Jessica
Bech, Per
Elklit, Ask
Mortensen, Erik Lykke
author_sort Sonne, Charlotte
collection PubMed
description 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 ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s12888-016-1081-5) contains supplementary material, which is available to authorized users.
format Online
Article
Text
id pubmed-5101827
institution National Center for Biotechnology Information
language English
publishDate 2016
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-51018272016-11-10 Treatment of trauma-affected refugees with venlafaxine versus sertraline combined with psychotherapy - a randomised study Sonne, Charlotte Carlsson, Jessica Bech, Per Elklit, Ask Mortensen, Erik Lykke BMC Psychiatry Research Article 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 ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s12888-016-1081-5) contains supplementary material, which is available to authorized users. BioMed Central 2016-11-08 /pmc/articles/PMC5101827/ /pubmed/27825327 http://dx.doi.org/10.1186/s12888-016-1081-5 Text en © The Author(s). 2016 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Research Article
Sonne, Charlotte
Carlsson, Jessica
Bech, Per
Elklit, Ask
Mortensen, Erik Lykke
Treatment of trauma-affected refugees with venlafaxine versus sertraline combined with psychotherapy - a randomised study
title Treatment of trauma-affected refugees with venlafaxine versus sertraline combined with psychotherapy - a randomised study
title_full Treatment of trauma-affected refugees with venlafaxine versus sertraline combined with psychotherapy - a randomised study
title_fullStr Treatment of trauma-affected refugees with venlafaxine versus sertraline combined with psychotherapy - a randomised study
title_full_unstemmed Treatment of trauma-affected refugees with venlafaxine versus sertraline combined with psychotherapy - a randomised study
title_short Treatment of trauma-affected refugees with venlafaxine versus sertraline combined with psychotherapy - a randomised study
title_sort treatment of trauma-affected refugees with venlafaxine versus sertraline combined with psychotherapy - a randomised study
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5101827/
https://www.ncbi.nlm.nih.gov/pubmed/27825327
http://dx.doi.org/10.1186/s12888-016-1081-5
work_keys_str_mv AT sonnecharlotte treatmentoftraumaaffectedrefugeeswithvenlafaxineversussertralinecombinedwithpsychotherapyarandomisedstudy
AT carlssonjessica treatmentoftraumaaffectedrefugeeswithvenlafaxineversussertralinecombinedwithpsychotherapyarandomisedstudy
AT bechper treatmentoftraumaaffectedrefugeeswithvenlafaxineversussertralinecombinedwithpsychotherapyarandomisedstudy
AT elklitask treatmentoftraumaaffectedrefugeeswithvenlafaxineversussertralinecombinedwithpsychotherapyarandomisedstudy
AT mortenseneriklykke treatmentoftraumaaffectedrefugeeswithvenlafaxineversussertralinecombinedwithpsychotherapyarandomisedstudy