Research Appraisals
Evidence-based critical appraisals of the latest medical research, systematically evaluated using Oxford CEBM methodology.
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The Cochrane database of systematic reviews
Pharmacotherapy for post traumatic stress disorder (PTSD)
BACKGROUND: Posttraumatic stress disorder (PTSD) is a prevalent and disabling disorder. Evidence that PTSD is characterised by specific psychobiological dysfunctions has contributed to a growing interest in the use of medication in its treatment. OBJECTIVES: To assess the effects of medication for reducing PTSD symptoms in adults with PTSD. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL; Issue 11, November 2020); MEDLINE (1946-), Embase (1974-), PsycINFO (1967-) and PTSDPubs (all available years) either directly or via the Cochrane Common Mental Disorders Controlled Trials Register (CCMDCTR). We also searched international trial registers. The date of the latest search was 13 November 2020. SELECTION CRITERIA: All randomised controlled trials (RCTs) of pharmacotherapy for adults with PTSD. DATA COLLECTION AND ANALYSIS: Three review authors (TW, JI, and NP) independently assessed RCTs for inclusion in the review, collated trial data, and assessed trial quality. We contacted investigators to obtain missing data. We stratified summary statistics by medication class, and by medication agent for all medications. We calculated dichotomous and continuous measures using a random-effects model, and assessed heterogeneity. MAIN RESULTS: We include 66 RCTs in the review (range: 13 days to 28 weeks; 7442 participants; age range 18 to 85 years) and 54 in the meta-analysis. For the primary outcome of treatment response, we found evidence of beneficial effect for selective serotonin reuptake inhibitors (SSRIs) compared with placebo (risk ratio (RR) 0.66, 95% confidence interval (CI) 0.59 to 0.74; 8 studies, 1078 participants), which improved PTSD symptoms in 58% of SSRI participants compared with 35% of placebo participants, based on moderate-certainty evidence. For this outcome we also found evidence of beneficial effect for the noradrenergic and specific serotonergic antidepressant (NaSSA) mirtazapine: (RR 0.45, 95% CI 0.22 to 0.94; 1 study, 26 participants) in 65% of people on mirtazapine compared with 22% of placebo participants, and for the tricyclic antidepressant (TCA) amitriptyline (RR 0.60, 95% CI 0.38 to 0.96; 1 study, 40 participants) in 50% of amitriptyline participants compared with 17% of placebo participants, which improved PTSD symptoms. These outcomes are based on low-certainty evidence. There was however no evidence of beneficial effect for the number of participants who improved with the antipsychotics (RR 0.51, 95% CI 0.16 to 1.67; 2 studies, 43 participants) compared to placebo, based on very low-certainty evidence. For the outcome of treatment withdrawal, we found evidence of a harm for the individual SSRI agents compared with placebo (RR 1.41, 95% CI 1.07 to 1.87; 14 studies, 2399 participants). Withdrawals were also higher for the separate SSRI paroxetine group compared to the placebo group (RR 1.55, 95% CI 1.05 to 2.29; 5 studies, 1101 participants). Nonetheless, the absolute proportion of individuals dropping out from treatment due to adverse events in the SSRI groups was low (9%), based on moderate-certainty evidence. For the rest of the medications compared to placebo, we did not find evidence of harm for individuals dropping out from treatment due to adverse events. AUTHORS' CONCLUSIONS: The findings of this review support the conclusion that SSRIs improve PTSD symptoms; they are first-line agents for the pharmacotherapy of PTSD, based on moderate-certainty evidence. The NaSSA mirtazapine and the TCA amitriptyline may also improve PTSD symptoms, but this is based on low-certainty evidence. In addition, we found no evidence of benefit for the number of participants who improved following treatment with the antipsychotic group compared to placebo, based on very low-certainty evidence. There remain important gaps in the evidence base, and a continued need for more effective agents in the management of PTSD.
30 May 2026
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Emotion regulation skills training as an adjunctive treatment to narrative exposure therapy for posttraumatic stress disorder (PTSD) in refugees: a pilot randomized controlled trial
Background: Responses to evidence-based interventions for posttraumatic stress disorder (PTSD) in refugees vary considerably. Emotion regulation difficulties are associated with greater PTSD severity in refugees and thus represent a potential treatment target.Objective: This study aimed to test the efficacy of Skills Training in Affective and Interpersonal Regulation for Refugees (STAIR-R) and Narrative Exposure Therapy (NET) or Supportive Problem-Solving (SPS) and NET. An exploratory aim was to examine relative efficacy in refugees with high and low levels of visa and family insecurity.Methods: Seventy-one participants were randomly assigned to STAIR-R (6 sessions) + NET (7 sessions) or SPS (6 sessions) +NET (7 sessions). Assessments occurred at baseline, post-treatment, and 3-month follow-up, with additional self-report at mid-treatment. The primary outcome was clinician-assessed PTSD symptom severity (CAPS-5) and secondary outcomes included self-reported PTSD symptoms, depression symptoms, emotion regulation difficulties, difficulties in relationships and environmental quality of life.Results: Intent-to-treat linear mixed models showed no significant between-group differences at mid-treatment, post-treatment, or follow-up. Both groups demonstrated significant improvements at 3-month follow-up in clinician-assessed (STAIR-R + NET, g = -1.41; SPS + NET, g = -1.54, p < .001) and self-reported (STAIR-R + NET, g = -0.49; SPS + NET, g = -0.44, p = .006) PTSD symptoms. Moderatorg analyses revealed that those with high insecurity (n = 16) obtained greater benefits in STAIR-R + NET from pre-treatment to follow-up on self-reported PTSD (g = 1.35), depression (g = 1.11), emotion regulation difficulties (g = 1.24), relationship difficulties (g = 1.12) and quality of life (g = -1.05).Conclusions: While there were no overall between group-differences, refugees in both conditions showed reduced PTSD symptoms. There is preliminary evidence that those with high insecurity showed a better response to STAIR-R + NET than SPS + NET across several clinical outcomes, although the small sample size necessitates replication of these. These findings highlight the potential importance of tailored intervention approaches for refugees living in different environmental circumstances. Emotion regulation difficulties represent a promising treatment target for refugees with PTSD.A randomized controlled trial comparing Skills Training in Affective and Interpersonal Regulation for Refugees + Narrative Exposure Therapy (STAIR-R + NET) to Supportive Problem Solving Training + Narrative Exposure Therapy (SPS + NET) revealed no significant differences at 3-month follow-up, with both groups improving on PTSD symptoms.Moderator analyses provided preliminary evidence that refugees living with high insecurity (i.e. insecure visa or separated from all family) showed greater improvements following STAIR-R + NET than SPS + NET.
9 Apr 2026
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