Smajkic 2001.
Study characteristics | ||
Methods | Design: single‐centre, randomised, open‐label controlled trial, parallel, flexible‐dose Duration of intervention: 6 weeks Placebo run‐in: No information Post‐treatment: Not specified |
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Participants | Setting: Single‐centre, Mental Health Clinic Sample size: 32 randomised to sertraline, venlafaxine and paroxetine Mean age: 51.34 years (24 ‐ 63) Sex: 14 men and 18 women, Bosnian refugees, no combat‐related trauma Diagnostic measure: DSM‐IV Inclusion criteria: Quote: “To meet diagnostic criteria for PTSD, a subject must have a requisite number of symptoms in each of the three symptom clusters corresponding with DSM‐III‐R criteria for PTSD; Participants were either referred to us by refugee resettlement organizations in Chicago, by family members, or by themselves. The participants reported in this study were all those who started treatment for PTSD at the Refugee and Bosnian Mental Health Programs at the Chicago Health Outreach over a 3‐month period in 1995. All participants received concurrent case management and supportive counseling but no other psychosocial treatments during the period of study" Exclusion criteria: Quote: “We excluded any refugees with prior history of major mental illness (e.g., schizophrenia, bipolar disorder). No refugee who met criteria declined the treatment with medications" Comorbidity: SCID, BDI Dropout rates: 8/40 (0/15 in the sertraline, 8/13 in the venlafaxine and 0/12 in the paroxetine group) |
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Interventions | Pharmacological intervention: Quote: “The dosages were as follows: Venlafaxine, 37.5 mg twice daily for 14 days, then if tolerated at 2 weeks, 75 mg twice daily; Sertraline, 50 mg once daily for 14 days, then if tolerated at 2 weeks, 100 mg once daily; Paroxetine, 20 mg once daily for 14 days, then if tolerated at 2 weeks, the dosage was continued. Patients were instructed to take the prescribed capsule daily unless side effects emerged" | |
Outcomes | Primary outcome: PSS
Secondary outcomes: GAF, BDI Time points: Quote: "Assessments were performed just before initialization of therapy and 6 weeks after initiating therapy" Data estimation: Completer values |
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Notes | Dates of trial: Not stated Industry‐funded: No Medication provided by industry: No Any of the authors work for industry: No |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | It was reported that the participants were randomised but no mention is made of the method of randomisation Quote: "Participants were all randomly assigned to Sertraline, Paroxetine, and Venlafaxine conditions" |
Allocation concealment (selection bias) | High risk | Not used, open‐label trial |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding of participants and personnel |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No blinding of outcome assessors |
Incomplete outcome data (attrition bias) All outcomes | High risk | A substantial amount of participants withdrew from the venlafaxine group (8/13, 62%) compared to the sertraline (0/15, 0%) and paroxetine groups (0/12, 0%). Reasons for withdrawal were provided. Data represent completer values. No information was provided on whether the 2 groups differed by sample characteristics at baseline and endpoint Quote: "There were no dropouts from the Sertraline and Paroxetine groups. However, Venlafaxine was discontinued in eight patients because of adverse effects. Most commonly reported adverse effects were abdominal pain, agitation, dizziness, diaphoresis, headache, nausea, and palpitations" |
Selective reporting (reporting bias) | Unclear risk | The study protocol was not available for this study |
Other bias | Unclear risk | Use of a nonblinded, open‐trial design with no placebo control group; Scales translated into Bosnian; Participants received concurrent case management and supportive therapy |