Panahi 2011.
Study characteristics | ||
Methods |
NEW TRIAL ADDED TO UPDATED REVIEW Design: single‐centre trial, randomised, placebo‐controlled, parallel arm, flexible‐dose, double‐blind Duration of intervention: 10 weeks Placebo run‐in: no information Post‐treatment: Not specified |
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Participants | Setting: Quote: “Out‐patients who had been referred to the neuropsychiatric clinic of Baqiyatallah Hospital (Tehran,
Iran)" Sample size: 70 randomised to sertraline and placebo Mean age: 45.55 years (SD: 5.25) Sex: 70 men, 48 military (69%), 7 mood and anxiety (10%) Diagnostic measure: DSM‐IV‐TR Inclusion criteria: Quote: “The subjects were male Iranian Iran–Iraq war veteran out‐patients who had been referred to the neuropsychiatric clinic of Baqiyatallah Hospital and met DSM‐IV‐TR criteria for a primary diagnosis of PTSD. A duration of at least 6 months of illness and a Clinical Global Impression scale – Severity (CGI‐S) score of ≥ 4 were also required at the baseline visit for inclusion into the trial" Exclusion criteria: Quote: “(1) the presence of any axis I disorder other than PTSD (subjects with concurrent depression were included provided that their depression was secondary to PTSD and initiated after PTSD); (2) evidence of clinically significant hepatic or renal disorder or any other medical condition (in acute or unstable form) that might confound the procedure or the results of the trial ; (3) alcohol or substance abuse or dependency within the preceding 6 months; (4) intolerance or hypersensitivity to sertraline ; (5) concurrent use of any psychotropic medication (except for chloral hydrate or diazepam, taken as needed) with clinically significant psychotropic activity within 2 weeks of randomization (or 5 weeks for fluoxetine); (6) any cognitive‐behavioral therapy during the trial ; and (7) psychotherapy that was initiated or ended during the trial" Comorbidity: history of mood and anxiety disorders Dropout rates: 8/70 (3/35 in the sertraline and 5/35 in the placebo group) |
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Interventions | Pharmacological intervention: Quote: “Sertraline treatment was initiated at a daily dose of 50 mg. Patients were visited every 2 weeks by a psychiatrist and, based on the examinations, clinical response and adverse effects, drug dosage could be flexibly adjusted to a maximum dose of 200 mg/day" | |
Outcomes | Outcomes: IES‐R, CGI‐S, CGI‐I (not clear whether primary or secondary) Time points: No information Data estimation: ITT, LVCF, completer analysis. |
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Notes | Dates of trial: Not stated Industry‐funded: No. Quote: "We gratefully acknowledge the financial support for this work that was provided by the Baqiyatallah University of Medical Sciences" Medication provided by industry: Yes 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) | Low risk | Quote: "Seventy subjects were randomized, using computer‐generated random numbers, to 10 weeks of double‐blind and parallel treatment with either sertraline (n=35) or matched placebo (n=35)" |
Allocation concealment (selection bias) | Unclear risk | There was insufficient information provided to determine if study medication allocation was concealed. Quote: "Sertraline and placebo were obtained from Razak Laboratories Co., Iran" |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | The study was described as "double‐blind", although no information was provided on which parties were blinded and how blinding was achieved Quote: "The present study aimed to evaluate the clinical efficacy of sertraline against combat‐related PTSD in a randomized, double‐blind, placebo‐controlled trial" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "CGI‐S and CGI‐I data were collected by a single rater (blinded to the allocations) who was different from the psychiatrist who performed the patients’ visits and from the statistician who analyzed the data" However, no information was provided for the IES‐R scale |
Incomplete outcome data (attrition bias) All outcomes | Low risk | A similar proportion of participants withdrew from the sertraline group (3/35, 9%) compared to the placebo group (5/35, 14%). Reasons for withdrawals include: adverse events; protocol violation; other reasons. The 2 groups did not differ by sample characteristics at baseline. Data estimation for ITT, LVCF and completer analysis Quote: "Three patients discontinued study treatment in the sertraline group (two because of adverse events and one because of protocol violation) and five in the placebo group (two on their own accord, two because of protocol violation, and one because of adverse events). The difference in the drop‐out rate was not significant between the groups. The groups were not significantly different in terms of age, occupation, education and the presence of chemical injury (p>0.05), nor was there any significant difference in the prevalence of mood or anxiety disorders between the groups at baseline (p>0.05)" |
Selective reporting (reporting bias) | Unclear risk | The study protocol was not available for this study |
Other bias | Low risk | Quote: "Sertraline and placebo were obtained from Razak Laboratories Co., Iran" However, no authors work for industry |