title: A randomized, double-blind, placebo-controlled trial on the efficacy and tolerability of sertraline in Iranian veterans with post-traumatic stress disorder.
abstract: BACKGROUND
  Unlike civilian post-traumatic stress disorder (PTSD), the efficacy of sertraline for the treatment of combat-related PTSD has not yet been proven. The present study aimed to evaluate the clinical efficacy of sertraline against combat-related PTSD in a randomized, double-blind, placebo-controlled trial.
  
  
  METHODS
  Seventy Iranian veterans of the Iran-Iraq war who met the DSM-IV criteria for diagnosis of PTSD were randomized to receive either flexibly dosed sertraline (50-200 mg/day) (n=35, completers=32) or placebo (n=35, completers=30) for 10 weeks. Efficacy was evaluated by the Impact of Event Scale--Revised (IES-R) and the Clinical Global Impression scale--Severity (CGI-S) and Improvement (CGI-I) ratings. Responder criteria were defined as a ≥30% reduction in the IES-R total score plus a CGI-I rating of 'much' or 'very much' improved.
  
  
  RESULTS
  On both intention-to-treat (ITT) and per protocol (completer) methods of analysis, the mean reductions in the IES-R total and subscale (re-experiencing/intrusion, avoidance/numbing and hyperarousal) scores (p<0.001) and also in the CGI-S score (p<0.01) were significantly greater in the sertraline group than in the placebo group. For the CGI-I, the mean endpoint score was significantly lower in the sertraline group than in the placebo group (p≤0.001). The number of responders in the sertraline group was significantly higher than in the placebo group (44% v. 3%, p≤0.001). Sertraline was well tolerated, with a 6% discontinuation rate as a result of adverse reactions.
  
  
  CONCLUSIONS
  The results of this study suggest that sertraline can be an effective, safe and tolerable treatment for combat-related PTSD in Iranian veterans.
authors.affiliation: Chemical Injuries Research Center, Department of Psychiatry, Faculty of Medicine, Baqiyatallah University of Medical Sciences, Tehran, Iran. yunespanahi@yahoo.com
authors.forename: Y
authors.initials: Y
authors.lastname: Panahi
authors.forename: B Rezazadeh
authors.initials: BR
authors.lastname: Moghaddam
authors.forename: A
authors.initials: A
authors.lastname: Sahebkar
authors.forename: M Abbasi
authors.initials: MA
authors.lastname: Nazari
authors.forename: F
authors.initials: F
authors.lastname: Beiraghdar
authors.forename: G
authors.initials: G
authors.lastname: Karami
authors.forename: A R
authors.initials: AR
authors.lastname: Saadat
mesh_terms: D000328:Adult; D004311:Double-Blind Method; D006801:Humans; D057194:Intention to Treat Analysis; D007492:Iran; D008297:Male; D008875:Middle Aged; D010919:Placebos; D011569:Psychiatric Status Rating Scales; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects / Q000592:standards / Q000627:therapeutic use*; D020280:Sertraline / Q000009:adverse effects / Q000592:standards / Q000627:therapeutic use*; D013313:Stress Disorders, Post-Traumatic / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D016896:Treatment Outcome; D014728:Veterans / Q000523:psychology*; D014857:Warfare
chemical_list: D010919:Placebos; D017367:Selective Serotonin Reuptake Inhibitors; D020280:Sertraline