Maintenance Therapy With Fluoxetine in Posttraumatic Stress Disorder

Article · May 2005with11 Reads
DOI: 10.1097/ · Source: PubMed
The effect of fluoxetine (FLU) in posttraumatic stress disorder was studied in a one-year trial. Subjects received open-label treatment for 6 months, followed by double-blind randomized treatment with FLU or placebo (PBO) for 6 months. Rates of relapse were compared using the Clinical Global Impressions of Improvement. One hundred twenty-three subjects entered open-label treatment, of whom 114 returned at least once. Sixty-two subjects were randomized to receive FLU or PBO, of whom 57 returned at least once and were analyzed. The dose of FLU ranged from 10 to 60 mg/d; at randomization, mean doses were 48.6 and 42.1 mg for FLU and PBO groups. Rates of relapse were 22% for FLU versus 50% for PBO (P = 0.02), and time to relapse on FLU was longer than for PBO (P = 0.02, log-rank statistic). The odds ratio for relapse on PBO relative to FLU was 3.50. No significant differences were found on other measures. Fluoxetine was well tolerated during double-blind treatment.
  • ...Most medication studies and several psychotherapy studies reported outcome data selectively or in a misleading manner. Examples included partial/nonstandard reporting between text and charts, [19, 20between standard deviations(SD)/confidence inter- vals/standard errors, [25, 26, 28, 30, 43, 44, 51, 55, 62, 64, 67, 71, 72] omitting baseline outcome data, [28, 33, 68] omitting variance measures completely, [28, 31, 68] omitting outcome measures at specific time points, [28, 40, 68] creation of nonstandard outcome measures by combining standard measures with other variables, [25, 28, 32, 41, 44, 51, 73] splitting outcome measures into subscales without providing total score, [39, 58] failure to cross-reference data spread over several publications, [25, 26, 43, 44] and including nonscaled graphs without providing corresponding means. [28, 40, 68] Data abstraction for most medication studies required mathematical conversion of provided data into mean total CAPS/SPRINT/PSS-I and SD. ...
  • ...Patients who were randomized to fluoxetine continued to improve significantly on the clinical and PTSD severity scores, as well as in anxiety and depression symptoms. Davidson et al. (2005), randomized 62 subjects to 6 months continuation treatment with fluoxetine or placebo after the same period of open-label treatment (max. 60 mg/d) with fluoxetine. ...
  • ...At least 34 randomized clinical pharmacology trials have been conducted since the diagnosis of PTSD was developed in the early 1980s (Friedman et al. 2009 ), and, though the majority of studies suggest that medications for PTSD are more effective than placebos, others have failed to show significant effects (Davidson et al. 2005; Friedman et al. 2007; Zohar et al. 2002). Furthermore, although most patients experience a reduction in symptoms, the long term effectiveness of pharmacotherapies for PTSD are limited, as only 30% achieve complete remission of their symptoms after three months of treatment compared to 65–79% with cognitivebehavioral approaches (Foa et al. 1999), and several studies have shown that discontinuation of these drugs is likely to result in relapse (Davidson et al. 2005; Martenyi and Soldatenkova 2006). Due to the oftentimes refractory nature of this disorder, different avenues of advancing treatment have been proposed (Cukor et al. 2009), one of them being the notion of combining biological and psychological interventions. ...
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