Table G-34Paroxetine compared with placebo

Domains Pertaining to Strength of EvidenceMagnitude of EffectStrength of Evidence
Number of Studies; Number of SubjectsRisk of Bias; DesignConsistencyDirectnessPrecisionSummary Effect Size (95% CI)High, Moderate, Low, Insufficient
PTSD Symptom Reduction: mean change from baseline in CAPS
2; 1074Medium; RCTsConsistent (I2=0%)DirectPreciseWMD −12.6 (−15.7 to −9.5)Moderate
PTSD Symptom Reduction: mean change from baseline in DTS
2; 1074Medium; RCTsConsistent (I2=0%)DirectPreciseWMD −12.2 (−15.8 to −8.7)Moderate
Remission (no longer having symptoms)
2; 346Medium; RCTsConsistentDirectPrecise12.9% more subjects in paroxetine group achieved remission (p=0.008)aModerate
Loss of Diagnosis
0; 0NANANANANAInsufficient
Prevention/reduction of comorbid depression: mean change from baseline in MADRS
2; 886Medium; RCTsConsistent (I2=0%)DirectPreciseWMD −5.7 (−7.1 to −4.3)Moderate
Prevention/reduction of comorbid anxiety
0; 0NANANANANAInsufficient
Quality of Life
0; 0NANANANANAInsufficient
Disability/functional impairment: mean change from baseline in SDS
2; 886Medium; RCTsConsistent (I2=0%)DirectPreciseWMD −2.3 (−3.3 to −1.4)Moderate
Return to work or return to active duty
0; 0NANANANANAInsufficient
a

Data is the best available evidence from a trial of paroxetine (N=323) that defined remission as a CAPS-2 total score less than 20 and found a significantly greater proportion of paroxetine-treated subjects achieved remission compared with placebo at week 12 (29.4% vs. 16.5%, p=0.008). The difference (12.9% difference between paroxetine and placebo) would translate to a number needed to treat of 7.8 to achieve one remission.20 The other trial contributing data for this outcome found similar percentages of subjects achieving remission (33% vs. 14%), but it was underpowered to detect anything but a very large difference for this outcome.21

Abbreviations: CI = confidence interval; NA = not applicable; RCT = randomized controlled trial

From: Appendix G, Strength of Evidence

Cover of Psychological and Pharmacological Treatments for Adults With Posttraumatic Stress Disorder (PTSD)
Psychological and Pharmacological Treatments for Adults With Posttraumatic Stress Disorder (PTSD) [Internet].
Comparative Effectiveness Reviews, No. 92.
Jonas DE, Cusack K, Forneris CA, et al.

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