Table G-48Strength of evidence for adverse events for paroxetine 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
Withdrawals due to Adverse Events
3; 911Medium; RCTsConsistent (I2=0%)DirectPreciseRD 0.04 (0.00 to 0.07)Moderate
Headaches
0; 0NANANANANAInsufficient
Nausea
2; 886Medium; RCTsConsistentDirectImpreciseRD 0.11 (0.04 to 0.18)aLow
Insomnia
0; 0NANANANANAInsufficient
Dry mouth
1; 323Medium; RCTNA, single studyDirectPreciseRD 0.10 (0.04 to 0.16)Low
Diarrhea
1; 563Medium; RCTNA, single studyDirectImpreciseIncidence of at least 10% and twice that of placebo23Insufficient
Dizziness
0; 0NANANANANAInsufficient
Fatigue
0; 0NANANANANAInsufficient
Somnolence
2; 886Medium; RCTsConsistentDirectImpreciseRD 0.13 (0.07 to 0.20)aLow
Drowsiness
1; 25Medium; RCTNA, single studyDirectImpreciseRD −0.15 (−0.51 to 0.21)Insufficient
Decreased appetite
0; 0NANANANANAInsufficient
Increased appetite
0; 0NANANANANAInsufficient
Constipation
0; 0NANANANANAInsufficient
Sexual adverse effects
1; 563Medium; RCTNA, single studyDirectImpreciseIncidence of at least 10% and twice that of placebo23Insufficient
a

Data are based on the only trial (N=323) reporting sufficient data to determine the risk difference.20 One additional trial (N=563) that provided narrative description reported that the most commonly reported adverse events associated with paroxetine use (with an incidence of at least 10% and twice that of placebo) were asthenia, diarrhea, abnormal ejaculation, impotence, nausea, and somnolence.23

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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