Table G-47Strength of evidence for adverse events for fluoxetine 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; 766Medium; RCTsConsistent (I2=4.3%)DirectImpreciseRD −0.01 (−0.04 to 0.03)Low
Headaches
3; 776Medium; RCTsConsistent (I2=28.2%)DirectImpreciseRD 0.03 (−0.04 to 0.09)Insufficient
Nausea
2; 712Medium; RCTsConsistent (I2=0%)DirectImpreciseRD 0.05 (0.00 to 0.09)Low
Insomnia
1; 301Medium; RCTNA, single studyDirectImpreciseRD 0.03 (−0.06 to 0.11)Insufficient
Dry mouth
0; 0NANANANANAInsufficient
Diarrhea
1; 64Medium; RCTNA, single studyDirectImpreciseRD 0.24 (0.01 to 0.47)Insufficient
Dizziness
0; 0NANANANANAInsufficient
Fatigue
0; 0NANANANANAInsufficient
Somnolence
1; 411Medium; RCTNA, single studyDirectImpreciseRD 0.05 (0.00 to 0.10)Insufficient
Drowsiness
0; 0NANANANANAInsufficient
Decreased appetite
0; 0NANANANANAInsufficient
Increased appetite
0; 0NANANANANAInsufficient
Constipation
0; 0NANANANANAInsufficient

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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