Table G-46Strength of evidence for adverse events for topiramate 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; 142Medium; RCTsInconsistent (2 trials trend in favor of placebo; 1 does not)DirectImpreciseRD 0.01 (−0.08 to 0.10)Insufficient
Headaches
2; 75Medium; RCTsInconsistentDirectImpreciseRD −0.01 (−0.21 to 0.18)Insufficient
Insomnia
2; 75Medium; RCTsInconsistentDirectImpreciseRD 0.12 (−0.05 to 0.28)Insufficient
Somnolence
1; 35Medium; RCTNA, single studyDirectImpreciseRD −0.10 (−0.39 to 0.20)Insufficient
Taste perversion
1; 40Medium; RCTNA, single studyDirectImpreciseRD 0.25 (0.04 to 0.46)Insufficient
Dyspespsia
1; 40Medium; RCTNA, single studyDirectImpreciseRD 0.10 (−0.12 to 0.32)Insufficient
Paresthesia
1; 40Medium; RCTNA, single studyDirectImpreciseRD 0.15 (−0.05 to 0.35)Insufficient
Nervousness
1; 40Medium; RCTNA, single studyDirectImpreciseRD 0.15 (−0.05 to 0.35)Insufficient
Fatigue
1; 40Medium; RCTNA, single studyDirectImpreciseRD 0.20 (0.00 to 0.40)Insufficient

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)
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