| Methods |
RCT, parallel |
| Participants |
Total randomised: 74
Age range = 12 years and above. Mean for topiramate group = 29.9 years and mean for placebo group = 31.9 years
All patients had intellectual disabilities
All patients taking 1 to 3 other AEDs
Baseline period = 4 weeks. Titration period = 18 weeks. Maintenance period = 12 weeks |
| Interventions |
Topiramate versus placebo |
| Outcomes |
Efficacy variables:
(1) Change in total seizure frequency between baseline and end of on‐drug phase (12 weeks)
(2) Change in seizure severity between baseline and end of on‐drug phase (12 weeks)
(3) Number of responders (response defined as a 50% reduction in seizure frequency)
(4) Changes from baseline to the end of the on‐drug phase were compared for the ABC total score, EOS total score and subscale scores and ELDQOL subscale scores
(5) Global assessments |
| Notes |
Numbers used in data analysis: efficacy data = 72, safety data = 74 (intention‐to‐treat analysis)
Actual numbers completing the study: topiramate = 28, placebo = 29 |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Insufficient information about how randomisation was achieved |
| Allocation concealment (selection bias) |
Low risk |
Pharmacist‐controlled allocation |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Participants and study personnel were blinded |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Outcome assessors were blinded |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Comparable dropout rates across groups |
| Selective reporting (reporting bias) |
Unclear risk |
Protocol unavailable |
| Other bias |
Low risk |
No other sources of bias identified |
