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. 2019 Oct 23;2019(10):CD001417. doi: 10.1002/14651858.CD001417.pub4

Zhang 2011.

Methods Randomised, placebo‐controlled trial
2 treatment arms: 1 placebo, 1 topiramate
Pre‐randomisation baseline period: 8 weeks
Treatment period: 12 weeks
Participants A single‐centre study (Shanghai, China)
86 participants were randomised (documented drug‐resistant focal epilepsy)
Age range: > 65 years old eligible
Mean age: 73.4 years
57% males
8 patients on 1 AED, 37 on 2 AEDs, 41 on 3 AEDs
Median baseline monthly seizure frequency: 17.3 for placebo group, 16.9 for topiramate group
Interventions 200 mg per day topiramate or placebo
Outcomes
  1. Percentage seizure reduction (≥ 50% reduction (classified as responders); 25% to 50% reduction; change within 25% of baseline; ≥ 25% seizure increase)

  2. Treatment withdrawal

  3. Adverse effects

Notes None
No trial sponsorship information provided
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "were randomly assigned, according to a computer‐generated randomization schedule"
Allocation concealment (selection bias) Unclear risk Comment: no information provided
Blinding (performance bias and detection bias) 
 All outcomes Unclear risk Comment: no information provided
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Comment: no information provided
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Comment: no information provided
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comment: no dropouts (data available for all patients)
Selective reporting (reporting bias) Low risk Comment: protocol unavailable, but appears all expected and prespecified outcomes are reported
Other bias Low risk Comment: the study appears to be free of other sources of bias

AED: antiepileptic drug