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. 2021 Jan 12;2021(1):CD001415. doi: 10.1002/14651858.CD001415.pub4

Anhut 1994.

Study characteristics
Methods Randomised, double‐blind, placebo‐controlled, parallel‐group study (conducted at 24 centres in Europe, Canada, South Africa and Australia)
3 treatment arms: 1 placebo and 2 gabapentin
Prospective prerandomisation baseline period: 12 weeks
Treatment period: 12 weeks
Participants Adults with drug‐resistant focal epilepsy
Total randomised: 272
109 to placebo; 111 to gabapentin 900 mg; 52 to gabapentin 1200 mg
56% men
Age range: 12–67 years
Other AEDs: ≤ 2
Median baseline seizure frequency per 28 days: 10.2 (range 0.5–634.3)
Interventions Gabapentin 900 mg/day
Gabapentin 1200 mg/day
Placebo
All tablets and packaging were identical in appearance.
Outcomes Proportion with a 50% reduction in seizure frequency
Response ratio (= (T – B)/(T + B) where T = number of seizures during the treatment period and B = number of seizures in the baseline period)
Adverse effects
Notes 27 participants excluded from published analyses: 10 from placebo group; 15 from gabapentin 900 mg group; 2 from gabapentin 1200 mg group
Additional unpublished data allowed the inclusion of participants excluded despite completing the treatment phase with adequate seizure data. The following participants contributed to the best‐case and worst‐case sensitivity analyses in this review: placebo: 7; gabapentin 900 mg: 9; gabapentin 1200 mg: 2.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Random permuted blocks to generate sequence for randomisation.
Allocation concealment (selection bias) Low risk Allocated sequentially, sealed, numbered packages.
Blinding (performance bias and detection bias)
All outcomes Low risk Tablets and packaging identical in appearance.
Incomplete outcome data (attrition bias)
All outcomes High risk 'As treated' analysis. Disproportionate numbers excluded across groups: 13 in placebo: 17 in gabapentin 900 mg: 2 in gabapentin 1200 mg, some excluded despite completing treatment phase. Exclusions not included in published analyses.
Selective reporting (reporting bias) Low risk Seizure diary for all groups, same outcomes. Published reports include all prespecified expected outcomes.
Other bias High risk Trial sponsored by Parke Davis.
Study appeared free of other sources of bias.