Skip to main content
. 2018 Oct 24;2018(10):CD001415. doi: 10.1002/14651858.CD001415.pub3

UK Gabapentin 1990.

Methods Randomised, double‐blind, placebo‐controlled, parallel‐group study (cross‐continent)
Prospective pre‐randomisation baseline period: 12 weeks
Treatment period: 14 weeks
Participants All adults
Cross‐continent study
Total randomised: 127; all with drug‐resistant focal epilepsy
Placebo: 66 participants; gabapentin 1200 mg/day: 61 participants
39% men
Age range: 14‐73 years
Other AEDs: ≤ 2
Median baseline seizure frequency/28 days: gabapentin 13 (range 3 to 368); placebo 13 (range 1 to 216)
Interventions Gabapentin 1200 mg/day
Placebo
All treatments and packaging identical in appearance
Outcomes Proportion with a 50% reduction in seizure frequency
Response ratio
Adverse effects
Notes 14 participants excluded from published analyses: 5 from the placebo group; 9 from the gabapentin 1200 mg/day group
Additional unpublished data allowed the inclusion of participants excluded despite completing the treatment phase with adequate seizure data. The following participants contribute to the best‐case and worst‐case sensitivity analyses in this review.
Placebo: 2; gabapentin 1200 mg: 8
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Used 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 Used tablets and packaging identical in appearance
Incomplete outcome data (attrition bias) 
 All outcomes High risk Attrition rate reported, 14 participants who withdrew were not included in published analyses. Report withdrawals and gave reasons for withdrawal.
Selective reporting (reporting bias) Low risk Included all prespecified, expected outcomes
Other bias High risk Trial sponsored by Parke Davis
Study appeared free of other sources of bias