Lindberger 2000.
| Methods | Randomised, double‐blind, dose titration study comparing gabapentin with vigabatrin (Denmark, Finland, Iceland, Norway and Sweden) 8‐week baseline period, 24‐week treatment period, evaluation period at 8 weeks compared with baseline. To allow flexibility, this was a dose adjustment regimen, with increases in doses of drug based on participant tolerance and seizure control, increased if required at 4‐week periods, with a maximum treatment period at each dose of 8 weeks. |
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| Participants | Multicentre in 34 Nordic countries 102 participants randomised, then 35 (gabapentin group) and 44 (vigabatrin group) post exclusions for not for fulfilling criteria People with focal epilepsy who had tried no more than 2 AED monotherapy regimens |
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| Interventions | Gabapentin: variable dose 1800 mg/day minimum, then 2400 mg then maximum 3600 mg/day, increased every 8 weeks as tolerated Vigabatrin: initial 1000 mg then 2000 mg then 4000 mg increased in the same manner as gabapentin |
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| Outcomes | Primary outcome: improvement rate: proportion of participants with 50% seizure reduction without adverse effects Seizure reduction rate: proportion of participants with 50% seizure reduction irrespective of adverse effects Responder rate: proportion of seizure‐free participants without adverse effects Secondary outcomes: quality of life measures, adverse effects, perimetry |
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| Notes | Results provided did not indicate the doses the participants had achieved of each drug | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not specified |
| Allocation concealment (selection bias) | Unclear risk | No details provided |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Double‐dummy technique, participants received active drug and corresponding placebo |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Analysed on an ITT basis |
| Selective reporting (reporting bias) | Low risk | Seizure activity reported |
| Other bias | High risk | Trial sponsored by Parke Davis Study appeared free of other sources of bias |