Sethi 2002.
| Methods | Randomised control trial in India Head‐to‐head trial; 2 treatment groups gabapentin and lamotrigine Treatment period: 12 weeks No formal baseline period (however, all had ≥ 4 seizures, unclear over what time, despite treatment with maximum dose carbamazepine monotherapy) |
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| Participants | 52 children and adults Indian study Refractory focal seizures 48% male 27 gabapentin (19 male: 8 female), 25 lamotrigine (6 male: 19 female) Aged 10‐60 years |
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| Interventions | Gabapentin: 300 mg day 1, 300 mg twice daily day 2, there after an increment of 300 mg daily until ≥ 50% reduction in seizures or toxic effects Lamotrigine: 50 mg/day for 2 weeks, increased to 50 mg twice daily, subsequently an increase of 50‐100 mg daily until above criteria met |
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| Outcomes | Efficacy: seizure frequency, pattern of seizures, seizure‐free interval. Including % change of seizure frequency from baseline, responder rate (reduction in seizure frequency of ≥ 50%), response ratio Safety: biochemical investigations and adverse effects |
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| Notes | As no clear baseline period, excluded from meta‐analysis | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No details provided |
| Allocation concealment (selection bias) | Unclear risk | No details provided |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | No details provided |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No participants seemed to be excluded from the results, but 1 participant in gabapentin group did not seem to be accounted for |
| Selective reporting (reporting bias) | Low risk | Included all prespecified expected outcomes |
| Other bias | Low risk | Study appeared free of other sources of bias |