Summary of findings 3. Lamotrigine compared with phenobarbital for the treatment of epilepsy in people with Alzheimer's disease.
| Lamotrigine compared with phenobarbitalfor the treatment of epilepsy in people with Alzheimer's disease | ||||||
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Patient or population: patients with AD and epileptic seizures Settings: the community of Caltanissetta, Italy Intervention: lamotrigine Comparison: phenobarbital | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of Participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Phenobarbital | Lamotrigine | |||||
| Proportion with seizure freedom | 286 per 1000 | 241 per 1000 (100 to 578) | RR 0.84 (0.35 to 2.02) | 57 (1 study) | ⊕⊝⊝⊝ very low¹ | RR less than 1 favours phenobarbital |
| Proportion with adverse events | 357 per 1000 | 241 per 1000 (107 to 546) | RR 0.68 (0.30 to 1.53) | 57 (1 study) | ⊕⊝⊝⊝ very low¹ | RR less than 1 favours lamotrigine |
| Reduction in seizure frequency of 50% or more | 643 per 1000 | 586 per 1000 (386 to 887) | RR 0.91 (0.60 to 1.38) | 57 (1 study) | ⊕⊝⊝⊝ very low¹ | RR less than 1 favours phenobarbital |
| Proportion with seizure freedom in dominantly inherited AD | Not reported | Not reported | ||||
| Change in cognition | See comment | See comment | 57 (1 study) | ⊕⊝⊝⊝ very low¹ | In the phenobarbital group, significant worsening of cognitive performance was found, with lower mean scores indicating aggravation of existing cognitive impairment at both 6 and 12 months post‐randomization on MMSE and ADAS‐Cog. In the lamotrigine group, participants showed slight declines in MMSE and ADAS‐Cog scores. | |
| Change in neuropsychiatric symptoms | See comment | See comment | 57 (1 study) | ⊕⊝⊝⊝ very low¹ | In the phenobarbital group, mood score worsened by 1.74 points. In the lamotrigine group, score change of −0.72 was recorded on the Cornell scale. | |
| Improvement in quality of life | Not reported | Not reported | ||||
| *The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes.² The corresponding risk (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). AD: Alzheimer's disease; ADAS‐Cog: Alzheimer's Disease Assessment Scale‐Cognitive; CI: confidence interval; MMSE: Mini Mental State Examination; RR: risk ratio | ||||||
| GRADE Working Group grades of evidence High certainty: Further research is very unlikely to change our confidence in the estimate of effect. Moderate certainty: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low certainty: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low certainty: We are very uncertain about the estimate. | ||||||
¹ Only one trial was included, with 57 randomized participants and potential methodological insufficiency.
² Assumed risk is calculated as the event rate in the control group per 1000 people (number of events divided by the number of participants receiving control treatment).