| Author, Year
Country
Study Design
Sample Size |
Methods |
Outcome |
|
Dikmen et al. (2000)
USA
RCT
PEDro=8
NInitial=279, NFinal=107
|
Population: TBI; Gender: Male=228, Female=51. Group 1 (n=94): Mean Age=37.14yr; Mean GCS=11.3. Group 2 (n=91): Mean Age=36.58yr; Mean GCS=11.23. Group 3 (n=94): Mean Age=35.85yr; Mean GCS=12.11.
Treatment: Patients were randomized into three groups within 24h of injury: 1) valproic acid (VPA) for 1mo then 5mo of placebo; 2) VPA for 6mo; and 3) phenytoin (PHT) for 1wk then placebo until 6mo post-injury.
Outcome Measure: A battery of neuropsychological measures. |
1. There was a trend towards a higher mortality rate in the VPA groups compared to the PHT group (p=0.07).
2. There were no significant differences at 1, 6 or 12mo on the composite neuropsychological measures, or on only the cognitive measures (0.551<p<0.812).
3. No individual neuropsychological measure showed a significant difference between the treatment groups at 1, 6 or 12 months post-injury. |
| Temkin et al. (1999)
USA
RCT
PEDro=7
NInitial=379, NFinal=283
|
Population: TBI; Gender: Male=310, Female=69. Phenytoin Group (n=132): Mean Age=36yr; Mean GCS=11.7. Valproate (1mo, n=120): Mean Age=40yr; Mean GCS=11.6. Valproate (6mo, n=127): Mean Age=36yr; Mean GCS=11.1.
Treatment: Patients were divided into three groups within 24h of injury: (1) phenytoin for 1wk (20mg/kg then 5mg/kg/d), placebo until 6mo post-injury; (2) Valproate (20mg/kg, then 15mg/kg/d) for 1mo, placebo for 5mo; or (3) Valproate for 6mo. Follow-up continued for 2yr.
Outcome Measure: Incidence of early and late (>7d post-injury) seizures, mortality rates. |
1. There was no significant difference in the number of early seizures between the combined valproate (4.5%) and phenytoin (1.5%, p=0.14) groups.
2. There was no significant difference between groups (p=0.19) in the occurrence of late seizures.
3. Late seizures occurred in 11, 17, and 15 participants in the 1mo and 6mo valproate groups and the phenytoin group, respectively.
4. There were no significant differences in mortality rates between groups (7.2% phenytoin versus 13.4% in the combined valproate group, p=0.07).
5. In the phenytoin group, a participant had a rash requiring medication at 1wk and in the valproate (6mo) group a participant had a low neutrophil count at 2-4wk, both thought to be treatment related. |
| Kwon et al. (2019)
USA
Retrospective Cohort
NInitial=481, NFinal=481 |
Population: TBI=481; Phenytoin Group (n=116): Mean Age=50±21yr; Gender: Male=82, Female=34; Time Post-Injury=Acute; Severity: Mean GCS=11.3±4.3. Lacosamide Group (n=365): Mean Age=58±22yr; Gender: Male=242, Female=123; Time Post-injury=Acute; Severity: Mean GCS=12.5±3.8.
Treatment: Lacosamide (50mg 2/d for 7d if GCS=13-15; 200mg once, followed by 100mg 2/d for 7d if GCS <13) versus phenytoin (loading dose: 15-20mg/kg; 300-400mg/d for 7d).
Outcome Measures: Incidence of early post-traumatic seizures, adverse events. |
1. No significant difference in early post-traumatic seizure incidence was observed between groups (p>.05).
2. The incidence of adverse events was significantly higher in the phenytoin group compared to lacosamide (p=.03). |
