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Cochrane Database Syst Rev. 2012 Jun 13;6:CD000173.
WITHDRAWN: Antiepileptic drugs for preventing seizures
following acute traumatic brain injury.
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Schierhout G, Roberts I.
c/o Cochrane Injuries Group, London School of Hygiene & Tropical Medicine, London, UK. [email protected]
Abstract
BACKGROUND: Seizure activity in the early post-traumatic period following head injury may
cause secondary brain damage as a result of increased metabolic demands, raised intracranial
pressure and excess neurotransmitter release.
OBJECTIVES: To determine the effects of prophylactic anti-epileptic agents for acute traumatic
head injury.
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SEARCH METHODS: We searched the Cochrane Injuries Group specialised register, MEDLINE Rep
CarcinogDocument
Backgr Doc.
Background
for 2010]
and the registers of the Cochrane Stroke Group and Cochrane Epilepsy Group. We contacted
Prophylactic antiepileptic agents
pharmaceutical companies who manufacture anti-epileptic agents, the National Institute of
Neurol
Neurosurg
after
head
injury: aPsychiatry....]
systematic
Neurological Disorders and Stroke, Epilepsy Division, and the United States' National Institute of
Review Mannitol for acute
Health.
hrane
Database
Syst Rev. 2005]
traumatic
brain injury.
SELECTION CRITERIA: All randomised trials of anti-epileptic agents, in which study participants
had a clinically defined acute traumatic head injury of any severity. Trials in which the
See reviews...
intervention was started more than eight weeks after injury were excluded.
See all...
DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data and
assessed the trial quality. Relative risks and 95% confidence intervals (95%CI) were calculated
for each trial on an intention-to-treat basis, which included pre-drug loading exclusions. As long
as statistical heterogeneity did not exist, for dichotomous data, summary relative risks and 95%
confidence intervals were calculated using a fixed effects model. Where the source of
heterogeneity could obviously be related to allocation concealment, drug type, or drug dose, we
stratified the analyses on that dimension.
MAIN RESULTS: We identified 10 eligible randomised controlled trials, including 2036
participants, but data was unavailable for four unpublished trials, representing 631 participants
and they were excluded. For the remaining six trials, the pooled relative risk (RR) for early
seizure prevention was 0.34 (95%CI 0.21, 0.54); based on this estimate, for every 100 patients
treated, 10 would be kept seizure free in the first week. Seizure control in the acute phase was
not accompanied by a reduction in mortality (RR = 1.15; 95%CI 0.89, 1.51), a reduction in death
and neurological disability (RR = 1.49; 95%CI 1.06, 2.08 for carbamazepine and RR = 0.96;
95%CI 0.72, 1.26 for phenytoin) or a reduction in late seizures (pooled RR = 1.28; 95%CI 0.90,
1.81). The pooled relative risk for skin rashes was 1.57 (95%CI 0.57, 39.88).
AUTHORS' CONCLUSIONS: Prophylactic anti-epileptics are effective in reducing early seizures,
but there is no evidence that treatment with prophylactic anti-epileptics reduces the occurrence
of late seizures, or has any effect on death and neurological disability. Insufficient evidence is
available to establish the net benefit of prophylactic treatment at any time after injury.
Update of
Cochrane Database Syst Rev. 2001;(4):CD000173.
PMID: 22696316 [PubMed - indexed for MEDLINE]
http://www.ncbi.nlm.nih.gov/pubmed/22696316[8/14/2012 12:16:38 AM]
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WITHDRAWN: Antiepileptic drugs fo... [Cochrane Database Syst Rev. 2012] - PubMed - NCBI
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http://www.ncbi.nlm.nih.gov/pubmed/22696316[8/14/2012 12:16:38 AM]