Neuropsychological outcomes in randomized controlled trials of antiepileptic drugs: a systematic review of methodology and reporting standards.
OBJECTIVE
To systematically review the methodology and use of neuropsychological tests in randomized controlled trials (RCTs) of antiepileptic drugs (AEDs) in patients with epilepsy.


METHODS
Trial reports were found by searching Medline 1966-1996 and searching through journals by hand. Inclusion and exclusion criteria were applied, and methodological and neuropsychological test data was extracted by using a proforma.


RESULTS
43 reports met our inclusion criteria, representing 40 RCTs. as three RCTs had generated two reports. Twenty-two were actively controlled, and 18 were placebo-controlled studies. Reporting of basic methods such as randomization method was poor. There has been no uniform approach to the use of neuropsychological tests, and a total of 87 has been used. The Stroop Colour Word Test and the Finger Tapping Test were most commonly used, at 13 times each, but were not used or reported in a uniform manner.


CONCLUSIONS
Poor reporting of methods and the use of a plethora of neuropsychological tests create great difficulties for anyone wishing to make sense of currently available data. If we are better to understand the neuropsychological effects of AEDs, a more rational approach is needed, for which recommendations are made.
The Department of Neurological Science, The Walton Centre, Liverpool, England, UK.
H C
HC
Cochrane
A G
AG
Marson
G A
GA
Baker
D W
DW
Chadwick
D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000927:Anticonvulsants / Q000009:adverse effects* / Q000627:therapeutic use; D002648:Child; D003071:Cognition / Q000187:drug effects*; D004827:Epilepsy / Q000188:drug therapy; D006801:Humans; D009483:Neuropsychological Tests / Q000706:statistics & numerical data*; D010919:Placebos; D016032:Randomized Controlled Trials as Topic / Q000379:methods; D012107:Research Design / Q000592:standards* / Q000706:statistics & numerical data; D012196:Review Literature as Topic; D003294:Seizures, Febrile / Q000188:drug therapy; D016896:Treatment Outcome
D000927:Anticonvulsants; D010919:Placebos