Neuropsychological Outcomes in Randomized Controlled Trials of Antiepileptic Drugs: A Systematic Review of Methodology and Reporting Standards

Abstract

Summary:Purpose: 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 1966-1 996 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.

Effects of antiepileptic drugs on associative LTP‐like plasticity in human motor cortex

“…It is likely that this is associated with a risk of adverse side effects, in particular with respect to central nervous system functions, such as learning or formation of memory, which depend on long‐term excitability change through increases or decreases in synaptic strength. Although a plethora of patients are treated by AEDs, systematic research of such side‐effects and valid interpretation are difficult, and the existing knowledge is largely anecdotal and stems from retrospective studies (Cochrane et al. , 1998; Goldstein, 1998; Kwan & Brodie, 2001).…”

A controlled, prospective study of neuropsychological outcomes post parathyroidectomy in primary hyperparathyroid patients

“…The RMMT, for example, is sensitive to changes in memory function produced by drug side effects 21 and anorexia nervosa. 22 A number of studies have found the Stroop test and the digit symbol subtest useful in assessing drug side effects, 23 treatment effects 24 and chronic occupational exposure to toxic substances. 25 These tests were also chosen on the basis of their ecological validity.…”

Commission on Outcome Measurement in Epilepsy, 1994–1997: Final Report

“…reported the methodological problems in these studies affecting interpretation and assessed the consistency, reliability, and validity of neuropsychological tests used in research on the cognitive effects of AEDs in people with epilepsy (33).…”