Felbamate as an add-on therapy for refractory epilepsy.
Author(s): Shi LL(1), Dong J, Ni H, Geng J, Wu T.
Affiliation(s): Author information:
(1)Nantong University Library, Evidence-based Medicine Center, Medical School of
Nantong University, Nantong, China.
Publication date & source: 2014, Cochrane Database Syst Rev. , 7:CD008295
BACKGROUND: This review is an update of a previously published review in The
Cochrane Database of Systematic Reviews (Issue 1, 2011) on 'Felbamate as an
add-on therapy for refractory epilepsy'. Epilepsy is a chronic and disabling
neurologic disorder, affecting approximately 1% of the population. Up to 30% of
people with epilepsy have seizures that are resistant to currently available
drugs. Felbamate is one of the second-generation antiepileptic drugs and its
effects as an add-on therapy to standard drugs are assessed in this review.
OBJECTIVES: To evaluate the efficacy and tolerability of felbamate versus placebo
when used as an add-on treatment for people with refractory partial-onset
epilepsy.
SEARCH METHODS: We searched the Cochrane Epilepsy Group Specialized Register (24
July 2013), the Cochrane Central Register of Controlled Trials (CENTRAL 2013,
Issue 6), and PubMed (24 July 2013). This search was run for the original review
on 20 May 2010. There were no language and time restrictions. We reviewed the
reference lists of retrieved studies to search for additional reports of relevant
studies. We also contacted the manufacturers of felbamate and experts in the
field for information about any unpublished or ongoing studies.
SELECTION CRITERIA: Randomized placebo-controlled add-on studies of people of any
age with refractory partial-onset seizures. The studies could be double-blind,
single-blind or unblinded and could be of parallel or crossover design.
DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies
for inclusion and extracted information. We resolved disagreements by discussion.
If disagreements persisted, the third review author arbitrated. We assessed the
following outcomes: 50% or greater reduction in seizure frequency; absolute or
percentage reduction in seizure frequency; treatment withdrawal; adverse effects;
quality of life.
MAIN RESULTS: Three randomised controlled trials with a total of 153 participants
were included. The first was a parallel design, the second had a two-period
crossover design, and the third had a three-period crossover design. One study
was at unclear risk of bias for random sequence generation and allocation
concealment. And in the same study, there was no description of how to blind
outcome assessment, performance blinding was for participants, might not be for
doctors. Two studies were at high risk of bias for incomplete outcome data. Due
to significant methodological heterogeneity, clinical heterogeneity and
differences in outcome measures, it was not possible to perform a meta-analysis
of the results. None of the three studies reported 50% or greater reduction in
seizure frequency. Only one study reported absolute and percentage reduction in
seizure frequency compared to placebo, P values were 0.046 and 0.018,
respectively. Adverse effects rates were higher during the felbamate period than
the placebo period, particularly headache, nausea and dizziness.
AUTHORS' CONCLUSIONS: In view of the methodological deficiencies, limited number
of individual studies and differences in outcome measure, we have found no
reliable evidence to support the use of felbamate as an add-on therapy in
patients with refractory partial-onset epilepsy. A large-scale, randomised
controlled trial conducted over a longer period of time is required to inform
clinical practice.Since the last version of this review no new studies have been
found.
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