title: Sulthiame monotherapy for epilepsy.
abstract: BACKGROUND
  Epilepsy is a common neurological condition characterised by recurrent seizures. Sulthiame (STM) is widely used as an antiepileptic drug in Europe and Israel. In this review, we present a summary of evidence for the use of STM as monotherapy in epilepsy.
  
  
  OBJECTIVE
  To examine the efficacy and side effect profile of STM as monotherapy when compared with placebo or another antiepileptic drug.
  
  
  METHODS
  We searched the Cochrane Epilepsy Group Specialised Register (24 October 2013), the Cochrane Central Register of Controlled Trials (CENTRAL) (2013, Issue 9), MEDLINE Ovid (1946 to 24 October 2013), SCOPUS (1823 to 24 October 2013), the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) search portal (28 October 2013) and ClinicalTrials.gov (28 October 2013). We imposed no language restrictions. We contacted the manufacturers of STM and researchers in the field to ask about ongoing and unpublished studies.
  
  
  METHODS
  Randomised controlled monotherapy trials of STM in people of any age with epilepsy of any aetiology.
  
  
  METHODS
  Two review authors independently selected trials for inclusion and extracted the relevant data.The following outcomes were assessed: (1) time to treatment failure; (2) time to 12-month remission; (3) proportion seizure free at 12 months; (4) adverse effects; and (5) quality of life scoring. Primary analyses were intention-to-treat when possible. A narrative analysis of the data was presented.
  
  
  RESULTS
  Two studies representing 100 participants with a diagnosis of benign epilepsy of childhood with centrotemporal spikes (BECTS) and one study representing 146 participants with a diagnosis of generalised tonic-clonic seizures (GTCS) were included. STM was given as monotherapy compared with placebo in the BECTS studies and compared with phenytoin in the GTCS study. An English translation of the full text of one of the BECTS studies could not be found, and analysis of this study was based solely on the English translation of the abstract. No data were reported for outcome (1), (2), (3) or (5). Reporting of adverse effects was incomplete. Participants receiving STM were significantly less likely to develop gingival hyperplasia than were participants receiving phenytoin in the GTCS study (risk ratio (RR) 0.03, 95% confidence interval (CI) 0.00 to 0.58). No further statistically significant adverse events were noted when STM was compared with phenytoin or placebo. Two ongoing studies comparing STM monotherapy versus placebo or levetiracetam in BECTS were identified.
  
  
  CONCLUSIONS
  Small sample size, poor methodological quality and lack of data on important outcome measures prevent any meaningful conclusions regarding the efficacy and safety of sulthiame as monotherapy in epilepsy.
authors.affiliation: The Walton Centre for Neurology & Neurosurgery NHS Foundation Trust, Lower Lane, Fazakerley, Liverpool, UK, L9 7LJ.
authors.forename: Philip
authors.initials: P
authors.lastname: Milburn-McNulty
authors.forename: Graham
authors.initials: G
authors.lastname: Powell
authors.forename: Graeme J
authors.initials: GJ
authors.lastname: Sills
authors.forename: Anthony G
authors.initials: AG
authors.lastname: Marson
mesh_terms: D000328:Adult; D000927:Anticonvulsants / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D057239:Early Termination of Clinical Trials; D004827:Epilepsy / Q000188:drug therapy*; D004830:Epilepsy, Tonic-Clonic / Q000188:drug therapy; D005260:Female; D006801:Humans; D008297:Male; D010672:Phenytoin / Q000627:therapeutic use; D016032:Randomized Controlled Trials as Topic; D013843:Thiazines / Q000627:therapeutic use*; D000096926:Benzenesulfonamides
chemical_list: D000927:Anticonvulsants; D010672:Phenytoin; D013843:Thiazines; C084593:sulthiame; D000096926:Benzenesulfonamides