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Intervention Review

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Sulthiame add-on therapy for epilepsy

  1. Philip Milburn-McNulty1,*,
  2. Graham Powell1,
  3. Graeme J Sills2,
  4. Anthony G Marson2

Editorial Group: Cochrane Epilepsy Group

Published Online: 28 MAR 2013

Assessed as up-to-date: 19 FEB 2013

DOI: 10.1002/14651858.CD009472.pub2


How to Cite

Milburn-McNulty P, Powell G, Sills GJ, Marson AG. Sulthiame add-on therapy for epilepsy. Cochrane Database of Systematic Reviews 2013, Issue 3. Art. No.: CD009472. DOI: 10.1002/14651858.CD009472.pub2.

Author Information

  1. 1

    The Walton Centre for Neurology & Neurosurgery NHS Trust, Liverpool, UK

  2. 2

    Institute of Translational Medicine, University of Liverpool, Department of Molecular and Clinical Pharmacology, Liverpool, Merseyside, UK

*Philip Milburn-McNulty, The Walton Centre for Neurology & Neurosurgery NHS Trust, Lower Lane, Fazakerley, Liverpool, L9 7LJ, UK. philmilburnmcnulty@gmail.com.

Publication History

  1. Publication Status: New
  2. Published Online: 28 MAR 2013

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This is not the most recent version of the article. View current version (28 OCT 2015)

 
Characteristics of included studies [ordered by study ID]
Debus 2004

MethodsDouble-blind, randomised placebo-controlled parallel study


Participants37 patients

Mean (range) age 7.7 months (3 to 15 months)

West syndrome


InterventionsAll patients received PDX (150 to 300 mg/kg/day) only during the first three days of the study

On day 4 STM (5 mg/kg/day) was added to the intervention group and placebo added to control

On day 7 the dose of STM and placebo were doubled in "non-responders"


OutcomesComplete cessation of seizure activity during 9-day study (P = 0.02)

Adverse effects - all (P = 0.63)

Adverse effects - somnolence (P = 0.2)


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskAllocation by roll of dice

Allocation concealment (selection bias)Low riskAllocation concealed in sealed envelope for duration of study

Incomplete outcome data (attrition bias)
All outcomes
Low riskIntention-to-treat analysis performed

Selective reporting (reporting bias)High riskIncomplete data reported for time to treatment withdrawal and adverse drug effects

Other biasLow riskNone identified

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskMethod not stated

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskMethod not stated

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Basnec 2005STM used as monotherapy in intervention group

Bast 2003STM used as monotherapy in intervention group

Griffiths 1964Not a randomised controlled trial

Groppa 2006Study on the effect of STM as a monotherapy on axonal excitability of cortical neurons in subjects with no history of epilepsy - same study as Siniatchkin 2006

Ingram 1963Not a randomised controlled trial

ISRCTN66730162STM used as monotherapy in intervention group

ISRCTN97864911STM used as monotherapy in intervention group

Li 2000Unable to verify citation. We will attempt to contact the author and any verified results will be included in an update of the review if appropriate

Livingston 1967Not a randomised controlled trial

Moffat 1970Study assessing the effects of STM on aggressive behaviour in both epileptic and non-epileptic patients

Rating 1999STM used as monotherapy in the intervention group - same study as Rating 2000

Rating 2000STM used as monotherapy in the intervention group - same study as Rating 1999

Siniatchkin 2006Study on the effect of STM as a monotherapy on axonal excitability of cortical neurons in subjects with no history of epilepsy - same study as Groppa 2006

 
Comparison 1. Sulthiame add-on versus placebo

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Complete cessation of seizures137Risk Ratio (M-H, Fixed, 95% CI)0.71 [0.53, 0.96]

 2 Adverse effects - total137Risk Ratio (M-H, Fixed, 95% CI)1.17 [0.62, 2.22]

 3 Adverse effects - somnolence137Risk Ratio (M-H, Fixed, 95% CI)0.85 [0.66, 1.09]

 
Summary of findings for the main comparison.

Sulthiame add-on therapy compared with placebo for epilepsy

Patient or population: Patients between 3 to 15 months with West syndrome

Settings: In-patient

Intervention: Sulthiame as add-on therapy to pyridoxine

Comparison: Placebo as add-on therapy to pyridoxine

OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of Participants
(studies)
Quality of the evidence
(GRADE)
Comments

Assumed riskCorresponding risk

PlaceboSulthiame

Complete cessation of seizures

9 days
0 per 1000300 per 1000RR 0.71 (0.53 to 0.96)37
(1)
⊕⊕⊝⊝
Low
Single, small study.

Adverse effects - total

9 days
529 per 1000450 per 1000RR 1.17 (0.62 to 2.22)37
(1)
⊕⊝⊝⊝
very low
Single, small study.

Risk of publication bias.

Adverse effects - somnolence

9 days
59 per 1000200 per 1000RR 0.85 (0.66 to 1.09)37
(1)
⊕⊕⊝⊝
Low
Single, small study.

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk Ratio;

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.