Abstract
Objective
To systematically review the effectiveness of oral baclofen versus placebo or other
antispastic oral medications in terms of body function, level of activity, and quality
of life in children and adolescents with spastic cerebral palsy who are younger than
18 years.
Data Sources
Cochrane Library, Health Science Databases, DARE, LILACS, Embase, MEDLINE, OTseeker,
PEDro, PsycINFO, SpeechBITE, ScienceDirect, Scopus, Trip, ClinicalTrials.gov, Google Scholar, OpenGrey, and manual search.
Study Selection
Randomized or not randomized controlled trials and cohort studies comparing the effect
of any dosage of oral baclofen with that of no treatment, placebo, or another antispastic
medication in children and adolescents with spastic cerebral palsy were selected.
Data Extraction
Following the Cochrane Handbook for Systematic Reviews of Interventions guidelines, 2 reviewers independently searched articles in databases from their inceptions
until October 2014.
Data Synthesis
Six randomized controlled trials involving a total of 130 patients were selected.
Studies show a great variability in motor classification, dosage of baclofen, and
outcome measures. There is conflicting evidence on the effectiveness of oral baclofen
in reducing muscle tone or improving motor function or the level of activity. The
overall methodological quality of the studies was low. The main qualitative limitations
of the studies correspond to serious risk of bias, inconsistency of results, unpowered
sample size, and publication bias.
Conclusions
There are insufficient data to support or refute the use of oral baclofen for reducing
spasticity or improving motor function in children and adolescents with spastic cerebral
palsy.
Keywords
List of abbreviations:
AE (adverse effect), AS (Ashworth Scale), CP (cerebral palsy), GAS (Goal Attainment Scaling), GMFCS (Gross Motor Function Classification System), ITB (intrathecal baclofen), MAS (Modified Ashworth Scale), PEDI (Pediatric Evaluation of Disability Inventory)To read this article in full you will need to make a payment
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References
- Baclofen in the treatment of cerebral palsy.J Child Neurol. 1996; 11: 77-83
- The descriptive epidemiology of cerebral palsy.Clin Perinatol. 2006; 33: 251-267
- Proposed definition and classification of cerebral palsy, April 2005.Dev Med Child Neurol. 2005; 47: 571-576
- Nonoperative management of spasticity in children.Childs Nerv Syst. 2007; 23: 943-956
- Pharmacotherapy of spasticity in children with cerebral palsy.Pediatr Neurol. 2006; 34: 1-6
- Long-term modification of spasticity.J Rehabil Med. 2003; : 60-65
- Pharmacotherapy of spasticity in children with cerebral palsy.J Formos Med Assoc. 2011; 110: 215-222
- AACPDM Treatment Outcomes Committee Review Panel. Evidence of the effects of intrathecal baclofen for spastic and dystonic cerebral palsy.Dev Med Child Neurol. 2000; 42: 634-645
- Intrathecal baclofen for severe spasticity: a meta-analysis.Int J Rehab Health. 1997; 3: 171-185
- Long-term safety and efficacy of continuous intrathecal baclofen.Dev Med Child Neurol. 2002; 44: 660-665
- Use of intrathecal baclofen therapy in ambulant children and adolescents with spasticity and dystonia of cerebral origin: a systematic review.Dev Med Child Neurol. 2011; 53: 885-895
- Rate of complications among the recipients of intrathecal baclofen pump in Japan: a multicenter study.Neuromodulation. 2013; 16 (discussion 272): 266-272
- Intrathecal baclofen for intractable spasticity of spinal origin: results of a long-term multicenter study.J Neurosurg. 1993; 78: 226-232
- Complications of intrathecal baclofen pump therapy in pediatric patients.J Pediatr Orthop. 2010; 30: 76-81
- Spasticity management: an overview.J Child Neurol. 2001; 16: 16-23
- Oral pharmacotherapy of childhood movement disorders.J Child Neurol. 2003; : S40-S49
- Pharmacotherapy of spasticity: oral medications and intrathecal baclofen.J Child Neurol. 2001; 16: 31-36
- The mode of action of the GABA derivative baclofen in human spasticy.Acta Neurol Scand. 1974; 50: 665-680
- Effect of antispastic drugs on motor reflexes and voluntary muscle contraction in incomplete spinal cord injury.Arch Phys Med Rehabil. 2014; 95: 622-632
U.S. Food Drug Administration. Drugs. Available at: http://www.fda.gov/Drugs/default.htm. Accessed March 19, 2015.
- A controlled pharmacokinetic evaluation of tizanidine and baclofen at steady state.Drug Metab Dispos. 1999; 27: 201-204
- Population pharmacokinetics of oral baclofen in pediatric patients with cerebral palsy.J Pediatr. 2014; 164: 1181-1188.e1188
- Management of spasticity.Am J Phys Med Rehabil. 1988; 67: 108-116
- Drugs used to treat spasticity.Drugs. 2000; 59: 487-495
- Hyperthermia associated with baclofen withdrawal and increased spasticity.Arch Phys Med Rehabil. 1993; 74: 96-97
- Complications of baclofen withdrawal.Arch Neurol. 1981; 38: 588-589
- Baclofen overdose: drug experimentation in a group of adolescents.Pediatrics. 1998; 101: 1045-1048
- Baclofen: its effect on seizure frequency.Arch Neurol. 1983; 40: 28-29
- Prolonged seizure activity after baclofen withdrawal.Neurology. 1992; 42: 697-698
- Long-lasting potentiation and epileptiform activity produced by GABAB receptor activation in the dentate gyrus of rat hippocampal slice.J Neurosci. 1991; 11: 1198-1209
SalcoBrand. Pharmacy Catalogue. Available at: http://www.salcobrand.cl/cl/consulta-precio/. Accessed July 12, 2015.
Higgins J, Green S, editors. Cochrane handbook for systematic reviews of interventions. Version 5.1.0. Available at: www.cochrane-handbook.org. Updated March 2011. Accessed May 22, 2015.
- Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement.Ann Intern Med. 2009; 151 (W264): 264-269
- Grading quality of evidence and strength of recommendations.BMJ. 2004; 328: 1490
- The use of baclofen in children with cerebral palsy.Folha Med. 1976; 73: 199-202
- Comparative study of oral diazepam and baclofen on spasticity in cerebral palsy.Dev Med Child Neurol. 2012; 54: 70-71
- Oral baclofen in children with cerebral palsy: a double-blind cross-over pilot study.J Paediatr Child Health. 2006; 42: 715-720
- Efectividad de baclofeno en el tratamiento de espasticidad de origen cerebral.Rev Chil Pediatr. 1996; 67: 206-211
- Baclofen: a team approach to drug evaluation of spasticity in childhood.Scott Med J. 1980; 25: S26-S28
- A controlled trial of baclofen in children with cerebral palsy.J Int Med Res. 1977; 5: 398-404
- Goal Attainment Scaling as a method of clinical service evaluation.Am J Occup Ther. 1990; 44: 519-525
Haley S, Coster W, Ludlow L, Haltiwanger J, Andrellos P. Pediatric evaluation of disability inventory. In: Assessing children’s well-being: a handbook of measures. Vol 11. 2003. p 13.
- Oral baclofen and clonidine for treatment of spasticity in children.J Child Neurol. 2006; 21: 1090-1092
- A review of the properties and limitations of the Ashworth and Modified Ashworth scales as measures of spasticity.Clin Rehabil. 1999; 13: 373-383
- Reliability of clinical spasticity measurements in patients with cervical spinal cord injury.Ortop Traumatol Rehabil. 2007; 9: 467-483
- Reliability of Ashworth and Modified Ashworth scales in children with spastic cerebral palsy.BMC Musculoskelet Disord. 2008; 9: 44
- Interrater reliability of a Modified Ashworth Scale of muscle spasticity.Phys Ther. 1987; 67: 206-207
- Interrater reliability of Modified Ashworth Scale and Modified Tardieu Scale in children with spastic cerebral palsy.J Child Neurol. 2006; 21: 1031-1035
- [Research on a technic for measurement of spasticity].Rev Neurol (Paris). 1954; 91 ([French]): 143-144
- A systematic review of the Tardieu Scale for the measurement of spasticity.Disabil Rehabil. 2006; 28: 899-907
- Measures of muscle and joint performance in the lower limb of children with cerebral palsy.Dev Med Child Neurol. 2003; 45: 664-670
- Development and reliability of a system to classify gross motor function in children with cerebral palsy.Dev Med Child Neurol. 1997; 39: 214-223
- Anti-spasticity medications.Saudi Med J. 2003; 24: 19-22
- A comparison of baclofen and diazepam in the treatment of spasticity.J Neurol Sci. 1974; 23: 17-24
- Traditional pharmacological treatments for spasticity. Part II: General and regional treatments.Muscle Nerve Suppl. 1997; 6: S92-120
- Oral baclofen in cerebral palsy: possible seizure potentiation?.Pediatr Neurol. 2003; 29: 203-206
- Baclofen has a proepileptic effect in the rat dentate gyrus.J Pharmacol Exp Ther. 1989; 249: 721-725
- Comparison of the actions of baclofen at pre- and postsynaptic receptors in the rat hippocampus in vitro.J Physiol. 1992; 451: 329-345
- Characteristics and prognosis of epilepsy in children with cerebral palsy.J Child Neurol. 1999; 14: 289-294
- Bacloffen (Lioresal) in the long-term management of spasticity.Med J Aust. 1976; 1: 654-657
- Practice parameter: pharmacologic treatment of spasticity in children and adolescents with cerebral palsy (an evidence-based review): report of the Quality Standards Subcommittee of the American Academy of Neurology and the Practice Committee of the Child Neurology Society.Neurology. 2010; 74: 336-343
- Observer bias in randomised clinical trials with binary outcomes: systematic review of trials with both blinded and non-blinded outcome assessors.BMJ. 2012; 344: e1119
- The assessment and management of hypertonus in cerebral palsy: a physiological atlas (road map).in: Management of the motor disorders of children with cerebral palsy. Vol 161. Mac Keith Pr, London2004: 85-104
- Cerebral palsy-management.Indian J Pediatr. 2004; 71: 635-639
- Clinical management of spasticity.J Neurol Neurosurg Psychiatry. 2005; 76: 459-463
- Current issues in spasticity management.Neurologist. 1997; 3: 261-275
- Effects of oral baclofen in children with cerebral palsy.Dev Med Child Neurol. 2009; 51: 43
- Clinical experience in the use of baclofen in children with spastic cerebral palsy: a preliminary report.in: Jukes A.M. Baclofen: spasticity and cerebral pathology. Northampton: Cambridge Medical Publications. 1978: 68-70
- Clinical experience in the use of baclofen in children with spastic cerebral palsy: a further report.Scott Med J. 1980; 25: S23-S25
- Adherence associated with oral medications in the treatment of spasticity.PMR. 2013; 5: 747-756
- Continuous intrathecal baclofen infusion for spasticity of cerebral origin.JAMA. 1993; 270: 2475-2477
- Intrathecal baclofen for management of spastic cerebral palsy: multicenter trial.J Child Neurol. 2000; 15: 71-77
- Cost-effectiveness modeling of intrathecal baclofen therapy versus other interventions for disabling spasticity.Neurorehabil Neural Repair. 2009; 23: 546-552
Article info
Publication history
Published online: August 27, 2015
Footnotes
Disclosures: none.
Identification
Copyright
© 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.
