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Effectiveness of oral baclofen for spasticity in children with cerebral palsy

1 Objective: To systematically review the effectiveness of oral baclofen versus placebo 2 or other antispastic oral medication in the areas of body function, activity, and quality of 3 life in children with spastic CP ≤ 18 years. Study Selection: randomized or not 4 randomized controlled clinical trials (RCT) and cohort studies were selected, comparing 5 the effect of any dose of oral baclofen with no treatment, placebo, or another antispastic 6 medication in children with spastic CP. Data Sources : The Cochrane library, Health 7 Science Databases, DARE, Lilacs, Embase, Medline, OTSeeker, PEDro, PsycINFO, 8 SpeechBITE, ScienceDirect, Scopus, Trip, clinicaltrial.gov, Google scholar, OpenGrey 9 and manual search. Data Extraction: Following the Cochrane Handbook for 10 Systematic Reviews of Interventions Guidelines, two reviewers independently classified 11 articles through October 2014. Data synthesis: Six RCT were selected involving 130 12 participants. Studies show a great variability in motor classification, dosage of baclofen, 13 and outcomes measurements. There is conflicting evidence regarding the effectiveness 14 of oral baclofen in reducing muscle tone, improving motor function or the level of 15 activity. The overall methodological quality of the studies was low. Main qualitative 16 deficiencies correspond to serious risk of bias, inconsistency of results, unpowered 17 sample size, and publication bias. Conclusions: There are insufficient data to support or 18 refute the use of oral baclofen in children with spastic CP. PROSPERO 2014: 19 CRD42014013658. 20