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document
Tetrahydrobiopterin as a treatment for autism spectrum disorders : a double-blind , placebo-controlled trial . OBJECTIVE The purpose of this study was to determine if tetrahydrobiopterin ( BH4 ) reduced core symptoms of autism spectrum disorder ( ASD ) . METHOD In this study , 46 children , 3-7 years of age diagnosed with an ASD were randomly assigned to double-blind treatment with 20 mg/kg/day BH4 or placebo for 16 weeks . The primary outcome measure was the Clinical Global Impressions Improvement and Severity Scales ( CGI-I and CGI-S ) ; secondary outcomes were the Preschool Language Scale-4 ( PLS-4 ) , Social Responsiveness Scale ( SRS ) , Aberrant Behavior Checklist ( ABC ) , and Vineland Adaptive Behavior Scales ( Vineland ) . RESULTS Overall , no differences were found on global improvement as measured with the CGI-I or CGI-S . Secondary measures indicated significant improvements for BH4 relative to placebo with regard to social awareness , autism mannerisms , hyperactivity , and inappropriate speech . Side effects were minimal and similar between both active medication and placebo . CONCLUSIONS These results indicate that BH4 offers promise in reducing symptoms of ASD . Clinical Trials.gov Identifier : NCT00850070 .
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Intervention_Pharmacological
Tetrahydrobiopterin
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Intervention_Control
placebo-controlled
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Intervention_Pharmacological
tetrahydrobiopterin ( BH4 )
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Outcome_Mental
Clinical Global Impressions Improvement and Severity Scales ( CGI-I and CGI-S )
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Outcome_Mental
Preschool Language Scale-4 ( PLS-4
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Outcome_Mental
Social Responsiveness Scale ( SRS )
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Outcome_Mental
Aberrant Behavior Checklist ( ABC )
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Outcome_Mental
Vineland Adaptive Behavior Scales ( Vineland )
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Outcome_Mental
CGI-I or CGI-S
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Outcome_Mental
social awareness , autism mannerisms , hyperactivity , and inappropriate speech
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Participant_Condition
autism spectrum disorders :