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document
Lack of benefit of a single dose of synthetic human secretin in the treatment of autism and pervasive developmental disorder . BACKGROUND Secretin is a peptide hormone that stimulates pancreatic secretion . After recent publicity about a child with autism whose condition markedly improved after a single dose of secretin , thousands of children with autistic disorders may have received secretin injections . METHODS We conducted a double-blind , placebo-controlled trial of a single intravenous dose of synthetic human secretin in 60 children ( age , 3 to 14 years ) with autism or pervasive developmental disorder . The children were randomly assigned to treatment with an intravenous infusion of synthetic human secretin ( 0.4 microg per kilogram of body weight ) or saline placebo . We used standardized behavioral measures of the primary and secondary features of autism , including the Autism Behavior Checklist , to assess the degree of impairment at base line and over the course of a four-week period after treatment . RESULTS Of the 60 children , 4 could not be evaluated - 2 received secretin outside the study , and 2 did not return for follow-up . Thus , 56 children ( 28 in each group ) completed the study . As compared with placebo , secretin treatment was not associated with significant improvements in any of the outcome measures . Among the children in the secretin group , the mean total score on the Autism Behavior Checklist at base line was 59.0 ( range of possible values , 0 to 158 , with a larger value corresponding to greater impairment ) , and among those in the placebo group it was 63.2 . The mean decreases in scores over the four-week period were 8.9 in the secretin group and 17.8 in the placebo group ( mean difference , -8.9 ; 95 percent confidence interval , -19.4 to 1.6 ; P=0.11 ) . None of the children had treatment-limiting adverse effects . After they were told the results , 69 percent of the parents of the children in this study said they remained interested in secretin as a treatment for their children . CONCLUSIONS A single dose of synthetic human secretin is not an effective treatment for autism or pervasive developmental disorder .
2091
Intervention_Physical
synthetic human secretin
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Intervention_Physical
Secretin
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Intervention_Physical
secretin
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Intervention_Physical
secretin injections
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Intervention_Control
placebo-controlled
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Intervention_Physical
synthetic human secretin
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Intervention_Control
saline placebo .
2098
Intervention_Physical
secretin
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Intervention_Control
placebo
2100
Intervention_Physical
secretin
2101
Intervention_Physical
secretin
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Intervention_Control
placebo
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Intervention_Physical
secretin
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Intervention_Physical
secretin
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Intervention_Physical
human secretin
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Outcome_Other
significant improvements in any of the outcome measures
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Outcome_Mental
mean total score on the Autism Behavior Checklist
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Outcome_Other
mean decreases in
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Outcome_Mental
scores
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Outcome_Adverse-effects
treatment-limiting adverse effects
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Outcome_Other
not an effective treatment
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Participant_Condition
autism
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Participant_Condition
pervasive developmental disorder
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Participant_Condition
autistic disorders
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Participant_Sample-size
60
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Participant_Age
children
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Participant_Age
3 to 14 years
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Participant_Sample-size
28