A randomized, double-blind, placebo-controlled trial of single-dose intravenous secretin as treatment for children with autism

Objective: To determine whether a single injection of intravenous secretin results in measurable improvements in socialization and/or communication sk ills in children with autism. Study design: Sixty subjects with autism were randomly selected and assigne d to either treatment or placebo group. Subjects in the treatment group rec eived 2.0 clinical units of secretin per kilogram of body weight as a singl e intravenous dose. Subjects in the placebo group received normal saline so lution. Neurodevelopmental and behavioral assessments were performed for al l subjects before injection and at 3 and 6 weeks after injection. Results: Assessment of language skills and parents' behavioral assessments revealed no significant differences between the treatment and placebo group s. Raters' assessments of severity of autistic symptoms did not differ for the 2 groups at 6 weeks after injection. A marginal statistically significa nt Improvement in autistic behaviors was seen in the treatment group at 3 w eeks after injection (P = .051). Conclusions: A single dose of intravenous secretin does not appear to have significant effects on either parents' perception of autistic behaviors or language skills at 6 weeks after injection. Transient, marginally significa nt improvements in autistic behaviors may occur in some children.