ABSTRACT. Background and Objectives. Anecdotal reports on the efficacy of secretin in autism raised great hopes for the treatment of children with this disorder. Initial single-dose, randomized, controlled trials failed to demonstrate any therapeutic effects of secretin. The present study is the first to test the outcome of repeated doses and to examine whether there is a subgroup of children who are more likely to achieve positive effects.Method. Sixty-four children with autism (ages 2-7 years; 55 boys and 9 girls) with a range of intelligence quotient and verbal ability were randomly assigned, in a double-blind manner, to secretin or placebo groups. Children received 2 doses of placebo or porcine secretin, 6 weeks apart. Assessments were performed at baseline and 3 weeks after each injection using several outcome measures.Results. There were no group differences on formal measures of language, cognition, or autistic symptomatology. Subgroupings based on cognitive level, the presence or absence of diarrhea, or a history of regression failed to show any significant therapeutic effects of secretin.Conclusion. No evidence is provided for the efficacy of repeated doses of porcine secretin in the treatment of children with autism. The possible relationship between relief of biological symptoms and enhanced skill performance is discussed. Pediatrics 2001;107(5). URL: http://www.pediatrics.org/cgi/content/full/107/5/ e71; autism, secretin, language, behavior, cognitive functioning, gastrointestinal abnormalities.ABBREVIATIONS. GI, gastrointestinal; HSC, Hospital for Sick Children; ADI-R, Autism Diagnostic Interview-Revised; ADOS-G, Autism Diagnostic Observation Scale-Generic; PLS-3, Preschool Language Scale, III; ABC, Autism Behavior Checklist; ANOVA, analysis of variance.A utism is a severe, life-long neurobiological disorder with high morbidity. The disorder affects virtually all areas of functioning, notably social, communicative, cognitive, and behavioral. Prevalence is estimated to be as high as 5/1000 for the full spectrum of autistic disorders 1 and prognosis is generally poor. 2,3 To date, the cause of autism remains unknown, and there is no specific medical treatment. Psychopharmacological management continues to be far from satisfactory, with no pharmacologic agent having been shown to alter the natural history of the disorder.Against this background, recent clinical reports of a positive response to secretin in children with autism have generated widespread interest in and demand for this hormone. In 1998, Horvath et al 4 reported an uncontrolled case series of 3 autistic children who showed marked improvements in their social and language skills after administration of secretin for an investigative gastrointestinal (GI) procedure. This report received considerable media attention and escalating claims of a potential cure for autism resulted in likely thousands of children with autism being given secretin injections.Recently published placebo-controlled trials 5-7 failed to show any effect of secretin on co...

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