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Clinical Trial
. 1999 Dec 9;341(24):1801-6.
doi: 10.1056/NEJM199912093412404.

Lack of benefit of a single dose of synthetic human secretin in the treatment of autism and pervasive developmental disorder

A D Sandler  1 , K A Sutton, J DeWeese, M A Girardi, V Sheppard, J W Bodfish
Affiliations
Free article
Clinical Trial

Lack of benefit of a single dose of synthetic human secretin in the treatment of autism and pervasive developmental disorder

A D Sandler et al. N Engl J Med. .
Free article

Abstract

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.

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Comment in

  • Lessons from secretin.
    Volkmar FR. Volkmar FR. N Engl J Med. 1999 Dec 9;341(24):1842-4. doi: 10.1056/NEJM199912093412412. N Engl J Med. 1999. PMID: 10588973 No abstract available.
  • Secretin treatment for autism.
    Horvath K. Horvath K. N Engl J Med. 2000 Apr 20;342(16):1216; author reply 1218. doi: 10.1056/NEJM200004203421614. N Engl J Med. 2000. PMID: 10777376 No abstract available.
  • Secretin treatment for autism.
    Rimland B. Rimland B. N Engl J Med. 2000 Apr 20;342(16):1216-7; author reply 1218. N Engl J Med. 2000. PMID: 10777377 No abstract available.
  • Secretin treatment for autism.
    Herlihy WC. Herlihy WC. N Engl J Med. 2000 Apr 20;342(16):1217; author reply 1218. N Engl J Med. 2000. PMID: 10777378 No abstract available.
  • Secretin treatment for autism.
    Said SI, Bodanszky M. Said SI, et al. N Engl J Med. 2000 Apr 20;342(16):1217-8. N Engl J Med. 2000. PMID: 10777379 No abstract available.

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