Autism Biomedical Information Network
Two controlled trials of secretin show no benefit
It has been over a year since an NBC Dateline program electrified families with the promise of a remarkable breakthrough treatment for autism. Of course, the reports were anecdotal and, in retrospect, sounded "too good to be true." There are now reports of two controlled trials which show no benefit of secretin treatment. There was a prominent placebo effect in the first study. Abstracts of each of the reports follows.
Title: Lack of Benefit of a Single Dose of Synthetic Human Secretin in the Treatment of Autism and Pervasive Developmental Disorder
Authors: Sandler AD, Sutton KA, DeWeese J, Girardi MA, Sheppard V, Bodfish JW. Olson Huff Center for Child Development, Thomas Rehabilitation Hospital, Asheville, NC, the Human Development Research and Training Institute, Western Carolina Center, Morganton, NC, and the Department of Psychiatry, University of North Carolina at Chapel Hill
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 microgram 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.
Reference: New England Journal of Medicine 1999;341:1801-6 (December 9)
Also see editorial commentary in the same issue by Fred R Volkmar MD, p. 1842-4.
("Lessons from Secretin")
Title: Double-Blind, Placebo-Controlled Trial of Secretin for the Treatment of Autistic Disorder
Authors: Thomas Owley, MD, Elisa Steele, MS, Christina Corsello, MA, Susan Risi, PhD, Kathryn McKaig, MS, Catherine Lord, PhD, Bennett L. Leventhal, MD, Edwin H. Cook Jr, MD, Section of Child and Adolescent Psychiatry, Department of Psychiatry, University of Chicago, Chicago, Ill.
Objective: This study examines the efficacy of intravenous porcine secretin for the treatment of autism.
Methods: Using a randomized, double-blind, placebo-controlled crossover design, 20 subjects with autistic disorder received either a secretin or placebo infusion at baseline and the other substance at week 4. Subjects were given the Autism Diagnostic Interview-Revised, the Autism Diagnostic Observation Schedule-Generic (ADOS-G), and other pertinent developmental measures at baseline and at weeks 4 and 8 to assess drug effects.
Results: For the primary efficacy analysis, change of ADOS-G social-communication total score from week 0 to week 4, no statistically significant difference was obtained between placebo (-1.0 ± 2.4) and secretin groups (-0.7 ± 1.4; t 0.34, df 18, P <.74). No significant differences were obtained for the other measures, including when all 20 subjects were compared by paired t-test from baseline to 4 weeks after secretin infusion.
Conclusion: There was no evidence for efficacy of secretin in this preliminary randomized controlled trial. These data were collected as part of a multicenter study with the University of California-Irvine and the University of Utah.
Reference: The full-text was published on the Medscape Web site. It may be necessary to register online before viewing the article. Point your browser to:
Medscape General Medicine on the Web
Return to list of commentaries and other autism links
This page last updated on 01/04/00