Repeated Doses of Porcine Secretin in the Treatment of Autism: A Randomized, Placebo-Controlled Trial

Roberts W, Weaver L , Brian J, Bryson S, Emelianova S, Griffiths, A-M, MacKinnon B, Yim C, Wolpin J, and Koren G.

Pediatrics May 2001; 107(5): e71

Question: Does the use of secretin result in measurable improvements in autistic symptoms, language or cognitive functioning as compared to placebo.

Background: Secretin is a gastrointestinal hormone that helps promote digestion of food by stimulating the stomach to produce the enzyme pepsin, the liver to produce bile and the pancreas to produce digestive juices that help neutralize acidity in the intestines. Starting with a report from parents of a child who apparently showed improvement after a GI investigation that involved the use of secretin, there has been a lot of media attention given to reports that injection of secretin has produced positive effects in children with autism, improving their autistic symptoms, especially their ability to relate to others. The results from controlled trials have not been as favourable. This is a report of one such study.

Design: A randomized, placebo-controlled trial was conducted. Block randomization was employed to ensure that there were equal numbers of children from each age group of 2 to 4 and 5 to 7 years in the placebo and active treatment groups.

Setting: The Autism Research Unit of the Child Development Centre at the Hospital for Sick Children, Toronto, Ontario, Canada.

Participants: Sixty-eight children aged 2 to 7, all of whom met the diagnostic criteria for either autism or autism spectrum disorder using either the ADI-R or the ADOS-G. All of the children had also received a diagnosis of autism from a community clinician based on the DSM-IV.

Intervention: The children were randomly assigned to receive either 2 placebo injections or 2 injections of porcine secretin, each given 6 weeks apart.

Main Outcome Measures: The ADOS-G was used to measure social, behavioural and language symptoms of autism both at baseline and at follow up. Cognitive functioning was tested using the Leiter scale. Language was tested using the Preschool Language Scale III (PLS-3). Visual-spatial performance was testing using a visual orienting task. Parents were asked to fill out a Gastrointestinal Symptoms Questionnaire designed for the study.

Main Results: Sixty-four of the original 68 children completed the study. There were no significant differences found on any of the objective outcome measures used. Both groups of children showed improvement in language, but this was likely due to maturation or other factors. When the data were analyzed according to the children's I.Q., the presence of gastrointestinal problems, or their history of regression, no difference in their response to the secretin was observed.

Conclusions: There is evidence from this study that secretin is not effective in children with autism. There was no difference in effectiveness for subgroups based on age, IQ, history of gastrointestinal symptoms, or history of regression. When the objective clinical data from children whose parents noted great improvement was scrutinized, there was no evidence of sustained improvement.

This study adds to the body of work that has shown that secretin is not effective in the treatment of autistic symptoms.

Other papers about secretin:

A randomized, double-blind, placebo-controlled trial of single-dose intravenous secretin as treatment for children with autism.
Coniglio SJ, Lewis JD, Lang C, Burns TG, Subhani-Siddique R, Weintraub A, Schub H, Holden EW.
Journal of Pediatrics May 2001; 138(5): 649-655.

Children with autistic spectrum disorders. II: parents are unable to distinguish secretin from placebo under double-blind conditions.
Coplan J, Souders MC, Mulberg AE, Belchic JK, Wray J, Jawad AF, Gallagher PR, Mitchell R, Gerdes M, Levy SE.
Archives of Disease in Childhood. August 2003; 88(8): 737-739.

Effect of secretin on children with autism: a randomized controlled trial.
Dunn-Geier J, Ho HH, Auersperg E, Doyle D, Eaves L, Matsuba C, Orrbine E, Pham B, Whiting S.
Developmental Medicine and Child Neurology. December 2000; 42(12): 796-802.

Multisite, double-blind, placebo-controlled trial of porcine secretin in autism.
Owley T, McMahon W, Cook EH, laulhere T, South M, Mays LZ, Shernoff ES, Lainhart J, Modahl CB, Corsello C, Ozonoff S, Risi S, Lord C, Leventhal BL, Filipek PA.
Journal of the American Academy of Child and Adolescent Psychiatry. November 2001; 40(11): 1293-1299.

A randomized, double-blind, placebo-controlled trial of porcine versus synthetic secretin for reducing symptoms of autism.
Unis AS, Munson JA, Rogers SJ, Goldson E, Osterling J, Gabriels R, Abbott RD, Dawson G.
Journal of the American Academy of Child and Adolescent Psychiatry November 2002; 41(11): 1315-1321.

Lack of benefit of intravenous synthetic human secretin in the treatment of autism.
Molloy CA, Manning-Courtney P, Swayne S, Bean J, Brown JM, Murra DS, Kinsman AM Brasington M, Ulrich CD 2nd.
Journal of Autism and Developmental Disorders. December 2002; 32(6):545-551.