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. 2023 Oct 9;2023(10):CD011769. doi: 10.1002/14651858.CD011769.pub2

Sandler 1999.

Methods Parallel trial of single‐dose secretin versus single‐dose placebo
Participants Inclusion criteria:
  • children 3‐14 years

  • diagnosis of autism or PDD

  • no previous secretin treatment

  • no diagnosis of pancreatitis, inflammatory bowel disease, or gastrinoma

  • written, voluntary informed consent for participation by a parent or legal guardian


Location/setting: Department of Psychiatry, University of North Carolina. Children were referred by the Treatment and Evaluation of Autism and Communication Handicaps program of the Department of Psychiatry at the University of North Carolina or whose parents responded to notices about this study placed in the newsletter of an autism‐support group.
Sample size: 60 children were randomised
Number of withdrawals/dropouts: 4 could not be evaluated (2 received secretin outside the study, and 2 did not return for follow‐up)
Gender: not reported
Mean age: secretin 7.6 years, placebo 7.4 years
IQ: secretin 65.6, placebo 60.1
Baseline ABC‐I or other BoC: not reported
Concomitant medications: secretin 8/30, placebo 11/30 were taking psychotropic medications
History of previous medications: not reported
Interventions Intervention (single‐dose secretin): 0.4 ug per kg of body weight
Comparator (single‐dose placebo): saline placebo
Outcomes Primary outcomes:
  • severity of autistic symtoms, measured using the Autism Behaviour Checklist and the CGI

  • AEs, measured using the Treatment Emergent Symptoms Scale (not reported)


Secondary outcomes: none reported
Timing of outcome assessments: baseline, weeks 1, 2 and 4 postinfusion
Notes Study start date: not reported
Study end date: not reported
Source of funding: Thoms Health Services Foundation and by a Public Health Service grant (30615) from the National Institutes of Child Health and Human Development
Conflicts of interest: none declared
Comment: study author contacted twice for information about AEs but no reply