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

Molloy 2002.

Methods Cross‐over trial of single dose secretin versus placebo
Participants Inclusion criteria:
  • 2–15 years of age

  • met the criteria for autism as outlined in the DSM‐IV following multidisciplinary evaluation, "Children not evaluated at our center were accepted into the sampling frame if documentation of diagnosis by a multidisciplinary team was sufficient as determined by a developmental pediatrician (SS)."


Exclusion criteria: "had known chromosomal or other genetic disorders, a structural abnormality on neuroimaging, had previously received secretin, had acute or chronic pancreatic disease or a medical condition that might make participation in the study unsafe".
Location/setting: Children's Hospital Medical Centre, Cincinnati, Ohio, USA
Sample size: 60
Number analysed: secretin first: 19, placebo first: 23
Number of withdrawals/dropouts: 18 dropped out from original 60, although reasons for only 1 participant provided (from placebo/secretin group) ‐ they did not return for the final assessment.
Gender: 37/42 analysed were male participants
Mean age: 6.8 years
IQ: not reported
Baseline ABC‐I or other BoC: not reported
Concurrent medications: not reported
History of previous medications: not reported
Interventions Intervention (single dose secretin): a single dose of 2 IU/kg of intravenous synthetic human secretin was given at the first visit of the phase.
Comparator (single dose placebo): a single dose of 2 IU/kg of placebo was given at first visit of the phase.
Outcomes Primary outcomes:
  • parent‐rated ABC (not reported) (Aman 1985)

  • AEs (not reported)


Secondary outcomes: none reported
Timing of outcome assessments: baseline, and weeks 1, 3, 6, 9 and 12
Notes Study start date: not reported
Study end date: not reported
Source of funding: "supported by Grant #4 T73 MC 00032‐10 awarded by the Maternal and Child Health Bureau, Health Resources and Service Administration, DHHS and by Grant #M01 RR‐08084, NIH. The human synthetic secretin used in the study was supplied by ChiRoClin (Silver Spring, MD) free of charge".
Conflicts of interest: none declared
Comment: author was contacted for information but no reply