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

Carey 2002.

Study characteristics
Methods 48‐week cross‐over trial of secretin versus placebo
Participants Inclusion criteria:
  • aged 2‐8 years

  • met DSM‐4 criteria for diagnosis of autism or PDD

  • had not had a recent case of acute pancreatitis

  • had not previously received an infusion of secretin


Exclusion criteria: not reported
Location/setting: Developmental and Behavioral Pediatrics Division at the Medical College of Ohio, USA
Sample size: 8 in total
Number of withdrawals/dropouts: not reported
Gender: 8 boys
Mean age: 5 years
IQ: "general developmental level based on parent report on the Child Development Inventory ranged from 16 to 39 months".
Baseline ABC‐I or other BoC: ABC‐I secretin 24.5, placebo 15.5
Concurrent drug use: details not provided
History of previous medications: details not provided
Interventions Intervention (single dose of secretin): single dose of 2 IU of secretin/kg of body weight
Comparator (single dose of placebo): equivalent single dose of placebo
Outcomes Primary outcomes: irritability, measured using the ABC‐I subscale (Aman 1985); AEs
Secondary outcomes: none reported
Timing of outcome assessment: ABC‐I: prior to infusion and then weekly for 8 weeks
Notes Study start date: not reported
Study end date: not reported
Funding source: not reported
Conflicts of interest: none declared
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk All participants were randomised into 2 groups.
Allocation concealment (selection bias) Unclear risk Details not provided
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Double‐blinded, however no further details provided
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Details not provided
Incomplete outcome data (attrition bias)
All outcomes High risk Complete parent and teacher data were obtained for 8 of the total 21 project participants.
Selective reporting (reporting bias) Unclear risk Protocol was not provided so unclear if all outcomes were reported
Other bias High risk Participants were recruited from a list of children whose parents contacted the Developmental and Behavioral Pediatrics Division at the Medical College of Ohio to request a trial of secretin for their child.