Methods |
Cross‐over
Double blind
Blinding of outcome assessor unclear
1/25 LTFU |
Participants |
Autism or PDD‐NOS (DSM‐IV)
6yrs ± 2.4
22 males, 3 females |
Interventions |
Treatment: porcine secretin 2CU/kg IV single dose at baseline or wk 4
Control: IV saline, single dose at baseline or wk 4 |
Outcomes |
CARS
Parent reported outcomes |
Notes |
Biased sample ("responders") from non‐controlled trial. Secretin in this trial each child's 2nd dose |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
High risk |
Alternating schedule at entry |
Allocation concealment (selection bias) |
Unclear risk |
Not specified |
Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
"Double blind" but blinding of outcome assessors unclear |
Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
4% loss to follow‐up |