A double-blind, placebo-controlled trial of oral human immunoglobulin for gastrointestinal dysfunction in children with autistic disorder.
Controversy exists regarding the extent and possible causal relationship between gastrointestinal symptoms and autism. A randomized, double-blind, placebo-controlled, parallel groups, dose-ranging study of oral, human immunoglobulin (IGOH 140, 420, or 840 mg/day) was utilized with 125 children (ages 2-17 years) with autism and persistent GI symptoms. Endpoint analysis revealed no significant differences across treatment groups on a modified global improvement scale (validated in irritable bowel syndrome studies), number of daily bowel movements, days of constipation, or severity of problem behaviors. IGOH was well-tolerated; there were no serious adverse events. This study demonstrates the importance of conducting rigorous trials in children with autism and casts doubt on one GI mechanism presumed to exert etiological and/or symptomatic effects in this population.
Handen
Benjamin L
BL
University of Pittsburgh School of Medicine, Pittsburgh, PA 15203, USA. handenbl@upmc.edu
Melmed
Raun D
RD
Hansen
Robin L
RL
Aman
Michael G
MG
Burnham
David L
DL
Bruss
Jon B
JB
McDougle
Christopher J
CJ
D000284:Administration, Oral; D000293:Adolescent; D001321:Autistic Disorder / Q000150:complications* / Q000503:physiopathology; D002648:Child; D002675:Child, Preschool; D003248:Constipation / Q000188:drug therapy* / Q000209:etiology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005767:Gastrointestinal Diseases / Q000188:drug therapy* / Q000209:etiology*; D006801:Humans; D007136:Immunoglobulins / Q000008:administration & dosage* / Q000009:adverse effects; D043183:Irritable Bowel Syndrome / Q000188:drug therapy / Q000209:etiology; D008297:Male; D011569:Psychiatric Status Rating Scales; D012720:Severity of Illness Index; D016896:Treatment Outcome
D007136:Immunoglobulins