A Double-Blind, Placebo-Controlled Trial of Oral Human Immunoglobulin for Gastrointestinal Dysfunction in Children with Autistic Disorder
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| Title: | A Double-Blind, Placebo-Controlled Trial of Oral Human Immunoglobulin for Gastrointestinal Dysfunction in Children with Autistic Disorder |
|---|---|
| Language: | English |
| Authors: | Handen, Benjamin L., Melmed, Raun D., Hansen, Robin L. |
| Source: | Journal of Autism and Developmental Disorders. May 2009 39(5):796-805. |
| Availability: | Springer. 233 Spring Street, New York, NY 10013. Tel: 800-777-4643; Tel: 212-460-1500; Fax: 212-348-4505; e-mail: service-ny@springer.com; Web site: http://www.springerlink.com |
| Peer Reviewed: | Y |
| Physical Description: | |
| Page Count: | 10 |
| Publication Date: | 2009 |
| Document Type: | Journal Articles Reports - Research |
| Descriptors: | Autism, Children, Human Body, Drug Therapy, Adolescents, Symptoms (Individual Disorders), Outcomes of Treatment, Behavior Problems, Severity (of Disability), Correlation |
| DOI: | 10.1007/s10803-008-0687-y |
| ISSN: | 0162-3257 |
| Abstract: | 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. |
| Abstractor: | As Provided |
| Entry Date: | 2009 |
| Accession Number: | EJ838798 |
| Database: | ERIC |
| Abstract: | 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. |
|---|---|
| ISSN: | 0162-3257 |
| DOI: | 10.1007/s10803-008-0687-y |
