Famotidine treatment of children with autistic spectrum disorders: pilot research using single subject research design

Using single subject research design, we performed pilot research to evalua te the safety and efficacy of famotidine for the treatment of children with autistic spectrum disorders. We studied 9 Caucasian boys, 3.8-8.1 years ol d, with a DSM-IV diagnosis of a pervasive developmental disorder, living wi th their families, receiving no chronic medications, and without significan t gastrointestinal symptoms. The dose of oral famotidine was 2mg/kg/day (gi ven in two divided doses); the maximum total daily dose was 100mg. Using si ngle-subject research analysis and medication given in a randomized, double -blind, placebo-controlled, cross-over design, 4 of 9 children randomized ( 44%) had evidence of behavioral improvement. Primary efficacy was based on data kept by primary caregivers, including a daily diary; daily visual anal ogue scales of affection, reciting, or aspects of social interaction; Aberr ant Behavior Checklists (ABC, Aman); and Clinical Global Improvement scales . Children with marked stereotypy (meaningless, repetitive behaviors) did n ot respond. Our subjects did not have prominent gastrointestinal symptoms a nd endoscopy was not part of our protocol; thus, we cannot exclude the poss ibility that our subjects improved due to the effective treatment of asympt omatic esophagitis. The use of famotidine for the treatment of children wit h autistic spectrum disorders warrants further investigation.