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A Placebo-Controlled Crossover Trial of Gastrin-Releasing Peptide in Childhood Autism
Josemar Marchezan1, Michele Becker, Gilberto Schwartsmann
1*Postgraduate Program in Child and Adolescent Health, School of Medicine, Federal University of Rio Grande do Sul; †Department of Pediatrics, Child Neurology Unit, Hospital de Clínicas de Porto Alegre; ‡Department of Internal Medicine, School of Medicine, Cancer and Neurobiology Laboratory, Experimental Research Center, Clinical Hospital (CPE-HCPA), §Department of Pharmacology, Institute for Basic Health Sciences, Cancer and Neurobiology Laboratory, Experimental Research Center, Clinical Hospital (CPE-HCPA), and ∥Department of Pediatrics, Child Neurology Unit, Postgraduate Program in Child and Adolescent Health, School of Medicine, Federal University of Rio Grande do Sul, Porto Alegre, RS, Brazil.
Objectives:
The aim of this study was to evaluate the efficacy, safety, and tolerability of gastrin-releasing peptide (GRP) compared with placebo in autism spectrum disorder symptoms.
Methodology:
This is a randomized, double-blind, placebo-controlled crossover trial using GRP 160 pmol/kg for 4 consecutive days in 10 children with autism. Outcomes were measured by the Aberrant Behavior Checklist (ABC) scale.
Results:
All participants were boys, aged between 4 and 9 years. There was a reduction in the scores of the ABC range and its subscales after use GRP and placebo. The reduction was more prominent with GRP, particularly in the subscale "hyperactivity and noncompliance," but there was no statistical difference between the results (P = 0.334). After a week of infusion, 5 children showed improvement of 25% or greater in the total score of the ABC scale with GRP use and 2 with placebo use; however, there was no statistical difference (P = 0.375). There were no adverse effects, changes in vital signs, or laboratory abnormalities associated with the use of GRP.
Conclusions:
The results of this study, despite the small sample size, reinforce previous data on the safety of the GRP in short-term use. There is a need for further research with other designs and a larger sample size to evaluate the efficacy and safety of GRP in children with autism.
