The Effect of Intranasal Oxytocin on Social Interaction in Adults and Children With Autism Spectrum Disorders: A
Gengjing Fang1,2,3, Wuyuan Pan1,4, Guokai Li1
1Department of Pharmacy, Fujian Maternity and Child Health Hospital, College of Clinical Medicine for Obstetrics & Gynecology and Pediatrics, Fujian Medical University, 350001 Fuzhou, Fujian, China.
Background:
Autism spectrum disorder (ASD) is a complex neurodevelopmental condition characterized by marked heterogeneity in cognitive, behavioral, and social functioning. Although oxytocin has been extensively investigated as a potential therapeutic agent for ASD, evidence regarding its clinical efficacy remains inconsistent and inconclusive. This systematic review and meta-analysis aimed to evaluate the therapeutic efficacy of intranasal oxytocin in improving core behavioral and social symptoms in individuals diagnosed with ASD by synthesizing evidence from randomized controlled trials.
Methods:
A systematic search of PubMed, Web of Science, and the Cochrane Library was conducted to identify peer-reviewed studies published up to February 16, 2025. Two independent reviewers performed study screening, data extraction, and critical appraisal of methodological quality and strength of evidence. Autism-related behavioral symptom scores were used as outcome measures. Meta-analyses were conducted using random-effects models.
Results:
Twelve randomized controlled trials encompassing a total of 733 participants met the inclusion criteria. Pooled results from the random-effects model indicated no statistically significant effect of oxytocin on social functioning outcomes (standardized mean difference [SMD] = -0.05, 95% confidence interval [CI]: -0.20 to 0.10; p = 0.54). Between-study heterogeneity was low (I2 = 4%; τ2 = 0.00). Exploratory subgroup analyses showed no significant differences across pre-specified moderators (all p > 0.05).
Conclusions:
The current body of evidence does not support a significant therapeutic effect of intranasal oxytocin on core behavioral symptoms in individuals with ASD. However, methodological limitations of the existing literature-including small sample sizes and heterogeneity in study design-limit the strength of conclusions that can be drawn regarding its potential clinical utility.
Registration:
The study has been registered on https://www.crd.york.ac.uk/prospero/ (registration number: CRD42024500088; registration link: https://www.crd.york.ac.uk/PROSPERO/view/CRD42024500088).
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