The Effect of Intranasal Oxytocin on Social Interaction in Adults and Children With Autism Spectrum Disorders: A Systematic Review and Meta-analysis of Randomized Controlled Trials.

Authors

Gengjing Fang, Wuyuan Pan, Guokai Li, Le Ma, Jinbao Wei

Published in

Alpha psychiatry. Volume 27. Issue 4. Pages 45322. Epub Jul 31, 2026.

Abstract

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.
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.
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).
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.
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).

PMID:
42694606
Bibliographic data and abstract were imported from PubMed on 04 Sep 2026.

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