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.

Fang G, Pan W, Li G, Ma L, Wei J

Alpha psychiatry31 Jul 2026

PMID42694606PMCIDPMC13540033DOI10.31083/ap45322PepBankPUB-42694606

Summary

BackgroundAutism 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.MethodsA 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.ResultsTwelve 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).ConclusionsThe 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.RegistrationThe 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).

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study2

2 results from studies that gave the peptide. 2 results from people.

01HumanSystematic reviewEfficacy outcome
In people with autism spectrum disorder, exploratory subgroup analyses of intranasal oxytocin trials showed no significant differences across pre-specified moderators.
In plain wordsIn people with autism, oxytocin trial subgroups showed no clear differences in effect.
Peptide
Oxytocin
Outcome
No significant changeSubgroup analyses by moderators
Study
n: not reported in source
Analysis
Exploratory
Outcome group
Anxiety and mood · Mental health and mood
Studied dose
Dose not stated · intranasalAs given in this study (human).
Source sentences
Summary
Exploratory subgroup analyses showed no significant differences across pre-specified moderators (all p > 0.05).
1 context sentence(design, population, supporting numbers)
Summary · context
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.
Show in the study text Report a problemFND-4269460602
02HumanSystematic reviewEfficacy outcome
In people with autism spectrum disorder, pooled randomized trials showed no statistically significant effect of intranasal oxytocin on social functioning.
In plain wordsIn people with autism, pooled trials found no clear effect of oxytocin on social functioning.
Peptide
Oxytocin
Outcome
No significant changeSocial functioning outcomes in autism spectrum disorder
Study
n = 733
Outcome group
Social behavior and cognition · Mental health and mood
Studied dose
Dose not stated · intranasalAs given in this study (human).
Measurements
SMD
−0.05 SMD
social functioning outcomes, random-effects model
Source sentences
Summary
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).
2 context sentences(design, population, supporting numbers)
Summary · context
Twelve randomized controlled trials encompassing a total of 733 participants met the inclusion criteria.
Summary · context
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.
Show in the study text Report a problemFND-4269460601

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Version 2Current
11 Oct 2026, 00:50 UTC
Study results updated
Version 1
9 Oct 2026, 02:47 UTC
First added · source update from Europe PMC

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