Hyperbaric Oxygen Therapy Approval Status

No Clearance by US Food and Drug Administration (FDA)

No Approval by the Undersea and Hyperbaric Medical Society (UHMS)

! Read the US Food and Drug Administration (FDA) position paper on off-label hyperbaric treatment:
Hyperbaric Oxygen Therapy: Don't Be Misled, published 22 August 2013.

About Clearance and Approval


Definition and Causes

Autism, or autism spectrum disorder (ASD), is a range of developmental or biomedical disorders that affect many parts of the brain. Symptoms begin in childhood and include a variety of social, communication, and behavioral impairments or differences.

Autism affects 1 in 88 children in the US, five times more boys (1 in 54) than girls (1 in 252). [ CDC, 2012 ]

Scientists little understand how or why autism occurs. Possible causes have become the subject of heated debate among medical practitioners and patient advocacy groups. Vaccines, heavy metal poisoning, wheat and dairy diet, and oxygen insufficiency have all been eliminated from serious consideration. Strong genetic ties have been firmly established. Most research today focuses on identifying specific genes, environmental triggers, infections, brain development, and problems before, during, and after childbirth.

Evidence Index

FDA cleared, widely reimbursed
Strong body of evidence
Repeatedly favorable results
Early or mixed results
Unfavorable or no evidence
Strong evidence against HBOT

Treatment with Hyperbaric Oxygen Therapy

Hyperbaric oxygen therapy (HBOT) and especially so-called mild HBOT (inflatable bags) are widely used off-label to treat autism at independent clinics and at home. Proponents hypothesize that HBOT enhances or restores neurologic function by oxygenating the brain or flushing toxins from cells, blood, tissues, and organs. The clinical evidence in the peer-reviewed medical literature does not support this physiologic rationale or the use of HBOT to treat autism spectrum disorder. The US Food and Drug Administration (FDA) mentions autism specifically in its Consumer Update about the potential dangers of using hyperbaric oxygen therapy to treat off-label conditions.

HyperbaricLink Commentary

People living with autism, beware. Perhaps no patient community today is so beset by healthcare fraud and quackery. Hyperbaric oxygen therapy has gotten caught up in a powerful movement away from evidence-based practice and toward alternative therapists promising miracle cures. Their claims are as wild as their HBOT is mild. What thin evidence we have on HBOT for autism (see Rossignol, et al, 2012) is fraught with contradictions and undercut by investigator bias. Thankfully, patients and families can turn to a growing network of trustworthy autism educators and caregivers. The first signs of ASD typically emerge before age 3. Early diagnosis is the key to success with evidence-based autism therapy, including applied behavior analysis (ABA) and other proven methodologies.

Given the absence of published results from controlled, double-blind studies by research hospitals and the solidified doubt in the scientific community about the quality of other research, we see no substantial basis for moving the Evidence Index rating for autism beyond None.

Patient Resources

HyperbaricLink recommends the following websites for anyone seeking authoritative information, patient advocacy, and community support for autism.

Autism Spectrum Disorder (ASD)
US National Center on Birth Defects and Developmental Disabilities (NCBDDD)
US Centers for Disease Control (CDC)

The US Centers for Disease Control and Prevention (CDC) provide a comprehensive evidience-based information resource on Autism Spectrum Disorder (ASD), including screening, treatments, research, and data. Healthcare consumers can rely on the CDC for and unbiased scientific information about this condition.

Autism Science Foundation

A nonprofit corporation that funds cutting-edge research into autism causes and treatments, the Autism Science Foundation adheres to rigorous scientific standards and values.

Association for Science in Autism Treatment (ASAT)

A not-for-profit organization committed to improving the education, treatment, and care of people with autism, the ASAT works for higher standards of accountability.

National Institute of Mental Health (NIMH)

With a mission to transform the understanding and treatment of mental illnesses through basic and clinical research, the NIMH also provides the excellent A Parent's Guide to Autism Spectrum Disorder.

Clinical Resources

Start with the following resources to explore current research activities and the peer-reviewed medical literature on hyperbaric oxygen therapy for autism.

 Use the search buttons below to go directly to research on hyperbaric oxygen therapy.
US National Institutes of Health keeps the official list of human clinical trials currently enrolling, in progress, and recently completed. One may reasonably question the size and legitimacy of any study not listed here.


Google Scholar

A specialized Google search engine, Google Scholar indexes scholarly articles, patents, and legal opinions and journals. Google Scholar may produce many search results, but entries provide easy access to full-text journal articles.

Search Google Scholar
US National Library of Medicine, US National Institutes of Health

PubMed keeps the official list of scientific papers published in reputable peer-reviewed medical journals. One may reasonably question the importance and legitimacy of any study not listed here.



News About Autism and Hyperbaric Oxygen Therapy

Update: Hyperbaric Oxygen for Autism

Friday, 11/22

We have updated and upgraded our Autism page. Finding scant evidence for hyperbaric oxygen therapy, we now provide more helpful links to patient and clinical resources, to the 2009 Undersea and Hyperbaric Medical Society (UHMS) read more...

Hyperbaric Oxygen for Autism: New Rossignol Literature Review Does Not Impress

Friday, 6/22

In May we cheered Ahmad Ghanizadeh's new systematic review of the published clinical evidence on hyperbaric oxygen for autism. Ghanizadeh encouraged further study but found scant evidence to support practice. This month another read more...

Freezer Malfunction at Harvard Tissue Bank a Setback for Autism and Other Brain Research

Thursday, 6/14

A freezer and alarm failure, causing severe damage to one-third of the frozen brain tissue specimens stored at one Harvard Brain Bank center at McLean Hospital in Belmont, Massachusetts, a collection owned by Autism Speaks, is a read more...

More news from O2.0 – the HyperbaricLink blog

Complete autism news archive from O2.0 — the HyperbaricLink blog

Further Reading

HyperbaricLink suggests Thinking Person's Guide to Autism, edited by Shannon Des Roches Rosa, Jennifer Byde Myers, Liz Ditz, Emily Willingham, and Carol Greenburg (Deadwood City Publishing, 2011).


Related Terms

  • Asperger syndrome
  • Asperger's disorder
  • Autism spectrum disorder (ASD)
  • Autistic disorder (classic autism)
  • Childhood disintegrative disorder (CDD)
  • Pervasive developmental disorder (PDD)
  • Pervasive developmental disorder not otherwise specified (PDD-NOS)
  • Rett syndrome
  • Rett's syndrome


US National Institute of Mental Health, Autism Spectrum Disorders.
Retrieved  02 May 2015.
US Centers for Disease Control and Prevention, Autism Spectrum Disorder Retrieved  02 May 2015.
Association for Science in Autism Science, What Is Autism? Retrieved  02 May 2015.
Page Data
Updated: 24 Jul 2015 01:48 PM
Created: 13 Jun 2009 12:00 AM
By: About the authors »