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

Migraine is a common neurologic syndrome characterized by severe headache, nausea, vomiting, and hypersensitivity to lights and sounds. Other common symptoms include chills, sweating, fatigue, weakness, loss of appetite, numbness or tingling, and difficulty speaking or concentrating. Some patients experience warning signs, such as visual disturbances or aura, a few minutes or a whole day before an attack, which may last 4 to 72 hours.

The precise causes and mechanisms of migraine are unknown. Attacks originate with chemical changes in the brain and nervous system and progress into painful restrictions in blood flow. Certain tastes, odors, lights, noises, and physical or emotional stress may trigger migraine.

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

HBOT has not been proven effective in preventing or reducing the frequency of migraine attacks. According to a 2012 review by the American Academy of Neurology and the American Headache Society, “Data are conflicting or inadequate to support or refute…use of hyperbaric oxygen for migraine prevention.” [ Neurology, 2012 ]

In a few small studies hyperbaric oxygen therapy (HBOT) appeared to relieve headache pain and terminate migraine attacks while they are in progress, but a systematic review of the published trials found the available evidence to be inconclusive. [ Cochrane, 2009 ] An updated review published in 2015 found no evidence that HBOT can prevent further occurence of migraine or cluster headache. The reviewers also assessed the evidence that HBOT can relieve migraine headache pain as being of “low quality”. [ Cochrane, 2015 ]

Clinicians feel the difficulty of gaining timely access to a hyperbaric chamber and the cost of a hyperbaric treatment limits the practicality of this therapeutic approach.

HyperbaricLink Commentary

More research into the potential analgesic effect of hyperbaric oxygen may establish the effectiveness of HBOT in relieving migraine attacks. A basis for further investigation may come from other studies currently underway to evalate the effectiveness of HBOT in treating pain associated with other conditions.

Perhaps more importantly, the practical problems associated with hyperbaric oxygen treatment of migraine and its ineffectiveness in preventing migraine attacks mean it will never be a frontline therapy for this condition.

Patient Resources

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

Headache and Migraine News (blog)

Frequently updated and written by a long-time migraine suffer, this blog provides current information and commentary of interest to migraine and headache suffers. Posts are clearly written, well-sourced, and cover a wide range of relevant topics.

NINDS Migraine Information Page
US National Institute of Neurological Disorders and Stroke (NINDS)
US National Institutes of Health (NIH)

The NINDS page on migraine provides a solid overview of migraine symptoms, possible causes, treatment, research and other reliable resources.

Migraine Research Foundation

The Migraine Research Foundation funds research into the causes and treatment of migraine.

National Headache Foundation

The National Headache Foundation website provides fact sheets on a wide range of topics of interest to migraine and headache suffers. Other educational resources on the site include sections on children's headache disorders, caffeine and headache, and guidance on talking about your headache with your doctor.

Clinical Resources

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

 Use the search buttons below to go directly to research on hyperbaric oxygen therapy.

US National Institutes of Health

ClinicalTrials.gov 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.

Search ClinicalTrials.gov


HBOEvidence uses computerized tools to appraise the key randomized controlled trials (RCTs) in the hyperbaric medical literature. One may reasonably question the overall strength of HBOT evidence for any disease or condition not covered here.

Search HBOEvidence

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.

Search PubMed.gov


News About Autism and Hyperbaric Oxygen Therapy

More news from O2.0 – the HyperbaricLink blog

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

Further Reading

HyperbaricLink suggests Cluster Headaches: The Worst Possible Pain?, by Julie Beck in The Atlantic, published 19 November 2013.

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Bennett MH, French C, Schnabel A, Wasiak J, Kranke P, Weibel S.
Normobaric and hyperbaric oxygen therapy for the treatment and prevention of migraine and cluster headache.
Cochrane Database of Systematic Reviews 2015, Issue 12. Art. No.: CD005219. Retrieved 05 January 2016.
doi: 10.1002/14651858.CD005219.pub3
US National Institute of Neurological Disorders and Stroke, Migraine Information Page. Retrieved 02 May 2015.
National Headache Foundation, Headache Topic Sheets: Migraine. Retrieved 02 May 2015.
Page Data
Updated: 05 Jan 2016 12:00 AM
Created: 06 Nov 2009 12:00 AM
By: About the authors »