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

Fibromyalgia (FM) or fibromyalgia syndrome (FMS) is a chronic pain disorder. Symptoms include widespread or localized muscle and joint pain, stiffness, swelling, and tenderness. Most people with fibromyalgia experience fatigue, sleep disturbances, headache, anxiety, and memory problems. Some also report high sensitivity to noises, lights, smells, and temperature changes.

Female sufferers of fibromyalgia outnumber males by about 9 to 1. It is the second most common illness presented to rheumatologists, led only by arthritis. Researchers estimate that 75 percent of fibromyalgia cases go unreported. [ Mayo Clinic Proceedings, 2011 ]

Fibromyalgia has no known cause. Researchers have observed abnormalities of central nervous system processes and imbalances of brain chemicals and growth hormone. People with fibromyalgia may have three times the normal concentration of Substance P, a spinal fluid chemical that amplifies pain signals. Many patients attribute the onset of fibromyalgia to a particular injury, illness, or traumatic event. The condition does not progress and does not damage bones, joints, or tissues.

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

In limited studies hyperbaric oxygen therapy (HBOT) has been shown to reduce the pain and tenderness associated with fibromyalgia and other chronic pain disorders. Some researchers believe HBOT also changes brain function associated with chronic pain conditions, although the causal relationship between brain activity measured with imaging systems and pain experienced by patients is not completely accepted by the scientific community.

HBOT has not been tested as a cure for fibromyalgia, the causes of which are currently unknown. Although hyperbaric treatment may provide symptomatic relief and improve functioning, the duration of these effects is unestablished and may be temporary. It is unknown whether later treatments will be equally effective.

HyperbaricLink Commentary

In a controlled study of 48 female patients by Assaf Harofeh Medical Center in Zerifin, Israel, hyperbaric oxygen appeared to aleviate the symptoms of fibromyalgia and improve quality of life. [ PLoS One, 2015 ] This is an early positive result, but not without limitations. The trial included a small number of patients. The brain imaging technique (SPECT) used to monitor changes in brain activity is controversial because there is no definitive understanding of what it measures. And the crossover control technique used in place of sham treatment does not completely exclude the possibility of placebo effect.

Nevertheless, a reliably conducted study can justify further research. As we have noted about other neurologic conditions with no established causes and complex diagnoses, treatments that consistently provide significant quality of life improvements with minimal side effects can be justifyable as interim measures if their benefit is founded on solid science.

In the meantime, patients and their caregivers should beware of practitioners making bold claims for the benefit of HBOT in treating a condition for which the cause and ultimate cure is unknown.

Patient Resources

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

Questions and Answers about Fibromyalgia
US National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
US National Institute of Health (NIH)

NIAMS supports research and clinician training relating to arthritis and other diseases of the muscles, skin, and bones. It also provides information about these activities and the relevant illnesses to the public and to clinicians. The Q&A is a good place to start for an overview of fibromyalgia.

National Fibromyalgia Association (NFA)

A non-profit educational organization, the NFA provides support for people with fibromyalgia and other chronic pain illnesses. They publish FM Aware magazine and promote events to commemorate national fibromyalgia awareness day, May 12th.

Clinical Resources

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

 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.



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.



News About Autism and Hyperbaric Oxygen Therapy

Fibromyalgia: After the Diagnosis, National Fibromyalgia Association. Retrieved 02 May 2015.
What is Fibromyalgia?, Arthritis Foundation. Retrieved 02 May 2015.
The Science of Fibromyalgia, Mayo Clinic Proceedings. Retrieved 02 May 2015.
Page Data
Updated: 05 Aug 2015 01:28 PM
Created: 19 Oct 2009 12:00 AM
By: About the authors »