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Recently, an article on examiner.com reignited some controversy regarding the use of hyperbaric oxygen for “off-label” (not yet approved by the FDA) diagnosis in general, and for the treatment of Autism Spectrum Disorders (ASD) in particular. As the medical director of a free-standing facility that treats all those who may benefit from HBOT therapy, it is my belief that the topic of “off-label” use of medical devices, particularly the safety of HBOT, needs further examination.

The basic principle of hyperbaric oxygen therapy is in fact the use of oxygen as a drug. The “off-label” use of drugs is not unusual; it happens every day, and many treatments that are common today were once considered investigational. 

Furthermore, hyperbaric oxygen therapy is FDA approved for 13 indications, including decompression illness, non-healing diabetic wounds, chronic infections, radiation injury, carbon monoxide poisoning, and flap failures, to name a few. Many of those who are treated in our facilities are chronically ill with many health challenges, yet we provide them with HBOT safely and effectively. Patients want an opportunity to improve their quality of life today, not when the FDA decides.

The use of HBOT by physicians who are knowledgeable in hyperbaric medicine is safe and well tolerated by most patients. While every therapy has risks, the use of HBOT under the supervision of a trained physician is very safe. A recent claim that HBOT may cause paralysis is intended to scare patients and their loved ones away from a treatment course that may offer them hope and relief of symptoms. 

At Hyperbaric Medical Solutions, we pride ourselves on the safe use of HBOT for both FDA-approved and “off-label” conditions. Every patient that is treated at our facility must undergo a comprehensive initial evaluation, a complete review of his or her medical history, and chest imaging clearance.

Our mission is to provide the revolutionary healing powers of hyperbaric oxygen therapy to all those who may benefit with a consistent standard of care—that which is hospital level or greater. We always maintain proper medical supervision of every treatment, regardless of condition, and there is a complete discussion regarding the risks, benefits and alternative methods of care. 

When we are treating conditions that are not FDA-approved for HBOT, we spend time discussing the fact that this treatment is currently deemed investigational in nature, and while there is no guarantee of a certain result, we review active studies, research, and experience that supports HBOT as a viable modality for their condition. Finally, in our consultations, we will discuss conventional, as well as alternative care options.

Hyperbaric oxygen therapy has long been called the "Cinderella" of modern medicine. The specialty spans across many conventional designations involving emergency medicine, surgery, wound care, vascular surgery, neurology, pediatrics, and more. In addition, the fact that no one can patent oxygen use, prevents the involvement of pharmaceutical companies (and their research dollars), as there is no new drug to be discovered. 

It is also quite difficult to study HBOT in the traditionally accepted double blinded randomized fashion. In the typical study, patients are unaware if they are getting treated or given placebo. How can you “hide” the use of a chamber or the presence of increased pressure (that akin to what you feel when diving to the bottom of a pool)?

Hyperbaric oxygen therapy is a safe and effective therapy for many conditions, including those that the FDA and insurance companies have yet to approve. The decision to use HBOT should be made after consultation with your healthcare providers. Just as false claims should be avoided, so should false statements regarding the dangers of HBOT.

Dr. Henry Prince, Chief Medical Officer

Written by Dr. Henry Prince, Chief Medical Officer

Dr. Henry Prince has led Hyperbaric Medical Solutions since its inception in 2011, forging important clinical relationships in the medical community and pioneering the practice’s effort to help patients experience optimal health using the incredible healing properties of HBOT....

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