Hyperbaric Oxygen Therapy: The Difference Between FDA Approval and FDA Non-Approval

Many alternative medicinal treatments lie just beyond the umbrella of what the FDA promotes and has approved. Hyperbaric oxygen therapy is one of them.

The Food and Drug Administration, or FDA for short, is the national agency in charge of protecting and promoting public health - be it through medication, medicinal procedures, or the regulation of devices used for the treatment of various illnesses.

The job the FDA does is a crucial one.

By rigorously testing and inciting research into a myriad of medical treatments, Americans are protected from false pharmaceutical claims, drug scams, untested procedures, and overt bodily harm.

But somewhere in the process of vetting treatments for absolute success, there is a potential for progressive, alternative health solutions to either fall through the cracks or be misrepresented to the public.

A very basic internet search of the history of hyperbaric oxygen therapy (HBOT) will quickly yield several articles written on the topic of FDA/non-FDA approval. Testimonies of users experiencing unprecedented physical healing are lumped in with government disclaimers, op-ed pieces, and risk/benefit lists of varying lengths.

The public’s interest in HBOT has grown over the years as an increasing number of athletes and celebrities have been found to utilize oxygen therapy as a tool to promote youth and accelerate the healing process after sustaining a sports injuries. Even so, the mystery surrounding HBOT is in large part due to the schism between what the FDA has approved hyperbaric therapy to treat, and what it has not.

There are thirteen FDA-approved uses for HBOT, and a much longer list of potential uses that have yet to receive approval. The following is a list for all FDA-approved uses of hyperbaric oxygen therapy:

  • Air embolism
  • Gas embolism
  • Acute traumatic ischemia
  • Burns
  • Carbon monoxide poisoning
  • Smoke inhalation
  • Diabetic foot ulcers
  • Exceptional blood loss
  • Decompression sickness
  • Gas gangrene
  • Necrotizing infections
  • Severe anemia
  • Skin grafts and flaps
  • Wound healing

Hyperbaric therapy can also be used for the following off-label uses, which have not been cleared by the FDA:

  • AIDS/HIV
  • Alzheimer's Disease
  • Asthma
  • Bell's Palsy
  • Brain Injury
  • Cerebral Palsy
  • Depression
  • Heart Disease
  • Hepatitis
  • Migraine
  • Multiple Sclerosis
  • Parkinson's Disease
  • Spinal Cord Injury
  • Sports Injury
  • Stroke

A quick glance at these two lists sheds light on the confusing nature of the approval versus non-approval dialogue: both lists are extensive, and share approximately the same number of neuro/physiological conditions.

The purpose of this article is to help potential hyperbaric users explore both sides of the discussion, and hopefully come to a better understanding of how HBOT works within the body. Once readers have gathered the facts, they will be better equipped to make a personal decision regarding the respective benefits of hyperbaric therapy.

The absence of an FDA-approval does not necessarily mean that utilizing HBOT for the treatment of a particular condition is unsafe.

It means that up until a given point in time, hyperbaric therapy has not been tested and proven by a meticulous amount of evidence. In order to be cleared for broad-spectrum use, any treatment or medication must be seen to provide similar results over a diverse number of patients with varying degrees of illness. Only then will it be seen as worthy of endorsement, and can be promoted to the public as a viable medicinal solution for that condition.

The approval process of a new drug or medical treatment under the administration of the FDA is lengthy, and takes a good deal of time. And because HBOT is still a relatively new treatment in terms of popularity and steadily documented validation, it makes sense that the FDA views it with a skeptical eye.

In August of 2013, the FDA released a statement cautioning people to beware HBOT and it’s false claims of remedy. In the statement, the following account was given: 

“No, hyperbaric oxygen therapy (HBOT) has not been clinically proven to cure or be effective in the treatment of cancer, autism, or diabetes. But do a quick search on the Internet, and you'll see all kinds of claims for these and other diseases for which the device has not been cleared or approved by FDA.”

What the FDA did not say in the article is more important than what it did - because while it does well to caution against the use of a scientifically unsupported, widespread utilization of alternative medicine, it did not take into account the overwhelming number of success stories of result-oriented HBOT testimonies that are being reported on almost a daily basis.

Because HBOT has not yet been tested and approved for widespread uses of certain conditions (autism, cerebral palsy, stroke, etc.), the message was one framed by uncertainty and fear.

While the FDA performs the critical job of keeping unsafe treatments and medicines out of the hands of vulnerable people, at times it also provides a hurdle of sorts for people seeking an antidote diversified from what is federally approved.

In a study published by the Center for Disease Control (CDC) in 2013, it was reported that 2.8 billion drugs were ordered or provided to patients in a hospital setting. 74% of patients entering physician’s offices for consultation about a medical condition left with a prescription note in their hand, and 21% of people with a prescription medication also consume three or more pharmaceutical drugs on a monthly basis. A glance at the list of side-effects tacked onto prescription labels or at the end of pharmaceutical commercials, and it is readily apparent that the cost for a majority of pharmaceutical relief comes at a steep price. At times, the pharmaceutical side effects can even overwhelm the supposed benefit of medication.

Polypharmacy, or the act of juggling multiple medications, continues to become more prevalent as patients find it necessary to seek additional medication simply to counteract the effects of the pre-existing medication in their system.

It is those who desire to look beyond traditional solutions who often find themselves at the door of hyperbaric therapy research.

It is unrealistic to expect that hyperbaric therapy will completely restore decades of chronic impairment or provide instantaneous healing where there is severe bodily harm, such as in cases of cancer or widespread trauma. But while it is absolutely true that HBOT cannot be used to treat or remedy all forms of physical and cognitive disabilities, no pharmaceutical treatment can make the claim of total restoration, either. The majority of users undergoing hyperbaric therapy choose oxygen treatments due to desire for an alternative option, or because conventional remedies have failed.

The major difference between HBOT and many doctor-prescribed drug courses is the lack of harmful side-effects, hormonal changes in the body, and chemical dependence so often found or created by prescription substances.

Depending on the illness or disability, HBOT can either be used as a primary treatment plan or as a supplementary treatment. Certain disabilities may benefit solely from the administration of HBOT, while others (such as infections and cancers) require the co-use of antibiotics and radiation.

But due to its non-invasive nature and generally mild side effects (the most dangerous of which is oxygen toxicity, a condition easily prevented by proper usage), HBOT continues to see an increase in popularity in hospitals and clinics nationwide. An estimated 1,800 of 2,000 hospitals now offer hyperbaric therapy, and 500 of 700 non-hospital clinics provide HBOT as a treatment option.

Doctors prescribe HBOT on a case by case basis, and possession of an off-label condition does not disqualify patients from access to hyperbaric sessions. However, most insurance plans will only compensate the user if they undergo hyperbaric therapy for an FDA-approved condition.

This financial prerequisite can be a hurdle for many families hoping to try hyperbaric therapy for treatment of a cognitive or behavioral disability, and lack of substantial research into the treatment of diagnoses such as autism, depression, post-traumatic stress disorder, and cerebral palsy remain a point of controversy between those seeking non-drug related regimens and the healthcare professionals unfamiliar with hyperbaric benefits.  

Maintaining the integrity of authorized treatment plans is an invaluable part of modern medicine, and the FDA continues to help millions of Americans navigate the complex and diverse field of physical and mental health.

Even so, it is important to do independent research into any new treatment plan, medication, or health regimen before integrating it. Below is a comprehensive list of several non-FDA approved uses for HBOT, along with greater insight into each condition and the potential health benefits when treated with hyperbaric therapy.

HBOT therapy works by flooding the body with pure oxygen in a pressurized environment. The air we breathe is comprised of 21%. While in a hyperbaric chamber, oxygen is the primary (or if concentrated, the only) element in the air.

During treatment, air pressure is increased several times the level of ambient air. By way of this increase of pressure, breathable oxygen inside the chamber is compressed, and oxygen is taken into the body via lungs and skin to be circulated by the bloodstream.

While being distributed throughout the body, the oxygen saturates tissues, organs, plasma, and spinal cord fluid, settling into places where circulation may have previously been blocked or hindered.

The presence of pure oxygen jump-starts the body’s cellular regeneration process and decreases intravascular inflammation - which is why hyperbaric therapy can be used to treat such a wide variety of medical conditions.

Alzheimer’s and Traumatic Brain Injuries

Alzheimer’s is a degenerative neurological disease categorized by the ongoing destruction of cells in the brain.

In the absence of clinical trials, hyperbaric therapy is still considered a fairly alternative treatment method for individuals with Alzheimer’s. Even so, HBOT may be used to counteract the nature of this disease by slowing or preventing cell death in the cranial region.

In 2002, forensic pathologist Bennet Omalu discovered an abnormality in the brain of deceased Steelers center Mike Webster. Webster, a lifetime athlete, had sustained massive trauma to the brain, and was concluded to have degenerated due to cognitive disability stemming from repeated blows to the head.

Although initially suppressed by the NFL, Omalu's findings went on to break ground in the science of traumatic brain injury and the long-term effects of concussions.

Chronic traumatic encephalopathy, a degenerative brain disease often resulting from multiple concussions, is speculated to have affected thousands of professional football players across the span of several decades. As studies into the use of hyperbarics to treat chronic cerebral trauma continue, we can expect to see the treatment process refined and made more widely available to individuals seeking to regenerate damaged brain tissue.

In cases of traumatic brain injuries, HBOT has been reported to halt or reverse the effects of concussion and blows sustained to the head. Joe Namath, Hall of Fame quarterback, spoke of the rejuvenating effects of hyperbaric therapy after sustaining a lifetime’s worth of head injuries and struggling with decreased cognition.

Anxiety, Depression, and PTSD

Reports of HBOT useage for depression, anxiety and other mood disorders vary in outcome. By looking at what goes on inside the body during episodes of cognitive dissonance, an individual may better understand whether HBOT is a beneficial form of treatment.

During periods of high stress and anxiety, heart rate increases, the arteries dilate, and blood is moved around the body at a higher rate - primarily away from the skin’s surface and into internal organs. This is why after the adrenaline of a high-stress situation wears off, many people report a feeling of sudden coldness or unexpected pain.

Individuals struggling with depression, anxiety or post-traumatic stress disorder experience this fight-or-flight response on a recurring basis. It is usually involuntarily, and at times when there is no real threat of physical danger.

Because humans were not designed to live under such constant mental strain, repeated exposure to high levels of adrenaline and cortisol (the body’s stress hormone) may negatively manifest itself physiologically, leaving stress-prone individuals increasingly vulnerable to conditions such as high blood pressure, heart disease, hypertension, insomnia, and weight gain.

Due to the theraputic nature of oxygen, patients with mental or mood disorders have been known to experience feelings of euphoria, relaxation, and decreased heart rate upon receiving hyperbaric treatment.

This feeling is able to be maintained up to several hours after treatment has ended, with repeated exposure building up the body’s ability to preserve the positive effects.

Asthma and Allergies

Asthma, a respiratory reaction marked by swelling of the airway and bronchial spasms, is another area where HBOT can truly shine.

In the same way steroids in inhalers cause the bronchial tubes to expand and allow increased airflow, oxygen therapy allows the inflamed bronchial pathways to dilate.

HBOT has also been seen to prevent and reverse mild levels of hypoxia (oxygen deficiency), which can occur due to allergy-related sinus pressure.

Use of HBOT therapy for individuals suffering from asthma or allergy symptoms could greatly improve quality of life, as the patient is able to experience and maintain reduced inflammation in a high-oxygen environment.

Autism

Characterized by an overabundance of synapses and increased swelling in the brain, autism manifests itself on a spectrum. Common behaviors in both children and adults involve a swing between over-responsiveness and under-responsiveness to sensory input and stimuli.

Simply stated, the brain of a neuro-typical child or adult responds to stimulation in a way that a person with autism-spectrum does not.

It is true that HBOT does not claim to ‘cure’ autism; however, in light of recent discussion surrounding the FDA’s decision to release a cautionary statement regarding HBOT for autism treatment, it’s important for potential users to remain aware of both sides of the conversation.

While HBOT does not treat the neurological overproduction of synapses, it may help to promote new capillary growth. In addition, it may promote circulation in cerebral areas where cellular production and blood flow have been hindered.

HBOT works by saturating the bloodstream with oxygen and providing means for oxygen to travel to poorly circulated areas, and it’s believed to be for this reason that children with autism undergoing HBOT repeatedly show varying levels of behavioral change following sessions of treatment.

Migraine

Migraines, along with tension and sinus headaches, begin when blood vessels in the cranial region begin contracting and expanding inappropriately.

During the first phase of a migraine, blood flow can be reduced up to 36%. This disruption in circulatory rhythm causes inflammation, leading to a restricted amount of blood and oxygen allowed into the brain tissue. Partnered with the rapid contraction of arteries, this creates widespread pain and a sensation of throbbing, or ‘aura’.

The nature of HBOT is the increase of oxygen and circulation to blocked parts of the body and brain. In a study conducted by two Texan doctors, 25 of 26 patients suffering from migraines experienced complete relief from pain within the first few minutes of hyperbaric therapy.

In addition, mild hyperbaric oxygen therapy (mHBOT) for individuals suffering migraines has proven to be as effective as HBOT administered in a hospital or clinic setting.

mHBOT is capable of delivering pressure at a lesser range than hospital-grade hyperbaric equipment. Because migraine patients have been seen to experience relief of symptoms at a lower level of atmospheric pressure - between 1.3 - 1.7 ATA - users with chronic or recurring migraines have the option to enjoy the benefits of oxygen therapy outside a clinic environment.

Purchase of a hyperbaric chamber for in-home use is possible with a doctor’s prescription.

Multiple Sclerosis

Multiple Sclerosis, abbreviated MS, is a disease that attacks the central nervous system. Occurring when the body’s immune system turns upon itself, multiple sclerosis degrades the protective covering around nerves, leaving persons vulnerable to chronic pain. This breakdown creates a disruption between brain and body, and symptoms frequently manifest themselves in lack of balance, vision problems, numbness, and loss of coordination.

Substantially more evidence exists for the success of HBOT in terms of MS than many other off-brand uses, beginning with a study published by the New England Medicine Journal where, after one year of receiving consistent treatment with hyperbaric therapy, only 12% of tested patients experienced nerve covering deterioration, compared with 55% who did not undergo hyperbaric treatment.

Due to the degenerative nature of the disease, early induction of HBOT is regarded as a key component in productive therapy. It can also be a key supplementary treatment, able to be employed alongside traditional treatment methods to boost overall effectiveness.

Sports injury

Recovery acceleration for the treatment of sports-related injuries is one of the most mainstream off-brand uses of HBOT. Utilized by professional athletes across a wide variety of sports, hyperbaric therapy is perhaps most extensively documented when used to treat injured athletes.

By cutting down on recovery time and aiding in the body’s self-healing process by promoting the regeneration of cells, HBOT boosts the body’s restorative process and organically encourages muscles and tissues to mend.

In addition to preventing hypoxia and scarring, HBOT can greatly aid the rehabilitation of sprains, fractures, and compartment syndrome.

Stroke

A stroke occurs when blood flow to the brain is interrupted by a blockage in a major artery. This lack of bloodflow to the brain manifests almost immediately, and results in the death of brain tissue (hypoxia). Left untreated, a blocked artery can cause widespread damage, capable of compounding over time.

While there is no way of knowing how much recoverable tissue exists in the days, weeks, and years following a stroke, HBOT can increase cell reproduction and administer oxygen to tissue that was previously cut off from blood flow. The dormant cells surrounding the damaged tissue area, also known as ischemic penumbra, are responsible for much of post-stroke dysfunction. If oxygen therapy can revive these cells, lost functionality may return to the individual.

Continue your exploration into the many uses of hyperbaric oxygen therapy with our Hyperbaric Chamber Brand List, and read further into the history of hyperbaric medicine with our article, 13 Interesting Facts About Hyperbaric Oxygen Therapy.

Sources:

FDA drug approval method: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/

Case of three autistic boys: https://anh-usa.org/hbot-healing-victory/

FDA statement regarding non-approval: https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm364687.htm

HBOT success stories: https://sarasgarden.org/category/success-stories/success-stories-hbot/

Brain swelling in autism: https://hub.jhu.edu/2014/12/15/autism-brain-inflammation/

Johns Hopkins medicine on autism: https://www.hopkinsmedicine.org/news/media/releases/brain_inflammation_a_hallmark_of_autism_large_scale_analysis_shows

FDA Device Approvals: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/

Natural healing for migraines: http://natural-health-alternative.blogspot.com/2010/02/migraines-dilationconstriction-of-blood.html

CDC published study on drug use stats: https://www.cdc.gov/nchs/fastats/drug-use-therapeutic.htm

HBOT and migraines: http://www.txhbo.com/industry-news/hyperbaric-oxygen-therapy-for-migraine-headaches/

HBOT and Multiple Sclerosis: https://www.nejm.org/doi/full/10.1056/NEJM198301273080402

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Author:

Co-Founder of Rehabmart and an Occupational Therapist since 1993. Mike has spent his professional career working in multiple areas of Occupational Therapy, including pediatrics, geriatrics, hand therapy, ergonomics and inpatient / outpatient rehabilitation. Mike enjoys writing articles that help people solve complex therapeutic problems and make better product choices.

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