What the FDA Says about Hyperbaric Oxygen Therapy (HBOT)

Even though hyperbaric oxygen therapy has not been clinically proven to cure or be effective in the treatment of cancer, autism, or diabetes, a quick internet search will reveal myriad claims of effectiveness for these and other conditions for which hyperbaric oxygen chambers have not been approved by the FDA.

Here, we’ll outline a consumer update advisory from FDA.gov that offers a brief overview of the FDA’s stance on the matter.

Related: Rehabmart's Ultimate Guide to Hyperbaric Oxygen Therapy (HBOT)

Hyperbaric therapy, which involves breathing pure oxygen in a pressurized chamber, has been cleared for certain medical issues like decompression sickness (commonly known as the bends) suffered by deep-sea divers. However, this therapeutic option has not been proven to be the kind of universal treatment as some claim. Let’s review the FDA’s actual stance on HBOT to avoid giving consumers the wrong impression:

It’s important to be aware that the safety and effectiveness of HBOT have not been established by the FDA for these conditions, but some individuals have regardless used HBOT as a treatment option for each. The FDA reports that 27 complaints have been submitted from consumers and health professionals in three years regarding treatment centers “promoting the hyperbaric chamber for uses not approved by the agency.”

Hyperbaric therapy is frequently used for the following off-label uses, which have not been cleared by the FDA:

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

How Hyperbaric Oxygen Therapy Works

HBOT involves inhaling pure oxygen in a pressurized chamber in which the atmospheric pressure is increased up to three times higher than normal.

This increase in pressure allows your lungs to receive up to three times more oxygen than is possible under normal air pressure.

Your body needs enough oxygen to function properly. When tissue is injured, it may need a higher supply of oxygen to heal. According to the FDA, hyperbaric oxygen therapy increases the amount of oxygen that’s dissolved in your blood, and that increase in blood oxygen may improve oxygen delivery for vital tissue function to help fight infection and/or minimize injury.

Hyperbaric chambers require FDA clearance, meaning the FDA has reviewed valid scientific evidence that supports the specific use, and the agency has determined the device is at least as safe and effective as another device that’s marketed in the United States.

That being said, the FDA has approved hyperbaric chambers for hyperbaric oxygen therapy in 14 use cases:

• 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

What are the Risks?

Mild injuries like sinus pain, ear pressure or joint pain, or serious conditions such as paralysis or air embolism are identified by the FDA as possible risks of hyperbaric oxygen therapy. Since hyperbaric chambers are often used with oxygen concentrators that increase the amount of oxygen delivered to the user, a risk of fire is present.

Any problems experienced with these devices can be reported to MedWatch, the FDA safety information and adverse events reporting program.