FDA Cautions Consumers About Hyperbaric Oxygen Therapy

Michael Jackson did it. Tim Tebow did it. Countless patients in search of relief for ear infections, burns, traumatic brain injuries and a host of other ailments have done it.

So does hyperbaric oxygen therapy (HBOT) work?

According to Slate.com, probably not. At least not for those problems, nor a long list of others for which people have tried it.

A review of scientific literature, Slate reported, showed the therapy might offer some help to people suffering from migraine and cluster headaches, and if treatment is begun quickly, maybe for hearing loss and heart attacks. The best evidence of the value of HBOT is to treat chronic wounds, especially those related to diabetes, and for treating decompressions sickness, commonly called the bends, or divers’ disease, because it can strike deep-sea divers during improper ascent.

But there’s little evidence to support using a hyperbaric therapy, in which patients lie down to breathe oxygen in a pressurized chamber, to alleviate muscle soreness and whatever it was Jackson thought it could cure.

That’s why last month the FDA issued a consumer update on the practice. “[H]yperbaric oxygen therapy (HBOT) has not been clinically proven to cure or be effective in the treatment of cancer, autism, or diabetes,” the material said. “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.”

The device has been approved for treating decompression sickness, but not for the universal treatment for which it’s often promoted. The FDA, according to the consumer alert, “is concerned that some claims made by treatment centers using HBOT may give consumers a wrong impression that could ultimately endanger their health.”

The potential harm, the agency says, is when a patient delays or forgoes a proven medical therapy in favor of this flavor-of-the-month approach. By doing so, the original complaint, in the best case, doesn’t improve, and in the worst case, deteriorates.

The safety and effectiveness of HBOT has not been established for:

  • 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
  • sport’s injury
  • stroke

The FDA has received 27 complaints from consumers and health care professionals over the last three years about treatment centers promoting the hyperbaric chamber for uses not cleared by the agency.

HBOT involves breathing oxygen in a chamber in which the atmospheric pressure is increased as much as three times higher than normal. That enables the lungs to process much more oxygen than would be possible breathing oxygen at normal air pressure.

Some tissue injuries heal better with more oxygen, and hyperbaric oxygen therapy increases the amount of oxygen dissolved in your blood. That can improve oxygen delivery for vital tissue function to help fight infection or minimize injury.

Hyperbaric chambers are medical devices that require FDA clearance. Thirteen uses of a hyperbaric chamber for HBOT have been cleared by FDA. They include treatment of air or gas embolism (dangerous “bubbles” in the bloodstream that obstruct circulation), carbon monoxide poisoning, decompression sickness and burns caused by heat or fire.

The risks of HBOT range from the relatively mild, such as sinus pain, ear pressure and painful joints, to the serious-paralysis and air embolism. And because hyperbaric chambers are oxygen-rich environments, there’s a risk of fire.

If you’re considering using HBOT, discuss other possible options with your doctor. If you experience or have experienced problems with HBOT, report them to MedWatch, the FDA’s safety information and adverse events reporting program.

To read news and other articles about FDA-regulated products, link to the agency’s Consumer Updates page.

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