Physicians prescribe medications every day for “off-label uses.” The medications haven’t undergone double-blind, placebo-controlled, FDA-approved trials for the alternate uses but are deemed acceptable because case studies have shown that they are effective for other illnesses. Woodie Fritz, MD asks fellow physicians to open their minds to similarly “off-label” uses for a long-accepted treatment: hyperbaric oxygen therapy.
Fritz, along with Wellness Pharmacy owner Rod Harbin, opened Hyperbaric Center of Alabama this summer in Homewood to offer an alternative for patients with conditions that might be helped by hyperbaric oxygen therapy (HBOT), but who can’t receive the therapy elsewhere in town. The hyperbaric oxygen chambers there are the same as those found in hospitals, with systemic delivery of 100 percent oxygen under increased atmospheric pressure. Fritz supervises the center, with a staff that includes an RN with decades of HBOT experience. Another center in town has the same hospital-quality equipment, but it focuses on treating autistic children.
While most hospitals have hyperbaric oxygen therapy units, their use is confined to a list of FDA-approved conditions that are also covered by insurance, Medicaid or Medicare. The FDA list includes skin conditions such as problem wounds, burns, necrotizing soft tissue infections, complications from radiation therapy, carbon monoxide poisoning, blood loss anemia and decompression sickness.
Fritz said thousands of case studies have shown that HBOT can be effective for many other conditions for which getting higher concentrations of oxygen to an affected area can speed healing and ameliorate tissue damage. Proponents of HBOT say it has been shown to help autism, Bell’s palsy, cerebral palsy, heart problems, Lyme disease, Meniere’s disease, migraine headaches, multiple sclerosis, Parkinson’s disease, reflex sympathetic dystrophy and sports injuries, among other conditions.
The Hyperbaric Center also gives an option to physicians who would like to refer patients for HBOT as a primary or adjunctive treatment for non-FDA-approved uses. Patients must have an outside doctor’s referral or see Dr. Fritz, who is a family practice physician, for an evaluation to get treatment.
Plastic surgeons are discovering that patients who get HBOT before and after surgery have less postoperative problems such as bruising. They also heal faster, Fritz said.
“I don’t want to sound like that we believe hyperbaric oxygen is a panacea for all illness — far from it,” Fritz said. “It’s useful for certain things. None of us is suggesting it’s a cure-all.”
Although it is not a complete cure, he said, it improves many conditions and patients’ quality of life.
“For example,” he said, “it can be effective in improving outcomes in strokes, heart attacks, traumatic brain injury and near-drowning cases — especially when administered early. The treatment promotes growth of blood vessels and increases the metabolic activity of previously marginally functioning cells throughout the body, including brain neurons. In a stroke patient or a head-injury patient, flooding the ischemic penumbra with hyperbaric oxygen heals those cells so they can start functioning again.”
But, he said, physicians in the United States are reluctant to accept that idea, despite the fact that they accept that HBOT does the same elsewhere in the body.
“One of the approved uses is treating diabetic wounds,” Fritz said, because HBOT causes new blood vessels to form. “The wounds heal, and you can keep (patients) from having to have their foot amputated. It’s getting oxygen to damaged tissue. It does the same thing to tissue all over the body, including the brain. It’s a systemic treatment — a whole body treatment. They recognize it as good therapy for getting oxygen to the foot but not to the brain. It makes no sense. It does the same thing to brain tissue. Patients who do get that therapy improve greatly.”
Hospitals in Germany and England commonly have hyperbaric units set up in the emergency departments for those kinds of cases, and it’s also standard treatment for multiple sclerosis patients in England.
Fritz said HBOT has the problem of not fitting the mold for traditional placebo controlled tests, because it would be obvious which test subjects were getting the treatment.
“There are lots of scientific studies,” Fritz said, including a study published in the New England Journal of Medicine. Noted physician and researcher Paul Harch wrote a book on the treatment called The Oxygen Revolution that offers more details for physicians and laymen.
Harbin said physicians and patients also need to change the mentality that if insurance doesn’t cover something, it can’t be done — or shouldn’t be done.
“Doctors use medicines and drugs off label every day in every field. It doesn’t mean they’re practicing bad medicine,” Fritz said. “Hyperbaric oxygen therapy is not voodoo medicine. It’s been used for 50 to 60 years.”
October 2007
