Will oxygen treatment finally be allowed by the government?
The country gives a great deal of lip service to “supporting the troops,” but some of the most persistent injuries our military personnel receive are mild traumatic brain injury (mTBI) and the related persistent post-concussion syndrome (PPCS). TBI can be caused by IEDs (improvised explosive devices) and rocket-propelled grenade explosions. Despite being termed “mild,” there’s nothing “mild” about it—it can destroy lives, tear families apart, and have a devastating impact on an individual’s quality of life.
According to mainstream medicine, there is no “specific treatment” for mTBI/PPCS. Instead, doctors attempt to allay symptoms through the use of dangerous migraine drugs, antidepressants and anti-anxiety medications, including anti-psychotic medications, all of which can also be very toxic and addictive, and (rarely) psychotherapy, the latter being mostly a cover for prescribing pills.
Meanwhile there is a safe, effective, and economical treatment that has shown great promise, both in trials and in practice: hyperbaric oxygen therapy (HBOT). And, in an exciting development, Dr. Paul G. Harch has announced the launch of a new study that will provide HBOT treatment to mTBI/PPCS sufferers for free.
Dr. Harch—a LSUHSC clinical professor and former ANH-USA board member—is generally recognized as a leading pioneer in HBOT research and treatment, and will serve as the study’s principal investigator. He gave an exclusive interview to ANH-USA staff on the new study, and discussed how those suffering from mTBI/PPCS can apply to participate.
What is mTBI/PPCS?
mTBI/PPCS occurs when mild brain damage caused by blunt force trauma (think a car crash or sports accident) results in a chronic and debilitating illness, with symptoms such as headaches, dizziness, fatigue, irritability, impaired memory and concentration, insomnia, mood swings/behavioral changes, and an “intolerance of stress, emotion, or alcohol.”
What is HBOT, and how does it help mTBI/PPCS?
HBOT saturates tissues with ten to thirteen times as much oxygen as can normally be breathed in, and is FDA-approved to treat decompression sickness, thermal burns, non-healing wounds, necrotizing soft tissue infections (a.k.a. flesh-eating bacterial disease), acute traumatic ischemias (e.g., crush injury, compartment syndrome), radiation tissue damage, smoke inhalation and carbon monoxide poisoning, air or gas embolism, severe blood loss anemia, refractory osteomyelitis, compromised skin grafts, and clostridial myonecrosis (gangrene).
How can HBOT help mTBI/PPCS sufferers?
According to Dr. Harch, “A traumatic brain injury causes a wound in the brain, just like a scraped knee or cut…it’s not different than a wound anywhere else in the body. We all know that we need oxygen to heal wounds. HBOT is a healing process for wounds anywhere in the body—including the brain. It increases oxygen and blood flow, and speeds the healing process.”
Why isn’t HBOT already approved to treat brain damage?
There has been an extraordinary amount of interference from the FDA on HBOT, which has raised roadblocks to the funding of a broad, randomized study.
There’s no single answer why the FDA is anti-HBOT, but it could be because of the “Catch-22:” since HBOT isn’t new (hyperbaric chambers and hyperbaric oxygen therapy have been used since the 1800s), and isn’t a drug, it is not currently patent protected. Because it can’t be patented, there’s really not much money to be made from it.
Historically, the FDA tends to protect therapies that are non-natural and patentable at the expense of non-patented treatments, so that drug companies can afford to spend billions for agency approval. Thanks to user fees, bringing new drugs through the approval process pays the agency’s bills, including salaries. Much of the FDA’s funding comes from drug companies, which creates a huge conflict of interest.
Is this the first human study of HBOT on TBI/PCS?
No. In 2010, Dr. Harch completed the first half of a pilot trial of HBOT in the treatment of US veterans suffering from TBI/PPCS. Click here to view a news report on how HBOT has helped veterans.
According to Dr. Harch, “The military sent some of their worst-injured marines” to participate in the trial. But after forty hour-long, low-pressure HBOT treatments, the veterans achieved substantial improvements in symptoms, psychical exams, cognitive testing, quality of life, and brain blood flow.
Additionally, a 2013 Israeli study found that HBOT significantly improved the symptoms of mTBI/PPCS sufferers and increased their cognition and brain blood flow. Dr. Harch called this “a fantastic reaffirmation of all of these years of work.”
Who is funding the new study, and what is its design?
In 2008, Dr. Harch and his team received congressional funding (via the FY2009 Defense Appropriations bill) to conduct a larger, more thorough study. However, since it took another four years to receive final approval from the FDA, the military, and Louisiana State University, the study has only now been launched officially.
Whereas the pilot study was intended to simply collect preliminary data on HBOT treatment for mTBI/PPCS, the new study will include more participants (fifty), and will also feature a control group.
This study will be conducted at the Louisiana State University Health Sciences Center–New Orleans (LSUHSC-NO), and is a randomized crossover design. This means participants will be randomly assigned to either the first treatment group or the control group, and will directly compare patients’ current treatment plan with the impact of HBOT therapy.
Who can participate in the study?
According to Dr. Harch, “The study is open to anyone with mTBI/PPCS from blunt or blast injury—civilians, active duty military, veterans, and athletes.”
If you had a mild traumatic brain injury at least six months ago and as long as ten years ago, and only lost consciousness for up to thirty minutes or had no lost of consciousness at all during the episode, you can apply to participate.
What do study participants need to know?
The study is fully funded (meaning that it won’t run out of money before it’s completed), and everyone who participates will receive HBOT treatment. However, those who are randomly assigned to the control group will have to wait eight weeks before starting treatment.
Each participant will undergo cognitive testing (oral, written, and computer tests) before and after treatment. However, no one will be subjected to brain imaging. The first fifty patients who qualify will be accepted into the study. You may be evaluated in-person, or over Skype/FaceTime.
The study will require travel to New Orleans at least twice: once for eight weeks of treatment, and again for a one-day follow-up six months after treatment. Study participants must pay for their own lodging while undergoing treatments, which will no doubt exclude many veterans. With all the waste recently revealed at the Veterans Administration and other government projects, one wonders whether the refusal to cover lodging costs was a deliberate attempt to stop the study before it got underway. However, local travel will be reimbursed, and those who cannot afford travel to New Orleans can apply for free transportation via Mercy Medical Angels.
How can I learn more about participating in the study?
Contact Cara Rowe, the study’s clinical coordinator, at 504.427.5632 or [email protected]. Or, visit www.hbottbistudy.org.
Click here for additional study requirements.
Had about 10,000 articles and several hundred books on natural health in the 90’s One was a very rare book from 1968 entitled “HYPERBARIC OXYGEN The Uncertain Miracle”. It is rare because it was published and three weeks later the books were off the shelves – magically.
There are references in there about a gent taken to the Hennepin County Hospital HBOT room – which is an extremely rare operation room instead of the small chambers. He’d had a stroke on a Monday, and on the next Tuesday – 8 days later – was put into the HBO room with a nurse. He was blind in his left eye, and paralyzed on his left side.
By the stopwatch, 23 minutes after entering the HBO chamber he was LITERALLY dancing with the nurse.
In 95 a man in San Bruno had been taking HBO treatments in the small chambers for skin reasons. He called his doctor i a panic explaining that his mother had just had a stroke and was paralyzed on her right side. They put her in the HBO chamber as much as they could for 24 hours, and she was 95% cured.
There are cases where a 9 year old boy with cerebral palsy after 3 months of HBO therapy was able to get out of his wheel chair and start using forearm crutches. A man who’d had a stroke 14 years before was able to find significant improvement but not a full cure through HBO treatment.
Another possible alternative is psychedelics although many will freak at the concept. Here is an interesting link to help you decide: http://www.bibliotecapleyades.net/ciencia/ciencia_industryhealthiermedica220.htm
Why doesn’t the people holding this study of hyperbaric oxygen for traumatic brain injury try to reach out through some type of media campain to try to get wealthy persons, corporations to help sponsor veteran’s loging/food/& other expenses while undergoing treatment. It would be a TRADGEDY! for them to miss out on this opportunity! Their, & their families stability & lives will DEPEND on them recovering from these war related injuries, & may truly be their only real hope at a recovery.
I wish everyone well and hope that you have a full contingent of participants. This seems like a logical approach to healing what too often still seems to be referred to as a “hidden wound”. I am a strong believer that we need methods such as this one which works with our body’s natural healing process and far less emphasis on medications which have side effects far worse than many realize.
IHBOT will help brain injuries. I understand studies already prove such. It also helps neuro disease such as MS, MD and RSD (or the new no progress name – Complex Regional Pain Syndrome)
HBOT also helps people with cancer.
Since insurance doesn’t cover this proven treatment, places have closed.
This sounds wonderful, but I’m wondering why none of my doctors have told me about this before now. It’s now been 18 years since I had major brainstem stroke and a nurse caused traumatic brain injury immediately following stroke. I was 28 years old initially, and typically major stroke recovery is 2 years. However, this traumatic brain injury has been dragging it out. Now, I’m 46 years old, but still praying for a way to speed up my brain damage healing process. Is it too late to participate in this study?
The wars in Afghanistan and Iraq have generated so many veterans who have lost so much. Great numbers of ouar wounded vets are afflicted with PPCS/TBI. From personal experience, a gunshot to the face in 1960, I how few effective treatment modalities exist. The stance on the FDA on this issue iis unconscionable. I had understood that First Lady Michelle Obama had succeeded in getting approval for HBOT in Veterans’ Administrations Hospitals. Apparently that is not the case. I feel strongly that it is vitally important that this happens and I will write my congresspeople about HBOT and the VA., Medicare and Medicaid.
If our traumatized vets were good enough to be inducted in the first place, they are good enough to receive the appropriate medical care, the hyperbaric oxygen treatment for impact damage to the brain. It is not appropriate to diddle the taxpaying public with the expense of innapropiate treatment, and the demand of the victims’ families for a self-perpetuating chain of more innapropriate treatments.
One wonders if an audit of such treatment of traumatized veterans will yield some hidden corruptions and some hidden fatcats, and maybe such an audit should take place pronto. We should be considered better servers of medical care than several small countries in Europe, especially servers of medical care to our own military wounded.
Respectfully submitted.
I have read many articles written by eminent doctors talking about the benefits of HBOT for trauma and hope that our injured military personnel can continue to have the benefit of this procedure.
Why not try oxygen therapy as in the hyperbaric treatment. When a person has an injury that is so hard to oxygenate as are various injuries that already allow hyperbaric treatment and show clinical improvement and the brain is not allowed the additional oxygen is not a good standard of care. The person with a brain injury is on supplemental oxygen via a nasal cannula at first so it would make sense to try hyperbaric treatment that provides additional oxygen at a higher level would be helpful.
The brain continues to heal for many, many years. I can still see additional improvement in my daughter who had a severe TBI (Traumatic Brain Injury) in a pedestrian v auto collision almost 19 years after the event. If hyperbaric treatment had been available to her then (and our soldiers now) as well as all persons with brain trauma we could see a lot more healing a reduced cost in the long run. Please reconsider and support hyperbaric treatment for traumatic brain injuries as well as the other injuries it already is used for. Thank you.
I hope this new oxygen treatment works out and gets more attention. Nobody should have to go into a war, and then come back with a serious injury like this on top of that. It’s horrible. I think “supporting our troops,” since the article mentioned it, I think that should mean “bring them home safely to their families.” It’s a lot harder to support the idea of families being torn apart and people getting wounded.
I am a veteran. The most important thing that America needs to do is take care of our returning service members. No matter wether they are totally intact or have mental or physical injuries. America wake up take care of those that stood between you and someone that wants to do harm to us.
Your article on HBOT treatment for traumatic brain injury was fascinating. Can the treatment also have benefit for those who have had brain surgery for malignant tumors?
Please begin the study ASAP so that veterans in need of such treatment will not have their
treatment prolonged and recovery delayed
Sounds interesting & shouldn’t there be plenty of local veterans for this study-therefore almost no cost?
I am SO glad this study is taking place. A number of years ago I had 4 HBOT treatments. They happened to occur right after a ACL surgery that left painful bone on bone contact. I had no meniscus left. Anyway. After the treatments the pain was gone and hasn’t returned. I have been frustrated recommending the treatment for perfectly appropriate applications only to have the patients be told they couldn’t receive it for various reasons: mostly “unapproved diagnostic categories, but even recognized applications. i.e. a diabetic’s double knee replacement with delayed wound healing!!
Anyway, there are so many applications that this relative safe intervention offers. At least our veterans may now get a chance!! I’ll look for appropriate applicants, though the travel costs certainly make it harder. All the previous FDA studies I’ve referred patients too covered those too!!! I greatly appreciate Dr. Harch’s perseverance in the face of the FDA’s obvious and detrimental bias!!
Give our troops the medical treatments they need, they put their lives on the line for us and now it’s VA’s turn to put their lives on the line to treat fellow veterans–no questions/ just action By a concerned veteran
I do believe that the hyperbaric chambers and oxygen therapy should be used much more than it is currently being used. In one of his newsletters, Dr. Whittaker says he uses it for stroke patients and it helps a lot. Insurance should pay for it and so should medicare.
I want the FDA to be so tightly regulated they are forced out of the business of protecting large corporations. The FDA protection of therapies that are non-natural and patentable at the expense of natural, sustainable, non-patented treatments needs to stop now.
Corporations need to be pressured to support sustainable treatments. Make some letters to every large corporation, especially those who oppose Dr Harsh study and I will sign and send. It is time corporation are called on to support natural and sustainable products. It is time America leads the way to variety of treatments of all kinds available to suit each individual, not just patentable products. Every week I hear of another countrys’ success with natural treatments and I wonder why isn’t that America – we are the leader, we are free, I want freedom of choice now and forever! I want any corporation that does business in the USA to be contacted to make financial donation to support sustainable and natural healthcare specifically.
Make a letter I can sign to send to FDA to let them know it is the time they must choose to be responsible to the citizens of America by supporting varieties of treatment for the variety of individuals with health issues. Let them know the people of America pay them too and we want our freedom to choose a natural product. Tell them they do not have the right to sell out our right to choose natural treatments. Ask them what they need to keep a neutral perspective and fight off the temptations and pressures of selling out to corporations. If they have a big pharma background and are against my right to choose treatment ask them to resign. If they will not resign make a letter to get them fired and I will sign it.
Co-enzyme Q10, Ubiquinone/Ubiquinol gives 100% oxygenation of every cell by mitochondrial conversion. Rep Denis Kucinich passed a bill to give CoQ10 to every Vet returning with PTSD. The AMA has denied its use to veterans because the cancer industry has known since 1986 that CoQ10 protects cells from the free radical cancer cells that are in everyone’s body. You want oxygenation. Give everyone Ubiquinone or Ubiquinol. There is no overdose. Here is my story, published by Barbara Minton of Align Life, in her article on the deadly effects of statin medications in elimination of all CoQ10 from every cell: http://alignlife.com/articles/cardiovascular/coq10-can-reduce-side-effects-from-statins/ My wife, Terry & I will talk to anyone, and have been telling our story for 7.5 years to anyone and everyone we come in personal contact with. We have told this story to Governors, Senators, News and TV media and have indicted the National Cancer Institute of First Degree Murder for anyone who has died of cancer since May 2008 for removing from their website that everyone being treated for cancer with chemo and radiation “must” be given CoQ10 in addition to chemo and radiation. Pete & Terry Mare, 7503 Glenmore Ave, Ozone Park, NY, 11417, 718-738-7934
I am always fascinated by the government! Hyperbaric treatment has been going on for years and with an incredible amount of success. My husband recently passed away from ALS. There is a large number of service men who are coming home with ALS. There are many people who are diagnosed with ALS who have suffered from great trauma, and were in perfect health prior to the diagnosis. No matter WHAT, this should be approved, supported and subsidized. DM
An extremely high percentage of government bureaucrats are hypocrites and damn liars. I’m 65 years old and all my life I’ve heard every administration say they will do everything possible to help the veterans. What a load of heap steaming piles. My entire life every several years there has been a scandal at the VA and every time they make the same promises and every time it’s the same old lies. They’re all liars and criminals. Most of them should be in prison, but it’s never gonna change unless and until God Almighty himself decides he has had enough. Nothing else will change one damn thing.
As a war veteran myself, I address you, the war veteran who has read this article, to make some noise: write to your senator, you congressman, the director of the VA, and to President Obama demanding that this therapy be made available to all veterans.
We went into harm’s way for our country, and our country owes us the utmost care for our wounds. We did our duty. It’s time they did theirs.
You need to look at doctors in the private sector who are currently using this therapy and experiencing good results with it. Don’t rely on government for cutting-edge science when it comes to your personal health.