Article by Joel Goldstein on Brainline

The theory of neural plasticity claims that long after a brain is injured it may still retain the ability to repair itself, to regain lost functions by establishing new neural pathways in response to experiences and functional demands. It is an exciting and potentially disruptive way of understanding the brain. The long-held belief that a brain injury survivors’ progress inevitably plateaus after a year or two is increasingly challenged by thought leaders such as Drs. Norman Doidge, Paul Harch, Xavier Figueroa, Carol Henricks, Michael Lewis, Margaret Naeser, David Perlmutter, among others. These physicians cite dramatic cases from their clinical practices of survivors making late-stage recoveries in response to alternative therapies such as, but not limited to hyperbaric oxygen therapy (HBOT), neurofeedback, photobiomodulation, nutraceutical supplementation and craniosacral therapy. They theorize that brain plasticity is the best way to understand such previously unheard of recoveries.

But if alternatives therapies are so great, if they really hold such promise, why are they not more widely embraced by medical professionals? If it turns out that there are persuasive reasons for doctors to steer clear of alternatives, what does that imply for the rest of us? Are those reasons equally compelling for survivors and caregivers?  Scientific proof and understanding of underlying causes is the gold standard in medicine, but what if it is absent? What are we to do about alternatives with long records of safety and mounting evidence of efficacy?  What should a reasonable and prudent person do? The answers to these questions are complex. If we untangle the threads, we may find a perspective from which to view safe alternatives in ways that help everyone involved in the circle of care – patients, caregivers, therapists, allied health professionals, and yes, even doctors and hospitals.

Physicians avoid alternatives for several reasons: They receive little if any exposure to them during their extensive education, no encouragement from their conservative professional culture, and no business incentive in their practices. If these influences weren’t enough, there may be serious hazards facing doctors who try alternatives. It exposes them to malpractice lawsuits when, inevitably, a patient is unsatisfied with an outcome.  Worse, they risk being disciplined by local medical societies and boards for using unconventional treatments, and in extreme cases, may even be censored, lose their license or face criminal charges, lodged by the FDA or others. Practitioners of safe alternatives have sometimes suffered these dire consequences. So for physicians there may be a high practical price to be paid for trying alternative therapies which, if they simply avoid, they cannot be faulted. We have met doctors who acknowledge being intrigued by the prospect of trying alternatives, but deterred by possible practical consequences.  It’s hard to fault them. It seems a truism, but even the best-trained, most skilled, and well-intentioned professionals in the world often suffer a kind of tunnel vision, sticking to familiar, well-trod paths that pioneers once blazed.

In his groundbreaking book When Brains Collide, Dr. Michael Lewis, Col. US Army (Ret.), rejoices that soldiers wounded in combat can be kept alive even after suffering devastating TBIs, thanks to dramatic improvements in emergency medicine and surgery. But since treatments for chronic brain injuries have not kept pace, he laments that afterwards often one can do little more than warehouse them in nursing homes. That is our starting place. Conventional medicine only takes survivors of severe brain injury so far, often ending at the nursing home door, or heavily medicated at home, facing long empty hours, and overwhelming family resources.

It may, after all, turn out that nothing more can be done. If there is any hope of improving these grim outcomes, it falls to those of us living with the consequences of inaction to keep an open mind, think outside the box and cautiously explore alternatives.  This seems to be the nub of the matter: Faced with a condition for which mainstream medicine has no satisfactory treatment, what should a reasonable and prudent person do? Accept the dismal verdict or cautiously explore alternatives? What harm is there in considering alternatives with long records of proven safety? For physicians, the obvious bar is the risks associated with running afoul of FDA approval. Costing tens of millions of dollars, the FDA process often effectively precludes alternative therapies from gaining traction– regardless of efficacy. But a therapy may have a good deal of supporting evidence, yet fail to meet the standards of FDA approval. And if safety can be reasonably assured, why not explore further? Our family felt compelled to do so after our teenage son suffered a severe brain injury in a car crash.

Nearly a year after Bart’s catastrophic injury he continued to suffer from crippling cognitive, emotive and physical deficits.  The school district and rehab hospital both agreed – he was not ready to return to class, and would be better served by placement in an institution. My wife, Dayle, and I balked at warehousing our 17 year old in a nursing home. We felt that he needed to be home, around familiar faces, among people who loved him, to have even a fighting chance at recovery. Over officials’ objections, we managed to bring him back home and into school, albeit in a highly modified and adaptive special ed. program. It was soon apparent that he was failing to meet even modest educational and therapeutic goals.

Desperate, Dayle and I turned to alternatives in a last-ditch effort to keep him home and in school.  As we were arranging for him to receive HBOT, a neurologist warned that it was a waste of time and money, even scolding the director of the HBOT clinic for holding out false hope to a family frantically clutching at straws. In his clinical experience, he had never seen patients improve through recourse to HBOT or any other alternatives. Survivors’ recoveries routinely plateaued after a year or so, and there was nothing more for it. His blanket rejection of alternatives was not bad faith or ill will, but authentically reflected years of clinical experience. (Contrary anecdotes were dismissed as spontaneous improvement, placebo, wishful thinking, and old wives tales…certainly not considered evidence). Nonetheless, we persisted with HBOT and Bart began to make dramatic, cumulative, lasting strides. We dedicated the book which recounts his recovery, No Stone Unturned, to the clinic’s director, Dr. Guisippina Feingold. That was 2002. Not much has changed – I recently heard a neurologist on NPR, and several at BIA conferences confidently declare that HBOT as treatment for ABI is not evidence-based. What they probably meant was that HBOT is not FDA approved as treatment for ABI. Pressed further, they may have referred to an absence of double-blind placebo trials – the gold standard in medicine. Since HBOT is the alternative therapy with the strongest supporting evidence, and which more than any other drove Bart’s recovery, let us take a deeper look at what seems to be the consensus opinion among physicians – that there is little or no hard evidence supporting HBOT.

What exactly is involved in HBOT? The patient is placed in a diving bell which is gradually pressurized to approximately 1.5 atmospheric pressures, the equivalent of being underneath 16 feet of water. The cabin is then flooded with pure oxygen, which the patient breathes for an hour or more. Normally oxygen, which constitutes 21% of the air we breathe, only enters the bloodstream one way — picked up in the lungs and carried via red blood cells to the body’s tissues. But breathing pure oxygen under pressure overwhelms the capacity of red blood cells, so blood plasma and other bodily fluids become saturated with oxygen — up to fifteen times the amount normally available.  Excess oxygen helps injured sites heal, by allowing them to revascularize – to re-grow the network of tiny arterioles and capillaries supplying blood to the injured tissue, a process known as angiogenesis. The new blood supply does the serious work of healing – removing toxins and bringing in needed oxygen, energy and other healing building blocks. That HBOT promotes healing is well established. Burn centers use it to speed recovery and reduce scarring. There are 14 conditions approved by the FDA for treatment with HBOT; acquired brain injury (ABI) is not among them.1

What about the claim that there are no double-blind placebo studies? It’s true. There are serious practical, logistical and even ethical obstacles to creating a true placebo when studying HBOT. It is not as simple as using a sugar tablet or gelatin capsule, as is often done in experimental trials of new drugs. In order to design a placebo control group for HBOT, one must create experimental conditions which, while simulating HBOT, have no therapeutic effect.  Why should that be a problem? Because “placebo” HBOT needs to have increased pressure in the chamber so that the subjective experience for the patient is indistinguishable from the therapeutic dose. But using ordinary air under pressure of 1.3 ATAs (the level at which a person can detect pressurization) increases oxygen saturation of blood by 50% – an increase which has been shown to yield therapeutic improvements. So if one were to set up a control or sham with room air at 1.3 ATA, the pressure itself may be responsible for a therapeutic increase of blood oxygen. Under such a protocol both trial and control groups are delivered increased doses of oxygen. Imagine testing whether aspirin reduces headaches by giving the trial group an aspirin, and the control group half an aspirin, rather than a sugar tablet. The only way to guarantee no increase of blood oxygen in the control group (and thus no therapeutic effect), would be to reduce the amount of O2 in air from roughly 20% to around 10% and then pressurize it back to 20%. But doing so is unethical, as it may cause harm.

So Israeli scientists did the next best thing – cross-over studies. Patients were divided into two groups: a trial group received HBOT; a control group received no treatment. After being closely monitored for 8 weeks, the trial group receiving HBOT was seen to make significant improvements, whereas the control group did not. Then the control group was also treated with HBOT and seen to make the same improvements as had the trial group, including functional gains measured by standardized tests of cognition and quality of life. SPECT scans showed greatly increased blood profusion in injured regions of the brain, averaging 40%. Analyses of scans were done blind to enhance reliability. Further laboratory studies also gave evidence of elevated brain activity, reduced inflammation, release of genes involved in healing, and increased production of neural stem cells. The Israeli investigators concluded: “HBOT can induce neuroplasticity leading to repair of chronically impaired brain functions and improved quality of life in mTBI (mild TBI) patients with prolonged PCS (post-concussion syndrome) at late chronic stage.” (Notably, participants were 1 to 5 years post-injury, to rule out spontaneous improvements which may occur in the first year after injury).2

Subsequent cross-over studies of stroke and other anoxic brain injuries all showed similar results – dramatically increased blood flow and brain activity accompanied by improved cognitive function and quality of life. HBOT seems to have neuroprotective effects, promoting vital healing processes in the brain, even in the chronic stage.

As a result of these studies, in 2015 Israel made HBOT part of the standard treatment for most brain injuries. Can it be that HBOT is evidence-based in Israel but not here in the States? Suppose one resides in a third country, say Spain. Should one travel to the US for best-in-class treatment absent HBOT, or fly to Israel and receive HBOT as a matter of course? What would a reasonable and prudent person do?  Perhaps wait and see. Clinical trials currently underway in the US – New Orleans under Dr. Paul Harch, and Florida under Dr. Barry Miskin, – both use similar top-tier designs and are beginning to replicate the Israeli results.3

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