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Hyperbaric Medicine Officially Enters the Prohibition Era


Hyperbaric Medicine Officially Enters the Prohibition Era

An article specifically written for ”Hyperbaric Medicine Today”
in their “Physicians’ Forum Counterpoint” feature.
From Volume 1 Issue 1
Research in Hyperbaric Medicine by Dr. Eric P. Kindwall

Dr. Paul G Harch writes:

The Physicians' Forum article in the inaugural issue is a comprehensive discourse with many good points on the legality of off-label HBOT, research funding, a registry, recommendations for patients seeking off-label treatment, and standardized testing/documentation. However, these points are nearly lost in an extremely confusing, obfuscating tangle of terms definitions, and concepts that is partly based on a double standard. Despite the confusion, the message and threat to the entire hyperbaric medicine community was transmitted so loud and clear in the final paragraph that I was moved to declare this the “Prohibition Era Of Hyperbaric Medicine” It appears that the purpose of the article is to alter the historical method of the practice of medicine and hyperbaric medicine by jeopardizing a physician's membership in a medical society should they dare to use HBOT for an off-label indication.

The article begins with a comment on “evidence-based medicine”' and then proceeds to speak about peer-reviewed, randomized, prospective, controlled, double-blinded trials (RCPT's) to assess validity of scientific information. The double standard in these two paragraphs can be appreciated in the 1996 approval of intracerebral abscess (ICA), (cerebral abscess, subdural empyema, and epidural empyema) by the Hyperbaric Oxygen Therapy Committee to the accepted indications list. The argument in the 1996 HBOT Committee Report was based on thirteen cases treated off-label, ten of which were published in the Journal of Hyperbaric Medicine, 1989. These were combined with six cases generated after years of open solicitation from an influential HBOT Committee member to any UHMS physician who had treated cerebral abscess with hyperbaric oxygen. These last six cases are strongly biased since very few physicians are willing to volunteer a personal/professional failure, i.e., a hyperbaric oxygen treated cerebral abscess case that died. The mortality from these twenty cases was compared to the latest figures, 1991, on the historical declining mortality rate in cerebral abscess to achieve statistical significance and approve cerebral abscess as an accepted indication. To summarize, the accepted indication, cerebral abscess, is a diagnosis composed of three separate diseases, based on twenty non controlled cases, none of which appear to be on an JRB-approved protocol, all of which were apparently treated off-label, only ten of which are in a peer reviewed journal, six of which are highly biased, non-published solicitations and the argument for which is based on a comparison to a historical declining mortality rate. Regardless of the strong pathophysiological argument this is weak science, especially when compared to data discussed below. To subsequently argue, in the Physicians' Forum article's lead paragraph for evidence-based medicine from randomized prospective controlled research published in peer-reviewed journals as an intro and backdrop to a critique of HBOT/cerebral palsy and off-label use of HBOT, is a double-standard.The article disparages the Hyperbaric Oxygen treatment data of cerebral palsy children by labeling it “anecdotal”

The double standard is more apparent in the article's review of HBOT cerebral palsy data. The article disparages the hyperbaric oxygen treatment data of cerebral palsy children by labeling it "anecdotal." This "anecdotal" experience includes six reports: 240 "anecdotal" cases by Machado, a single "anecdotal" case reported by me in 1994 (the first cerebral palsy case treated with HBOT in North America), three "anecdotal" cases reported by Dr. Neubauer and me at a hyperbaric meeting in Buenos Aires in 1996, an additional "anecdotal" case reported by Neubauer and me in the Third Edition of K.K. Jain 's Textbook of Hyperbaric Medicine in July/99, 18 "anecdotal" predominantly IRB cases reported by me at the Boca Raton July 1999 Conference, and now 25 IRB "anecdotal" cases reported by Montgomery at McGill in 1999. While a number of the above reports are abstracts, three of the studies (Machado, Harch, and Montgomery) are prospective and controlled (each patient serving as his own control). The Montgomery study also used blinded examiners and was published in a peer reviewed journal. This constitutes greater experience for HBOT treatment of cerebral palsy than for the nineteen "anecdotal" HBOT/ICA cases which generated inclusion on the accepted indications list in 1996. To disparage the evidence for HBOT/CP is inconsistent.

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VTX Wounded Worrier Bike Run


 California VTX Riders Honor a Wounded Warrior at the 8th Annual Wounded Warrior Run

Please join us on this day as we honor this years Wounded Warrior. Our event is a fundraiser and 100% of funds collected will be donated to our Warrior. Join us for lunch, drinks, live music and dancing, visiting with old friends and making new ones. It's for the Warrior so please join us.

Our day starts at Loma Linda VA Hospital in Riverside, CA to have breakfast with our Veterans. Then we move to the junction of Hwy 138 and Interstate 15 to line up for the ride up the hill at 10:00am, we will stop at Silverwood lake to take a group picture then on to the BBQ!!

There will be T-shirts for sale and well some very good food! All proceeds are donated to our Wounded Warrior. You do not need a motorcycle to join us, and this is a family event!! See you there!!

CRAO a Continuing Look at HBOT as a Treatment for this Vascular Event

We believe our experience with HBOT for CRAO justifies continuing its use as the treatment of choice. It is hoped that our experience will encourage more referrals in the favorable first eight hours. The intensive treatment regimen was satisfying to us, and we hope others find it equally effective in preserving vision.  HBOT is a logical treatment for central retinal artery occlusion.  This continuing study corroborates improvement of vision using HBOT when the occlusion is under 24 hours, and further study will be needed to determine effectiveness of treatment after a 24-hour period has elapsed.

Hyperbaric Oxygen Therapy in Central Retinal Artery Occlusion


By Paul G. Harch, M.D.
Clinical Associate Professor
LSU School of Medicine, New Orleans



Central Retinal Artery Occlusion (CRAO) is a painless, severe, usually sudden onset loss of vision in the eye that is due to occlusion of the central retinal artery. Visual loss is in the range of light perception to counting fingers in 90% of cases. In primates, if vision isn't restored within approximately 90-100 minutes, permanent injury to retinal cells occurs. In humans, however, the situation is more complicated and depends on retinal vascular anatomy. In patients with a cilioretinal artery that supplies part of the fovea, 10% of the population, 80% will have return of 20/50 vision. In the remainder of the population with CRAO, vision remains at the counting fingers to hand-motion level.

In the 1980s, the physician team at the JoEIIen Smith Hyperbaric Medicine Department in New Orleans, under the direction of Dr. Keith Van Meter, began to treat central retinal artery occlusion. The cases were referred by forward thinking retinal specialists who had read case reports of a small series of patients who had been treated with hyperbaric oxygen therapy. Eventually, we were referred every CRAO patient from a particular ophthalmology practice. Given the typically grim prognosis of these patients and the lack of substantive evidence that established a firm timeline beyond which HBOT would be ineffective, we treated every patient. We were able to achieve improvement in vision in the great majority of patients, despite delays to treatment beyond 12 hours. One of the key features of this treatment was an adaptive approach to dosing where we would decrease the HBOT dose from the traditional 2.4-2.8 ATA to as low as 1.5 ATA, as the patient plateaued at the higher pressures. In 2004, one of our hyperbaric fellows, Dr. Heather Murphy-Lavoie, reviewed our patient series and compared them to an age-matched control group from Charity Hospital, New Orleans. She presented the abstract at the 2004 UHMS meeting in Sydney, Australia. Based on this presentation, she was invited to submit an application to the UHMS HBOT Committee to add CRAO to the accepted indications list. That application was submitted and approved in 2008 with an American Heart Association Class lib level of evidence: "There is fair to good evidence to support its use with retrospective case series but no prospective randomized controlled trials. It is acceptable, safe, considered efficacious but lacks confirmation of efficacy by level 1 studies. There is no evidence of harm and consistently positive results. In addition, there are no alternative therapies with similar outcomes."¹

The importance of the CRAO HBOT Committee approval lies in the implications for the future of additional occlusive vascular indications. CRAO is a rare condition. The impact of HBOT on individual cases is substantial and justifies the application of HBOT for this condition. However, the impact on society is minimal. What is more important is the scientific argument for HBOT that is based on the pathophysiology of CRAO, which is a sudden complete occlusion of arterial blood supply to nervous tissue. Sudden arterial occlusion is nearly identical pathophysiologically to the accepted indication of traumatic interruption of peripheral arterial supply and the Medicare indication of acute peripheral arterial insufficiency. CRAO is the same pathophysiology in the retinal circulation. In all three of these conditions, there is a period of complete or near complete interruption of blood supply which is followed by a period of reperfusion injury as circulation is re-established either surgically or by recanalization. The peripheral arterial interruptions/insufficiencies are better described in lay terms as "acute traumatic stroke" or "acute stroke of the arm or leg" while CRAO then is an "acute stroke of the eye."

The analogy to "stroke" is important because HBOT is the use of greater than atmospheric pressure oxygen as a drug to treat basic disease processes. In all three of these conditions we are treating an underlying complete occlusion or interruption of blood supply to human tissue. Two of the tissues are outside the central nervous system and the third is in the central nervous system. The tissue and its location are somewhat irrelevant, but if we can now accept stroke of the eye based on Class lib evidence, it should expand our thinking to the broad range of pathophysiologically similar conditions characterized by gross cessation/interruption and then re-establishment of blood supply. Examples include hepatic artery occlusion (there are a number of references for HBOT treatment of this condition in the pediatric liver transplant literature), mesenteric artery occlusion, coronary artery occlusion, (acute myocardial infarction), the group of global ischemias (cardiac arrest, near-hanging, near-drowning), and of course, cerebral artery occlusion (stroke). Interestingly, HBOT in cerebral stroke is supported by over 35 animal and an equal number of human studies, some prospective and controlled, with the great majority at least meeting the Class lib or higher level of evidence. The following cases should stimulate your thinking of application of HBOT based on pathophysiology rather than diagnosis.


Reference List

1. Heather Murphy-Lavoie, Frank Butler and Catherine Hagan. Central Retinal Artery Occlusion. In: Gesell LB, Chair and Editor, Hyperbaric Oxygen Therapy Indications, 12th Edition. The Hyperbaric Oxygen Therapy Committee Report, Durham, NC: Undersea and Hyperbaric Medical Society, 2008. p.57-66.



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