Hyperbaric Oxygen Therapy?

With Hyperbaric Oxygen Therapy (HBOT) one breathes 100% oxygen at pressures (baric) greater (hyper) than sea level atmospheric pressure, which enhances the body’s natural-healing process virtually risk free. Hyperbaric Medicine grew out of the problems encountered by divers exposed to high pressures. Hyperbarics represents an emerging medical specialty whose scientific basis, while supported by over 6,000 studies, continues to be explored. Today, HBOT is approved for use in air embolism, blood loss, bone infections, burns, carbon monoxide poisoning (smoke inhalation), crush injuries, decompression sickness, gangrene, soft tissue infections, intracranial abscess, non-healing wounds, radiation tissue damage, and skin grafts.

Other conditions that show evidence of HBOT value as a treatment include: stroke (cerbrovascular accident), head injury (cerebral edema/coma), cerebral palsy, bone-fracture, acute retinal artery occlusion, migraine & cluster headaches, chronic fatigue-syndrome (CFS), sports injuries, AIDS, sickle cell anemia crisis, acute spinal cord injury, multiple sclerosis (MS), Lyme disease, diabetic retinopathy, colitis, diabetic foot ulcers, and plastic/reconstructive surgery (preparation and recovery). While these conditions are-considered off-label indications for HBOT, there is stronger scientific evidence for a-number of these indications than there is for almost half of all the approved indications; nevertheless, because these conditions are off-label, by law no claims can be made.

Hyperbaric Medical Center of New Mexico, under the supervision and directorship of Kenneth Stoller, MD, will provide consultation for any indication which HBOT has been shown to benefit, approved or off-label. Physician referral is desirable, but no one will be excluded because of lack of physician referral. Patients who seek out HBOT are often facing life-threatening medical problems and have exhausted established medical treatment options, which is why Hyperbaric Medical Center of New Mexico adheres to the highest professional and ethical standards when using HBOT for new and unapproved medical indications.

We strongly believe it is important to provide hyperbaric therapy on a compassionate basis for unapproved indications, using clear guidelines for specific conditions. Our state-of-the-art facility is open now.

Address: 404 Brunn School Rd, Suite E, Santa Fe (505) 955-8560

Hyperbaric Oxygen Therapy For Neuro Rehabilitation

The Collet (Quebec) trial [1] that was published in the Lancet in 2001, and was the largest randomized trial of Hyperbaric Oxygen Therapy (HBOT) for children with cerebral palsy (CP) and it followed the McGill pilot study on the same subject [2].

The evidence showed that both groups of children treated with two very different hyperbaric treatment dosages improved significantly. The motor improvements that were seen and measured with the G.M.F.M.[3] were greater; more generalized, and were obtained in a shorter period of time than most of the changes found in any other studies of recognized conventional therapies in the treatment of children with cerebral palsy [4-17]. The children in both groups improved an average of ten times more during the two months of HBO (whilst all other therapies and medication were stopped) than during the three months follow-up (when medication and all the ancillary treatments were restarted). This impressive change in the rate of improvements clearly indicates the probable effectiveness of hyperbaric treatment. The Lancet commentary [19] and even the flawed tech report by the Agency for Healthcare Research and Quality (AHRQ) [20] concluded that the hypothesis of both treatments being equally effective should be retained, possibly as the main hypothesis.

As an aside, the 2003 AHRQ report, guided by its UHMS handlers, attempted to put their stamp of disapproval on using hyperbaric oxygen for neuro-rehabilitation in children, but their methodology was widely criticized. The Oregon Health Sciences Center for Evidence Based Medicine ended up reviewing the literature with a rigid and unorthodox scoring system on a 3 point scale: good, fair, poor, a methodology so simplistically and unusual that when one of their own consultants sent them a random sampling of all of the controlled studies from three of the latest issues of each of the New England Journal of Medicine, JAMA, and the British Medical Journal, 14 of the 22 articles completely failed their criteria.

Since the Quebec study of HBOT for children with CP, many reports [21-22] have been made on the possible efficacy of a low pressure hyperbaric treatment and all the trials [23-31] conducted with HBOT in CP have demonstrated positive results.

The below references are a reflection of some of the literature in this area:

• Holbach K. H., Wassmann H., Kolberg T. Improved reversibility of the traumatic midbrain syndrome using hyperbaric oxygen. Acta Neurochir (Wien) 1974; 30(3-4): 247-256.

• Neubauer R. A., Gottlieb S. F., Miale A. Identification of hypometabolic areas in the brain using brain imaging and hyperbaric oxygen. Clin Nucl Med 1992; 17(6): 477-481.

• Neubauer R. A., James P. Cerebral oxygenation and the recoverable brain. Neurol Res 1998; 20 Suppl 1: S33-S36.

• Rockswold G. L., Ford S. E., Anderson D. C., Bergman T. A., Sherman R. E. Results of a prospective randomized trial for the treatment of severely brain-injured patients with hyperbaric oxygen. J Neurosurg 1992; 76(6): 929-934.

• Sheffield PJ, Davis JC. Application of hyperbaric oxygen therapy in a case of prolonged cerebral hypoxia following rapid decompression. Aviat Space Environ Med 1976;47(7):759-62.

• Vlodavsky E, Palzur E, Soustiel JF. Hyperbaric oxygen therapy reduces neuroinflammation and expression of matrix meralloproteinase-9 in the rat model of traumatic brain injury. Neuropathol Appl Neurobiol 2006;32(1):40-50.

• Waalkes P, Fitzpatrick DT, Stankus S, Topolski R. Adjunctive HBO treatment of children with cerebral anoxic injury. Army Medical Department Journal 2002;April-June:13-21.

• Lou M, Chen Y, Ding M, Eschenfelder CC, Deuschl G. Involvement of the mitochondrial ATP-sensitive potassium channel in the neuroprotective effect of hyperbaric oxygenation after cerebral ischemia. Brain Res Bull 2006;69(2):109-16.

• Nighoghossian N., Trouillas P., Adeleine P., Salord F. Hyperbaric oxygen in the treatment of acute ischemic stroke. Stroke 1995; 26: 1369-1372.

• SHI Xiao-yan, TANG Zhong-quan, SUN Da and HE Xiao-jun. Evaluation of hyperbaric oxygen treatment of neuropsychiatric disorders following traumatic brain injury. Chin Med J 2006;119(23):1978-1982.

Middle ear barotrauma (MEBT) is always a consideration in treating both children and adults in a hyperbaric environment, but most children currently being treated with HBOT for autism are being pressurized to 1.3 ATA which greatly reduces the risks of potential side effects of any kind.

The senior clinicians who ran the Quebec/McGill trials (co-authors on the Collet’s Lancet article), Pierre Marois, MD., FRCP, a physiatrist, and Michel Vanasse, MD., FRCP, a neurologist, were responsible for more than 4,500 pressurizations during the course of these studies and have followed 40,000 other HBO treatments given to children with CP that they follow regularly. Only a few children have been referred for myringotomy because of a MEBT, and no complication or permanent injury has ever been observed.

These clinicians have always stated that in the vast majority of cases, children with CP can undertake HBOT without significant complications and in most cases it will improve their quality of life and that of their families.

Even the misleading article of Muller-Bolla [32] states that: “This study shows that exposure to low hyperbaric pressure is associated with minor signs of barotrauma compared to very low exposure. All other side effects were rare and similar in both groups” (referring to the children who participated in the Quebec study)

Several studies in the literature show that markers of hypoxia in the autistic brain are higher than in control brains:

• Fatemi, S.H., A.R. Halt, 2001. Altered levels of Bcl2 and p53 proteins in parietal cortex reflect deranged apoptotic regulation in autism. Synapse, 42:281-284.

• Araghi-Niknam, M., S.H Fatemi, 2003. Levels of Bcl-2 and P53 are altered in superior frontal and cerebellar cortices of autistic subjects. Cell Mol. Neurobiol., 23:945-952.

• Fatemi SH, Stary JM, Halt AR, Realmuto GR. Dysregulation of Reelin and Bcl-2 proteins in autistic cerebellum. J Autism Dev Disord. 2001 Dec;31(6):529-35.

• Fatemi SH, Halt AR, Stary JM, Realmuto GM, Jalali-Mousavi M. Reduction in anti-apoptotic protein Bcl-2 in autistic cerebellum. Neuroreport. 2001 Apr 17;12(5):929-33.

This is important because one of the most important mechanisms of HBO protection is the inhibition of apoptosis in hypoxia-ischemia. Inhibition of apoptosis by HBO translates into brain tissue preservation. HBO decreases the activity and expression of capase-3, reduces PARP cleavage, and abolishes DNA fragmentation.HBO causes the up-regulation of pro-survival Bc1-2 genes, protects the blood brain barrier, and improves Metabolism of Glutamate, Glucose, and Pyruvate. HBO decreases hypoxia-inducible factor-1a (hip-1a) & multiple genes related to apoptosis. In fact, HBO reduces all pathological events consequent to hypoxia.

It is regrettable that there has been so much politics in this new and emerging specialty, but that is the sad fact. The abhorrence of using HBOT to treat neurological conditions has become institutionalized at the UHMS. Even the funding for research is subject to this political pressure and hyperbaric medicine has had its share of that. This whole area has truly been a black spot on modern medicine because the reality is HBOT is a relatively risk-free, humanitarian, and non-invasive therapy that has such great promise for improving patient functionality across so many neurological indications.

Fischer et al. [33] in New York University performed the first randomized, placebo-controlled, double-blind trial on MS patients treated with HBOT. Improvements in balance and bladder function were found in 12 of 17 patients (P < 0.0001). Those patients with a less severe form of the disease had a more favorable and long lasting response. After a year with no further treatment, the treated group showed a positive change (P < 0.0008). Barnes et al. [34] found overall benefit in their treated group (P < 0.03) and a year later there was less deterioration in cerebellar function (P < 0.03). They called for further studies. Two other controlled studies have reported sustained benefit with follow-up. Oriani et al. [35] used patients with a low Kurtzke [36] disability score 7 and compared 22 controls with 22 patients treated each week for a year. They detected an appreciable difference in outcome ( P < 0.01). Pallotta et al [37] followed 22 patients for 8 years.

A logical and thoughtful analysis of HBOT reveals that it is a therapy that helps a great many indications, beyond the narrow number on some chamber’s FDA labels. In fact treating off-label is an established and important part of the practice of medicine in the USA, won three decades ago in United States v. Evers, 453 F. Supp. 1141, 1149 (M.D. Ala. 1978).

The off-label uses of medical devices and drugs perform an important therapeutic role in many, if not most, areas of medical practice. Prescriptions for off-label uses of drug products may account for more than 25% of the approximately 1.6 billion prescriptions written each year, with some recent estimates running as high as 60%. Pediatric uses also are mostly off-label. It should not be a requirement to have IRB supervision just to treat off-label. In fact, in some cases, if certain drugs weren’t used in the off-label way, one would be guilty of malpractice (Beck, James and Elizabeth Azari. FDA, Off-Label Use, and Informed Consent: Debunking Myths and Misconceptions.. Food and Drug Law Journal, 53 [1998]: 71 . 104 page 80)

REFERENCES
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2-Montgomery, D., Goldberg, J., Amar, M., Lacroix, V., Lecomte, J., Lambert, J., Vanasse, M., & Marois, P. (1999). Effects of hyperbaric oxygen therapy on children with spastic diplegic cerebral palsy: A pilot project. Undersea and Hyperbaric Medicine, 26(4), 235-242.

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20-Agency for Healthcare US Department. (2003). Web page : http://www.ahrq.gov/clinic/epcsums/hypoxsum.htm

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33-Fischer BH, Marks M, Reich T. Hyperbaric-oxygen treatment of multiple sclerosis: a randomized, placebo-controlled, double-blind study. N Engl J Med 1983; 308:181-6.

34-Barnes MP, Bates D, Cartlidge NEF, et al. Hyper-baric oxygen and multiple sclerosis: short term results of a placebo-controlled, double-blind trial. Lancet 1985; ii:297-3006.

35-Oriani G, Barbieri S, Cislaghi G, Albonico G et al. Hyperbaric oxygen in multiple sclerosis: a placebo-controlled, double-blind, randomized study with evoked potential studies. J Hyp Med 1990; 5: 237-45.

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37-Pallotta R, Anceschi S, Costilgliola N, et al. Prospecttive di terapia iperbarica nella sclerosi a placce. Ann Med Nav 1980; 85: 57-62.