Ozone Info

This is a whole lot of information regarding a few ways that ozone therapy or ozone treatment is being used.  It's incredibly useful info, if you actually give a damn.  But if you don't .... please feel free to skip this massive post.

CRPS, Complex Regional Pain Syndrome also known as RSD, Reflex Sympathetic Dystrophy has been a dilemma for all doctors and especially surgeons since it was identified. Often occurring shortly after surgery, or following an injury, this severely painful condition has perplexed the medical profession both as to cause and effective treatment. Coderre, T.J., that Foisie, in 1947, may have been somewhat correct in suggesting that arterial vasospasms were the key etiological cause. His research proposes that a “slow-flow/no-reflow phenomenon in the capillaries initiates and maintains deep-tissue ischemia and inflammation” as the leading cause. Goebal,A., et al. and others suggest that “autoantibodies directed against peripheral nerves” particularly IgG autoantibodies. Tan, EC., et al., and others suggest that venous oxygen saturation is greatly increased “corresponding with impaired oxygen diffusion” and “mitochondrial dysfunction”. All this is very interesting but how to fix the problem has been a mystery until now.

Until now the main treatment has been pain management, which has proven only moderately effective. In recent years Hyperbaric Oxygen Therapy (HBO a.k.a. HBO2 a.k.a. HBOT) has been used with some success. Research findings by MZ Kiralp,Yildiz, D Vural et al. and others suggest that it is a somewhat effective and well tolerated approach to decreasing pain and edema and increasing the range of motion in CRPS due to possible better oxygenation of the tissues. While this method has had minimal beneficial results, it suggests why Direct Intravenous Ozone Therapy (DIV) could work, as HBOT creates many of the same radicals in the blood as medical grade ozone by compressing the oxygen in the blood under several atmospheres of pressure.

This debilitating and disabling condition affects thousands of people every year often leading to lawsuits against surgeons when it is acquired as a post-op complication. The most important symptom is intense, continuous pain dramatically out of proportion, which worsens over time. Frequently the pain will spread to include an entire foot and leg or hand and arm and may encompass one side or the entire body. I have been unable to find any research published using intravenous ozone therapy for the treatment of this condition.

Direct Intravenous Ozone Therapy (DIV) has been used for the past 70 years, in over 36 countries by over 36,000 physicians worldwide. While there are hundreds of research studies worldwide they are published in foreign language medical journals, predominately German, Russian, Polish, Spanish and Italian. Searching on our National Library of Medicine (http://www.pubmed.gov/) for “intravenous ozone therapy” reveals only a small number of these studies that have been translated and in many areas of medicine. Many of these studies pertain directly to podiatry, particularly on diabetic peripheral vascular disease and ulcers.

Ozone gas is a trivalent oxygen molecule lacking an electron. Its’ main mechanism of action is to “steal” an electron from any molecule that cannot defend itself against such an attack. This causes a severe disruption in the atomic field of the molecule attacked followed by its destruction. This is the case for all viruses, bacteria, fungus, yeast and molds. Unless the organism was manufactured in a military laboratory to be resistant to oxidation, all pathologic organisms, including mutated ones, will be destroyed. In addition, ozone will chelate all metals from the body, including lead, mercury, aluminum, arsenic, etc., extracting them from blood, cells and off all nerve tissue. Here ozone will transform the metals into oxides, which the body can eliminate usually through urine, which can be measured. Ozone will also, very importantly make red blood cells flow with less viscosity as well as become more flexible to flow through narrowed or clogged arteries.

Healthy cells in the human body, on the other hand, can manufacture large amounts of glutathione peroxidase, superoxide dismutase, catalase and reductase, so called “antioxidants” which protect them against attack by ozone molecules which will try to enter via the “peroxide pump” mechanism. This explains why there is such an extremely low incidence of adverse reactions. Jacobs, M. in 1982 published a study in Germany, in which there was an incidence of only .00007% adverse reaction rate in over 385,000 people treated. Bocci,V. explains that while ozone forms Reactive Oxygen Species (ROS) they are short lived and thus different from the ROS’s that are continually attacking and harming our body. Bocci, V. says “In contrast to the dogma that “ozone is always toxic” three decades of clinical experience, although mostly acquired in private clinics in millions of patients, have shown that ozone can act as a disinfectant, an oxygen donor, an immunomodulator, a paradoxical inducer of antioxident enzymes, a metabolic enhancer, an inducer of endothelial nitric oxide synthase and possibly an activator of stem cells with consequent neovascularization and tissue reconstruction”.

If DIV works on controlling or eliminating CRPS it would seem that the cause of CRPS, in at least some if not all cases, is viral, bacterial, fungal/yeast or toxic metal attacking nerve tissue causing the symptoms, in addition, possibbly to micro-circulatory disturbances as this is what Ozone therapy mainly effects. How this may occur will be discussed later. Permanent nerve damage also has to be considered as well as slowing or stopping progression of the condition.

Since January 1990 we have performed over 155,000 intravenous ozone therapies. 45,000 Major Auto-Hemotherapies (MAH), and 105,000 DIV’s. We have found that MAH may improve many diseases and conditions but it rarely eliminates them. DIV apparently has the empowerment to do what MAH cannot and do it consistently. It is also safer, easier to administrate and takes only a few minutes.

Beginning in July, 1994 we have focused our research solely on DIV and have developed our own extremely assertive protocols. Frequency of treatment at a minimum of three times to as much as twelve times a week; accurate concentration of medical grade ozone usually at 55mcg per cc to a low of 42mcg per cc; given at rates of one cc per 5 to 15 seconds using 25gauge butterfly needles. It is necessary to adjust these parameters and modulate all of the above to avoid Jarrisch-Herksheimer (kill-off) reactions as well as damage to veins.

All patients are told to consume up to a gallon of purified water and other healthy liquids combined daily as well as Vitamin C taken five to six times a day (every two hours) in doses to bowel tolerance in addition to special probiotics once daily.

The Reflex Sympathetic Dystrophy Association (on their website) suggests the following:
Complex Regional Pain Syndrome (CRPS), also known as Reflex Sympathetic Dystrophy (RSD), is a chronic neurological syndrome characterized by:
Severe burning pain
Pathological changes in bone and skin
Excessive sweating
Tissue swelling
Extreme sensitivity to touch
There are Two Types of CRPS - Type I and Type II
CRPS Type I (also referred to as RSD) - cases in which the nerve injury cannot be immediately identified
CRPS Type II (also referred to as Causalgia) - cases in which a distinct "major" nerve injury has occurred
CRPS is best described in terms of an injury to a nerve or soft tissue (e.g. broken bone) that does not follow the normal healing path
CRPS development does not appear to depend on the magnitude of the injury. The sympathetic nervous system seems to assume an abnormal function after an injury.
Since there is no single laboratory test to diagnose CRPS, the physician must assess and document both subjective complaints (medical history) and, if present, objective findings (physical examination).

Criteria for Diagnosing Complex Regional Pain Syndrome Type I (RSD)
The presence of an initiating noxious event, or a cause of immobilization
Continuing pain, allodynia, or hyperalgesia with which the pain is disproportionate to any inciting event
Evidence at some time of edema, changes in skin blood flow (skin color changes, skin temperature changes more than 1.1°C difference from the homologous body part), or abnormal sudomotor activity in the region of the pain
This diagnosis is excluded by the existence of conditions that would otherwise account for the degree of pain and dysfunction

Shortly after appearing as a guest on an Internet radio show that focuses on Reflex Sympathetic Dystrophy (RSD) a.k.a. Complex Regional Pain Syndrome (CRPS) and not knowing if DIV would help as it has with other peripheral neuropathies, it was suggested that the host, Trudy Thomas, would recommend a patient who I would treat for free as part of my independent research in DIV.

Case Study One

Mrs. D. S. arrived at my office with her husband on August 18, 2010. D. S. is a 39 year old, 5’10 ½”, 280lb. female with a chief complaint of RSD for over 4 years which started post-op hammertoe surgery left foot over 4 years ago. She had undergone many years of traditional care at pain clinics with minimal success.

She complained of burning and shooting pain starting in her toes “that shoots” up her left foot and leg. In addition she complained of painful, arthritic-like hammertoes; severe muscle spasms in her feet, legs, back and shoulders; back pain; spinal stenosis and Degenerative Disk Syndrome effecting C-5, C-8, L-4, L-5 and S-1; Fibromyalgia throughout her body; Myofascial Pain Syndrome; polycystic ovaries; hypertension; and chronic constipation.

Examination of her feet revealed: normal pedal pulses; past hammertoe surgery left foot, mild Hallux valgus both feet; diminished light touch, sharp and dull sensation in left foot, normal in right foot, and diminished deep tendon reflexes in both feet; mild, +1 pitting edema in both feet.

A discussion of her problem and the possible benefits (many) and risks (virtually none) of DIV led to her decision with her husbands’ confirmation to go ahead and sign into my study #13 titled “Chronic painful neuropathy of the foot and ankle due to local pedal trauma ( in this case, hammertoe surgery)”. As is my policy no promises or guarantees were given or implied orally or in writing as to relief of pain, success or cure of her condition at any time on any visit.

She was advised to have three to five treatments per week of DIV and 1cc. (1000mcg’s) Vitamin B12 intramuscular injection every five to seven days. This care and the consultation would all be provided her free of charge.

After four treatments and no adverse reactions to therapy, D. S. shared with me and I quote :
“I already noticed in 4 treatments sleep has improved drastically, less stiffness in AM, less pain meds needed especially at nighttime, walked with less pain in back and legs, asthma not as bad, nails growing, less consistent nerve pain although I still have it it seems to not shoot as far or for as long, pain is more concentrated, less spacey, less constipated”.
“I won’t lie and say I am all better and ready to go home, but even just sleeping is amazing. I have not slept like this in 4 years. The nerve pain is intense and I still have pain in all the areas I did but it is more concentrated, not shooting as far and doesn’t debilitate me to tears every single day. I have been able to walk better…”.

She continued therapy at a three time a week rate for a total of nine treatments. She had continued to improve walking as much as 5 miles at a time, pain free during and after.

Case Study Two

Mrs. K. C. arrived at my office with her husband on August 2, 2010. K.C. is a 55 year old, 5’4”, 160 lb female with a chief complaint of burning pain radiating from her right foot throughout her body. She had been to an emergency room and was admitted to a hospital on July 24, 2010 for one week “to try and get the pain under control with IV Dilaudid and Ativan. K.C. is an R.N. that had been employed coincidently as nurse in a pain management clinic prior to undergoing Morton’s Neuroma surgery in March 23, 2005. Following the surgery pain and edema began immediately from the third toe and along the lateral side of the right foot.

Due to continual uncontrolled pain and edema a revision of the neuroma and scar tissue was performed on Nov. 23, 2005, which was unsuccessful. Peripheral nerve blocks, lumbar sympathetic nerve blocks and acupuncture (caused increased pain) failed to help. On August 6, 2007 an exploration and excision of a neural with a sural nerve graft and removal of additional scar tissue was performed, which also was unsuccessful at stopping her pain. Her pain now extended from her right foot up the right side of her body (both front and back), her face to the top of her head. Episodes of profuse sweating burning pain likened to “severe sunburn” and head pain which was described as being like “brain-freeze” (caused by eating something ice cold too fast), which could last from minutes to hours began. She was diagnosed with CRPS on Feb 19, 2008.

Lyrica, Kadian, nortryptyline, Fentanyl patch,Vicodin, Nucynta, Medrol, Opana and Namenda were used in various combinations all completely ineffective at controlling her pain symptoms throughout the course of her condition.

Examination of her feet revealed: mild Hallux valgus (greater in the right foot than the left) bilaterally; scarring from past surgeries second interspace right foot; mild edema 2nd toe right foot; normal pedal pulses, and CRT; slight tenderness on palpation over 2nd interspace; lessened sharp and dull sensation right foot as well as with 5.07 monofilament and diminished deep tendon reflexes right side.

She began DIV on August 2, 2010 and was treated three times a week along with injections of 1000mcg. Vitamin B12 IM, every five days. After two months of therapy most of her symptoms had changed from either diminished greatly to virtually not present. By November she had 30 out of 36 days with no pain and required little to no pain medication even on the painful days. She currently is being slowly taken off the Fentanyl patches and very rarely needs any pain medication. She is looking forward to returning to work in the spring when we will complete her care.

Discussion

Direct Intravenous Therapy (DIV) is useful in destroying all viruses, funguses, yeasts, molds and bacteria’s in the human body. In addition it can chelate toxic metals off nerve tissue as well as from blood and cells and help restore proper blow flow and oxygenation to the cells. As the results of these patients have been so impressive it reasons that one or more of the above must be the cause at least in some if not all cases of RSD. Surgery and accidents are very stressful to the body’s immune system. In addition, post-op antibiotics are often used to prevent or treat infections further stressing and weakening the body’s natural immune system following surgery. It follows that this allows these antagonists, previously present on the nerve tissue, to attack resulting in CRPS.

Conclusion

RSD (CRPS) is a serious debilitating condition that until now has had no definitive treatment or cause, except pain management and speculation. It is estimated that as many as 1.2 million Americans are effected by CRPS. DIV ozone therapy appears to be a treatment that may help many people who suffer from this serious disorder. Further clinical trials are needed to test this treatments effectiveness. This research may lead to a breakthrough in care and help thousands of people achieve relief from this relentless pain. As RSD often results from pedal surgery or trauma it is wonderful coincidence that a podiatrist may have found an answer.

References

Bacchini M, Volenti, Sondni G: Postraumatic reflex sympathetic dystrophy in the ankle and foot: a study of 32 cases. ChIr Organi Mov 1999; 84; 189-196.

Bocci, V., Borrelli, E., Travagli, V., Zanardi, I., The ozone paradox: ozone is a strong oxidant as well as a medical drug. Med. Res. Rev. 2009 Jul 29(4): 646-82

Bocci, V., The case for oxygen-ozonetherapy. Br. J. Biomed. Sci. 2007; 61(1):44-9.

Bocci,V., Is it true that ozone is always toxic? The end of a dogma. Toxicol. Appl. Pharmacol. 2006 Nov 1;216(3): 493-504.

Bocci, V., Scientific and medical aspects of ozone therapy. State of the art. Arch. Med Res. 2006 May; 37(4): 425-35.

Bocci, V., 1999b, Ozone as a bioregulator. Pharmacology and toxicology of ozonetherapy today. J. Biol. Regulat.Homest. Agent 10:31-53.

Bocci, V., 1998b, Is ozonetherapy theraputic?, Perspect. Biol. Med. 42:131-143.

Bocci, V., 1999a, Biological and clinical effects of ozone. Has ozonetherapy a future in medicine. Brit. J. Biomed. Sci. 56: 270-279.

Bocci,V., 2004, Ozone as Janus: this controversial gas can be either toxic or medically useful. Mediators. Inflamm. 13:3-11.

Bondy, S.C., 1955, The relation of oxidative stress and hyperexcitation to neurologic disease. Proc. Soc. Rxp. Bio. Med. 208:337-345.

Coderre, TJ. Complex Regional pain Syndrome: What’s is a name? J Pain 2011
Jan 12(1): 2-12. Epub 2010 Jul 15.

Coderrer, TJ, Bennett, GJ, A hypothesis for the cause of complex regional pain syndrome-type I (reflex sympathetic dystrophy): pain due to s deep-tissue microvascular pathology. Pain Med. 2010 Aug. 11(8): 1224-38.

Goebel, A., Leite, MI., Yanf, I., Deacon, R., Cendon, CM., Lewis, A., Vincent, A., The passive transfer of immunoglobulin G serum antibodies from patients with longstanding Complex Regional Pain Syndrome. Eur J Pain. 2010Nov 11. (Epub ahead of print)

Jacobs, M.-T., 1982, Untersuchung uber Zwischenfalle und typische Komplikationen in der Ozon-Sauerstoff-Therapie. OzoNachrichten 1:5.

Konrad, H., 2001, Ozone therapy for post-herpetic neuralgia. A retrospective study of 55 cases in Proceedings of the 15th Ozone world Congress, London, UK, 11th-15th September 2001. Medical Therapy Conference (IOA 2001 Ed.) Speedprint MacMedia Ltd. Raling, London, UK, pp85-88.

Kontorschikova, C.N., Yefremenko, J.R. Biochemical properties of ozone therapy. 4th International Symposia on Ozone Appications April 6th -9th 2004, Havana City, Cuba.

Leon, O.S., Menendez, S., Merino, N., Castillo, R., Sam, S., Perez, L., Cruz, E., Bocci, V., 1998 Ozone oxidative preconditioning: a protection against cellular damage by free radicals. Mediate. Inflamm. 7: 289-294.

Madej, P., Antoszewski, Z., Madej, JA. Ozonotherapy. Mater Med Pol. 1995 Apr-Jun; 27(2); 53-56.

Mandzhgaladze, NR., Kharebava, ER., Didia, TsG., Ardzhevvanishvili, MD., Chigiashvili, TsN. Influence of intravenous ozone treatment on the level of different specificity antibodies. Geprgian Med. News. 2006 sep; (138): 93-5.

MZ Kiralp, ~ Yildiz,D Vural et al. Dept of Physical Therapy and Rehabilitation and Dept. of Underwater and Hyperbaric Medicine Gulhane Military Academy, Haydarpasa Training Hospital, Istanbul, Turkey. Effectiveness of Hyperbaric Oxygen Therapy in the Treatment of Complex Regional pain Syndrome. Journal of International Medical Research 2004; 32: 258-262.

Tan, Ec., Ter Laak, HJ., Hopman, MT., van Goor, H., A Goris, RJ., Impaired Oxygen Utilization in Skeletal Muscle of CRPS I Patients. J Surg Res. 2010 Sep 16. (Epub ahead of print)

Yu, B. P., 1994, Cellular defenses against damage from reactive oxygen species. Physiol. Rev. 74:139-162