Medical Research & References

Some people, including a number of doctors and biochemists, believe ozone has remarkable healing properties. [1] [2] [3] Others have argued that it is nonscientific and has no proven benefits. [4] [5] [6] [7] For many years ozone’s medical value or non-value has been the subject of controversial and emotional debate. [8]

The advent of precise medical ozone generators has only recently allowed the mechanisms, action and possible toxicity of ozone to be evaluated by clinical trials. [9] Ozone has a capacity to oxidize organic compounds, [10] and has wellknown toxic effects on the respiratory tract when present in smog. [11] [12] In medical use the gas — produced from medical grade oxygen — is administered in precise therapeutic doses, and never via inhalation, and advocates claim it has holistic health benefits. [13]

Therapeutic use of ozone is not endorsed by health authorities or medical associations in any English speaking country, and most US states prohibit the marketing of ozone generators, its medical use, and even research and clinical
trials of ozone therapy, so that doctors risk losing their medical licenses by administering or prescribing ozone therapies. There is anecdotal evidence of ozone therapy having caused remission in a variety of diseases, but only a few of these life saving administrations have been verified. [14]

Contents:

  1. Historical origins of ozone therapy
  2. Evidence of medical benefits of ozone therapy
  3. Studies of the toxicity and side effects of blood ozonation
  4. Physiology of ozone
  5. Countries and states where ozone therapy is practiced
  6. Methods of administration
  7. Ozone therapy in cancer treatment
  8. Ozone in the treatment of Viral Diseases
  9. See also
  10. References
  11. External links

1. Historical origins of ozone therapy

In 1856, just 16 years after its discovery (by homeopath Joseph Lloyd Martin [15] ), ozone was first used in a health care setting to disinfect operating rooms and sterilize surgical instruments. [16] This surgical application has recently been rediscovered. [17] By the end of the 19th century the use of ozone to disinfect drinking water of bacteria and viruses was well established in mainland Europe.

The earliest record of therapeutic use of ozone in an English language medical journal is in 1885 titled ‘Ozone’ by Charles J. Kenworthy, M. D., M.R.S.V. from Jacksonville USA, published by the Florida Medical Association. [21] Today, Florida is where the prohibition of ozone therapy is most rigorously enforced in the United States. [22]

In 1892 The Lancet published an article describing the administration of ozone for treatment of tuberculosis. [23] In 1902 they published another article claiming success in treating chronic middle ear deafness with ozone. [24]

During the first world war (1914-18) Doctors by then familiar with ozone’s anti bacterial properties, and with few other medical resources available to them applied it topically to infected wounds and discovered ozone not only remedied infection, but also had hemodynamic and anti inflammatory properties. In The Lancet of 1916, the following is reported by Major George Stoker, MRCS: “The accompanying tabulation statement of the results of the first 21 cases treated by ozone at the Queen Alexandra Military Hospital “England” cannot be regarded as anything but satisfactory from every standpoint, be it humanitarian, scientific or economic. The cases were, for the most part, those of cavities and sinuses in the femur and tibia. It is the great experience of those who have seen a great deal of war surgery that such cases obstinately resist treatment and are apt to remain unhealed for months and years … I have failed in only one case … the properties of ozone which have a wonderful healing effect are … an increased flow of blood to the affected part … as a germicide it destroys all hostile microorganic growth … as the French chemist Hennocque has shown it has great powers in the formation of oxyhaemoglobin … at present our knowledge of the effects of ozone is but small, but later I hope to bring before the medical public further satisfactory facts with reference to its working and results ” [25]

Stoker’s sequel to this article was published the following year, [26] and since then there have been few publications of ozone research by medical associations in English speaking countries, notable articles being Quain’s “Ozone Treatment of Wounds” (The Lancet 1940), [27] Thwaities’ “Ozone Healing” (Australian Medical Journal, 1977), [28] and Braggs’ “Are Worry Free Blood Transfusions Just a Whiff of Ozone Away” (Canadian Medical Journal 1993). [29] However, many medical journals published by international specialist medical research societies have in recent years lent considerable publicity to ozone research.

2. Evidence of medical benefits of ozone therapy

With regards to the debate of the merits of ozone therapy, the promotional claims by some marketers of ozone generators that it is a miraculous cure for all disease including cancer and AIDS have given many people false hope and
hurt the credibility of ozone therapy. [30] Leading the opposing argument is the US Food and Drug Administration who state that ozone is a toxic gas with no known useful medical application in specific, adjunctive, or preventive therapy and in order for ozone to be effective as a germicide, it must be present in a concentration far greater than that which can be safely tolerated by man and animals. [31] The FDA recently approved ozone ’s use as a disinfectant in the food processing industry, however.

Neither the Journal of the American Medical Association (JAMA) nor the Geneva-based World Health Organization (WHO) have published any research reporting benefits of ozone use in medicine. However in international peer reviewed medical journals hundreds of articles have been published reporting positive outcomes of medical ozone research and application for a range of pathology. Most of these were published since 1990 and are accessible on medline, and they include pre-clinical studies, animal experiments, patient case histories, placebo-controlled blinded human trials and reviews. The authors are mostly from Italy, Poland, Russia, Germany, Cuba, Spain, Israel, Japan and United States of America, and they draw conclusions that conflict with the FDA. The literature in their native languages is more abundant. [32]

Gérard V. Sunnen has made claims that medical use of ozonating blood to kill viruses and bacteria in the blood shows a potential area for scientific research.

3. Studies of the toxicity and side effects of blood ozonation

Much of the concern related to ozone therapy revolves around the safety of blood ozonation. It is well established that when inhaled by mammals, ozone reacts with compounds in tissues lining the lungs and triggers a cascade of pathological effects. Saul Green [34] has argued that since ozone has the capacity to oxidize organic compounds in an atmospheric environment, it should also logically oxidize blood components and endogenous human tissues. Researchers advocating ozone therapy concede that when infused into human blood, ozone produces reactive oxygen species (ROS) or free radicals, [35] an over-abundance of which is known to cause oxidative stress and cell damage, and is implicated in the progression of some degenerative diseases, however they argue that the body’s anti-oxidant defense system is resistant to the quantities of ROS produced by the therapy. Interestingly, ROS have also been discovered to also perform an array of essential cell signaling functions. [36]

The impact on blood chemistry and biological function of blood ozonation treatments like ozone autohemotherapy (03-AHT) has been investigated in a number of studies. 03-AHT is a procedure that has been practiced for over 50 years by European physicians. [37] It involves withdrawing up to 200ml of venous blood, then immediately mixing it with therapeutic concentrations of soluble

ozone gas and a minimal amount of anticoagulant, usually heparin, then reinfused, usually into the basilic vein at the elbow. In 2000, The International Society of Hematology, published an investigation into the effect of blood ozonation on red blood cell enzymes and intermediates, the research group included three biochemists from the Scripps Research Institute , California, USA, they reported the following: “Ozone autohemotherapy has been considered a form of alternative medicine and has not yet been subjected to the rigors of well-designed clinical trials. Despite encouraging anecdotal reports regarding the use of ozone in various disorders, there has been a concern that ozone per se may adversely affect red cell membranes and metabolites. The purpose of this study was to ascertain the effect of ozone administration at a concentration commonly used in autohemotherapy on a panel of red cell enzymes and intermediates, as well as its effect on red cell integrity. Since these parameters were unaffected by ozone, we suggest that clinical trials for the use of ozone autohemotherapy should be encouraged.” [38]

Previously in 1991 at a Canadian hospital 03-AHT was subjected to its first and last clinical trial in North America. In the late 1980s, reports had emerged that German physicians were successfully treating HIV patients with 03-AHT. There was then no pharmaceutical treatment for HIV, and a pandemic was feared, so Canadian authorities authorized the study to test safety and efficacy of 03-AHT in AIDS patients. Ozone had shown promise in in vitro testing, Ozone was seen effective at disinfecting extracorporeal blood samples of HIV; [39] [40] unfortunately for AIDS patients, ozone autohemotherapy (03-AHT), proved not to be an effective treatment in vivo . As part of the Canadian trial, though, the safety of re-infusing ozonated blood was critically investigated in 10 patients and no toxicity or adverse effects were observed after 12 weeks of treatment. [41] This non toxicity and absence of any significant side effects has been confirmed by Italian, [42] [43] Israeli, [44] Japanese [45] and Polish studies.

The indication of these studies is that human blood is resistant to the oxidative powers of ozone at concentrations up to at least 42μg/ml, while the mechanisms for defense against ozone damage or the biochemical cascade blood ozonation triggers seem to be impaired in pathogens that are not protected by the body’s anti-oxidant system. [51] [52]

Ozone is not the only gas that is toxic when inhaled but has medical benefits when administered by other means. Mustard gas is a schedule 1 substance in the Chemical Weapons Convention, but when injected intravenously nitrogen mustard served for many years as the worlds first chemotherapy drug. [53] Nitric oxide is another toxic atmospheric pollutant, but when created in vivo as a byproduct of enzyme synthesis in mammals it has a physiological role as a cell signaling molecule essential for numerous biological processes. Although classed as a free radical, a deficiency in nitric oxide is now implicated in a great variety of diseases.

4. Physiology of ozone

Studies by Dr. Paul Wentworth Jr and colleagues at the Scripps Research Institute USA have led them to believe ozone is naturally created by human neutrophils (a type of white blood cell) in the context of immune system function. [55] [56] The same researchers have also discovered evidence that ozone may be produced in atherosclerotic arteries as a by-product of inflammation. [57] Others have argued that the Scripps studies are inconclusive, since the biomarkers used to determine the production and reaction of ozone could also be evident with non ozone dependent reactions. [58] [59] So to date it is uncertain whether ozone has a natural physiological role. If ozone is indeed produced endogenously by the human immune system, even skeptics have conceded this would be of great significance and give merit to the concept of ozone as a medicine. A number of other gas molecules have been confirmed as having essential biological functions including cell signaling.

5. Countries and states where ozone therapy is practiced

Ozone therapy is a well established alternative and complementary therapy in most mainland European countries where health authorities have tolerated its practice. The European Cooperation of Medical Ozone Societies, founded in 1972, publishes guidelines on medical indications and contraindications of ozone and hosts training seminars. [60] In the early 1980’s, a German survey and investigation into ozone therapy by the University Klinikum in Giessen and the Institute for Medical Statistics, published in the Empirical Medical Acts revealed over 5 million ozone treatments had been delivered to some 350,000 patients, by more than 1000 therapists, of this number about half were medical doctors. [61] Although ozone is used in a complementary capacity by a significant number of doctors in Italy, Switzerland, Austria and Germany, it has still not gained popular support with mainstream industry policy makers in those countries, it is not covered by health insurance , nor is it part of the curriculum at most esteemed medical schools. Proposals to include ozone therapy in German health insurance schemes invoked hostile objections from pharmaceutical researchers who question its evidence base. [62] In general, countries with more socialist-style health systems seem to have had less difficulty in accepting ozone as a medicine. [63] [64] No prohibition of ozone therapy is evident in Bulgaria, Cuba, Czech Republic, France, Germany, Greece, Israel, Italy, Japan, Malaysia, Mexico, Poland, Romania, Russia, Switzerland, Turkey, United Arab Emirates and Ukraine. In the USA, recently passed Alternative Therapy Legislation has made ozone therapy an option for patients in some states. In Alaska, Arizona, Colorado, Georgia, Minnesota, New York, New Jersey, North Carolina, Ohio, Oklahoma, Oregon, South Carolina, and Washington, physicians can legally use ozone treatments in their practice without fear of prosecution.

6. Methods of administration

Traditional ozone therapies include: intravenous autohaemotransfusion – also known as ozone autohemotherapy (O 3 -AHT) [65] , intramuscular (O 3 -AHT), intra-articular & intradiscal O 2 /O 3 gas injections, [66] rectal and vaginal insufflation, [67] [68] transdermal ozone gas sauna, [citation needed] [69] limb bagging or booting, [citation needed ] ozonated oil (such as avocado, olive, hempseed, canola or sunflower) liniments & poultices, [70] drinking ozonated water, [citation needed ] dental applications. [71] [72]

Contra Applications of ozone, the European Cooperation of Medical Ozone Societies, warns that direct intravenous injections of ozone/oxygen gas [73] should not be practiced due to the possible risk of air embolism; at least one death in the USA has been attributed to such an embolism occurring during autohemotransfusion (O3-AHT) for psoriasis. [74] Therapists also take all precautions to avoid the patient and themselves inhaling concentrated ozone gas.[citation needed ]

More modern applications of medical ozone that are currently being evaluated in clinical trials include; Healozone , [75] OzonyTron [76] Medizone, Celacade, Lipidvirotech’s d-OSAB and Extra-Corporeal Blood Oxygenation & Ozonation EBOO a unique hemofiltration and blood purification procedure now practiced routinely at the University of Sienna in Italy.

7. Ozone therapy in cancer treatment

The American Cancer Foundation has always strongly advised cancer patients against resorting to ozone therapy. In its last reviews of Ozone therapy in 1993/94 it insisted although ozone has been subject to legitimate research there is no evidence that ozone is effective for the treatment of cancer in humans and could possibly have harmful effects. This remains the American Cancer Foundation’s policy to date. [78] [79] Other industry opinion leaders in the UK and Australia as recently as 2001 also suggest that knowledge regarding the potential benefit and harm of ozone in cancer patients is insufficient. Therefore such therapy can’t be recommended as an alternative form of treatment for cancer patients. [80]

With regards to the small amount of research of ozone in the treatment of cancer that has been done. In 1980 laboratory studies by main stream cancer researchers at Washington University discovered ozone inhibited growth of lung, breast and uterine cancer cells in a dose dependent manner while healthy tissues were not damaged by ozone. [81] Although these very encouraging preliminary findings have long been argued justified funding for further research it should not be assumed that ozone would be similarly effective in vivo and could cure cancer.

In 1990 pre-clinical French studies reported ozone enhanced the treatment of chemo resistant tumors and seemed to act adjunctively to chemotherapy in tumors derived from the colon and breast. [82]

Although the Warburg hypothesis is not considered the cause of cancer, tumor hypoxia or oxygen deficiency is still implicated by modern cancer researchers in the growth of tumors and is a known adverse factor in the effectiveness of conventional radiation and chemotherapy. [83] [84] Unlike oxygenation and hydrogen peroxide [85] , recent research by radiation and oncology researchers has shown ozone therapy can improve oxygenation in hypoxic tumors. [86] [87] [88]

In 2004 Oxford University reported of a Spanish cancer research institute’s human trial of ozone therapy. Involving 19 patients with incurable head and neck tumors receiving radiotherapy and tegafur, plus either chemotherapy (12 patients) or ozone therapy (7 patients). Those receiving ozone intravenously during radiotherapy where on average 10 years older, and their tumors significantly more abundant and progressed than the chemotherapy group. But on average the ozone group survived slightly longer than those receiving chemotherapy. They conclude these results warrant further researcher of ozone as a treatment for cancer. [89]

There are reports that ozone may be useful in treating the debilitating side effects of orthodox cancer treatment. Radiation-induced injuries have been successfully treated with ozone application. [90] Recent Cuban experiments on rats have shown that ozone treatment can alleviate the adverse effects of Cisplatin, a popular modern anticancer drug, that has been well documented to induce extreme toxicity and acute damage in the kidneys of animals and humans. [91] [92] [93]

Human trials at the Department of Oncology, Nizhni Novgorod State Medical in Russia also report benefits of complimentary ozone treatment with regards to drug complications. [94] [95] Female researchers at the same institute also report “We have followed up on 52 women with breast cancer, 32 patients along with cytostatic therapy have undergone a course of ozone therapy. 20 women were on only conventional polychemotherapy. The groups were compatible according to age, stage of the disease and accompanying pathology. Involvement of ozone therapy diminished the incidence and degree of cytostatics toxical side effects, improve their life quality and immunological parameters and significally increase the activity of antioxidant defence system”.

8. Ozone in the treatment of viral diseases

Japanese, [97] Russian, [98] and Scandinavian [99] medical journals report benefits of blood ozonation in the treatment Hepatitis C. In 2002, actions by the New York State Department of Health are claimed to have stopped a clinical trial evaluating the safety and effectiveness of blood ozonation in the treatment of Hepatitis C.

9. See also

  • Air ioniser
  • Alternative medicine

10. References

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