Ozone therapy
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Ozone therapy is an alternative medical treatment that introduces ozone or ozonides to the body. The United States Food and Drug Administration (FDA) prohibits all medical uses of ozone "in any medical condition for which there is no proof of safety and effectiveness", stating "ozone is a toxic gas with no known useful medical application in specific, adjunctive, or preventive therapy. For ozone to be germicidal, it must be present in a concentration far greater than that which can be safely tolerated by man and animals."<ref name="FDA" />
Ozone therapy has been sold as an unproven treatment for various illnesses, including cancer, a practice which has been characterized as "pure quackery".<ref name=sbm/> The therapy can cause serious adverse effects, including death.<ref name=cass/>
Proposed uses
Ozone therapy consists of the introduction of ozone into the body via various methods, usually involving its mixture with various gases and liquids before injection, with potential routes including the vagina, rectum, into a muscle, under the skin, or directly into a vein. Ozone can also be introduced via autohemotherapy, in which blood is drawn from the patient, exposed to ozone, and re-injected into the patient.<ref name="ACS">Template:Cite web</ref>
This therapy has been proposed as a primary or adjunct therapy for various diseases, including osteoarthritis,<ref>Template:Cite journal</ref><ref>Template:Cite journal</ref><ref>Template:Cite journal</ref> herniated disk,<ref>Template:Cite journal</ref> chronic wounds,<ref>Template:Cite journal</ref> hepatitis B<ref>Template:Cite journal</ref><ref>Template:Cite journal</ref> and C,<ref>Template:Cite journal</ref><ref>Template:Cite journal</ref> herpes zoster,<ref>Template:Cite journal</ref> human papillomavirus infection,<ref>Template:Cite journal</ref> HIV-AIDS,<ref>Template:Cite journal</ref> multiple sclerosis,<ref>Template:Cite journal</ref> cancer, heart disease, Alzheimer's dementia, and Lyme disease, though supportive evidence for some of these applications is limited. The American Cancer Society warned in 2010 that evidence for the efficacy of ozone therapy against cancer is inconclusive, and the therapy may be dangerous.<ref name = ACS/> For treatment of HIV/AIDS, although ozone deactivates the viral particles in vitro, well-designed studies have shown there is no benefit for living patients.<ref>Template:Cite web</ref>
The United States Food and Drug Administration initially stated in 1976, and reiterated its position in 2006, that when inhaled, ozone is a toxic gas that has no demonstrated safe medical application, though their position statements primarily deal with its potential for causing inflammation and pulmonary edema in the lungs. They also emphasize that for ozone to be effective as a germicide, it must be present at concentrations far greater than can be safely tolerated by humans or other animals.<ref>Template:Cite webTemplate:Dead linkTemplate:Cbignore</ref> More recent reviews have highlighted that different routes of administration may result in different therapeutic and side-effect profiles.<ref name="Zanardi"/>
Some reviews have suggested ozone as a potential treatment for herniated discs<ref>Template:Cite journal</ref> and diabetic neuropathy.<ref>Template:Cite journal</ref> There is some controversy about its use by athletes to increase performance despite numerous adverse side effects within the pulmonary and/or skeletal muscle systems. Although its use is not disallowed in and of itself, it can be mixed with banned substances for administration prior to injection.<ref>Template:Cite web</ref>
Safety
Ozone therapy has potentially serious adverse effects, and Template:As of at least five deaths had been reported due to the therapy's use on people with cancer.<ref name=cass>Template:Cite journal</ref> From 1975 to 1983 in Germany, research revealed six deaths, four cases of visual disturbance, three cases of paraplegias, four gas embolisms in the pulmonary circuit, two myocardial infarction, four pulmonary embolisms, two cases of apoplexy paralysis, and two cases of cardiac arrhythmia following ozone therapy. More commonly, pulmonary edema is the most prevalent adverse effect of ozone treatment. In the muscular system, many cases of tendon rupture, osteoarthritis, myositis, synovitis, joint infections, and muscle tears have been documented as results of ozone therapy. In the integumentary system, benign skin discoloration is most common. These all occurred following direct injection of O2/O3 gas: a method now regarded as malpractice by most ozone practitioners. In each case, the clinical picture corresponded either to gas embolism, or allergic shock. The fact that one case of apparent allergic shock followed the injection of a minute quantity of gas raises the unknown possibility that other methods of administration might also carry the risk of allergic shock.<ref name="OzonTherapieArbeitsausschusses">Template:Cite book pp 17-18.</ref><ref name="EisenmengerZurOzontherapie">Eisenmenger W. Zur Ozontherapie. In: Oepen I, Prokop O, editors. Außenseitermethoden in der Medizin. Ursprünge, Gefahren, Konsequenzen. Darmstadt. Darmstadt: 1986, 195-220. https://core.ac.uk/reader/12167629</ref>
Much of the concern related to ozone therapy revolves around the safety of blood ozonation. When inhaled by mammals in high levels, ozone reacts with compounds in tissues lining the lungs and triggers a cascade of pathological effects, including pulmonary edema, however, ozone therapy does not usually involve inhalation of ozone gas.<ref name="Zanardi">Template:Cite journal</ref><ref>Template:Cite journal</ref> It has been argued that while peroxides (a product of ozone) are naturally generated inside phagocyte cells to kill bacteria, outside the cell they can damage tissue.<ref name=qw>Template:Cite web</ref> Proponents suggest that its effects are tissue-dependent, though the subject is still debated.<ref name="Zanardi"/><ref>Template:Cite journal</ref>
Other serious incidents reported include transmission of hepatitis C.<ref name=MJA>Template:Cite journal [citation requires membership to industry magazine]. This article also reports 5 fatalities, which are included in the six fatalities reported by Eisenmenger (1986).</ref> Ozone-based treatments can be associated with central nervous system toxicity, termed Ozone Induced Encephalopathy (OIE).<ref>Template:Cite journal</ref>
Regulation and ethics
The FDA prohibits the medical use of ozone "in any medical condition for which there is no proof of safety and effectiveness", stating that "ozone is a toxic gas with no known useful medical application in specific, adjunctive, or preventive therapy. For ozone to be germicidal, it must be present in a concentration far greater than that which can be safely tolerated by man and animals."<ref name="FDA">Code of Federal Regulations Title 21 Sec. 801.415 Maximum acceptable level of ozone (FDA Website, as of 2022-07-18)</ref>
Beginning in 1991 the FDA has prosecuted and sent to jail several people presenting themselves as medical doctors and selling ozone therapy products as a medical cure or operating medical clinics using ozone therapy for healing human illness.<ref name="Knotts">Template:Cite news</ref><ref name="Whitlock">Template:Cite book</ref> Arrests following similar activity have been made in other countries as well, including Uganda and Thailand.<ref name="Malaba">Template:Cite news</ref><ref name="Thai">Template:Cite news</ref>
Ozone therapy is sold as an expensive alternative cancer treatment in Germany. David Gorski has described the practice as "pure quackery".<ref name=sbm>Template:Cite web</ref> Proponents of the therapy falsely claim it is a recognized therapy there, but the German medical establishment has not approved ozone therapy.<ref name=qw/>
In 2009, a panel of experts consulted by Forbes recommended that ozone therapy be included on a "list of the most egregious, dangerous, aggressively marketed health scams."<ref name="health-scams">Template:Cite news</ref>
Ozone therapy was banned in Malaysia in 2017. The Malaysian Health Ministry determined that the treatment could cause serious harm and had no scientific support as a treatment for any condition.<ref name="malaysia-ban">Template:Cite news</ref>
On 7 August 2023, the Brazilian government legalized ozone therapy as a complementary therapy, ignoring a request for veto due to lack of scientific evidence made in an open letter from the Brazilian National Academy of Medicine.<ref>Template:Cite news</ref>
History
In 1856, just 16 years after its discovery, ozone was first used in a healthcare setting to disinfect operating rooms and sterilize surgical instruments.<ref name="Chemical Technology Encyclopedia pp 82-3">Chemical Technology Encyclopedia; Barnes & Noble 1968 vol.1 pp.82–83</ref> 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.<ref name="Chemical Technology Encyclopedia pp 82-3"/><ref>Template:Cite journal</ref>
In 1892 The Lancet published an article describing the administration of ozone for treatment of tuberculosis.<ref>Template:Cite journal</ref> During World War I, ozone was tested at Queen Alexandra Military Hospital in London as a possible disinfectant for wounds. The gas was applied directly to wounds for as long as 15 minutes. This resulted in damage to both bacterial cells and human tissue. Other sanitizing techniques, such as irrigation with antiseptics, were preferable.<ref name="Distillations">Template:Cite journal</ref><ref name="Stoker">Template:Cite journal</ref>
The psychoanalyst Wilhelm Reich was a proponent of ozone therapy, which was supposed to enhance an imaginary life force he called orgone. Reich developed a device utilizing ozonides in his work on bioenergetic analysis.<ref>Template:Cite web</ref>
See also
- Ozone health effects
- Air ioniser
- Gerson therapy - which can involve the use of ozone solutions for enemas
- List of unproven and disproven cancer treatments
References
External links
- Ozone Generators that are Sold as Air Cleaners - factsheet at US EPA
Template:Unproven and disproven cancer treatments Template:Authority control