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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. 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."[1]

Ozone therapy has been sold as an unproven treatment for various illnesses, including cancer, a practice which has been characterized as "pure quackery".[2] The therapy can cause serious adverse effects, including death.[3]

A man reading with an IV in his arm. The tubing is filled with blood
A man undergoes autohemotherapy, where blood is drawn, exposed to ozone, and reinjected

Proposed uses

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Ozone therapy as a dental procedure

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, intramuscular (in a muscle), subcutaneously (under the skin), or intravenously (directly into veins). Ozone can also be introduced via autohemotherapy, in which blood is drawn from the patient, exposed to ozone and re-injected into the patient.[4]

This therapy has been proposed as a primary or adjunct therapy for various diseases, including osteoarthritis,[5][6][7] herniated disk,[8] chronic wounds,[9] hepatitis B[10][11] and C,[12][13] herpes zoster,[14] HIV-AIDS,[15] multiple sclerosis,[16] 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.[4] 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.[17]

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 which 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.[18] More recent reviews have highlighted that different routes of administration may result in different therapeutic and side-effect profiles.[19]

Some reviews have suggested ozone as a potential treatment for herniated discs[20] and diabetic neuropathy.[21] 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.[22]

Safety

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Ozone therapy has potentially serious adverse effects, and as of 2012 at least five deaths had been reported due to the therapy's use on people with cancer.[3] 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 injection of a very small quantity of gas raises the unknown possibility that other methods of administration might also carry the risk of allergic shock.[23][24]

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.[19][25] 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.[26] Proponents suggest that its effects are tissue dependent, though the subject is still debated.[19][27]

Other serious incidents reported include transmission of hepatitis C.[28] Ozone-based treatments can be associated with central nervous system toxicity, termed Ozone Induced Encephalopathy (OIE).[29]

Regulation and ethics

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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. 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."[1]

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.[30][31] Arrests following similar activity have been made in other countries as well, including Uganda and Thailand.[32][33]

Ozone therapy is sold as an expensive alternative cancer treatment in Germany. David Gorski has described the practice as "pure quackery".[2] Proponents of the therapy falsely claim it is a recognized therapy there, but ozone therapy is not approved by the German medical establishment.[26]

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."[34]

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.[35]

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.[36]

History

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In 1856, just 16 years after its discovery, ozone was first used in a health care setting to disinfect operating rooms and sterilize surgical instruments.[37] 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.[37][38]

In 1892 The Lancet published an article describing the administration of ozone for treatment of tuberculosis.[39] 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 found preferable.[40][41]

The psychoanalyst Wilhelm Reich was a proponent of ozone therapy, which was supposed to enhance an imaginary life force he called orgone. In his work on bioenergetic analysis, Reich developed a device utilizing ozonides.[42]

See also

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References

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  1. ^ a b Code of Federal Regulations Title 21 Sec. 801.415 Maximum acceptable level of ozone (FDA Website, as of 2022-07-18)
  2. ^ a b Gorski, David (24 October 2016). "German alternative cancer clinics: Combining experimental therapeutics with rank quackery and charging big bucks for it". Science-Based Medicine.
  3. ^ a b Cassileth BR, Yarett IR (August 2012). "Cancer quackery: the persistent popularity of useless, irrational 'alternative' treatments". Oncology (Williston Park, N.Y.) (Review). 26 (8): 754–8. PMID 22957409.
  4. ^ a b "Oxygen Therapy". American Cancer Society. Archived from the original on 21 July 2010. Retrieved 29 November 2012.
  5. ^ Arias-Vázquez, Pedro Iván; Tovilla-Zárate, Carlos Alfonso; Hernández-Díaz, Yazmín; González-Castro, Thelma Beatriz; Juárez-Rojop, Isela Esther; López-Narváez, María Lilia; Bermudez-Ocaña, Deysi Yadira; Barjau-Madrígal, Hugo Adrián; Legorreta-Ramírez, Gabriela (30 May 2019). "Short-Term Therapeutic Effects of Ozone in the Management of Pain in Knee Osteoarthritis: A Meta-Analysis". PM&R. 11 (8): 879–887. doi:10.1002/pmrj.12088. PMID 30689297. S2CID 59307186.
  6. ^ Raeissadat, Seyed Ahmad; Tabibian, Elnaz; Rayegani, Seyed Mansoor; Rahimi-Dehgolan, Shahram; Babaei-Ghazani, Arash (October 2018). "An investigation into the efficacy of intra-articular ozone (O2–O3) injection in patients with knee osteoarthritis: a systematic review and meta-analysis". Journal of Pain Research. 11: 2537–2550. doi:10.2147/JPR.S175441. PMC 6207244. PMID 30498370.
  7. ^ Noori-Zadeh, Ali; Bakhtiyari, Salar; Khooz, Roghayeh; Haghani, Karimeh; Darabi, Shahram (1 February 2019). "Intra-articular ozone therapy efficiently attenuates pain in knee osteoarthritic subjects: A systematic review and meta-analysis". Complementary Therapies in Medicine. 42: 240–247. doi:10.1016/j.ctim.2018.11.023. PMID 30670248. S2CID 58951422.
  8. ^ Steppan, Jim; Meaders, Thomas; Muto, Mario; Murphy, Kieran J. (1 April 2010). "A Metaanalysis of the Effectiveness and Safety of Ozone Treatments for Herniated Lumbar Discs". Journal of Vascular and Interventional Radiology. 21 (4): 534–548. doi:10.1016/j.jvir.2009.12.393. PMID 20188591.
  9. ^ Fitzpatrick, Erin; Holland, Olivia J; Vanderlelie, Jessica J (August 2018). "Ozone therapy for the treatment of chronic wounds: A systematic review". International Wound Journal. 15 (4): 633–644. doi:10.1111/iwj.12907. PMC 7949634. PMID 29536625. S2CID 3855845.
  10. ^ Cespedes-Suarez, Javier; Martin-Serrano, Yanisley; Carballosa-Peña, Maria Rosa; Dager-Carballosa, Diana Rosa (15 December 2018). "Response of patients with chronic Hepatitis B in one year of treatment with Major Autohemotherapy". Journal of Ozone Therapy. 2 (3). doi:10.7203/jo3t.2.3.2018.11459. hdl:10550/72124. S2CID 196554051.
  11. ^ Jiao, XJ; Peng, X (December 2008). "Clinilal study of medical ozone therapy in chronic hepatitis B of 20 patients". Zhonghua Shi Yan He Lin Chuang Bing du Xue Za Zhi = Zhonghua Shiyan He Linchuang Bingduxue Zazhi = Chinese Journal of Experimental and Clinical Virology. 22 (6): 484–5. PMID 19544653.
  12. ^ Zaky, Saad; Kamel, Sherif Ebrahiem; Hassan, Magda Shahata; Sallam, Nadia Abdel; Shahata, Mohamad Ahmad; Helal, Shaaban Redwan; Mahmoud, Heba (March 2011). "Preliminary Results of Ozone Therapy as a Possible Treatment for Patients with Chronic Hepatitis C". The Journal of Alternative and Complementary Medicine. 17 (3): 259–263. doi:10.1089/acm.2010.0016. PMID 21417811.
  13. ^ Mawsouf, M.N.; Tanbouli, T.T.; Viebahn-Hänsler, R. (November 2012). "Ozone Therapy in Patients with Viral Hepatitis C: Ten Years' Experience". Ozone: Science & Engineering. 34 (6): 451–458. Bibcode:2012OzSE...34..451M. doi:10.1080/01919512.2012.720161. S2CID 96088027.
  14. ^ Huang, Jian; Xiang, Yaping; Gao, Lihua; Pan, Yizhi; Lu, Jianyun; Huang, Jinhua (28 February 2018). "[Topical ozone therapy: An innovative solution to patients with herpes zoster]". Zhong Nan da Xue Xue Bao. Yi Xue Ban = Journal of Central South University. Medical Sciences. 43 (2): 168–172. doi:10.11817/j.issn.1672-7347.2018.02.011. PMID 29559601.
  15. ^ Cespedes-Suarez, Javier; Martin-Serrano, Yanisley; Carballosa-Peña, Maria Rosa; Dager-Carballosa, Diana Rosa (15 December 2018). "The immune response behavior in HIV-AIDS patients treated with Ozone therapy for two years". Journal of Ozone Therapy. 2 (3). doi:10.7203/jo3t.2.3.2018.11458. hdl:10550/72131. S2CID 196563719.
  16. ^ Delgado-Roche, Livan; Riera-Romo, Mario; Mesta, Fernando; Hernández-Matos, Yanet; Barrios, Juan M.; Martínez-Sánchez, Gregorio; Al-Dalaien, Said M. (September 2017). "Medical ozone promotes Nrf2 phosphorylation reducing oxidative stress and pro-inflammatory cytokines in multiple sclerosis patients". European Journal of Pharmacology. 811: 148–154. doi:10.1016/j.ejphar.2017.06.017. PMID 28623000.
  17. ^ Green S (1997). "Oxygenation Therapy: Unproven Treatments for Cancer and AIDS". Scientific Review of Alternative Medicine.
  18. ^ "Code of Federal Regulations, Title 21 Vol 8 section 801.415". Food and Drug Administration. 1 April 2011. Retrieved 4 October 2011.
  19. ^ a b c Zanardi I, Borrelli E, Valacchi G, Travagli V, Bocci V (2016). "Ozone: A Multifaceted Molecule with Unexpected Therapeutic Activity". Current Medicinal Chemistry. 23 (4): 304–14. doi:10.2174/0929867323666151221150420. hdl:11365/998522. PMID 26687830.
  20. ^ Steppan J, Meaders T, Muto M, Murphy KJ (April 2010). "A metaanalysis of the effectiveness and safety of ozone treatments for herniated lumbar discs". Journal of Vascular and Interventional Radiology. 21 (4): 534–48. doi:10.1016/j.jvir.2009.12.393. PMID 20188591.
  21. ^ Braidy N, Izadi M, Sureda A, Jonaidi-Jafari N, Banki A, Nabavi SF, Nabavi SM (April 2018). "Therapeutic relevance of ozone therapy in degenerative diseases: Focus on diabetes and spinal pain". Journal of Cellular Physiology. 233 (4): 2705–2714. doi:10.1002/jcp.26044. PMID 28594115. S2CID 10266228.
  22. ^ "Belgian Court Continuing Investigation Of Ozone-therapy Doctor". Cycling News. 9 February 2013. Retrieved 10 February 2013.
  23. ^ Ozon-Therapie, Ozon-Eigenbluttherapie, Sauerstoff-OzonEigenbluttherapie, Oxyontherapie, Hyperbare Ozontherapie: Zusammenfassender Bericht des Arbeitsausschusses "Ärztliche Behandlung" des Bundesausschusses der Ärzte und Krankenkassen [Ozone therapy, Autologous ozone blood therapy, Oxygen-ozone autologous blood therapy, Oxyon therapy, Hyperbaric ozone therapy: Summary report of the "Medical Treatment" Working Committee of the Federal Committee of Doctors and Health Insurance Companies] (PDF) (in German). Geschäftsführung des Arbeitsausschusses "Ärztliche Behandlung" des Bundesausschusses der Ärzte und Krankenkassen. 30 March 2001. pp 17-18.
  24. ^ 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
  25. ^ Bocci V, Borrelli E, Travagli V, Zanardi I (July 2009). "The ozone paradox: ozone is a strong oxidant as well as a medical drug". Medicinal Research Reviews. 29 (4): 646–82. doi:10.1002/med.20150. hdl:11365/8222. PMID 19260079. S2CID 206250706.
  26. ^ a b Green S (17 June 2001). "Oxygenation therapy: Unproven treatments for Cancer and AIDS". Quackwatch.
  27. ^ Bocci V, Zanardia I, Valacchi G, Borrelli E, Travagli V (2015). "Validity of Oxygen-Ozone Therapy as Integrated Medication Form in Chronic Inflammatory Diseases". Cardiovascular & Hematological Disorders Drug Targets. 15 (2): 127–38. doi:10.2174/1871529x1502151209114642. hdl:11365/1000206. PMID 26126818.
  28. ^ Ernst E (January 2001). "A primer of complementary and alternative medicine commonly used by cancer patients". The Medical Journal of Australia. 174 (2): 88–92. doi:10.5694/j.1326-5377.2001.tb143161.x. PMID 11245510. S2CID 45055625. [citation requires membership to industry magazine]. This article also reports 5 fatalities, which are included in the 6 fatalities reported by Eisenmenger (1986).
  29. ^ Haggiag S, Prosperini L, Stasolla A, Gerace C, Tortorella C, Gasperini C (March 2021). "Ozone-induced encephalopathy: A novel iatrogenic entity". Eur J Neurol. 28 (8): 2471–2478. doi:10.1111/ene.14793. PMID 33657263. S2CID 232114612.
  30. ^ Knotts B (19 October 1990). "Judge Won't Reduce Bail For Ozone Therapy Advocate". The Sentinel Sun. Archived from the original on 23 October 2015. Retrieved 1 May 2018.
  31. ^ Whitlock, Chuck (2001). MediScams: how to spot and avoid health care scams, medical frauds, and quackery from the local physician to the major health care providers and drug manufacturers (1st ed.). Renaissance Books. p. 139. ISBN 978-1-58063-180-8.
  32. ^ Malaba T, Kiwanuka C (15 December 2008). "Ozone Therapy Lands Kampala Doctor in Trouble". Uganda Radio Network. Retrieved 1 May 2018.
  33. ^ "Woman who sought Thai "Ozone Therapy" dies". The New Zealand Herald. 7 September 2006. Retrieved 1 May 2018.
  34. ^ Detwiler, Jacqueline (5 January 2009). "Most Dangerous Health Scams". Forbes.
  35. ^ Kannan, Hashini Kavishtri (3 May 2017). "Ozone therapy treatments now banned in Malaysia". New Straits Times. Retrieved 27 December 2023.
  36. ^ "Lula sanciona lei que autoriza ozonioterapia no Brasil; texto diz que tratamento é complementar" [Lula signs law authorizing ozone therapy in Brazil; text states that the treatment is complementary] (in Portuguese). 7 August 2023. Retrieved 7 August 2023.
  37. ^ a b Chemical Technology Encyclopedia; Barnes & Noble 1968 vol.1 pp.82–83
  38. ^ Suchkov BP (June 1964). "[Study of the ozonization of drinking water containing pathogenic bacteria and viruses]". Gigiena i Sanitariia (in Russian). 29: 22–9. PMID 14235449.
  39. ^ "The Internal Administration of Ozone in the Treatment of Phthisis". Lancet. 140 (3612): 1180–1181. 1892. doi:10.1016/S0140-6736(01)92422-5.
  40. ^ Jacewicz N (2017). "A Killer of a Cure". Distillations. 3 (1): 34–37. Retrieved 13 April 2018.
  41. ^ Stoker G (1916). "The Surgical Uses of Ozone". Lancet. 188 (4860): 712. doi:10.1016/S0140-6736(01)31717-8.
  42. ^ MazzocchI, Alberto. "A Preliminary Study of the Reich Orgone Accumulator Effects on Human Physiology".
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