Ozone therapy is an alternative medical treatment that introduces ozone or ozonides to the body. In April 2003, the United States Food and Drug Administration (FDA) prohibited 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."
Ozone therapy has been sold as an unproven treatment for various illnesses, including cancer, a practice which has been characterized as "pure quackery". The therapy can cause serious adverse effects, including death.
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.
This therapy has been proposed as a primary or adjunct therapy for various diseases, including osteoarthritis, herniated disk, chronic wounds, hepatitis B and C, herpes zoster, HIV-AIDS, multiple sclerosis, 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. For treatment of HIV/AIDS, although ozone deactivates the viral particles outside the body, well-designed studies have shown there is no benefit for living patients.
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 in order 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. More recent reviews have highlighted that different routes of administration may result in different therapeutic and side effect profiles, though a statistically robust meta-analysis of available research has not been performed to date.
There is some controversy about its use by athletes in an attempt 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.
Ozone therapy has potentially serious adverse effects and as of 2012[update] at least five deaths had been reported as a result of the therapy's use on people with cancer. In Germany from 1975 to 1983, research revealed six deaths, four cases of visual disturbance, three cases of paraplegias, four gas embolisms in the pulmonary circuit, two heart attacks, four pulmonary embolisms, two cases of apoplectic paralysis, and two cases of abnormal heart rhythm 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 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 (though not all) 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 a risk of allergic shock.
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. 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. Proponents suggest that its effects are tissue dependent, though the subject is still debated.
Regulation and ethicsEdit
In April 2016, the FDA prohibited the medical use 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."
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. Arrests following similar activity have been made in other countries as well, including Uganda and Thailand.
Ozone therapy is sold as an expensive alternative cancer treatment in Germany. David Gorski has described the practice as "pure quackery". Proponents of the therapy falsely claim it is a recognized therapy there, but ozone therapy is not approved by the German medical establishment.
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. 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.
In 1892 The Lancet published an article describing the administration of ozone for treatment of tuberculosis. 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.
- Code of Federal Regulations Title 21 Sec. 801.415 Maximum acceptable level of ozone (FDA Website)
- David Gorski (24 October 2016). "German alternative cancer clinics: Combining experimental therapeutics with rank quackery and charging big bucks for it". Science-Based Medicine.
- 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.
- "Oxygen Therapy". American Cancer Society. Archived from the original on 21 July 2010. Retrieved 29 November 2012.CS1 maint: unfit url (link)
- 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.
- 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.
- 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.
- 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.
- 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. PMID 29536625.
- 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.
- 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.
- 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.
- 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. doi:10.1080/01919512.2012.720161.
- Huang, J; Huang, J; Xiang, Y; Gao, L; Pan, Y; Lu, J (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.
- 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.
- 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.
- Green S (1997). "Oxygenation Therapy: Unproven Treatments for Cancer and AIDS". Scientific Review of Alternative Medicine.
- "Code of Federal Regulations, Title 21 Vol 8 section 801.415". United States Food & Drug Administration. 1 April 2011. Retrieved 4 October 2011.
- 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. PMID 26687830.
- 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.
- 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.
- "Belgian Court Continuing Investigation Of Ozone-therapy Doctor". Cycling News. 9 February 2013. Retrieved 10 February 2013.
- 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). Köln: Geschäftsführung des Arbeitsausschusses "Ärztliche Behandlung" des Bundesausschusses der Ärzte und Krankenkassen. 30 March 2001. pp 17-18.
- 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
- 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. PMID 19260079.
- Green S (17 June 2001). "Oxygenation therapy: Unproven treatments for Cancer and AIDS". Quackwatch.
- 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. PMID 26126818.
- 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. [citation requires membership to industry magazine]. This article also reports 5 fatalities, which are included in the 6 fatalities reported by Eisenmenger (1986).
- Üreyen ÇM, Baş CY, Arslan Ş (June 2015). "Myocardial Infarction after Ozone Therapy: Is Ozone Therapy Dr. Jekyll or Mr. Hyde?". Cardiology. 132 (2): 101–104. doi:10.1159/000431078. PMID 26139204.
- Knotts B (19 October 1990). "Judge Won't Reduce Bail For Ozone Therapy Advocate". The Sentinel Sun. Retrieved 1 May 2018.
- Whitlock C (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.). Los Angeles: Renaissance Books. p. 139. ISBN 9781580631808. Retrieved 1 May 2018.
- Malaba T, Kiwanuka C (15 December 2008). "Ozone Therapy Lands Kampala Doctor in Trouble". Uganda Radio Network. Retrieved 1 May 2018.
- "Woman who sought Thai "Ozone Therapy" dies". The New Zealand Herald. 7 September 2006. Retrieved 1 May 2018.
- Chemical Technology Encyclopedia; Barnes & Noble 1968 vol. 1 pp. 82–83
- 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.
- "The Internal Administration of Ozone in the Treatment of Phthisis". Lancet. 140 (3612): 1180–1181. 1892. doi:10.1016/S0140-6736(01)92422-5.
- Jacewicz N (2017). "A Killer of a Cure". Distillations. 3 (1): 34–37. Retrieved 13 April 2018.
- Stoker G (1916). "The Surgical Uses of Ozone". Lancet. 188 (4860): 712. doi:10.1016/S0140-6736(01)31717-8.