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Ozone therapy is an alternative medical treatment that introduces
ozone Ozone (), or trioxygen, is an inorganic molecule with the chemical formula . It is a pale blue gas with a distinctively pungent smell. It is an allotrope of oxygen that is much less stable than the diatomic allotrope , breaking down in the lowe ...
or
ozonide Ozonide is the polyatomic anion . Cyclic organic compounds formed by the addition of ozone () to an alkene are also called ozonides. Ionic ozonides Inorganic ozonides are dark red salts. The anion has the bent shape of the ozone molecule. Ino ...
s to the body. The United States
Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food s ...
(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." Ozone therapy has been sold as an unproven treatment for various illnesses, including cancer, a practice which has been characterized as "pure
quackery Quackery, often synonymous with health fraud, is the promotion of fraudulent or ignorant medical practices. A quack is a "fraudulent or ignorant pretender to medical skill" or "a person who pretends, professionally or publicly, to have skill, k ...
". The therapy can cause serious
adverse effect An adverse effect is an undesired harmful effect resulting from a medication or other intervention, such as surgery. An adverse effect may be termed a "side effect", when judged to be secondary to a main or therapeutic effect. The term complica ...
s, including death.


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 In mammals, the vagina is the elastic, muscular part of the female genital tract. In humans, it extends from the vestibule to the cervix. The outer vaginal opening is normally partly covered by a thin layer of mucosal tissue called the hymen ...
,
rectum The rectum is the final straight portion of the large intestine in humans and some other mammals, and the gut in others. The adult human rectum is about long, and begins at the rectosigmoid junction (the end of the sigmoid colon) at the le ...
,
intramuscular Intramuscular injection, often abbreviated IM, is the injection of a substance into a muscle. In medicine, it is one of several methods for parenteral administration of medications. Intramuscular injection may be preferred because muscles have ...
(in a muscle),
subcutaneously The subcutaneous tissue (), also called the hypodermis, hypoderm (), subcutis, superficial fascia, is the lowermost layer of the integumentary system in vertebrates. The types of cells found in the layer are fibroblasts, adipose cells, and macro ...
(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 Osteoarthritis (OA) is a type of degenerative joint disease that results from breakdown of joint cartilage and underlying bone which affects 1 in 7 adults in the United States. It is believed to be the fourth leading cause of disability in the ...
, herniated disk, chronic wounds,
hepatitis B Hepatitis B is an infectious disease caused by the ''Hepatitis B virus'' (HBV) that affects the liver; it is a type of viral hepatitis. It can cause both acute and chronic infection. Many people have no symptoms during an initial infection. For ...
and C,
herpes zoster Shingles, also known as zoster or herpes zoster, is a viral disease characterized by a painful skin rash with blisters in a localized area. Typically the rash occurs in a single, wide mark either on the left or right side of the body or face. ...
, HIV-AIDS,
multiple sclerosis Multiple (cerebral) sclerosis (MS), also known as encephalomyelitis disseminata or disseminated sclerosis, is the most common demyelinating disease, in which the insulating covers of nerve cells in the brain and spinal cord are damaged. This ...
, cancer,
heart disease Cardiovascular disease (CVD) is a class of diseases that involve the heart or blood vessels. CVD includes coronary artery diseases (CAD) such as angina and myocardial infarction (commonly known as a heart attack). Other CVDs include stroke, h ...
,
Alzheimer's dementia Alzheimer's disease (AD) is a neurodegenerative disease that usually starts slowly and progressively worsens. It is the cause of 60–70% of cases of dementia. The most common early symptom is difficulty in remembering recent events. As t ...
, and
Lyme disease Lyme disease, also known as Lyme borreliosis, is a vector-borne disease caused by the ''Borrelia'' bacterium, which is spread by ticks in the genus ''Ixodes''. The most common sign of infection is an expanding red rash, known as erythema migran ...
, though supportive evidence for some of these applications is limited. The
American Cancer Society The American Cancer Society (ACS) is a nationwide voluntary health organization dedicated to eliminating cancer. Established in 1913, the society is organized into six geographical regions of both medical and lay volunteers operating in more than ...
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 Human immunodeficiency virus infection and acquired immunodeficiency syndrome (HIV/AIDS) is a spectrum of conditions caused by infection with the human immunodeficiency virus (HIV), a retrovirus. Following initial infection an individual ma ...
, 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 The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food s ...
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 Pulmonary edema, also known as pulmonary congestion, is excessive liquid accumulation in the tissue and air spaces (usually alveoli) of the lungs. It leads to impaired gas exchange and may cause hypoxemia and respiratory failure. It is due to ...
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. 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. Some reviews have suggested ozone as a potential treatment for
herniated disc Spinal disc herniation is an injury to the cushioning and connective tissue between vertebrae, usually caused by excessive strain or trauma to the spine. It may result in back pain, pain or sensation in different parts of the body, and physica ...
s and
diabetic neuropathy Diabetic neuropathy is various types of nerve damage associated with diabetes mellitus. Symptoms depend on the site of nerve damage and can include motor changes such as weakness; sensory symptoms such as numbness, tingling, or pain; or autonomic c ...
. 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.


Safety

Ozone therapy has potentially serious
adverse effect An adverse effect is an undesired harmful effect resulting from a medication or other intervention, such as surgery. An adverse effect may be termed a "side effect", when judged to be secondary to a main or therapeutic effect. The term complica ...
s, and at least five deaths had been reported due to the therapy's use on people with cancer. From 1975 to 1983 in Germany, research revealed six deaths, four cases of visual disturbance, three cases of
paraplegia Paraplegia, or paraparesis, is an impairment in motor or sensory function of the lower extremities. The word comes from Ionic Greek () "half-stricken". It is usually caused by spinal cord injury or a congenital condition that affects the neural ...
s, four
gas embolism An air embolism, also known as a gas embolism, is a blood vessel blockage caused by one or more bubbles of air or other gas in the circulatory system. Air can be introduced into the circulation during surgical procedures, lung over-expansion ...
s in the pulmonary circuit, two
heart attacks A myocardial infarction (MI), commonly known as a heart attack, occurs when Hemodynamics, blood flow decreases or stops to the coronary artery of the heart, causing ischemia, damage to the cardiac muscle, heart muscle. The most common symptom i ...
, four
pulmonary embolism Pulmonary embolism (PE) is a blockage of an artery in the lungs by a substance that has moved from elsewhere in the body through the bloodstream (embolism). Symptoms of a PE may include shortness of breath, chest pain particularly upon breathing ...
s, two cases of
apoplectic Apoplexy () is rupture of an internal organ and the accompanying symptoms. The term formerly referred to what is now called a stroke. Nowadays, health care professionals do not use the term, but instead specify the anatomic location of the bleedi ...
paralysis, and two cases of
abnormal heart rhythm Arrhythmias, also known as cardiac arrhythmias, heart arrhythmias, or dysrhythmias, are irregularities in the heartbeat, including when it is too fast or too slow. A resting heart rate that is too fast – above 100 beats per minute in adults ...
following ozone therapy. More commonly,
pulmonary edema Pulmonary edema, also known as pulmonary congestion, is excessive liquid accumulation in the tissue and air spaces (usually alveoli) of the lungs. It leads to impaired gas exchange and may cause hypoxemia and respiratory failure. It is due to ...
is the most prevalent adverse effect of ozone treatment. In the muscular system, many cases of
tendon rupture Tendon rupture is a condition in which a tendon separates in whole or in part from tissue to which it is attached, or is itself torn or otherwise divided in whole or in part. Examples include: * Achilles tendon rupture * Biceps tendon rupture * A ...
,
osteoarthritis Osteoarthritis (OA) is a type of degenerative joint disease that results from breakdown of joint cartilage and underlying bone which affects 1 in 7 adults in the United States. It is believed to be the fourth leading cause of disability in the ...
,
myositis Myositis is a rare disease that involves inflammation of the muscles. This can present with a variety of symptoms such as skin involvement (i.e., rashes), muscle weakness, and other organ involvement. Systemic symptoms such as weight loss, fatigue ...
,
synovitis Synovitis is the medical term for inflammation of the synovial membrane. This membrane lines joints that possess cavities, known as synovial joints. The condition is usually painful, particularly when the joint is moved. The joint usually swel ...
, joint infections, and muscle tears have been documented results of ozone therapy. In the
integumentary system The integumentary system is the set of organs forming the outermost layer of an animal's body. It comprises the skin and its appendages, which act as a physical barrier between the external environment and the internal environment that it serves ...
, 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. 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 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 Pulmonary edema, also known as pulmonary congestion, is excessive liquid accumulation in the tissue and air spaces (usually alveoli) of the lungs. It leads to impaired gas exchange and may cause hypoxemia and respiratory failure. It is due to ...
, 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. Other serious incidents reported include transmission of
hepatitis C Hepatitis C is an infectious disease caused by the hepatitis C virus (HCV) that primarily affects the liver; it is a type of viral hepatitis. During the initial infection people often have mild or no symptoms. Occasionally a fever, dark urine, a ...
, itation requires membership to industry magazine This article also reports 5 fatalities, which are included in the 6 fatalities reported by Eisenmenger (1986). and one case of a
heart attack A myocardial infarction (MI), commonly known as a heart attack, occurs when blood flow decreases or stops to the coronary artery of the heart, causing damage to the heart muscle. The most common symptom is chest pain or discomfort which may tr ...
following some hours after autohemotherapy. Ozone-based treatments can be associated with central nervous system toxicity, termed Ozone Induced Encephalopathy (OIE). OIE may include cortical visual impairment, altered mental status, headache, focal neurological deficits, seizures, dizziness, nausea, and vomiting, regardless of the route of administration. OIE should be considered in patients presenting with neurological symptoms in close relation to Ozone Therapy.


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 "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."Code of Federal Regulations Title 21
Sec. 801.415 Maximum acceptable level of ozone (FDA Website, as of 2022-07-18)
Beginning in 1991 the
FDA The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food s ...
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 David Henry Gorski is an American surgical oncologist, professor of surgery at Wayne State University School of Medicine, and a surgical oncologist at the Barbara Ann Karmanos Cancer Institute, specializing in breast cancer surgery. He is an ou ...
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.


History

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.Chemical Technology Encyclopedia; Barnes & Noble 1968 vol. 1 pp. 82–83 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 his work on
bioenergetic analysis Body psychotherapy, also called body-oriented psychotherapy, is an approach to psychotherapy which applies basic principles of somatic psychology. It originated in the work of Pierre Janet, Sigmund Freud and particularly Wilhelm Reich who develope ...
, proponent of ozone therapy William Reich developed a device utilizing ozonides which "...one inserted their testiculars '' ic'". William Reich's work on alternative medicine on the pseudoscientific lifeforce known as
Orgone Orgone () is a pseudoscientific concept variously described as an esoteric energy or hypothetical universal life force. Originally proposed in the 1930s by Wilhelm Reich, and developed by Reich's student Charles Kelley after Reich's death in ...
which ozone therapy was said to enhance. In 1892 ''
The Lancet ''The Lancet'' is a weekly peer-reviewed general medical journal and one of the oldest of its kind. It is also the world's highest-impact academic journal. It was founded in England in 1823. The journal publishes original research articles, ...
'' published an article describing the administration of ozone for treatment of
tuberculosis Tuberculosis (TB) is an infectious disease usually caused by ''Mycobacterium tuberculosis'' (MTB) bacteria. Tuberculosis generally affects the lungs, but it can also affect other parts of the body. Most infections show no symptoms, in w ...
. During World War I, ozone was tested at
Queen Alexandra Military Hospital The Queen Alexandra Military Hospital (QAMH) opened in July 1905. It was constructed immediately to the north of the Tate Britain (across a side-street) adjacent to the River Thames on the borders of the neighbourhoods of Millbank and Pimlico, ...
in London as a possible
disinfectant A disinfectant is a chemical substance or compound used to inactivate or destroy microorganisms on inert surfaces. Disinfection does not necessarily kill all microorganisms, especially resistant bacterial spores; it is less effective than st ...
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 An antiseptic (from Greek ἀντί ''anti'', "against" and σηπτικός ''sēptikos'', "putrefactive") is an antimicrobial substance or compound that is applied to living tissue/skin to reduce the possibility of infection, sepsis, or putre ...
, were found preferable.


See also

* Ozone health effects *
Air ioniser An air ioniser (or negative ion generator or Chizhevsky's chandelier) is a device that uses high voltage to ionise (electrically charge) air molecules. Negative ions, or anions, are particles with one or more extra electrons, conferring a net ...
*
List of unproven and disproven cancer treatments This is a non-exhaustive list of alternative treatments that have been promoted to treat or prevent cancer in humans but which lack scientific and medical evidence of effectiveness. In many cases, there is scientific evidence that the alleged tr ...


References

{{Reflist


External links


Ozone Generators that are Sold as Air Cleaners
- factsheet at US EPA Doping in sport Alternative medicine Pseudoscience Health fraud