Ozone therapy: notes on the infamous German safety study

Many ozone therapy proponents cite a “German study” into the safety of the treatment, which showed an extremely low risk of side effects based on over 5.5 million treatments. In fact, this appears to be misleading, and serious side effects including deaths have occurred over the years. Apparent causes of death have been gas embolism and allergic shock. The actual risk appears to still be fairly low for autohaemotherapy, though with possible remaining risk of allergic shock. I’m still in the process of translating these sources from German.

Regarding the widely-cited German study on safety:
https://www.g-ba.de/downloads/40-268-248/HTA-Ozon-Therapie.pdf pp 17-18

Side effects
Information on the risks and complications of ozone therapy is largely based on the dissertation by M.T. Attributed to Jacobs from 1982. The author calculated his results from the data provided by 23% of the 2,815 ozone therapists contacted. Thereafter, there were 336 incidents in 5,579,238 ozone applications (in 384,775 treated patients), of which 309 were “certainly” not due to “ozone per se”. In 27 “real” incidents, there were 3 eczematous skin reactions, 2 hypoglycemic conditions, 11 allergic reactions and 11 “unexplained cases” (including 1 death, 1 amaurosis). Jacobs calculated a side effect rate of 0.006%, “attributable to the substance ozone” was 0.0005%.
Eisenmenger criticized Jacobs’ calculations in 1986. A fundamental criticism was initially when there was doubt about the representativeness of the sample and the validity of the results. For example, no information on the basis of the success assessment shown was documented.
The main point of criticism, however, was the way in which the side effect rate was calculated. Jacobs based the incident rate on the millions of ozone applications, but not on the number of patients treated. If, as with drug side effects, the number of incidents is related to the number of patients treated, the incidence rate is between 0.1 and 0.2%. This quota would be considered to be questionable under pharmaceutical law.
In addition, publications on Jacobs’ work showed deviations from the data given in the dissertation, which are probably due to different, subjective conclusions drawn with regard to the relationship between ozone treatment and symptoms in the patient. This gives changing information on the number of incidents and deaths. The number of reported deaths directly related to ozone treatment varied between 1 and 6 patients. In contrast to the descriptions given above from Jacobs’ dissertation, Eisenmenger found the following tabular list of incidents in one publication:

  • Deaths 6
  • Visual disturbances 4
  • Paraplegia 3
  • Gas embolism in the pulmonary circuit 4
  • Heart attacks 2
  • Pulmonary embolism 4
  • Apoplectic paralysis 2
  • Cardiac arrhythmias 2

According to the previous publications, the criteria used to select 27 of the 336 incidents reported, the cause of which was assumed to be the substance “ozone per se”.
Further reports on various side effects (transmission of hepatitis C and AIDS pathogens; gas embolism, anaphylactic reactions, neurological symptoms, syringe abscesses) were later published. [i.a. Binder 96, Daschner 89,96,97; Eisenmenger 86; Gabriel et al. 96; Lüth et al. 83; Mattig et al. 87; Mayer 91; Oepen 89.92; Pencz 78; RKI 97; Roeckl 96; Schmitt 82]
The Committee draws the conclusion from the present publications on potential risks of ozone therapy that scientifically valid studies on the safety of the process are not yet available, but these are essential in view of the potentially fatal side effects of ozone therapy.

 

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

This article counters the claim of near complete safety, and lists a number of severe complications including deaths from apparent gas embolism or allergic shock (starting after the image of actress Jenny Jugo below). These followed direct gas injection, which is now regarded by many practitioners as malpractice; but even with autohaemotherapy (withdrawing blood, interacting it with oxygen-ozone, then re-injecting the blood) there remains a possible risk of allergic shock.

ON OZONE THERAPY
By WOLFGANG EISENMENGER

In recent years, ozone therapy has become known to a broad lay public, above all through reports in the daily press and in magazines. During the well-known naturopath Dr. jur. Köhnlechner described them as “the sharpest therapeutic weapon in the fight against circulatory disorders”, court experts and angiologists in trade journals have increasingly commented critically on this outsider method. The method is named after the ozone that is used in gas form. Ozone is a molecule composed of three atoms of oxygen with the chemical formula 03. It is created from oxygen in Ultraviolet radiation or electrical discharges and is a natural part of the earth’s atmosphere. Often the layman is also familiar with the smell of ozone, which can be perceived after lightning strikes and has led to the naming (ozein, Greek = smell). Ozone is extremely reactive chemically, since its decomposition produces molecular and nascent oxygen and because it supplies OH and OOH radicals in an aqueous environment. With organic compounds it can form ozonides, of which those of unsaturated fatty acids, sorbic acid and some terpenes are known. Large quantities of pure ozone were first produced in 1857 by Werner von Siemens using a tube generator. This principle is still used today for the production of ozone, whereby the development of ozone-resistant plastics today allows ozone to be produced in relatively compact and practical devices. Today, ozone has a wide range of applications, which has led to the establishment in 1973 of an “International Ozone Association” which deals with the production and use of ozone in nature and technology. The application in the treatment of drinking water and wastewater has become more well-known. The application in the medical field had its first beginnings in the second half of the 19th century. Jaroszyk [26] quotes e.g. Work from the years 1873/74 and 1888, in which the use of ozone in the treatment of malignant tumors is reported, whereby in one case ozonized water was injected into the surroundings of tumors, with the result of tumor regression.

The use of gaseous ozone in medicine goes back to A. Wolff [61]. The latter treated infected wounds during the First World War with an oxygen-ozone gas stream, whereby he claims to have had good results. The “crown witness” of ozone therapy was the Leipzig professor of surgery Payr. He had found contact with the ozone application through his own experience when in 1932 the dentist Fisch treated him with an ozone-oxygen injection into the pulp cavity because of gangrene pulpitis and Payr quickly became symptom-free. Payr then carried out experiments with ozone at his clinic, about which he reported both at the 59th meeting of the German Society for Surgery and in a publication [42]. In essence, he limited himself to the treatment of soft tissue infections when using ozone. In the pre-antibiotic era, these were cases where the limits of therapeutic success were reached. However, he also discussed intravenous use and administration for malignant tumors, sinus insufflations, intestinal insufflations, use for vascular occlusions, gangrene, rheumatism. A word by Payrs from his publication at the time can be found in a large number of new publications by ozone therapists: “What oxygen cannot do, ozone can do.”

Before the Second World War, there were further attempts at therapeutic use of ozone in France by Aubourg, in Switzerland by Bircher and at the Dermatological University Clinic in Munich, whereby the dermatologist Thieme clearly described successes and failures and described ozone as a good, irritant disinfectant, an analysis of the effort, time and costs had to decide on its further use. In the Second World War, therapeutic use does not appear to have been carried out on a larger scale, at least.

The “Renaissance” began after the war with the so-called hematogenous oxidation therapy according to Wehrli [57], briefly referred to as HOT, in which blood was oxygenated extracorporeally under UV radiation and then reinjected. Steinbart [51, 52] pointed out in the 1950s that the active principle of this treatment was based on the ozone generated by the UV radiation of the oxygen, and constructed a practical device for producing ozone. Soon afterwards, the physicist Hänssler developed other devices that were more widespread in the Federal Republic under the brand name “Ozo-nosan”. At the moment, newer devices from this manufacturer are called “PM 80”, “PM 81 D”, “PM 82 L “and” PM 83 K “on the market. Recently, another manufacturer has launched a device called” Bio-zomat “onto the market, especially for hyperbaric ozone therapy according to Kief.

The ozone application found its most active supporter in the internist Η. H. Wolff, became the chairman of the “Medical Society for Ozone Therapy eV” founded in 1972. His 1979 book> The Medical Ozone <[63] is generally referred to by ozone therapists as a basic source work. In it, Wolff gives a summary of the theoretical foundations and the therapeutic application of ozone and names the following types of application: subcutaneous, intramuscular, intravenous, intraarterial and intra-abdominal injections; Insufflations in the intestine, bladder, ureter, vagina; Fumigation of the skin; Injections in fistulas; extracorporeal introduction of ozone-oxygen mixtures (02/03) into the extracted blood with reinjection or infusion, depending on the amount of blood referred to as “small” or “large autologous blood treatment”. Ultimately, dentistry propagates the insufflation of ozone into root canals and the rinsing of inflamed tissue with ozone water as well as the introduction of instruments into ozone water.

The catalog of indications spans a wide range of ailments and diseases from many areas of medicine.

A compilation of the indications from the Vademecum for ozone therapy of the “Medical Society for Ozontherapy eV” is given in Table 1 by Oepen et al , coronary insufficiency and ulcer ventriculi et duodeni, lactation inhibition, kidney diseases of various origins, myocardial damage, condition after heart attack, dysmenorrhea, vegetative dystonia, therapy-resistant anemia, pylorospasm and dermatomycosis are no longer listed and fresh organ bleeding that is not directly accessible to ozone treatment. It is striking that, compared to previous indications, actinomycosis, cardiac and circulatory insufficiency with and without cyanosis, coronary insufficiency and ulcer ventriculi et duodeni, lactation inhibition, kidney diseases of various origins, myocardial damage, condition after heart attack, dysmenorrhea, vegetative dystonia, therapy-resistant Pylorospasm and dermatomycoses are no longer listed. Only two diseases in the literature are highlighted as contraindications: thyrotoxicosis and fresh organ bleeding, which are not directly accessible to ozone treatment.

Regardless of the proposals of the “Medical Society for Ozone Therapy e. V. “, there are numerous other indications in the ozone therapist literature. These include, for example, subcutaneous 02/03 injections for the treatment of migraines and cerebral circulatory disorders due to traumatic, apoplectic, arteriosclerotic and epileptic causes, use in cases of dyspnea with myogenic heart failure , Valve veins, angina pectoris and pulmonary emphysema. Astonishing successes are reported in Sudeck’s atrophy. For a number of years, ozone additive therapy for cancer patients has been added as a special indication area. Here Wolff mentions it as one of 10 points that were developed based on Seeger [48]. The use of ozone is mentioned here on an equal footing with the “suppression of all interference fields according to Huneke”, the administration of “preparations containing carcinoma antigens”, the injection of freshly extracted raw breast milk, the administration of mistletoe extracts, the ban on the absorption of glucose in all forms and the “omission harmful agents and methods, including cytostatics “.

Tab. 1: Compilation of the indications for ozone-oxygen therapy, from: Vademecum for ozone therapy of the “Medical Society for Ozone Therapy eV” (status 1.4.1981). Here, 03/02 gas quantities and concentrations ( K) administered in the following order: for intestinal insufflation 50 to 500 ml (maximum 1000 ml) gas for 10 to 30 seconds, K24 to 75 μg 03 / ml; for injection (ia, iv or im) 5 to 20 ml gas, K5 to 70 μg 03 / ml; for autologous blood treatment 10 ml gas for 10 ml blood or 10 ml gas for 50 (up to 70 ml) blood, Κ16 to 60 μg 03 / ml.
Diseases:                  Type of ozone application
  1. Anal fissures and fistulas: Inject fissures; Filling the fistula wall with a long needle, gassing on the outside;
  2. Anal eczema: Intestinal insufflation
  3. Proctitis, hemorrhoidal syndrome: Intestinal insufflation
  4. Ulcerative and mucosal colitis: Intestinal insufflation
  5. “Colibacillosis”: Intestinal insufflation
  6. Spastic constipation: Intestinal insufflation
  7. Bladder fistula: Insufflation
  8. Chronic cystitis: Insufflation
  9. Chronic hepatitis: Large autologous blood treatment
  10. Cirrhosis of the liver: Large autologous blood treatment
  11. Osteomyelitis: with a long needle directly to the bone, leaving the needle.
  12. Acne vulgaris: Small autologous blood treatment
  13. Furunculosis: Small autologous blood treatment
  14. Rhinitis vasomotorica: Small autologous blood treatment
  15. Ulcus cruris, decubitus ulcers, poorly healing wounds, X-ray ulcers, painful indurations: Flushing with ozonated water, fumigation in a plastic bag, vacuum fumigation.
  16. Varicose complex of symptoms: According to Wolff: Applying an Esmarch dust bandage on the thigh, filling the veins with ozone by injection.
  17. Fresh thrombophlebitis, varicose veins: Insufflation by injection with the thigh constricted.
  18. Obliterating arterial vascular diseases, gangrene and atonic ulcers of the legs: Fumigation, intra-arterial injections.
  19. Peripheral circulatory disorders , diabetic gangrene: intraarterial injection
  20. Arteritis obliterans: intraarterial injection
  21. Arteriosclerosis, cerebral sclerosis, arteriosclerotic gangrene: intra-arterial injections into the femoral artery, possibly small autologous blood treatment
  22. M. Parkinson: Large autologous blood treatment
  23. Primarily chronic polyarthritis: Large autologous blood treatment
  24. Bronchial asthma: Large autologous blood treatment
  25. Malignant diseases: i. m. possibly s. c. Injection in each half of the buttocks.
  26. geriatric conditions: small or large autologous blood treatment.
  27. Treatment of preserved blood: 100 ml gas with 54 μg 03 / ml on 500 ml blood
With such a wide range of alleged indications, ozone therapists naturally strive to provide illuminating explanations of the principles of action. From the historical development of the use of ozone and from the application in the biological-technical field for water disinfection, it seems obvious to put special emphasis on the effect of ozone on microorganisms. This highlights the bactericidal and virucidal effects of ozone in an aqueous environment and also the similar effects of ozonides as are present in ozonated olive oil. This explains the positive effect on inflammation caused by bacteria or viruses in the human body.

Another key active principle is the chemical reaction of ozone with various substances in the human body. Wolff cites studies [11, 12, 49] that ozone weakens the effects of diastase, emulsin, pepsin, invertin, ptyalin, pancreatin and rennet, that is, it reacts with enzymes. Another target is the oxidation of free amino acids, according to Mudd et al. [37] specifically methionine and tryptophan. The same author assumes that ozone plays a role in the formation of peptide chains and that ozone reacts with nicotinamide coenzymes, whereby NADH is preferentially oxidized by ozone and, among other things, but only to a small extent, NAD is formed. From this, Wolff concludes that ozone in the NAD-NADH equilibrium causes a shift to NAD with the consequence of an increase in the willingness to reduce all metabolic steps. Furthermore, a special effect of ozone on unsaturated fatty acids in the blood with the formation of ozonides is postulated, based on studies by Albers [1,2], who examined the oxygen uptake of a linseed oil emulsion in vitro when adding erythrocytes, whole blood, plasma and ozone. Albers concluded from his results that there were inhibitors of oxidation in the blood which were destroyed by ozone. In connection with the formation of peroxides in the blood, the special effect on tumor cells is also discussed. Wolff [63] also points out the effect of ozone on other substances in the blood, such as creatinine, uric acid, pyruvate, protein and bilirubin. According to this, the total protein content is independent of the ozone, while uric acid, pyruvate, glucose and bilirubin decrease significantly depending on the ozone concentration used, i.e. would be broken down. Wolff also reports that the deformability of erythrocytes is increasing, referring to more recent literature [9], which describes membrane biochemical changes. The structure of the membrane lipids should be loosened by shortening the unsaturated fatty acids in the erythrocyte membrane, and the resulting ozonides should intervene in the glucose metabolism in the erythrocytes, with an increase in 2,3-diphosphoglycerate being attributed to the essential effect of the curative ozone effect. As the most important physiological effect, Wolff states that the oxygen partial pressure of the blood increases when ozone is given, so that a higher oxygen saturation of the blood is achieved.

The success stories of the ozone therapists are impressive. A work by Tabakova from the 3rd Surgical Clinic of the University of Sofia / Bulgaria [54] is cited particularly frequently. According to the study, 165 patients suffering from endarteritis obliterans, leg ulcers and varicosum, arteriosclerotic gangrene, diabetic gangrene and Raynaud’s disease managed to achieve an effective recovery in almost 98% of cases with obliterating vascular disease. The atonic ulcers were also healed with fumigation and injection with ozone. Wolff [64] reported 84% of excellent results in arterial circulatory disorders of stages III and IV according to Fontaine, and in 13% still moderate results. Ionescu u. Employee [22] reported an improvement in stage II to IV arterial circulatory disorders according to Fontaine in 54% of 46 cases and in 26% freedom from symptoms. Impressive success has also been reported with fumigation of skin lesions of different origins [59]. Constipation, ulcerative colitis, neurological diseases such as the condition after apo-plectic insult, liver diseases such as chronically aggressive hepatitis and also psychological symptoms were positively influenced according to various authors at the 1st International Ozone Therapy Congress. Biochemical parameters were also changed positively in vivo and in vitro. For example, reported a significant reduction in elevated cholesterol and transaminase levels in the blood and a significant reduction in uric acid levels [29].

Regarding possible complications and incidents, it had been claimed for years that the method was completely harmless. Although it was pointed out in individual publications that there were pressure sensations under the sternum, coughing and nausea after i.v. injection of 02/03, there were also reports of rippling noises above the heart after injection of 150 cm3 (!) of gas mixture into the cubital vein. In 1980, however, Wolff claimed at the 2nd Congress of the “Austrian Medical Society for Ozone Therapy” that there were no typical incidents caused by ozone. In the same year, the “Medical Society for Ozone Therapy e.V.” a survey of doctors and naturopaths to record observed side effects and incidents. The evaluation should be done as a dissertation.

Before the work was accepted as a dissertation by the relevant faculty, the results contained therein were partially published and used for argumentation. After that, out of 2,815 ozone therapists contacted – both doctors and naturopaths – 644 replied. They reported treating at least 384775 patients with a minimum of 5579238 ozone applications. 336 incidents were reported. The author analyzed that 309 of them were certainly not due to ozone per se, but rather reactions to e.g. B. Procaine preparations injected at the same time, hypocalcemic reactions to the administration of sodium citricum, result of defective technology such as air injection or intravascular, especially IV injection, which was too fast. 27 were then identified as real incidents, which were made up as follows: 3 eczematous skin reactions, 2 hypoglycanic conditions, 11 allergic reactions and 11 other unexplained cases, including one death and one case of bilateral amaurosis (blindness). It was concluded that the ozone application had a side effect rate of 0.006%, of which 0.0005% was due to the substance ozone. This incidence rate is surprisingly low compared to general serious drug reactions. However, after the publication of these results, a warning was given for the first time before the iv injection, since it is the most likely to cause an accident and offers no advantages over the “large autologous blood treatment”. Only in recent publications has this warning been formulated so clearly that the iv injection is considered obsolete or was called “malpractice” [17].

If one draws the conclusion from the previously cited representations of ozone therapists, it can be stated in a simplistic manner that, in the opinion of its users, ozone therapy is a method which has enormous positive effects, which are rarely achieved in medicine, according to statistical data, in a large number of cases Diseases of the most diverse etiology and pathogenesis are guaranteed and at the same time only cause a negligible number of side effects. If the latter occur at all, they can largely be traced back to mistakes made by the therapist. The application is so simple that the remedy or method is harmless even in the hands of the naturopath!

Actress Jenny Jugo with symptoms of paralysis after “ozone injection” (photo Weggemann / Stern).

With all of this, the question arises, why ozone therapy must still exist as an outsider method and has not found its way into conventional medicine. It also remains incomprehensible why statutory insurance companies still refuse to include ozone therapy in their service catalog and why processes are being carried out to determine the effects and consequences of ozone therapy. The very last point was the reason why the method had to be paid attention to by forensic medicine. The first serious incidents did not become known, however, in connection with investigations by the public prosecutor, but because the press took care of them. In 1975, a well-known former film actress suddenly developed severe paralysis and emotional disturbances after intra-arterial injection of a 02/03 mixture, which only partially resolved (Fig. 1). This resulted in permanent damage to the left lumbar mark and additional spinal Brown-Sequard hemiplegia of D V / D VI. The case was taken up by the press because the treatment had been given by a well-known naturopath. Another issue of paraplegia after intra-arterial 02/03 injection, which has been associated with this naturopath, was dealt with in the magazine “Der Spiegel” in its No. 8, 1976.

It may be surprising that, for many years, no medical incidents after ozone therapy have been mentioned in medical literature and that the first specialist publication was preceded by reports in the lay press. One explanation can be found in the fact that even in large clinics, more than one serious complication was rarely treated within a manageable period of time, and that the clinical pictures that occurred under ozone therapy were also very difficult to interpret by differential diagnosis. Severe malfunctions of the central nervous system such as Passenger amauroses, which were observed several times after IV injection, were classified as hysterical blindness. In this context, a case from 1968 appears to be characteristic, when a 49-year-old patient after ozone injection with amaurosis and confusion was admitted to a Cologne clinic, whereby, as in later cases, considerable general changes were found in the EEG. The treating physicians considered the clinical picture to be an encephalitis of unknown origin after an unambiguous diagnostic clarification was not possible; the amaurosis was disqualified as psychologically.

Ozone therapy reached a forensic dimension when deaths were subjected to a forensic medical examination. The first such case occurred in Munich when, at the beginning of 1978, a 70-year-old woman became blind and passed out during an IV injection from 02/03 by a naturopath into the cubital vein. About three weeks later, the patient died of pneumonia in inpatient treatment. The neuropathological examination revealed numerous focussed softenings in the brain as with local circulatory disorders, with no pathological changes in the vessel wall being observed. An allergic shock and gas embolism were therefore discussed as the cause.

Just a few weeks later, a 33-year-old woman died in Schweinfurt in the practice of an alternative practitioner immediately after supposedly intra-arterial 02/03 injection. During the autopsy it was found that the injection was carried out intravenously. Since gas embolism could not be demonstrated and histologically there was allergic vasculitis, an allergic shock was assumed to be the cause of death.

At this time, incidents after ozone therapy were first mentioned in the medical literature. Pencz [43] reported on two cases: A 59-year-old patient had undergone complete amaurosis after i.v. injection of 15 ml gas mixture by a medical practitioner, combined with retrograde amnesia and impaired consciousness, which resolved after 6 days. The clinical picture corresponded to massive cerebral gas embolism. He also reported on a 72-year-old patient who had a complete spinal cross-sectional syndrome a few minutes after intra-arterial injection of an unknown amount 02/03 in both groin arteries and died a few weeks later. Pencz discussed here the cause of anterior spinal syndrome caused by an injection-induced vascular spasm or a drop in blood pressure.

At the end of 1978 there was another serious incident in Munich. A 68-year-old patient went blind immediately following an IV injection administered by a doctor, with only a few milliliters 02/03 being inserted into the cubital vein. As a result, a severe organic psycho-syndrome developed, so that the patient became a nursing case; the amaurosis was irreversible. After her death in 1980, the forensic medical examination of the brain revealed findings similar to those in the case autopsied in 1978, namely numerous, locally limited, smaller brain softenings without vascular disease.
Since this case had been taken up by the law enforcement agency, the legal doctor commissioned with the assessment turned to the then chairman of the “Medical Society for Ozontherapy eV”, Dr. Wolff. He had been made aware of three other incidents from 1979 by a registered doctor. An 80-year-old patient with a condition after apoplectic insult died immediately after IV administration of 20 cm3 32 / Ο3 after circulatory collapse. A 66-year-old patient with Parkinson’s disease also had paleness of the left hand, sweating and left-sided visual disturbance after administration of 20 cm3 02/03, which only regressed after 14 days of inpatient treatment. In the same practice, a 52-year-old female patient with leg ulcers died a few minutes after 02 injection into the soft tissues around the ulcer, whereby an autopsy had shown no organic illnesses that could explain death, but also had no gas embolism, so that again allergic reaction had to be discussed.
In 1981, a gas embolism in the meninges and subpleural was positive for the first time during an autopsy in Bremen. The 40-year-old woman died after a 02/03 injection in varicose veins by a naturopath. In the same year, a 71-year-old patient in Mannheim, who had been injected with 20cm3 02/03 due to circulatory disorders, collapsed paraplegic shortly after leaving the doctor’s office. The clinical picture fully corresponded to the cases observed in Munich in the mid-1970s. In 1982 another case of a serious complication was observed in Bad Pyrmont, when a 63-year-old patient collapsed after IV injection of 2 cm3 of the gas mixture. She was hospitalized in a state of mental confusion. The blindness she indicated was initially also thought to be hysterically induced. In the further course there was soon unconsciousness, seizures and the picture of Jackson epilepsy. While mental disorders and seizures disappeared under clinical treatment, a severe visual disorder remained.
Finally, two further cases leading to clinical treatment were published in 1983 [32]. Here, too, severe neurological dysfunction had led to hospital admission. In one case, a 62-year-old patient suddenly had left-sided chest pain, dizziness, ringing in the ears and double vision after IV injection into the cubital vein from 02/03. At home there were visual disturbances, sweating and confusion. When admitted to a clinic in Hamburg, the patient was sleepy, disoriented, showed disorders of memory and concentration, a vertical gaze palsy upward, a right hemiparesis and other neurological disorders. Under clinical treatment, the neurological symptoms resolved except for a complete external ophthalmoplegia on the left and an upward palsy.
The second case underlying this publication had already preoccupied the courts. A 56-year-old patient received an 02/03 injection into the cubital artery from the alternative practitioner due to alleged poor circulation in the arms. Following the injection, nausea and dizziness occurred and there was a loss of consciousness. A doctor who had been brought in after hours ordered hospitalization, from there the transfer to the Neurological University Clinic in Mainz took place on the third day of illness. There the patient was disoriented in terms of time, location and person, showed psychomotor agitation, aphasia with pronounced word finding disorders and considerable visual disturbances. Moderate general changes and an intermittent focus were temporarily detectable in the EEG. Clinical treatment resulted in the regression of all symptoms apart from retrograde amnesia for the entire course of the disease, narrowly defined mnestic failures and mild word finding disorders.
The cases are dealt with here in detail because, in 1980, Wolff, based on the results of the study by Jacobs [23, 24, 25] cited at the beginning, claimed that there were no typical “incidents” due to ozone: assuming skillful use and regular maintenance of the devices, 02/03 therapy is a safe method of treatment. For the attentive observer, however, Jacobs’ investigation changed the number of deaths. Jacobs once cited the individual incident groups in a publication [25] and mentioned an unexplained exitus letalis, so that the unwary reader could get the impression that this was the only death, even though at least 6 deaths were known to her at the time. In a lecture in Baden-Baden in 1981, she also listed these 6 deaths in a table, in order to assert at the end of this lecture that only 3 deaths had become known, the cause of which was still unknown. With reference to the same investigation, the “Medical Society for Ozontherapy eV” stated in a statement to the press on 1.12.1981 that there were 4 deaths. In a discussion letter to the journal >Kassenarzt<, the ozone therapist S. Schmidt called it “about 3 deaths”. In a published tabular list of the results of Jacobs’ work, in addition to the 6 cases of exitus letalis, 3 cases of paraplegia, 2 heart attacks, 2 apoplectiform paralysis, 4 visual disturbances, 4 gas embolisms in the pulmonary circulation, 4 pulmonary embolisms and 3 cardiac arrhythmias are then given [17, 24 ]. These confusing figures are probably due to the fact that Jacobs himself assigned which of the incidents were due to ozone and which were due to errors by the therapists. According to Jacobs’ previous publications, the criteria used to select 27 out of a total of 336 incidents reported as the cause of which ozone substance was assumed or ascertained cannot be deduced, nor can it be discussed, especially since 40 of the incidents mentioned in her 1981 lecture were mentioned as ozone-related.
Since this study is constantly cited as an argument for the low level of danger of ozone therapy, it appears necessary to point out further weak points in the surveys. Of the 2,815 therapists contacted, only 644 responded, or about 23%. With these numbers it must be doubted that a sample can be used for a generally valid statement, because the motives with which one therapist answered and the other did not, is not known, nor can it be determined to what extent the motivation influenced the answers. It is already arousing attention if 50% of the answering doctors rate the success as “good”, 50% of the naturopaths rate it as “very good” and no objective basis for this assessment becomes apparent. It is also typical that Jacobs stated to prove the quality of the survey that an inquiry to all directors of forensic medicine institutes belonging to the “German Society for Forensic Medicine in the Professional Association of German Pathologists” had not recorded any incidents that were not already known. However, since by no means all of the directors of the forensic medicine institutes belong to this association, and only a small part of the above-mentioned incidents were examined and assessed by forensic medicine, such an inquiry cannot have any evidence. The statistical evaluation in Jacobs’ investigation also appears to be extremely problematic. The incident rate is based on the number of ozone applications, but not on the number of patients treated. If one refers to the treated patients, the incidence rate is between 1: 1000 and 1: 2000, thus within the range in which an explanation of possible complications must be given according to the highest judicial decisions.
The negative effects of such an investigation are obvious. The users of ozone therapy do not see the real dangers of introducing gaseous substances into the circuit, but rather trust that it is the colleague’s mistakes that are the basis of an incident. For example, always invoked the good solubility of 02/03 in the blood, although so far no reliable publication confirms what the conditions in the flowing blood really are and which parameters they depend on.
It sounds downright macabre when Wolff states in the prospectus for the Ozonosan 60 device that the best thing to do when practicing intravenous injection is to use “thin, transparent patients” first. When the injection rate is correct, one sees “small gas bubbles strung through the vein without them flowing together. This phenomenon is accompanied by a rippling sound that only disappears after 6 to 7 seconds. The previously mentioned work by Chamorro [6], who was able to pick up phonocardiographically rippling noises after the injection of 150cm3 of gas mixture into the cubital vein, is cited accordingly.
Obviously, it is not understood that the frequently cited pain is substernal and coughing after intravenous ozone is a classic gas embolism of the lungs, and it is completely negated that, according to the literature, about 25% of all post-mortem examinations reveal an open oval foramen is, so that the passage of gas bubbles into the large circulation after intravenous injection is possible for every fourth patient. In addition, arteriovenous anastomoses in the lungs can cause gas bubbles to pass rapidly into the arterial limb of the large circulation and thus lead to cerebral gas embolism, as Meessen and Stochdorph have pointed out many years ago [36].
After all, there have recently been signs of a change in the perception of the danger of using ozone therapy through IV injection. As a conclusion of her investigation, Jacobs pointed out that the study raised the question of the justification of the IV application [25]. In the same year, these doubts condensed in a publication, together with Herget [17], to the conclusion that the intravenous injection should be regarded as a malpractice. But here, too, it becomes apparent how low the consensus within the group of ozone therapists is when, in a recently published book [53], the naturopath Stockburger still describes the iv injection as a possible treatment method, without going into the recent complete rejection by Herget and Jacobs.
But even if the dangers of intravenous gas injection have now been acknowledged by a wide range of ozone users, this unfortunately does not apply to the dangers of intra-arterial application, although corresponding dangers were already mentioned in >The alternative practitioner and in the communications for members of the German alternative practitioner, Landesverband Bayern e. V.< in 1977. After all, half a dozen of the serious incidents cited at the beginning were caused by intra-arterial injection. The cause must be assumed to be a retrograde gas embolism which, when injected in the area of ​​the femoral artery, causes gas bubbles to rise in the abdominal aorta and from there to occlude an anterior spinal artery and then lead to paraplegia. When injected in the area of ​​a cubital artery, the retrograde rise of gas bubbles through the vertebral artery into the brain has been observed. These dangers have been known since the mid-1950s when corresponding incidents were reported in the intra-arterial oxygen insufflation then used in large clinics [8,27]. Since the 02/03 mixture contains a very high volume percentage of oxygen, the experience at that time is undoubtedly transferable. This raises the question of whether the sad experiences of earlier generations of doctors with the introduction of gaseous substances into blood vessels in the circle of ozone therapists were consciously negated or simply forgotten. In our opinion, however, there is a lot to be said for negating, because if – as in conventional medicine after the negative experiences with oxygen insufflation – gas insufflation is considered dangerous and ineffective in the event of circulatory disorders, the domain of its use is no longer applicable to ozone therapy.
But even with the remaining application options, there are dangers, the causes of which are not clearly understood. According to the experts, one death was caused by an allergic shock, and part of the serious incidents actually make such a cause seem likely if the amount of the gas mixture injected was really as low as stated. The neuropathological findings also partially support such a pathogenetic explanation too. Jacobs’ study shows that allergic reactions to ozone occur, although in certain cases the cause of such allergic reactions has been blamed on the therapists’ lack of hygiene. As long as final clarity is not created by the users themselves, the risk of serious allergy-related incidents cannot be excluded with any form of ozone application.
Although the occurrence of incidents is now acknowledged by ozone therapists even with the correct use of ozone therapy, the method’s justification is further affirmed with the reference to the low incidence of incidents in Jacobs’ work compared to other common therapeutic and diagnostic methods. In particular, reference is made to more serious drug reactions, which occur to about 0.2% [31]. This comparison is not limited to just one side. The methodological weaknesses of the survey were already pointed out.
It is much more serious, however, that a comparison is made with medicinal products without taking into account the fact that, according to recent legislation, proof of efficacy has to be provided for medicinal products. But this is where the greatest criticism must be made of the efforts that ozone therapists have made to date. It sounds prophetic when Thieme quotes Payr in 1937, who are the enemies of successful ozone therapy [55], stating that “a business-oriented advertisement had promised more of ozone than it could keep”. This quote also seems to us to be current state of things. Kleinschmidt and Schnizer [30] agree unconditionally when they summed up after the 5th Ozone World Congress in 1981 that the touchstone for therapeutic efficacy was the controlled clinical trial and that the lectures offered were not satisfactory planning and statistical requirements that have to be demanded for scientific studies today. If one looks at the results and successes so far presented by ozone therapists, these are mostly case reports and in vitro tests.
[translated to p. 209 so far; still in progress]
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