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Ozone therapy, involving doses of the reactive oxygen gas, has long been in Europe a popular alternative treatment for a variety of ailments. While health authorities chide practitioners for using this "unproven" therapy, reports continue to describe favorable results. Scientists also continue to investigate the potential of ozone therapy to eliminate disease-causing organisms from the bloodstream. In the mid-1980s, German researchers began using a process called autohemotherapy to test the use of ozone on blood infected with HIV and hepatitis B and, in 1986, a biotech company called Medizone International was created to follow up on the approach.

Since then, Canadian and American scientists have confirmed ozone's direct antiviral effects, and its ability to boost key parts of the immune system. Last May, a Canadian study reported that ozone completely inactivated SIV, the simian equivalent of HIV, in monkey blood. The implications for safeguarding the blood supply are clear, although the therapeutic potential is not. Nevertheless, according to Medizone, preliminary trials are being conducted at five centers in Italy using an ozone/oxygen mix to treat patients with HIV and hepatitis B. A great deal of research remains to be performed on ozone, but advocates predict that because ozone cannot be patented, it will not attract financial backing for the scientific studies needed to win FDA approval. Longevity (04/94) Vol. 6, No. 5, P. 54.

Frankum B. Katelaris CH. Ozone Therapy in AIDS--Truly Innocuous? [letter]. Med J Aust. 1993 Oct 4;159(7):493.

Carpendale MT. Freeberg J. Griffiss JM. Does Ozone Alleviate AIDS Diarrhea? J Clin Gastroenterol. 1993 Sep;17(2):142-5.

Five patients with acquired immune deficiency syndrome (AIDS) or AIDS-related complex (ARC) and intractable diarrhea were treated with daily colonic insufflations of medical ozone (oxygen/ozone mixture) for 21-28 days. The daily dose of ozone (O3) ranged from 2.7 to 30 mg. Three of the four patients whose diarrhea was of unknown etiology experienced complete resolution, and one patient had marked improvement. The fifth patient, whose diarrhea was due to Cryptosporidium, experienced no change. No consistent change in the absolute number of helper (CD4) or suppressor (CD8) lymphocytes was detected, and no obvious changes were seen in the PO2 or the results of routine hematologic and blood chemistry studies. Patients had mild to moderate local discomfort during ozone administration early in the course of treatment, but no adverse systemic effects were observed. The results of this series suggest that medical ozone administered by rectal insufflation is simple, safe, and effective. Should this simple treatment be used routinely to treat chronic intractable ARC/AIDS diarrhea?

Carpendale MT. Griffiss J. Is There a Role for Medical Ozone in the Treatment of HIV and Associated Infections? In: Ozone in Medicine. Proceedings of the Eleventh Ozone World Congress, August 29-September 3, 1993, San Francisco, CA. PP. M-1-32-M-1- 45. International Ozone Association, Pan American Committee, 31 Strawberry Hill Ave., Stanford, CT 06902-2608.

Medical Oxone inactivates many pathogenic viruses including HIV in vitro. Pilot studies in man suggest positive benefits in the early stages of HIV infection (t-4 cells greater thanf 400).

These include incrased T4 and T8 cells, normalizing of T4:T8 ratio, and a general feeling of wellbeing and minimal evidence of infection. Improvement also occurs in AIDS patients (T4 cells less than 200) but less evidence of T4 cell resurgence. These studies indicate that at least in vitro there is a good safety margin between the ozone dose required to inactivate HIV and the earliest suggestion of suppression of lymhocytes. In fact, the lymphocytes are being stimulated at doses that completely inactivates HIV. More work needs to be done to clarify the most effective dosage and means of treating HIV infections with medical ozone.

LoLordo, Ann. AIDS Treatment Documentary Premieres Amidst Controversy. PR Newswire, San Francisco, 08/30/93.

The medical world [criticized] a documentary about an unapproved medical treatment called ozone therapy, which may allegedly deter cancer and AIDS. Canadian filmmaker Geoffrey Rogers' "Ozone and the Politics of Medicine" [described] a potential breakthrough drug that is dismissed by health officials, although millions of patients in Europe have already used it. Rogers [included] scientific evidence that ozone can inhibit cancer cells and inactivate viruses. A recent study by the Canadian military and the International Red Cross discovered that monkeys injected with blood plasma tainted with SIV, the primate equivalent of the AIDS virus, died within two weeks. Monkeys receiving ozone injections, however, remained healthy and were not infected. The Food and Drug Administration has condemned ozone therapy, and even labeled its use as health care fraud. The drug gained national attention [in July, 1993] when the famous New York doctor Robert Atkins lost his medical license over a complaint about the use of ozone therapy. Dr. Atkins' license was subsequently reinstated.

Wolfstadter HD. Sacher J. Hopfenmuller W. Stange R. Retrospective Benefit Following Individualized Naturopathic Therapy in HIV-patients at Different Stages. Int Conf AIDS. 1992 Jul 19-24;8(3):147 (abstract no. PuB 7588).

OBJECTIVE: To assess the long-term efficacy and benefit of a complementary treatment regimen, we investigated on laboratory findings and clinical outcome in a cohort of 175 out-patients (CDC II-IV E) successively treated since 1986. METHODS AND PATIENTS: The therapeutic regimen comprised autologous ozone transfusions, homeopathy, phytotherapy, therapy with enzymes, mineral-, vitamin- and trace element substitution, nutritional management, correction of intestinal dysbacteria and psychophysical means, set up on an individualized basis. No conventional antiviral therapy was given. Patients (all male homosexuals) were divided into 5 groups (Gr. I-V) according to their CD4 lymphocyte counts at entry into therapy (Gr.I n = 22, CD4 0-50; Gr. II n = 12, CD4 51-100; Gr. III n = 17, CD4 101- 200; Gr. IV n = 81, CD4 201-500; Gr. V n = 53, CD4 greater than 500 [/microliters]) and 15 hematological and biochemical parameters were evaluated with individual regression analysis according to the length of observation of patients (min. obs.time in Gr. I-III 3 months, min. obs.time in Gr. IV and V 6 months). Moreover we studied the incidence and severity of opportunistic infections and overall QOL during the observed period. RESULTS: Patients in Gr. I presented a median loss of CD4 lymphocytes per month of 0.54 cells/microliters(range -42.0 to 4.50, median obs.time 8 months), Gr. II median loss 3.65 cells/microliters (range -5.9 to 8.8, median obs.time 10.5 mo.), Gr. III median loss 4.98 cells/microliters (range -13.5 to 11.0, median obs.time 16.8 mo.). In Gr. V, apparently due to the earlier stage of disease, no clear statistical trend of helper- cell deterioration could be observed. Patients in Gr. IV, with an approved indication for antiviral therapy, presented a median loss of CD4-cells of 4.47/microliters (range -17.2 to 37.5, median obs.time was 25.4 mo.).

Compared to CD4 lymphocyte deterioration given in the literature for patients under antiviral therapy, 52% of our patients in Gr. IV exceeded these values, while 24.6% remained below. No substantial adverse events or side effects accompanied the therapies, thus we found QOL generally increased. CONCLUSIONS: Our results suggest that patient performance under a combined and individualized naturopathic regimen might be to some extend improved with respect to data collected from cohorts in the literature. Further investigation including controlled clinical trials on different aspects of the single therapies is necessary.

Brown, David. A New Look at Alternative Therapies. Washington Post (Health), 06/23/92, P. 8.

The National Institutes of Health will soon examine alternative therapies more closely because of the possible efficacy of the treatments. John C. Pittman, a physician in Raleigh, N.C., discontinued his ozone gas therapy for AIDS patients after the North Carolina Board of Medical Examiners told him they were looking into his controversial practices. However, an advisory board at the NIH last week expressed interest in Pittman's work and requested more information on his claim that three out of 25 patients with HIV had overcome the virus after having the highly reactive gas inserted into their blood. Ed McCabe, author of a book on unconventional uses of oxygen, also told an NIH panel how ozone treatment had significantly improved the conditions of 300 HIV-positive patients. In ozone therapy, a blood sample can be treated with the gas and returned to the patient, or a small volume of gas can be inserted directly into the vein. Advocates say the procedure should be done twice daily for three weeks to treat HIV infection. The Office for the Study of Unconventional Medical Practices, established after the 1992 federal budget requested that NIH spend at least $2 million on such an effort, will attempt to determine which treatments may be promising and can be tested in conventional experiments.

Hooker MH. Gazzard BG. Ozone-Treated Blood in the Treatment of HIV Infection [letter; comment]. AIDS. 1992 Jan;6(1):131.

Carpendale MT. Freeberg JK. Ozone Inactivates HIV at Noncytotoxic Concentrations. Antiviral Res. 1991 Oct;16(3):281- 92.

The inactivation of human immunodeficiency virus (HIV) and cytotoxic properties of ozone-treated serum and serum- supplemented media were examined. The titer of HIV suspensions in human serum was reduced in a dose-dependent manner when treated with total reacted ozone concentrations at a range of 0.5 to 3.5 micrograms/ml-1. Complete inactivation of HIV suspensions was achieved by 4.0 micrograms/ml-1 of ozone in the presence or absence of H-9 cells. In contrast, cellular metabolism, as measured by MTT dye cleavage, and DNA replication, as measured by BUdR incorporation, were enhanced in H-9 cells grown in media treated with quantities of ozone that completely inactivate HIV. The permissively HIV-infected cell line HXB/H-9 was cultured in ozone-treated media for six days with culture supernatants being sampled and assayed on alternate days for HIV p24 core protein. HIV p24 was reduced in all treated cultures compared to control cultures, with an average reduction of 46% [p24].

Wells KH. Latino J. Gavalchin J. Poiesz BJ. Inactivation of Human Immunodeficiency Virus Type 1 by Ozone in vitro. Blood. 1991 Oct 1;78(7):1882-90.

A device was designed to deliver a constant source of given concentrations of ozone to fluids containing human immunodeficiency virus type 1 (HIV-1). Ozone was found to inactivate HIV-1 virions in a dose-dependent manner. Greater than 11 log inactivation was achieved within 2 hours at a concentration of 1,200 ppm ozone. Similar concentrations of ozone had minimal effect on factor VIII activity in both plasma and immunoaffinity-purified preparations of factor VIII treated for the same time period. The data indicate that the antiviral effects of ozone include viral particle disruption, reverse transcriptase inactivation, and/or a perturbation of the ability of the virus to bind to its receptor on target cells. Ozone treatment offers promise as a means to inactivate human retroviruses in human body fluids and blood product preparations.

Garber GE. Cameron DW. Hawley-Foss N. Greenway D. Shannon ME. The Use of Ozone-Treated Blood in the Therapy of HIV I=fection and Immune Disease: A Pilot Study of Safety and Efficacy [see comments]. AIDS. 1991 Aug;5(8):981-4.

The use of ozone therapy is reported to be effective in a variety of viral illnesses, including HIV disease. We performed a phase I study of ozone blood treatments in 10 patients in whom no significant toxicity was observed. Three patients with moderate immunodeficiency showed improvement in surrogate markers of HIV-associated immune disease. A phase II controlled and randomized double-blinded study was initiated comparing reinjection of ozone-treated blood, and reinjection of unprocessed blood for 8 weeks, followed by a 4-week observation period. Ozone had no significant effect on hematologic, biochemical or clinical toxicity when compared with placebo. CD4 cell count, interleukin-2, gamma- interferon, beta 2- microglobulin, neopterin and p24 antigen were also unaffected by both treatment arms. In conclusion, ozone therapy does not enhance parameters of immune activation nor does it diminish measureable p24 antigen in HIV-infected individuals.

Mayer C. Soyka. Naber D. [Paranoid hallucinatory psychoses in an HIV infected patient on ozone therapy]. Nervenarzt. 1991 Mar;62(3):194-7.

Roder W. Muller WE. Merz H. [Is Ozone Suitable for Sterilization of HIV infected Bones?] Unfallchirurg. 1991 Jan;94(1):50-1.

HIV infection can be transferred by blood, blood products and organ transplantation. In traumatic surgery allogeneic bone transplantation is commonly used for reconstruction in severe bone injuries. This technique has been abandoned since the appearance of reports of infections with HIV. In an experimental in vitro study we showed that ozone treatment cannot inactivate HIV in bone for transplantation.

Wagner K. Mayers D. Toro L. Baker JR Jr. The Effect of Ozone (03) on Lymphocyte Populations in Normal and HIV1-Infected Blood. Int Conf AIDS. 1989 Jun 4-9;5:656 (abstract no. C.587).

OBJECTIVE: Measure the effect of varying 03 concentrations on lymphocytes in whole blood from an uninfected and a Walter Reed Stage 2 HIV1 patient. METHODS: Heparinized whole blood samples were exposed in triplicate to (03) of 20, 40, and 60 ug/ml with an oxygen control. Coded, blinded blood samples were gently agitated for 10 min. and incubated for 1 hr. at 27 C. Mononuclear cells were separated using Ficoll-hypaque gradients and stained for FACS analysis using labelled monoclonal antibodies. RESULTS: 03 had no effect on lymphocyte populations of the uninfected donor as numbers of total T cells, CD4, CD8, and B cell subpopulations did not change. In contrast, there were marked changes in the lymphocyte populations of the HIV positive donor with increasing (03). CONCLUSIONS: Ozone, at concentrations previously shown to inactivate HIV1, may alter lymphocyte surface markers in HIV1 infected patients. Further studies are indicated to examine this effect.

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[Editor's Note: This is the text of a letter from Medizone International Inc. in response to inquiries regarding ozone.]

---

Medizone International Inc
123 East 54th Street,
Suite 2H,
New York
NY 10022
(212) 421-0303
Fax: (212) 888-2798

June 29, 1993

Dear xxxx,

Thank you for your letter. At present Medizone International Inc and Medizone Canada Ltd are awaiting US Food and Drug Administration and Canadian Health and Welfare approval, respectively, to commence human clinical trials for the use of the Medizone (R) (ozone/oxygen) drug in the treatment of Acquired Immune Deficiency Syndrome (AIDS). The following is a brief overview of Medizone International Inc's research to date.

Acquired Immune Deficiency Syndrome (AIDS) is a condition described in 1981 and found to be caused by a retrovirus (HILV- III/HIV). To date, treatment only affords temporary suppression of the virus.

Since the identification of Acquired Immune Deficiency Syndrome (AIDS), researchers have employed many modalities to treat patients with HIV-related disease. In Europe, one modality employed has been an ozone/oxygen mixture. The mixture is introduced into fixed volumes of the patient's blood 'ex vivo'. This procedure has been entitled autohemotherapy, but may be referred to more descriptively as extracorporeal circulation. Anecdotal reports on the results of this work are extremely encouraging. However, in view of the fact that no controlled trials have been performed, these results must be carefully evaluated.

In March 1986 Medizone International Inc was created specifically to scientifically evaluate this treatment and bring the technology to market. A series of studies were undertaken to establish:

a) the safety of extracoporeal circulation with an ozone/oxygen (Medizone(R)) mixture in a variety of animal models (toxicity studies);

b) the effect(s) of ozone/oxygen mixture (Medizone(R)) on a human HIV target cell line, HUT-78;

c) the anti-retroviral activity of ozone/oxygen (Medizone(R)) on HIV 'in vitro';

d) the effect of ozone/oxygen (Medizone(R)) in human peripheral blood 'ex vivo';

e) the effect of ozone/oxygen (Medizone(R)) on exogenously HIV-1 'spiked' Factor VIII preparations.

The studies and results to date include:

a) A preliminary rabbit animal model treated with (ozone/oxygen) Medizone(R) in a manner analogous to the proposed human treatment regime at the Long Island College of Pharmacy suggested no toxicity at concentrations up to ten times the dose proposed in man.

b) A limited feline model toxicity study performed at the Cornell Feline Health Centre, Cornell Veterinarian College, Ithaca, to investigate the relative toxicity of Medizone(R) has yielded no detectable toxic effects.

c) Cell-free HIV treated with (ozone/oxygen) Medizone(R) resulted in 100% inactivation of the virus while maintaining HUT-78 viability. These studies were performed at the State University of New York at Syracuse under the auspices of Dr Bernard Poiesz.

d) Implementation of a patented hollow fibre technology has demonstrated Medizone(R)'s ability to *reduce* intracellular viral expression by greater than 99% while maintaining target cell viability.

e) Treatment of human peripheral blood with Medizone(R) revealed hemolysis and coagulation changes well within the standard for re-infusion of packed human blood. These studies were performed at the Mount Sinai School of Medicine in New York, under the auspices of Dr Michael Greenburg.

f) Published results (Blood, Vol. 78(7):1882, 1991) involving the treatment by Medizone(R) of Factor VIII preparations exogenously 'spiked' with HIV-1 yielded a minimum (ten) log diminution of viral load while maintaining 90% biological activity of this blood component.

g) Investigation with Visna Virus and Feline Intestinal Peritonitis Virus, two lipid enveloped viruses, have been inactivated with measurable lipid peroxides derived from Medizone(R) treatment.

h) 'In vitro' inactivation by Medizone(R) of a variety of Simian Immune Deficiency (SIV) variants studied through a multi-agency Canadian government collaboration have paralleled those results published by Poiesz et al.

The hypotheses underlying ozone's virucidal activity are based upon the drug's propensity toward lipid peroxidation. Those viruses which are lipid-encapsulated (ie. lentivirus family) are highly susceptible to the direct oxidative effect of ozone, and are thereby inactivated.

Data indicate the differential effect on lipid envelope viruses versus those whose lipid capsid composition is minimal.

We postulate that ozone will inactivate cell-incorporated viruses by at least two discreet mechanisms:

1. Due to the high degree of lipid peroxidation catalysed by ozone interaction(s), viral binding to specific receptors (ie. HIV to CD4A receptor), whose membranous nature (both viral coat and receptor) implies a finite composition of lipid [including polyunsaturated fatty acids (PUFA)], may indeed be ozone sensitive. Investigations with Rhodamine-labelled HIV, challenged with ozone sensitized HIV virions, have suggested alterations in receptor/ligand binding capacity yielding diminished viral binding. This data suggests that ozone, delivered by hollow fiber technology at antiviral concentrations, does impair HIV's ability to bind to CA4A + target cells.

2. It has been demonstrated that target cells with pro-viral DNA incorporated into its genome have decreased titers of certain protective enzyme systems with respect to oxidative perturbations. In particular, superoxide distumase (SOD), catalase (CAT) and glutathione peroxidase (GSHPx) levels are diminished in a number of virally transformed cell lines. Such decreases may render these cells selectively sensitive to the oxidative effects initiated by ozone. It should be noted that ozone's effects are instantaneous with regard to peroxidation and the products of this reaction with cellular membrane lipids (hydroperoxides) are relatively stable and can participate in a host of oxidative (including free-radical) propagating reactions. It is our intention to generate, via ozone's direct activity and product(s) derived through lipid interactions, data to support:

a) inactivation of those viruses [ie. HIV, Hepatitis B, non-A and non-B (Hepatitis C)] associated with transfusion associated diseases while maintaining the replacement value of the blood fractionate of interest (ie. plasma proteins, packed red cell preparations and platelets).

b) reduction of cell incorporation by virus through impairment of viral-receptor binding;

c) inactivation of cell-incorporated virus render them non- viable while maintaining normal target cell viability.

The results of experimental work have demonstrated non-toxicity in treating; a preliminary animal rabbit model, human HIV target cells, a limited feline model, human peripheral blood, and Factor VIII preparations exogenously 'spiked' with HIV-1, all with ozone/oxygen mixtures (Medizone(R)). Anti-retroviral was demonstrated at concentrations maintaining HUT-78 viability, as well as Factor VIII biological activity, respectively.

On June 2nd, 1993, Medizone International Inc announced the successful completion of the first two phases of a Canadian research project that has demonstrated preliminary scientific evidence supporting the use of the company's blood decontamination technology in a live, primate (monkey) model.

In making the announcement, Medizone president, Dr Joseph S Latino said, "To date, the research program has successfully demonstrated that monkeys receiving blood fractioned plasma, purposely infected with a highly virulent strain of Simian Immunodeficiency virus (monkey equivalent to HIV), but treated with Medizone's process, did not demonstrate any signs of infection over the course of the study (35 days). However, all animals receiving similarly infected products without the intervention of Medizone's contamination technology died within 12-14 days."

This research project was under the direction of an international collaborative team of scientists representing the Canadian Red Cross, Canadian Departments of Defence and Agriculture, Cornell University Veterinary Medical College, and Medizone Canada Ltd.

Please do not hesitate to contact me should you require any additional information.

Your sincerely,

Katherine M Kalinowski
Corporate Secretary

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