Ozone Therapy: The Science Behind the Scandal
AIDS NEWS SERVICE
Michael Howe, MSLS, Editor
AIDS Information Center
VA Medical Center, San Francisco
(415) 221-4810 ext 3305
April 15, 1994
OZONE THERAPY (Part I)
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
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-
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
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
Roder W. Muller WE. Merz H. [Is Ozone Suitable for
Sterilization of HIV infected Bones?] Unfallchirurg. 1991
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
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.
[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,
Fax: (212) 888-2798
June 29, 1993
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
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
a) the safety of extracoporeal circulation with an ozone/oxygen
(Medizone(R)) mixture in a variety of animal models (toxicity
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
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
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
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:
- 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 +
- 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
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
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
Katherine M Kalinowski