OZONE MARCHES ON
Medical Applications Update
Excerpt from "Family News" - October, 1997 edition - (305) 759-9500
In medicine, ozone has a number of well-established properties: It is antibacterial, antiviral, and antifungal. The largest commercial use of ozone is in the purlfication of water. When you buy your next gallon jug of water at the grocery store, the label will say "ozone treated." Both the FDA and EPA certify that ozone destroys 99.9992 percent of all pathogenic germs, while oxidizing (destroying) 99.9992 percent of all pollutants in the water at the same time. In Germany, over 7,000 doctors utilize ozone in the treatment of various diseases. Ozone is widely used in Cuba, Russia, France and Italy.
Researchers hope that ozone sterilization for blood fractionates such as Factor VIII, a clotting agent given to hemophiliacs, will be available soon. Technologies for sterilizing whole blood may be on the market in a few years. Ozone sterilization technologies may be approved only for emergency blood supplies at first, but if evidence is found that some viruses are not being screened, the treatment may be extended to all blood collections.
"The products of this research have worldwide applications," says DND's Commodore Michael Shannon, who is Canada's equivalent of the U.S. Surgeon General. "In the right concentration, ozone for blood purlfication sounds almost too good to be true. We're trying not to be overly enthusiastic, but the data so far is very compelling."
Blood purification isn't the only or even the main use ozone therapy is being put to. In a 1994 book written by a German doctor and scientist Dr. Renate Viebahn there is an indexed compilation of a half century long body of medical literature that documents the therapy's benefits in over 40 different medical conditions.
Although few of the references cited would pass scientific muster in mainstream journals, a 1980 survey in Europe, where ozone has long been a popular alternative therapy, found that over 90 percent of practitioners who had used it on 384,000 patients reported "good" to "very good" results. Moreover, the rate of side effects was extremely low; the few that occurred were mainly attributable to improperly administered intravenous injection.
Many therapists, however, bypass that risk by opting for other methods of delivery; rectal or vaginal applications, treating blood outside the body, or absorption through the skin while the patient wears a "sauna bag" that is filled with an oxygen ozone mixture.
One problem, say proponents, is that the demand generated by the tremendous number of scientific studies that have been published over the years has created a grass roots interest. This has prompted many practitioners to equip themselves with ozone generators before the industry has had an opportunity to establish standards. This would be risky business if ozone weren't so safe, but in a way it does harm the progress of this therapy. A great deal of valuable findings and results go undocumented.
Another factor is an unreasonable bias against this approach in mainstream medicine. Don't expect one cent of the billions spent by CDC or NIH to be earmarked for ozone research until there is an epidemic of antibiotic resistant hepatitis or tuberculosis or there is a substantial urban "bloom" of Marburg or Ebola virus.
At the same time health authorities are taking action against practitioners for using an "unproven" therapy, many scientists continue to investigate its potential for ridding blood of disease causing microbes.
In the mid-1980s, German researchers began testing the use of ozone on HIV and hepatitis B infected blood outside the body, a procedure called autohemotherapy, and in 1986 a New York based biotech company called Medizone International was established to follow up on this approach. Since then, Canadian and American scientists have confirmed ozone's direct antiviral effects as well as its ability to boost key components of the immune system.
One Canadian study found that ozone completely inactivated deadly SIV, the simian version of HIV, in monkey blood. The implications for safeguarding of the human blood supply - from HIV as well as other common viral contaminants are obvious.
Preliminary clinical trials are under way at five centers in Italy using an ozone/oxygen mix, diffused through blood, as it is passed outside the body to treat patients with HIV and hepatitis B infection.
Much research remains to be done to confirm ozone's promise. Unfortunately, say advocates, since ozone can't be patented, it isn't likely to attract financial backing for the extensive scientific studies needed to win FDA approval.
Geoffrey Rogers in his documentary "Ozone and The Politics of Medicine" an award-winning documentary on the medical applications of ozone, which Rogers produced and directed says, "It's the information that counts." The film provides evidence which documents that ozone therapy -- essentially mixing blood with ozone -- is an effective treatment for people suffering from a number of conditions, including AIDS-related illnesses and cancer.
"The statistics are staggering," says Rogers. "Ten million people have used this in continental Europe. Millions of people are getting effective results."
Rogers traveled to locations in Europe, Mexico, the U.S., and Canada to interview numerous researchers, doctors and patients who attested to ozone therapy's value in combating disease.
Among those captured on camera was Capt. Mike Shannon, Director of Medical Operations for the Canadian Department of National Defence. Shannon said tests have yielded a "profound demonstration" of ozone's potential to act as an antiviral agent against the human immunodeficiency virus (HIV), which is widely believed to cause AIDS. Specifically, the Canadian military was involved in a study that showed that monkeys receiving blood plasma contaminated with SIV (The simian equivalent of HIV), but treated with ozone, remained healthy.
Despite such studies, the therapy is illegal in North America; itis use is restricted to the alternative-medicine underground. David Bates, former dean of the UBC Faculty of medicine, goes so far as to say in the documentary that "This is lunatic medicine, and I really won't pay any attention to it."
Regulatory agencies, particularly the Food and Drug Administration in the U.S., have rejected applications to legalize ozone generating equipment used in the therapy. That's attributed to the potential risks involved in using ozone. A major message of the film, however, is that the underlying reason for opposition to the therapy is the vast influence large pharmaceutical companies have over the medical establishment. Those companies wouldn't stand to make much of a profit on something as inexpensive to produce as ozone.
Why was Rogers, who has no medical training, so consumed with making a film about ozone therapy? Back in 1986, when Rogers was finishing his film studies at UBC, he first heard about the therapy from his father. Both of his parents are doctors. After interviewing some of the key proponents of ozone use, Rogers became convinced that the therapy represents a major, but neglected, medical breakthrough.
NEW TREATMENT OF HERNIATED DISC:
In Italy, orthopedic surgeons who used to perform surgery on herniated discs are now using a special mixture of ozone to treat the pathology of this condition.
Dr. Cesare Verga, an Orthopedic Surgeon developed the system in 1984 and has treated over 6,000 patients. Dr. Verga claims that surgery really doesn't address the underlying cause of back pain. As a matter of fact, it offsets the biomechanics of the spine.
Ozone, or the "Discosan method" as it is known in Italy, represents a new approach in the treatment of herniated discs which resolves both the biological and biomedical aspect of the pathology. Dr. Verga states that this approach has a success rate of over 95 percent.
Some of the principal characteristics that make this method so unique are the following: There have been no contraindications with an over 95 percent success rate. There is virtually zero recovery time and no side effects. This should come as welcome news for someone suffering from chronic back pain and facing surgery.
The treatment consists of injections of a special mixture of ozone and oxygen applied around the herniated zone. At the beginning, the therapy requires two treatments per week for a period of one to two months. On average, a total of 14 treatments are required, depending on the patient. The Discosan method has even been shown efficacious in cases where surgery could not alleviate the discomfort.
One of the main questions often asked about the Discosan method is: "How does this method work?", When we look at the anatomy of an intervertebral disc, we see an outer fibrous covering and an inner soft nucleus, much like a ripe cantaloupe with a hard outer shell and soft fruit inside. A herniation occurs when trauma ruptures a part of this outer fibrous covering, most commonly in the lumbosacral and cervical regions. This then causes the inner soft region to protrude and compress a nerve root, causing the pain associated with a herniated disc. The Discosan method addresses this pathology by three different modes of action:
The whole concept of treating a herniated disc without surgery is an exciting one. The fact that the Discosan method has some sound scientific principles gives real hope to people suffering from this debilitating condition.
OZONE AND SICKLE CELL ANEMIA
CAPMED, an American Corporation in Philadelphia, received Orphan Drug Designation from the U.S. FDA for the use of ozone oxygen for the treatment of Sickle Cell Anemia in March, 1992.
This coming after they completed clinical trials in cooperation with the National Institute for Scientific Research, Havana, Cuba, the Institute of Hematology and Oncology, Havana, Cuba, and the Salvador Allende Clinic, Havana, Cuba.
These trials were carried out in the years 1989, 1990 and 1991 culminating in ozone oxygen being approved by the Cuban Ministry of health for general use in the treatment of sickle cell crisis, the ulcers ensuant to sickle cell disease, and as a preventative treatment for the disease. The safety and efficacy established in these trials led to the use of ozone oxygen in the general population for healing wounds and diseases of the extremities (e.g., diabetic leg ulcers), where below or above knee amputation would be otherwise indicated.
In patients with sickle cell anemia, the reduction in the availability of oxygen for the cells, produces painful crises, organ infarction, abdominal and/or muscular pains, ulcers, etc.
On the basis of some medical properties of ozone, concerning ability to increase the rate and the capacity of absorption of oxygen in red blood cells, an evaluation about the effectiveness this treatment for the prevention and/or the timely resolution of the crisis was made.
For the controlled clinical trial 55 adult sickle cell anemia patients were studied, each suffering from painful crisis. Two groups were established; a control group, comprised of 25 patients who received conventional treatment and ozone/oxygen treated group, comprising 30 patients who received the same treatment plus ozone therapy, by intra rectal administration, during 15 sessions.
The average time required for resolution of painful sickle cell crisis in ozone oxygen treated patients was half the number of hours required to solve painful crisis in control patients. Frequency and severity of painful crises in sickle cell anemia patients who received ongoing ozone oxygen therapy diminished in the six month followup period, in comparison with control group patients.
Sickle cell anemia, a genetic disease which involves the sickle shape of red blood cells (erythrocytes), when blood oxygen tension is low, is represented by a modified hemoglobin, HbS, due to the substitution of glutamic acid by valine in the amino acid chain.
The crystallization of the molecules of HbS occurs when those cells are deprived of oxygen up to a partial pressure of oxygen PO2 below the threshold level at which the cells sickle. In these conditions, the erythrocytes lose their normal elasticity and shape, also losing their capacity to take and deliver oxygen and increasing the viscosity of the blood.
This leads to a reduction in the availability of oxygen to the cells, producing painful crisis, infarction, abdominal and/or muscular pain, ulcers, etc. This process is reversible in the early stages, for when the HbS molecule is reoxygenated the cell distortion disappears and resumes its normal shape. The longer the period of time necessary for the reoxygenation of the molecules of HbS, the greater number of red cells die. Therefore, the increase in the partial pressure of oxygen and the promptness with which it is normalized are determining factors for the symptoms to diminish and disappear.
Numerous reports have been published on the safety and clinical results obtained by the application of medical ozone oxygen in diseases related to insufficient oxygen supply to tissues and various organs, and/or the disruption of its utilization in the cells. Ozone's virucidal effect has been reported at dose levels at which no undesirable side effects take place, offering promise as a means to inactivate viruses in human body fluids and blood products preparation.
Among the medical properties of ozone documented are the ability to increase the rate and capacity of oxygen absorption in erythrocytes and the activation of glycolysis in the cells via the pentose pathway. This enhances the production of 2,3 DPG, which is known to act as a coadjuvant of oxygen release from oxyhemoglobin at tissue level.
Both effects lead to significant improvement in oxygen supply to the body, demonstrated in vivo by the measurement of PO2 increase in arterial blood as well as the reduction in venous CO2.
In addition, the rheological properties of the blood improve, especially in regard to red blood cell aggregation. Ozone prevents rouleaux formation and clumping of cells. There is an increase in membrane permeability and flexibility, because of the effect of ozone/oxygen on it. As a consequence of these effects, reduction of blood viscosity and enhancement of blood flow are achieved.
Numerous preclinical experiments have been performed in vitro and in vivo to test possible ozone oxygen toxicity related to the therapeutic methods and ways of administration according to which medical ozone oxygen is currently applied. Controlled in vitro testing on the degree of hemolysis and "Heinz Body formation" induced by the administration of ozone to blood at adequate dosage was performed.
Not finding any significant effect, no damage to the red blood cells nor in the resistance of erythrocytes to further oxidative stress. These results are consistent with the fact that ozone stimulates several enzymatic redox systems responsible for cells protection against oxidation. Ozone is a free radical scavenger and natural antioxidant contrary to what an individual is likely to conclude at first glance.
Doses up to more than ten times the maximum therapeutic levels were tested for toxicity. These studies comprised cytotoxicity, organs function, hematological parameters, histological studies by electron microscopy, teratogenicity and cytogenetic testing. All the results demonstrated the nontoxic nature of medical ozone/oxygen within the range of therapeutic dose levels when administered intravascularly, intramuscularly and intrarectally.
Based on the role blood deoxygenation and hypoxia play in the painful sickle cell crisis, and considering the established therapeutic properties of medical ozone oxygen, and the absence of negative side effects, an evaluation of the effectiveness of this treatment for the prevention and/or the timely resolution of the crisis was made, by means of controlled in vitro and clinical trials.
It was encouraged by extensive successful practice in numerous Havana City Hospitals, fundamentally that regarding the treatment of patients suffering circulatory insufficiencies, diabetes and many other diseases related to insufficient supply of oxygen to tissue.
After resolution of the initial crisis, ozone oxygen treatments were continued to prevent a relapse. The treatments were administered once every 14 days over a period of 6 months to patients in the treated group. The number of subsequent crises per patient in this period were significantly smaller in the ozone oxygen treated group, compared to the control group (receiving conventional therapy). The proportion of severe crises also diminished very sharply in the treated group, compared to the initial proportion.
There were no adverse reactions observed during or after the administration of ozone in any of the patients treated. Additionally, it is of interest to mention that some of the patients in the treated group who suffered from associated clinical manifestations including: acute severe chest syndrome, priapism and duodenal ulcer, showed remarkably favorable resolution of such conditions. The following can be said of the Cuban sickle cell work:
OZONE BLOOD STERILIZATION
Ozone may soon be used to destroy viruses in donated blood, thanks to researchers at the Department of National Defence (DND) and the Canadian Red Cross Society (CRCS).
Under a contract with the Surgeon General Branch of Canada's National Defence Headquarters, researchers from the national Reference Laboratory at the CRCS are investigating two ozone sterilization technologies to confirm their reported efficacy in deactivating a variety of potential viral contaminants of blood, including HIV-1 and hepatitis.
Many developing countries cannot afford blood-screening, which costs about $45 for each unit of blood and requires a trained technician. "If the Canadian military is operating in an underdeveloped part of the world and is cut off from its supplies, we may have to resort to local blood sources," says Major Brian Crowell, Health Services Research Coordinator at DND. "We're looking for a sterilization technique that can be taken to the field, put together on the tailboard of a truck or in a tent, and used to sterilize donated blood quickly and effectively."
Once developed, such a sterilization technique would have applications beyond the military. Dr. Peter Gill, Difector of the CRCS's National Reference laboratory, says ozone sterilization technology could be used in disasters to aid civilian populations. Ozone gas is produced by passing electricity through pure oxygen.
Although ozone is harmful when inhaled over time, at the right concentrations it is highly effective as an antimicrobial. Over 2,000 water-purification plants worldwide, including those in Moscow, Los Angeles and Montreal, use ozone to decontaminate water.
Researchers are investigating two methods of sterilizing blood with ozone that have been patented by Medizone (Canada) Inc. and Mueller Medical International, Inc. One of these methods exposes 10 cm 3 of blood to heat (43.5 C) and ultraviolet light. Ozone gas is bubbled in through a tube. The blood foams up alongside the vial, exposing more blood surface area to the light, heat and ozone. Following treatment, the container is spun to force the blood down.
The other method uses a hollow fibre system between the ozone and the blood. The membrane separates the blood from~the ozone and oxygen. Over time, a predetermined amount of ozone absorbed is measured by subtracting the amount of ozone going back into the machine from the amount that left the machine.
These ozone sterilization methods are easy to operate, quick to perform, from three to 60 minutes, and cost no more than $15 for each unit of blood. Researchers will also investigate ways to combine ozone sterilization and filtration technologies.
Filtering the blood to reduce the number of white cells, the site of most intracellular viral infections, means viruses can be deactivated using low leveIs of ozone. This is preferable to using high levels of ozone, which could change the molecular structure of the blood. For example, the hemoglobin structure may be altered so that it no longer acts as an oxygen carrier.
Test results so far indicate that even low concentrations of ozone are extremely effective at deactivating extracellular viruses. In one study, ozone sterilized 10 cm of blood containing enough HIV to infect the entire world population 10 times.
Results from Bethesda Naval Hospital in Bethesda, Maryland, indicate that ozone can also be effective against intracellular viruses when used in higher concentrations. The ozone seems to destroy only infected cells, exposing the viral material to the gas and ultimately deactivating the virus, all without creating toxicity problems.
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