Ozone therapy
In the crosshairs of the anti-ozone forces

Despite comprehensive anecdotal evidence pointing to the important role ozone therapy can play in the treatment of Hepatitis and HIV, there is surprisingly little peer reviewed research published about its benefits. Some doctors claim big drug companies and their agents are determined to hinder their research efforts. Callan Emery reports.

The medical use of ozone for therapeutic purposes has a long history. Since the late 1800s it has been used in many areas of medical practice ranging from its use as an antiseptic for wound care to its use as an antiviral to treat Hepatitis. The first reports of it medical use date back to 1885 when the Florida Medical Association published “Ozone” by Charles J Kentworthy MD. Since then there have been many reports of its powerful therapeutic properties.

However, much of the evidence pointing to ozone's impressive efficacy as a therapy for a wide range of diseases remains anecdotal, with peer-reviewed clinical research rather thin on the ground. For one reason or another large scale clinical trials have not been carried out to prove its apparent therapeutic benefits.

One of the reasons given for this is that many of the patents related to ozone treatment are in the public domain and that there is no financial incentive for large corporations to fund clinical research. But in a number of instances in the United States when researchers have stepped up to the plate to conduct peerreviewed clinical studies, it appears their efforts have been stifled by US government agencies before these trials could get off the ground.

My interest in ozone therapy sparked when I met Dr Nabil Mawsouf, an ozone therapist and researcher, in Cairo in 2004. It was further aroused when, earlier this year, I received an email from Dr Gerard Sunnen, an internationally recognised medical ozone expert in New York, renowned in ozone therapy circles since his 1988 paper “Ozone in Medicine: Overview and Future Directions”, published in the Journal for the Advancement of Medicine.

Dr Sunnen stated in his email that a clinical research programme his company Medizone had set up with the Egyptian National Research Centre (NRC) in Cairo to study the efficacy of ozone therapy for Hepatitis C (HCV) patients had been squashed by the New York State Department of Health (NYSDOH).

Upon further research it became apparent that Dr Sunnen’s case was not an isolated one. US-based research journalist Ed McCabe’s Chronology of Ozone Medical References points to a number of similar instances where ozone research has been hindered by US government agencies.

In one of these instances McCabe refers to research carried out by George Perez, MD, director of Virology at Saint Michael’s Medical Center, Newark, New Jersey, US, and chief investigator of the hospital's Institutional Review Board. Perez was commissioned to conduct a 75-day institutional review board-supervised ozone-AIDS protocol with five terminally ill AIDS patients. The results were extremely positive with all five being released from hospital after only 15 days of treatment with greatly reduced viral load and no signs of toxicity. Several MDs came out in support of the protocol and said ozone therapy should be adopted. Following this, however, McCabe alleges Perez was coerced by the FDA to sign a document stating ozone is worthless or he would “be through as a doctor” and lose significant funding for the hospital. He notes that a “heavily censored” copy of this document is available under the US Freedom of Information Act.

Background

Before we look at this apparent suppression of ozone therapy in the US and Dr Sunnen’s case in particular, let us look briefly at the history of ozone in medical practice. Ozone¸ a gas discovered in the mid-nineteenth century occurs naturally as three oxygen atoms bonded together – O3.

It is an unstable molecule and as such is a powerful oxidising agent. O2, or oxygen, is the stable form of this gas. Ozone is colourless, acrid in odour and explosive in liquid or solid form. It has a half-life of 40 minutes at 20°C and about 140 min at 0°C.

In nature it is abundant only in the stratosphere (20,000-30,000 metres) where its concentrations reach 16-20 mg/m3. In this layer, it is produced by the action of ultraviolet solar radiation and in turn, protects the earth from ultraviolet solar radiation.

Atmospheric pollution has resulted in what is now popularly known as the “ozone hole” – a hole in the ozone layer above the South Pole. On the Earth's surface ozone concentrations are less than 20 µg/m3. These concentrations are compatible with life. Ozone has found abundant application in industry and is now commonly used for purifying water, sterilising air, and bleaching certain foods. Its use in medicine is rather more controversial, with some doctors of medicine claiming it has remarkable healing properties, while others say it is mere quackery.

The supporters of ozone therapy point to a large body of anecdotal evidence to support their claims, while the detractors say there is no rigorous scientific evidence to support the use of ozone for medical treatments. If inhaled, ozone can be harmful to the lungs and in 1976 the US Federal Drug Administration declared ozone “a toxic gas with no known medical uses”.

Ozone therapy is not endorsed by the health authorities of many countries countries and in the United States many states outlaw the sale of ozone generators and its use in medical practice, research and clinical trials on humans. Medical doctors who practise ozone therapy in these states risk losing their medical licence.

This may be changing in the US as a few states have apparently legalised ozone therapy as an alternate therapy under new alternative therapy legislation. In most European countries ozone therapy is well established as a complementary and alternative medicine where health authorities allow its practice for certain disorders. Its use in this Europe is widespread.

According to a German study by the University Klinikum Griessen and the Institute for Medical Statistics published in 1982, more than five million ozone treatments had been given to some 350,000 patients by more than 1,000 therapists, about half of whom were medical doctors.

Ozone administration

Medical ozone is made in an ozone generator by passing an electrical current through oxygen in a closed container. However, due to the short halflife of ozone, it has to be generated at the point of application.

Inhalation of concentrated ozone gas is toxic. It is also not recommended that ozone be intravenously injected due to the risk of air embolism.

There are in essence seven ways in which ozone can be administered for therapy:

1. as a topical treatment in gaseous form

2. as a topical treatment, combined with barriers, for example, ozonated olive oil liniments or poultices

3. as ozonated drinking water

4. as a transdermal gas sauna

5. as intra-articular and intra-discal gas injections

6. as ozonated blood via autohemotherapy

7. as extracorporeal ozone therapy

As a topical treatment there is considerable anecdotal evidence showing ozone to have powerful anti-bacterial, antiseptic, anti-inflammatory, and circulation-enhancing properties. This makes it an interesting candidate for healing diabetic ulcers, burns, and poorly-healing wounds (such as found in war wounds).

But more interesting is ozone's apparently powerful antiviral properties when administered via extracorporeal therapy (extracorporeal ozonation of the entire blood and lymph volume, as in dialysis), or autohemotherapy – the extraction of 50ml to 250ml of blood from a patient, mixing it with an anticoagulant such as heparin, infusing it with a mixture of oxygen/ozone (15-80 µg/ml for 5-10 min) and then returning it to the patient.

This is usually done twice a week for 7-8 weeks depending on the condition being treated.

In his paper Hepatitis C and Ozone Therapy (2005) Dr Sunnen points out the importance of precise ozone dosing during treatment.

“Administrating ozone to whole blood shows that beyond a certain threshold there is a rise in the rate of haemolysis.

This threshold, depending upon various parameters, begins to be reached at 40 to 60 microgrammes of ozone per millilitre of blood and becomes significant when higher levels are attained.


Precise ozone dosing capacity is therefore essential in clinical practice and research.” There is considerable evidence from in vitro studies, animal studies, human case studies, preclinical trials and considerable anecdotal evidence which indicates the antiviral capacity of ozonated blood.

According to McCabe’s list of medical references of ozone therapy, in 1991, Blood Journal published (Volume 78 Number 7, Oct 11, 1991, pg 1882) a paper by Dr Bernard Poiesz et al (from Syracuse State University of New York Research Hospital), entitled “Inactivation of HIV Type 1 by Ozone in Vitro”, which describes how researchers performed 15 replications of an ozone study that interfaced ozone with HIVinfected factor VIII blood.

The ozone completely removed the HIV virus from the blood 97% to 100% of the time, yet was non-toxic to normal healthy blood components. McCabe's reference also refers to a 1991 case where “a brave humanitarian US MD (Dr JB, ret.) in a southern state comes forward with his secret clinical ozone/hyperbaric therapy results.

All his testing was performed at a major hospital and within independent labs. Out of 248 HIV positive patients he reported bringing 113 to HIV negative, each within 60 days, using ozone autohemotherapy immediately followed by hyperbaric therapy.”

Dr Sunnen’s case

Dr Sunnen says his 1988 article, 'Ozone in medicine: overview and future directions' spurred a lot of interest in ozone.

“I received many calls and faxes regarding the paper and was invited many times to give public seminars and talk on the radio about the topic,” he says. Dr Sunnen joined Medizone International in New York in 1997 as the company’s research director.

Medizone, at that stage, was a research and development company engaged in the development of ozonebased treatments for diseases caused by lipid enveloped viruses, such as HIV, hepatitis B & C, and herpes.

The company held a patent for the technology to decontaminate blood and blood products using ozone. It also was developing a patented system to deliver ozone to the blood. “Following widespread interest in my ozone in medicine publication, the National Research Centre (NRC) in Cairo contacted me.

In view of the Egyptian hepatitis C (HCV) emergency, health authorities were interested in new therapeutic approaches for hepatitis C, namely novel technologies of oxygen/ozone administration,” Dr Sunnen explained. Middle East Health reported in March this year on Egypt's chronic hepatitis situation.

Egypt has the world’s highest percentage population infected with HCV. Figures vary, but conservative estimates from Egypt’s newly formed National Hepatitis Committee put the figure at 10% to 15% of the population who carry HCV antibodies, with around five million actively infected.

The extremely high HCV prevalence is largely the result of a government drive prior to the 1980s to treat rural populations for schistosomiasis (bilharzia). The treatment campaign, involving repeated injections, did not follow rigorous hygiene standards and blood-borne HCV was spread throughout the population.

Dr Mawsouf told Middle East Health he reckons more than 15% of the population has HCV, “that's more than 10 million cases, however there is no accurate statistical data”. Dr Sunnen explained that “NRC representatives came to New York where a meeting was held with Medizone on 7 August 2000.

Research protocols were agreed upon and a contractual agreement was signed by all parties.” The study was officially named: “Safety and efficacy of ozone in the treatment of patients with chronic hepatitis C.” Dr Sunnen pointed out that the study was to involve 66 patients with the main objectives being to evaluate:

- Hepatitis C viral load reduction with blood ozonation
- Liver enzyme recovery
- Clinical improvement, as measured by scales of health and well-being

This was a trial that, had it been completed, had the potential for wide ranging benefits not only for Egyptian HCV sufferers, but for people with HCV around the world.

Based on preclinical studies medical ozone has the potential to offer a highly efficacious and relatively inexpensive solution for the chronic HCV situation in Egypt as opposed to the current retinue of relatively expensive antiviral drugs that have low patient compliance, and can lead to the development of HCV resistance to the medication.

According to the Egyptian National Hepatitis Committee more than 70,000 people are newly infected with HCV in the country each year.

The trial was just getting under way when Dr Sunnen resigned under pressure from investors who threatened to withdraw their money from Medizone. As he was no longer involved as director of research the study was aborted. The reasons that lead to Dr Sunnen’s resignation are key to this article.

In 1996 Dr Sunnen was brought before the New York State Department of Health (NYSDOH) Board of Professional Medical Conduct on charges stemming from an incident in 1986. He was charged with having a relationship with a patient and practising medicine with negligence.

Dr Sunnen says the woman in question was not a patient, but a person he was having a relationship with at the time and that he had prescribed medication for her. “It's unfortunate that when you prescribe medicine for a friend, the friend legally becomes a patient,” he noted. More significantly he was not allowed any witnesses at the hearing, which he claims was a sham.

His license to practise medicine was withdrawn. Dr Sunnen outlines this struggle with the NYSDOH in his account “Sorry, no witnesses for you” on page 34. He said the charges were trumped up and shamefully fabricated and that there was no due process of law as he was not allowed any witnesses for his defence.

When approached by Middle East Health for comment about this case the NYSDOH did not to respond. “Please believe that I would not go public if there was really any truth in what they were saying and part of my motivation is to speak for the hundreds of innocent doctors who are being persecuted,” Dr Sunnen told Middle East Health.

“I have never transgressed patient boundaries. My mistake was to prescribe to non-patients. They got me on that,” he said. Nonetheless, in 1997 he joined Medizone as president and research director.

In this position Dr Sunnen received many calls from potential investors. “Potential investors told me about their conversations at the highest levels of a number of major pharmaceutical manufacturing companies.

They asked the company executives if they knew of ozone and if ozone could be a newcomer in the hepatitis C field. I believe that pharmaceutical firms knew of ozone all along, but it is then that they started to be concerned about it.

Of me, the investors frequently asked about details of the economics of ozone treatments. It was evident to anyone that blood ozonation would be much cheaper than conventional interferon/ribavirin [the conventional drug regimen for HCV].

Medizone stock climbed,” Dr Sunnen explained. Around this stage he was interrogated by NYSDOH agents “about my ozone activities”.

In 2001, the Egyptian study, now underway, began to spark interest. Dr Sunnen says it was at this same time that a campaign of character assassination was launched against him on the Medizone website’s open forum with “spiced up NYSDOH reports” about Dr Sunnen having lost his licence.

Dr Sunnen believes they were placed there by the NYSDOH. The CEO of Medizone, Ed Marshall, raised the issue with the NYSDOH, who, according to Dr Sunnen, said they would continue with their campaign to discredit him.

The end result was that investors, after reading these damning reports, threatened to withdraw their money from Medizone. Dr Sunnen resigned to placate these investors. “Without my presence the study folded because Medizone's technical contributions – as per the contract with the NRC – could not be sustained,” Dr Sunnen said.

Professor Shadia Ragab of National Research Center in Cairo, who was involved with the study confirmed to Middle East Health that the trial was aborted in its early stages, but she said she does not know why.

She says it was stopped in the very early stages, while they were selecting prospective candidates who had HCV, but no other diseases. She added that the ozone generators had not yet been brought into Egypt for the study. Dr Sunnen believes there was more to it than just the NYSDOH at work here.

He believes that the multi billion-dollar interests of the big money drug companies were being threatened by this study. These powerful companies – the ones producing the current crop of HCV medications – wield a lot of influence among the political elite in Washington DC and in turn at the closed-door world trade talks of the World Trade Organisation.

A BBC radio documentary last year highlighted the power that the drug companies wield at the world trade talks.

The report outlined how the United States, serving the interests of these drug companies, would threaten to withhold aid or block trade concessions to certain countries, in return for those countries not producing cheap generic drugs, for example.

Dr Sunnen explained to Middle East Health: “If this study had been successful it would have had devastating implications for the status quo in hepatitis C therapeutics. “It must be remembered that blood ozonation is much less expensive than conventional treatments. In addition, ozone itself, as a natural gas, cannot be patented; only its delivery process can.

“If serious research validates the vast clinical experience accumulated so far, ozone-based therapeutics will become an important player in hepatitis C management. In view of these facts, one can easily imagine, with billions of dollars in the balance, how special interests could work to inhibit the progress of parallel therapies.”

Going forward

Dr Sunnen says he would like to restart this important study and points out that he would approach the research differently this time round.

“My suggestion to the Egyptian MoH would be to give priority to a comprehensive clinical (human) study on hepatitis C and blood ozonation, much as was envisioned in the NRC study. I would design the study a bit differently, this time with more attention paid to the immunological dimensions.

This would, at this time, still be a world-first study. I would do studies determining blood ozonation’s role in hepatitis C treatment to show if it can be a standalone treatment, or a complementary add-on treatment to the standard interferon/ ribavirin cocktail.

With millions affected, I would envision (as the NRC did) a system of regional clinics throughout Egypt incorporating this treatment within the context of comprehensive clinical care.” Dr Sunnen has now set up a new company, Ozonics International, where he focuses on the external applications of ozone-based therapeutics.

For more information about the medical ozone controversy - Use of Ozone in Medicine - a documentary film


“SORRY, NO WITNESSES FOR YOU”

Dr Gerard Sunnen describes his experiences with the New York State Department of Health and how a US-based medical ozone R&D company he worked with clashed with US political agendas and special interests.

In 1988, I toured several German medical facilities that applied ozone-based therapies to clinical practice, including the renowned Hansler Institute in the Black Forest. This exploratory venture came from a dear friend's plea to explore new therapies for his daughter who had exhausted all regimens for her cancer.

My experience on this trip was sufficiently powerful that I wrote my first paper on the medical applications of ozone. Entitled “Ozone in medicine: Overview and future directions,” and published in the Journal of Advancement in Medicine, this paper aimed to separate ozone science from ozone fiction.

In writing this paper reviewed over 200 articles culled from the international medical literature and, from those, chose 59 which I felt had solid scientific validity. In fact, this paper was the first to comprehensively review the world literature on ozone therapeutics.

I was surprised, and delighted, by the success of this article, as seen from the volume of requests for reprints. In due time, I was invited to speak on radio health shows, and to lecture and write articles in lay magazines and newsletters.

The New York State Department of Health (NYSDOH) has never looked kindly on so-called alternative or complementary therapies. A favourite tool for expressing its displeasure has been the repression of physicians engaged in their research and practice.

One can only visit several websites such as the Foundation for the Advancement of Innovative Medicine (FAIM), or Google “OPMC Reform,” to become aware of the NYSDOH clashing with the rights of patients to choose their medical destinies.

I am often asked why there seems to be such a consistent, almost reflexive official bias specifically against ozone's now established medicinal properties. After all this time, I must admit I am still searching for satisfactory answers.

The psychological association linking ozone and toxicity appears remarkably resistant to enlightenment. There are, I am sure, additional explanations for this puzzling phenomenon.

As word spread of my interest in medical ozone, my office increasingly received calls from prospective patients inquiring about the applicability of ozone-based therapies in all manner of conditions. Could it be used in cancer, multiple sclerosis, AIDS, etc? Some of these calls struck me as unusually insistent and somehow disingenuous. The idea finally occurred to me to trace their origin.

What a surprise when I found out that many of them came from the NYSDOH! These calls, then, did not come from patients, but from pseudopatients. If I had erred in blatantly recommending unaccepted ozone treatments, I could have been accused of fraud. Fortunately, I always tempered my comments with balanced scientific evidence.

In 1996, the NYSDOH took it upon itself to charge me with transgressing patient boundaries. This bogus charge astounded me, as it was patently false. The problem remained that I could not prove it wrong, and I will tell you why. A hearing was set, with a panel of three judges and one administrative law judge (ALJ).


On my first contact with this panel, I immediately recognised my ex-boss at the hospital where I worked, and asked that he recuse himself. He refused, and this was sustained by the ALJ. I then asked for four witnesses. When the ALJ balked, my lawyer pleaded for two. Eventually, incredible as it may seem, all were denied! My attorney leaned over and whispered in my ear, “Sorry, no witnesses for you.”

For the sake of appearances, I was allowed one character reference. But without core witnesses for my support, clearing myself became an impossibility.

The panel ruled against me. The phrase “kangaroo court” repeatedly came to my mind. The appeal of this decision went to the highest court in New York State.

This court, in turning me down, essentially signalled that it was acceptable to be deprived of any and all witnesses for one's defence. This struck me as being profoundly at odds with the spirit of American democratic ideals.

A bill was subsequently introduced by the New York State legislature to guarantee physicians the right to due process. Lamentably, in 2004, George E. Pataki, the then governor of New York vetoed it. The company in the U.S. with the most expertise in ozone therapeutics has always been Medizone International, Inc.

In 1997, I joined its Board of Directors and later that year, I was elected President and Director of Research by 99% of its 7000 or so shareholders. The company needed fresh ideas and a focused direction. Ideally, it needed basic research in ozone science, including human studies.

I did not anticipate, once president, receiving the volume of inquiries about Medizone's direction. Daily, investors and potential investors increasingly bombarded me with good questions.

How well could the Medizone process apply to hepatitis and to other viral conditions? To cancer? To wound healing when applied externally? If, in fact, it had remarkably few side effects as shown in animal studies, what could its potential be in five years? Or in ten years?... Even more pointed were financial queries.

Assuming Medizone's success in developing a therapy for hepatitis C, for example, would it displace current regimens? How expensive would the ozone treatments be? What market share would I expect these treatments to take, in what time frame? This part of my job was edgy.

On one hand I had to maintain company confidentiality, and on the other, I sought to be cordial, helpful, and, above all, ethical. I could never, of course, hold out false claims or exaggerated hopes.

Some of the queries surprised me by their financial acumen and sophistication. When their frequency increased, I began to wonder: “Who are these savvy marketing people?” My curiosity, on a lark, led me to trace some of these calls.

What a surprise when I found that a good number of them originated from pharmaceutical companies! The National Research Centre (NRC) in Cairo contacted me about its hepatitis C public health emergency and its interest in exploring a possible role for blood ozonation for its control.

Contracts between the NRC and Medizone were eventually signed and research protocols agreed upon for a study officially entitled “Safety and efficacy of ozone therapy in the treatment of patients with chronic hepatitis C.”

The Egyptian Minister of Health and Population endorsed this world-first fully scientific study of blood ozonation in his cordial letters to me. The excitement about this new approach to hepatitis C treatment galvanised most everyone.

Although Medizone did not put out press releases about this project, word spread surprisingly quickly. The habitual calls from investors now included queries about “the Egyptian study” and its implications as a potential breakthrough therapy. Then, two NYSDOH agents came to my home.

Basically, they interrogated me. After shutting off their tape recorder, they grilled me about ozone. They knew about Egypt. The context of this interaction was palpably uncomfortable, if not frankly threatening.

I remained as tempered as possible under the strenuous circumstances, and was clearly pleased when they finally left. The NYSDOH exerts great power over doctors. One of NYSDOH signature power methods is the posting of physician data on its Internet site.

This “data” is often so egregiously defamatory that physicians cower from it and go underground, too frightened and ashamed to protest.

Shame, however, should be allowed only when there is veritable guilt, and so, aggrieved innocent physicians need never let shame bring their heads down. On the NYSDOH website you will find thousands of doctors listed with all kinds of alleged sins.

I know from personal experience that most of the postings are drivel, souped up with hyperboles and gratuitous fabrications. In order to justify its own existence by flaunting sheer numbers of convictions, the NYSDOH site even features physicians who have been dead for years.

I personally knew one physician who committed suicide years ago who remains alive and well on this site! At this time there suddenly appeared, on Medizone International's blog Raging Bull, verbatim postings from the NYSDOH website. About me! The NYSDOH had struck a powerful blow. Although the majority of investors saw this in its proper perspective, a few vociferous investors demanded a change of management.

I discovered that the NYSDOH and the Medizone CEO had directly engaged in several intensive communications. The company, already strained by President-to-CEO differences about Medizone's direction, and now reeling from NYSDOH's onslaught, imploded. I resigned.

Unfortunately, with my departure, also came the crash of the Egyptian study because of my close collaborative relationship with the Egyptian scientists. In the balance, were also my patents on interfacing blood with oxygen/ozone mixtures.

The NYSDOH won this particular round, but in the process, it paid a price it may have never thought about: severely crippling a US public company; and stopping a hepatitis C study that was intended to help millions of Egyptian and other patients afflicted with this disease.

The latter, to me, is the saddest part of this unfortunate story. In protest, I began writing to legislators, in New York State and in Washington, DC. I received many acknowledgments of receipt but there was never any follow-up.

What transpired, instead, was a creative riposte from the NYSDOH: it incrementally amended its website entries about me so that I would clearly appear, to anyone, as the most reviled person on earth! Serendipitously, and thanks to the Internet, it was uncovered, a few years after my hearing, that the ALJ in my case had lived for many years at the same address as the instigating plaintiff.

Quite a surprise! And what a revelation! This new information became the focal point of my lawsuit, “Sunnen vs. NYSDOH,” with me charging that a connection between a judge and a plaintiff of this magnitude constituted a gross effrontery to due process. The first judge to examine this case ruled against me, and this without any stated explanation.

Unfortunately, it took well over a year for her one sentence edict. The appeal then went to the Chief Judge of the State of New York. Surely, I thought, she could well see that I had been denied all witnesses for my defence and that I was provided with grossly tainted judges.

Evidently, these points of law were irrelevant and once again I was struck down. Not one to be easily discouraged, I asked my seasoned erudite lawyer about my options. He looked at me askance through his thick eyebrows.

“Yes, you have one more chance, the Supreme Court. But I must warn you that only 4% of cases like yours are ever heard.” Surely, I thought, justice could well prevail there, and that would be worth the expense.

The wait was awfully long. Finally, the verdict came: my case failed to be chosen by the Supreme Court of the United States. I believe that New York State will eventually see fundamental rules of democracy prevail in all of its sectors, including its Department of Health.

There is a global democratic thrust under way which the world needs in order to flourish and survive. For this to take place in New York State’s medical system, all physicians will need the recognition of full due process – including the inalienable right to have witnesses for their defence, and the right to untainted judges.

Justice itself will then evolve to a higher level. Hopefully, in parallel, there will also be an expanded openness for embracing promising innovative medical technologies – including ozone-based therapeutics – which, I have no doubt, will inexorably merge with the mainstream medicine of the future. Middle East Health approached the NYSDOH for comment about this case, but they failed to respond.

Egyptian doctor claims good results for HCV patients

Dr Nabil Mawsouf, professor of Pain Management and head of the Ozone Therapy Unit, National Cancer Institute, Cairo University, Egypt has published a provisional study to evaluate the effectiveness of ozone therapy in hepatitis C genotype 4 infections and to evaluate a proposed ozone therapy protocol in HCV genotype 4 treatment.

The study was conducted on 60 type 4 hepatitis C patients, 45 males and 15 females ranging in age from 34 to 65.

The results were very positive and showed that after 8 weeks of ozone therapy (autohaemotherapy + rectal insufflation) the viral load decreased in 91.67% of cases and reached zero level in 20% of cases. After 24 weeks of ozone therapy viral load decreased in 95% of cases and reached zero level in 36.67% of cases. After 8 weeks of ozone therapy, the abnormal enzyme levels were back to normal in 20% of cases for the SGPT enzyme, and were back to normal in 23.33% of cases for the SGOT enzyme.

Dr Mawsouf says another study presented at the 17th International Ozone Association Conference in Strasburg, France, September 2005, performed on 50 type 4 hepatitis C patients showed almost the same results as regards PCR (Polymerase Chain Reaction to check viral load in blood) and there was a statistically significant improvement as regards the parameters of SGOT, SGPT, albumin, bilirubin and prothrombin after 8 weeks from the start of the study.

Dr Mawsouf, who is also chairman of The Egyptian Medical Society for Ozone Therapy and Complementary Medicine, concludes that as a preliminary study ozone therapy was found to be an effective, safe and less expensive method [than conventional medication] in Hepatitis C patients, but points out that further studies are important.

Speaking to Middle Easy Health Dr Mawsouf, who estimates that more than 15% of the Egyptian population has HCV, says his “research, carried out at a Ministry of Health hospital, was conducted by some enthusiastic doctors and professors with a personal agreement from the Minister of Health at that time.

“However we are still being opposed strongly by some narrow minded hepatologists and I can never ignore the strong opposition by drug companies that are gaining huge amounts of money by selling their high cost, low efficacy drugs. In spite of the success of the research, it is still not yet approved by the Ministry of Health as a line of treatment in hepatitis patients. They have requested more research.”

Ozone therapy units have been set up in three universities in Egypt, namely Cairo, Assuit and Al Menofeya. Ozone therapy units have also been established in Al Haram Hospital, an MoH hospital, as well as Al Agouza Rehabilitation Military Center in Cairo, Mostafa Kamel Military Hospital in Alexandria, Navy Hospital and Navy Hyperbaric Medicine Center in Alexandria. According to Dr Mawsouf, the Egyptian Government passed ozone therapy regulations in December 1999, which approves its use as an ‘adjuvant therapy’.

He said the importation of medical ozone generators was approved at the same time, but this decision was later suspended temporarily. “The strange thing is that this ‘temporary’ suspension has now lasted for around six years,” he added. He said initially ozone therapy could be practised in any clinic “as is the case in many parts of the world. However, recent new legislation permits only rectal insufflations and topical administration in clinics. “If ozone is administered by major autohaemotherapy or ozone sauna it can only be given in hospitals equipped with an ICU unit.”

Dr Mawsouf said that following legislation in 1999, ozone therapy was approved as a complementary medicine for many indications including some viral diseases, some degenerative diseases, some auto-immune diseases, some allergic conditions and so on. “But the new legislation permits medical ozone use only for diseases due to anaerobic bacteria, burns, diabetic complications and peripheral vascular diseases. It specifically outlaws ozone therapy for HCV patients – until further research is carried out.

“However, this research has now been completed by the MoH. The study entitled ‘Effect of ozone therapy with and without antioxidants on viral kinetics and liver histopathology on hepatitis C patients, phase III clinical study’ shows that ozone therapy has an anti-inflammatory and anti-fibrotic effect, yet there is still no approval for the treatment of HCV patients,” he emphasised.

Asked if he thought it possible to treat a large population of HCV patients with autohaemotherapy and rectal insufflation, Dr Mawsouf said he thought it could be done and did not foresee any technical drawbacks “apart from it being opposed by some hepatologists and some doctors in the Ministry of Health”.

“You must also keep in mind that thousands of patients have been treated by my colleagues and I in the past eight years in a number of ozone centres in Egypt with encouraging results,” he emphasised.

Dr Mawsouf recommends that a large clinical study be carried out under the umbrella of the World Health Organisation’s Eastern Mediterranean Regional Office, which is based in Cairo, to properly evaluate the efficacy of ozone therapy for HCV patients. The WHO EMRO failed to respond when Middle East Health approached them for comment about the issue.

                                  
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