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The Open letter to professor V.Bocci

Econika Medical Engineering

The Open letter to professor V.Bocci

Dear Professor Bocci,

Allow me to continue the discussion, which took place at the conference in Istanbul. It seems to me that some important questions, which you put for the consideration to the congress, were not considered in sufficient details. Allow me to return to them again, in order to express the position of the Russian school of ozone therapy.

On one of your slides these questions were formulated as follows:


1. to discuss and clarify the best technological advances,

2. the need of using ozone-resistant materials to avoid toxicity. Plastic bags regularly used for blood storage are unsuitable as, in the presence of ozone, they release phthalates and plastic microparticles into blood. Neutral glass bottles are idoneous.

First, about phtalates. More than 90% of phthalates produced in Europe are used to plasticize PVC. We use many PVC products every day but tend to take many of them for granted. They include everything from lifesaving medical devices such as medical tubing and blood bags. Phthalates have been used for more than 40 years in flexible vinyl (PVC) products. Their use has led to improvements in the health and well being of billions of patients, many of them children, throughout the world. No plasticizer (materials used to make plastic soft) has ever been subjected to toxicity and safety testing to the same degree as DEHP. It has been a known fact in the scientific community for many years that di -(2-ethylhexyl) phthalate, DEHP, migrates from medical devices, such as blood bags and tubing, in minute amounts. However, not one single piece of validated scientific evidence shows that these products cause adverse health effects in humans.

Thus, many yearspractice of blood storage in PVC bags showed absence of any toxic effect of phthalates. Can ozone accelerate the migration of phthalates into the blood? Are there any solidly established scientific facts of the acceleration of phthalate migration from PVC into the blood under the action of ozone and ozone- induced formation of PVC microparticles? We will be glad to get acquainted with such data, if they exist. In any case, while estimating possible risks of the application of plastic bags of PVC one should take into consideration the following:

1) ozone does not interact with the bag material directly, since the conventional practice of big autohemotherapy lies in the fact that ozone- oxygen mixture first comes in contact with the blood, which must neutralize ozone for a split second.

We have made the measurement of ozone concentration in the bag immediately after the completion of the blood treatment with the ozone- oxygen mixture with the ozone concentration equal to 20 micrograms per milliliter. We have not discovered the content of ozone in the bag, in the sensitivity of the method of 0.1 micrograms per milliliter. It is obvious that only one of the components of ozone- oxygen mixture — oxygen comes in contact with the bag walls.

2) There were carried out about 200 000 procedures of big autohemotherapy with the use of PVC bags in Ukraine, Russia, Turkey, in some EU countries, in Latin America and countries of the Southeastern Asia. Being the inventor of the method variant of big autohemotherapy based on the use of the peristaltic pump and PVC- bag of special construction, I collect information about the excesses and complications, which appear in the practice of doctors, who use instruments and bags of my construction carefully. Since 2001, when the practice of this variant of big autohemotherapy have begun, I obtained 1137 reports about the complications while conducting this procedure. Complications can be divided into two types — during the procedure (862) and in the first twenty-four hours after the procedure (275). Complications during the procedure were manifested by vertigo, nausea, decreased arterial pressure, fainting.

As a rule, such patients admitted that this reaction usually appeared in them at the sight of the blood. The second type of complications was expressed by the increased body temperature of the patients after the first procedure, sleepiness, weakness. In certain cases, especially after the complaints of patients on sleepiness, the single dosage of ozone was reduced. These symptoms disappeared during the course.

We consider these complications to be a routine reaction of patients to the procedures associated with the blood taking, since this is a usual profile of complications in the donor practice.

In conclusion, it should be noted that on the basis of the positive experience of using polypropylene in your works on EBOO, and prejudices which some doctors have, especially in the West, we mastered the production of the plastic bags of 100% polypropylene, which we presented at the congress. Thus, doctors can select between two types of bags based on PVC and polypropylene, which are produced by us.

The next question which you submit for the consideration at the conference was the following:

3. Recently it has become fashionable to use the IV infusion of ozonized saline. In comparison to the classical ozonized autohemotherapy, this method is quick and inexpensive but is it valid Ozonized saline must be compared with oxygenated saline and appropriate chemical and clinical data must be presented. A valid and extensive comparison between clinical results achieved with either ozonized autohemotherapy or ozonized saline must be presented.

There are two aspects in this question:

1) whether hydrogen peroxide and sodium hypochlorite are formed during treatment of NaCl solution, which may be the cause for complications in intravenous infusion

2) is the dose of ozone obtained by the patient in this procedure sufficient for full therapy

The affirmative answer is given to the first question in your report. However, lets consider the facts.

Id like to cite the data represented in your report at the congress. It is seen from the diagram that in treatment of the saline with ozone in the concentration of 50 mg/l for 10 minutes the level of hydrogen peroxide is approximately 2.5 mcmol/l. Is this large or small Simple calculation shows that weight unit, concentration of hydrogen peroxide is 85 micrograms per liter or < 0.00001%. On the other hand, while bubbling the saline solution with ozone- oxygen mixture with this concentration, we increase the level of dissolved ozone to 4 mg/l. The comparison of the ozone concentration and hydrogen peroxide shows that ozone concentration exceeds peroxide concentration 47 times under the conditions described by you. It is obvious that presence of hydrogen peroxide, and therefore sodium hypochlorite should be disregarded under such conditions.

A question about adequacy of therapy by the method of the intravenous infusion of the ozonized saline solution seems to me to be more important. Let us calculate the dose of ozone, which the patient obtains during the procedure of the intravenous infusion of the ozonized saline solution. As a rule, the ozone concentration in the liquid is equal to 1-3 mg/l used in the Russian method. In this case the patient is infused 0.2-0.4 liters of the ozonized saline solution. It is easy to calculate that the patient obtains a dose of 0.2 — 0.6 mg or 0.4 -1.2 mg of ozone, respectively. Thus, a question about is the Russian method effective is brought to a question — is the dose of ozone of 0.2 — 1.2 mg sufficient for treatment of forms of diseases traditional for ozone therapy. There is no simple answer to this question. For some diseases, for example autoimmune ones, this dosage is insufficient. In case of such diseases big autohemotherapy should be used. At the same time there is an enormous list of the diseases, for which the Russian method is completely adequate. As an example I will give the basic results of the dissertation work made at Odessa medical university Use of ozone therapy in rehabilitation treatment of patients with ischemic heart disease of Dr.A.V.Artiomenko, Odessa, 2004.

Object of the research.

157 patients with stable stenocardia of exertion of 2-3 functional class by criterion class WHO/ISH,1993, heart deficiency of 2-3 functional class by the classification New York Heart Association and indications of the endothelial dysfunction became the object of the research .

Control group. 32 patients got standard therapy: digozin 0.25 mg/24 hours, Amlodilin 5-10 mg/24 hours, aspirin 100 mg/24 hours., furosemide 40-80 mg/24 hours. The basic group consisted of 63 patients; ozone therapy was conducted against the background, and consisted of infusion of 150 ml saline solution in a day started from 1 mg/l, with the following increase to 0.5 mg/l for 3 mg/l and following decrease to the initial dose, in all 10 procedures. One more group of patients got basic therapy and placebo in the form of infusion of 150 ml oxygenated saline solution in a day.

In 6 months after finishing the course of ozone therapy the main group was divided into two sub-groups. One of these sub-groups got the repeated course of ozone therapy.

All patients got the standard cycle of clinical-laboratory studies including the spirocycleergometry, Holter monitoring ECG, dopplerography of brachial artery, Doppler echocardiography, ultrasonic examination of the heart and others.

Some results of this research are given below.

On the basis of the data analyzed the author came to a conclusion that:

1. Application of ozone therapy in the reconstructive period of treatment of sick people with IDH increases the antianginal effectiveness of therapy, decreasing frequency to 55.7+-7.8% and daily quantity of episodes of ischemia of the myocardium to 61.3+-8.2% in comparison with the group receiving medicamentous therapy.

2. Ozone therapy corrects effectively the endothelidependent dysfunction of patients with IHD, providing growth of endothelidependent vasodilation by 83%, that is 2.1 times more than by medicamentous therapy.

3. Ozone therapy increases tolerance to physical work, decreasing the functional class of stenocardia and heart deficiency for sure and fast.

4. Ozone therapy at the out-patient stage of rehabilitations of patients with IHD improves pharmacoeconomic effectiveness of treatment, decreasing necessity of extra antianginal therapy by 61.5% and frequency of repeated hospitalizations by 58.2%

I assume that this work answers your question, taking into account that oxygenated saline solution was used as the placebo. We have tens of documented scientific research made in strict accordance with the modern criteria of the probative medicine, which have no doubts as to the effectiveness of the method of infusion of the ozonized saline of solution. More than twenty-year practice of application of this method in a number of the countries of Asia, Europe and Latin America is evidence of it.

What is a basic difference in the method of infusion of the ozonized saline solution from the method of big autohemotherapy, which allows to achieve a significant therapeutic effect in considerably lower dosages of ozone I believe that the reason for this lies in the fact that substantially larger volume of the blood is treated in the Russian method. In fact, if the velocity of blood flow in the cubital vein is 50 ml/min, then 1500 ml of the blood is treated for 30 minutes of infusion, which is 15 times more than in big autohemotherapy. Probably, this circumstance is decisive in the Russian method.

In conclusion I propose you to participate in the organization of the joint project on objective and independent assessment of the comparative effectiveness of the methods of big autohemotherapy and infusion of the ozonized saline solution. I propose to select the form of nosologies and the place of test conduction together.

I thank you for attention, which you paid to my letter. I hope that I managed to elucidate our position to you.

Accept my sincere assurances in respect and admiration by your works and by the contribution, which you have made in development of ozone therapy in the world.

President of the Ukrainian Association of ozone therapists

DrSci, Professor Eugeny Nazarov.

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