Three more trials are going on in China; two coordinated by Tinjian Universiy and a third one in Wuhan’s Union Hospital. We only have a preliminary report of the first two cases. Another trial is waiting for approval in Italy and two more trials are being prepared in Portugal and Brazil, all last three with WFOT’s help. We hope that last trials are approved and we soon get data enough to help our patients. WFOT will not publish preliminary protocols or data without permission from the trial’s coordinator unless it is required by health authorities. Meanwhile, we must follow STRICTLY the advises from these authorities.
UPDATE – 27/03/2020
Other trials have been accepted in hospitals of Romania and Turkey and are pending their ethic committees’ final approval.
UPDATE – 28/03/2020
Other trial promoted by NuovaFIO has already started in Poliambulanza Institute Hospital Foundation in Brescia after approval of its Ethic Committee. It also pending of registration in the web of Clinical Trials.
UPDATE – 06/04/2020
The University Hospital Santa Maria della Misericordia in Udine – Italy has done a pilot study under the approval of the hospital’s ethic committee. They obtained very positive results in 35 of the 36 patients treated, reducing the intubation rate from 15% to 3%. They have applied for approval from Spallanzani Institute in Rome to start a randomized clinical trial.
UPDATE – 10/04/2020
The University Hospital Santa Maria della Misericordia in Udine – Italy has got approval of its Ethic Committee to start a randomized clinical trial. Spallanzani Institute in Rome and AIFA (Italian Drug Agency) have declared themselves as not competent to approve the trial as ozone is not a drug. Several hospitals are sending applications to this hospital in order to join its clinical trial.
In February, when COVID19 epidemic was declared in the north of Italy, the President, Vice-President and Chairman of the Scientific Advisory Committee contacted several Chinese doctors, including the Chairman of the Chinese Federation of Ozone Therapy to ask about the use of systemic ozone in their country. The replied after a while saying that ozone had been used for disinfection and only one hospital in Guangshan had treated COVID19 patients with good results but without idea of protocols used or an official document with verifiable information. Later on, we found the information about other 3 clinical trials being carried out in China using systemic ozone.
WFOT has not received official information about the results from the 3 trials coordinated by Tiajin University and Union Hospital in Wuhan nor from the trial in Guangshan People’s Hospital yet. Despite this, as the unofficial information from China is encouraging, our Scientific Advisory Committee, with the few details received from the protocol being used in China, the protocol developed by NuovaFIO and after a systematic review of the papers published about ozone therapy is working in a proposal for clinical studies. This proposal has been sent to doctors that have real chances to develop a clinical study strictly executable ONLY under formal authorization from hospital’s ethic committee or equivalent responsible authority.
The patients should be ALSO treated according the recommendations of the Health Authorities of the country, as the ozone treatment presently can only complement the official treatments.
We have the greatest interest in save lives with ozone therapy, if it is really useful as we have been told, in COVID19 patients, but we don’t want to encourage any doctor to use ozone with these patients without the mandatory official authorization. This will cause a very negative effect on the still weak reputation of ozone therapy in the scientific community.
It is appearing more and more often in the media and social networks that ozone treatment could be useful in the treatment of this novel viral infection named Covid-19.
Taking into account that the recognized antiviral efficacy of the ozone molecule when used for disinfection at high concentration must not be confused with the scientifically proven therapeutic use of ozone.
Hoping that the efforts actually made by some Chinese hospitals to get approval from local ethics committees to perform clinical trials in specific cases of this viral infection will be supported by our strictest respect for the confidentiality and prudence that such an infection and its severity requires.
The Scientific Committee of WFOT declares:
WFOT will not support any information on the possible positive effects induced by ozone in Covid-19 patients, claiming for reports in the absence of strong and validated evidence, as required by a serious medical association.
WFOT scientific reputation requires us to keep our Chinese colleagues activity confidential, unless supported by consolidated scientific evidence.
WFOT also point out how unethical it is to propose our therapeutic method in a practically unexplored clinical field, which is also full of pitfalls. On the other hand, it appears to be more appropriate to express a certain discretion, being ready to respond to any request for help if either local or international Health and Political Organizations decide to request it.
After many many hours of hard work made by the Sociedade Brasileria de Ozonioterapia Medica – SOBOM and this World Federation, with the help of the Virtual Health Library – BVS, belonging to the PanAmerican Health Office, we have finished and published the first map of evidences of ozonetherapy.
As part of the World Health Organization – WHO’s plan of integrating complementary therapies inside the “orthodox” stream of medicine, the publication of evidence maps of these therapies is a basic goal to do away with the preset idea in the medical population that these techniques do not have any scientific evidence of their safety and efficacy.
Fourteen systematic reviews and metaanalysis have been compiled and studied to build this map that shows graphically the quality of the evidence in the different indications referred to in the papers. SOBOM and WFOT are presently writing down this work in order to publish it in detail in a top scientific journal.
Access to the evidence map here!
Yesterday we were informed by the Family that Professor Velio Bocci had left us at 11pm on Sunday 13 October. We preferred to keep a day of silence before publicly expressing our sadness at the loss of a brilliant Scientist, a great Man and a fierce and strenuous Warrior .. Thank you Friend and Master for having spent most of your life in study and exaltation of Ozone Therapy in the World. Thanks for having supported this Federation during the past 4 years. We will continue in your battle and we promise to defend the prestige of your person in Italy and in the world.
2019’s Nobel Prize work: a surprising adaptive machinery activated by low oxygen throughout genes modulation.
They identified the molecular mechanism that regulates the activity of genes in response to varying levels of oxygen.
A similar machinery that adapt cells inducing genes activation in response to oxidative stress and Ozone show parallel cellular mechanism.
According to the awarded’s work, when oxygen levels are normal, cells contain very little HIF-1α, a transcription factor that joins onto DNA to activate the synthesis of proteins that regulate the oxygen levels in the body. On the contrary, when oxygen levels are low, the amount of HIF-1α increases so that it can bind to and thus regulate the EPO gene as well as other genes with HIF-binding DNA segments (Figure 1).
Several research groups showed that HIF-1α, which is normally rapidly degraded, is protected from degradation in hypoxia. At normal oxygen levels, a cellular machine called the proteasome, recognized by the 2004 Nobel Prize in Chemistry to Aaron Ciechanover, Avram Hershko and Irwin Rose, degrades HIF-1α. Under such conditions a small peptide, ubiquitin, is added to the HIF-1α protein. Ubiquitin functions as a tag for proteins destined for degradation in the proteasome.
In the last years it is emerging the importance of another intracellular and ubiquitous protein that, differently from H1F, regulates the expression of antioxidant proteins that protect against oxidative damage triggered by injury and inflammation, the Nrf2 machinery (Figure 2). In normal condition and when the oxidative status of the cell is normal the Nrf2 is maintained at low level and, as occurs for HIF-1 α, it is marked with ubiquitin for
proteasome degradation. On the other hand, in case of mild oxidative stress, like that induced by adequate Ozone doses, the levels of Nrf2 increase and following the binding DNA segments it promotes the synthesis of proteins that induce a regulation of the redox status and not only: another surprising adaptive condition in order to maintain our cells health and protected either from hypoxia or from oxidative stress.
We can conclude that the importance of oxygen metabolism is fundamental for life on earth. For the above reason we are not surprised that our cells, during evolution, have equipped themselves with sophisticated machineries in the aim to maintain constant the vital functions even in extreme situations.
The discoveries of these metabolic pathways, such as the one that was worth the Nobel Prize to the 3 colleagues Kaelin, Ratcliffe and Semenza, are becoming clearer.
Cellular defense mechanisms linked to oxygen and oxidative stress are crucial for the live on the Earth.
The perfect machineries that defend the cell in extreme conditions.
The healing power of the human body, a perfect machine!!
We already have venue place and final dates for the next VII WFOT meeting, that will be hold in Bucharest – Romania on 2020:
- JW Marriott Bucharest Grand Hotel.
Calea 13 Septembrie 90, București 050726
- 16th and 17th of October, 2020.
- Pre-meeting workshops on 15th
MORE INFO COMING SOON!
In the past General Assembly (April 25th) 2 more society members were accepted:
- Austrian association.
- Moldavian association.
Other associations have recently applied and will be presented for acceptance in the next General Assembly yo be hold in Chile during the next FILAOT meeting.
And also several individual members, some of them from countries without a formal association.
The next WFOT General Assembly will take place on 25th of May in Bucharest (Romania) during the XVIII edition of the SSROOT master classes organized by our President Dr. Stefan Tiron. In the next days, the members entitled to vote will receive an email with the agenda.
Following a wide discussion at the last meeting of Guangzhou, it is in progress a strong work on a new official document that could support all the people associated to us and more. After our first theoretical document (“WFOT’s review on evidence based ozone therapy”) 3 years ago, many of you have asked us to develop clinical guidelines.
We apologize for the delay in preparing this document, that could be intended for a strong support to the daily practice of ozone therapy, trying not to impose methods or forbid others, but to justify scientifically our therapeutic decisions.
It is our aim produce a document which could be used as an international reference advise devoted to the Best Practice of ozone therapy, following the directives of the Scientific Advisory Board and hearing also the most recognized colleagues practicing ozone since its first uses in medicine.
We confirm, then, that we are hardly working on the document discussed in Guangzhou and, very soon, all the ozone therapists could have finally a support to their work. Any other news that could appear on the WEB regarding the possible support of WFOT and its members to Madrid Declaration or other documents not developed by us are not true.
All the re-founding members of WFOT, including our President Dr Tiron and our friend and colleague Dr. Nabil Mawsouf, decided to follow this new road – WFOT – to be faithful to our principles of reinforcing the image of ozone therapy worldwide and creating a unique Home of a unique Family by the use of science.