MADRID DECLARATION ON OZONE THERAPY (3rd edition) Official document of ISCO3 EDITION No. 01 ISSUE DATE: June 4th, 2010 EDITION No. 02 ISSUE DATE: June 12th, 2015 EDITION No. 03 ISSUE DATE: May 14th, 2020 Copyright (©) 2010, 2015, 2020. ISCO3 (International Scientific Committee of Ozone Therapy) Avenida Juan Andrés 60, local 1 bajo, 28035, Madrid (Spain). All rights reserved. www.isco3.org [email protected] Tel. + 34 91 351 51 75 / +34 669 685 429 ISBN: 978-84-09-19932-7 Statutory Deposit: M-11427-2020 Original language: English. Reviewers: Adriana Schwartz, M.D. Gregorio Martínez Sánchez, Pharm. Dr., Ph.D. Cum Laude. Roberto Quintero, Lawyer Revision of English style: Wayne McCarthy and other members of ISCO3. The only official version of the Madrid Declaration on Ozone Therapy (ISCO3, 3rd edition, 2020) is published in English. Graphic design: Clara Barrachina. Secretarial support: Olga Moreno. Layout and printed by Grafox Imprenta, S.L. (Spain). International Scientific Committee of Ozone Therapy (3rd ed., 2020) “For the Unification of Criteria in the Practice of Ozone Therapy” Official document of ISCO3 1st edition: Approved at the “International Meeting of Ozone Therapy Schools” held at the Royal National Academy of Medicine in Madrid on June 4th, 2010, under the auspices of AEPROMO (Spanish Association of Medical Professionals in Ozone Therapy). 2nd edition with updates and addendum on Dentistry: Approved by ISCO3 on May 10th, 2015 and officially presented at the “International Meeting of the Madrid Declaration on Ozone Therapy (2nd ed.)” held at the Spanish Royal National Academy of Medicine in Madrid on June 12th, 2015, under the auspices of ISCO3 (International Scientific Committee of Ozone Therapy) and the administrative and logistical support of AEPROMO (Spanish Association of Medical Professionals in Ozone Therapy). 3rd edition with updates and addendums on Dentistry and Veterinary Medicine: Approved by ISCO3 (International Scientific Committee of Ozone Therapy) onMarch 22th, 2020. Suggestion on how to cite this paper ISCO3 (2020) Madrid Declaration on Ozone Therapy, 3rd ed. Madrid. www.isco3.org. International Scientific Committee of Ozone Therapy. Madrid Declaration on Ozone Therapy (3rd edition, 2020) MADRID DECLARATION ON OZONE THERAPY 3rd EDITION, 2020 Official document of ISCO3 Authors of the Declaration (members of ISCO3) 1. Adriana Schwartz, M.D. 2. Gregorio Martínez Sánchez, Pharm. Dr., Ph.D Cum Laude. 3. Fadi Sabbah. DDS. Addendum A. Applications of Ozone in Dentistry. 4. Mercedes Hernández Avilés. D.V.M. Addendum B. Applications of Ozone in Veterinary Medicine. The Declaration was approved by the members of ISCO3 on March 22, 2020. Carmen Helena Acevedo, M.D. Froylán Alvarado Güémez, M.D. Dario Apuzzo, M.D. Robert Banner, M.D. Mauricio Carreño Peñaranda, M.D. Jaime Ulises Cachay Agurto, M.D. Francisco Ubiratan Ferreira de Campos, D.D.S. Bernardino Clavo, M.D. Ph.D. Cum Laude. Valerie Davis, M.D. Michael K. Gossweiler, D.D.S. Ana Gutiérrez Gossweiler, D.D.S. Mercedes Hernández Avilés, D.V.M. Suzanne Humphries, M.D. Gerardo Ibáñez Sánchez, D.V.M. Heinz Konrad, M.D. Víctor Leonel Llacsa Saravia, M.D. Kevin Logan, M.D. Gregorio Martínez Sánchez, Pharm. D., Ph.D. Cum Laude. Wayne McCarthy, N.D. Miguel Ángel Montoya Díaz, M.D., Ph.D. Carlos Goes Nogales, DDS., Ph.D. Sergey Peretyagin, M.D. Miriam Portero Fuentes, D.V.M., Ph.D. Cum Laude. Fadi Sabbah. D.D.S. Adriana Schwartz, M.D. Magda Siqueira, D.D.S. Roberto Siqueira, D.V.M. Roberto Quintero, Lawyer. Dr. Political Science. Expert, International Relations. Legal Adviser of ISCO3 (No ISCO3 member). • 4 • Madrid Declaration on Ozone Therapy (3rd edition, 2020) For the Unification of Criteria in the Practice of Ozone Therapy The updating process of the 3rd edition of the Madrid Declaration took nearly one year. Since July 2019 ISCO3 issued several international calls asking ozone therapists to send their proposals and suggestions for the updating of the Madrid Declaration on Ozone Therapy. Last day to receive proposals: November 30, 2019. Based on the proposals received the authors wrote different drafts until agreeing on the text. Then it was submitted for discussion among the ISCO3 members. After an intensive exchange of comments, suggestions, and revisions, finally, the 27 members of ISCO3 unanimously approved the 3rd edition of the Declaration on March 22, 2020 and it became an official document of the committee. ISCO3 wants to thank all those who participated and/or supported the committee in the challenging efforts of updating the Declaration. WHO IS ISCO3? ISCO3 is a scientific non-profit association founded in 2010 and its activities are governed by the Spanish legislation. ISCO3 is an independent scientific medical body from national and international associations or federations of ozone therapy; and commercial companies. As a consequence, its twenty- seven members do not represent any or various national or international ozone therapy associations, or commercial companies. Its members act within ISCO3 only in their own capacity. ISCO3 has been created with the clear intention that it has to turn into an international scientific authority due to the composition of its members; and that its recommendations may become a source of reference to all those who practice this medical therapy. The members are elected every five years. ISCO3 issued an international call at the beginning of July 2019 asking health professionals from any place, directly related to the practice of ozone therapy, to apply. The deadline set was October 31, 2019. Based on the applications received the current members have been elected for the five years period that stared on January 1, 2020 and will end on December 31, 2024. The new members elected the Governing Board of the committee integrated by the President, the Vice President, and the Scientific Secretary. Main Objectives of ISCO3 To determine the scientific and medical merits of each particular application of ozone, as well as a code of good practice, in order to create a standard practice and prevent the possibility of malpractice. To standardize each particular application of ozone based on scientific evidence. To achieve these objectives ISCO3 has the following three tools: • The approval and publication of the Madrid Declaration on Ozone Therapy. First publica- tion in 2010, and two updates in 2015 and 2020. • The approval and publication of different papers on subjects related to ozone therapy. • 5 • Madrid Declaration on Ozone Therapy (3rd edition, 2020) • The ISCO3 Ozone Therapy International Library, with all published and presented papers on ozone therapy. It is online, of free access, and is updated frequently. DISCLAIMER ISCO3 documents (including the Madrid Declaration on ozone Therapy) are recommendations and serve as a source of guidance and reference tor all those who practice ozone therapy. They are not mandatory. It is up to each ozone therapist to use his or her own clinical judgment in applying the recommendations issued by ISCO3. All technical publications of ISCO3 are under ISCO3’s name, including codes of practice, safety procedures and any other technical information. The content of these publications, were obtained from reliable sources, based on technical information, published research, from the experience of the members of ISCO3 and from others at the date of their approval. ISCO3 does not guarantee results and assumes no liability or responsibility in connection with the references for the use of information or suggestions contained in ISCO3’s publications. ISCO3 has no control whatsoever with regards to performance or non-performance, misinterpretation, proper or improper use of any information or suggestions contained in ISCO3’s publications by any person or entity (including ISCO3 members) and ISCO3 expressly assumes no liability in connection thereto. ISCO3’s publications are subject to periodic review and users are advised to obtain the latest edition. • 6 • Madrid Declaration on Ozone Therapy (3rd edition, 2020) For the Unification of Criteria in the Practice of Ozone Therapy MADRID DECLARATION ON OZONE THERAPY 3rd ed., 2020 Official document of ISCO3 Taking into account since the discovery of ozone by the Dutch physician Martinus van Marum in 1781 and synthesized by the German chemist Christian Friedrich Schönbein in 1840, its medical use has increased in different parts of the world and health professionals are showing more interest in ozone’s benefits and how it works. Accordingly, with the increase in the number of ozone therapists all over the world, the number of patients reaping benefits from ozone has risen. Although great efforts and advances have been made since the approval of the 1st edition of the Declaration in 2010, the consolidation of ozone therapy has not been easy. Resistance is still found within the medical community and ozone’s recognition in the legal field will require more coordinated efforts. Recalling that pre-clinical research and clinical trials on the use of ozone therapy have been carried out in different countries, with considerable scientific rigor, obtaining results that support its practice using systematic medical protocols. Bearing in mind that the preclinical studies, genotoxic, toxicology and clinical studies carried out, endorse the safe application and the generally innocuous character of this medical therapy under a wide range of doses. More detail in ISCO3 official document: Ozone Therapy and its Scientific Foundations.1 Emphasizing that research and