Comments on “Intraforaminal ozone therapy and particular side effects: preliminary results and early warning” by Daniele Vanni, Renato Galzio et al. – DOI 10.1007/s00701-015-2545-y
José Baeza-Noci, MD., PhD.
Orthopedic and Trauma Surgeon. Hospital Virgen del Consuelo. Valencia (SPAIN)
Professor of Human Anatomy – School of Medicine – University of Valencia (SPAIN)
President of the WFOT – World Federation of Ozone Therapy
President of the SEOT – Sociedad Española de Ozono Terapia
Email: jose.baeza@uv.es
Dear Editor,
After a careful reading of the paper entitled “Intraforaminal ozone therapy and particular side effects: preliminary results and early warning” by Daniele Vanni, Renato Galzio et al. Published in your Journal Acta Neurochir – DOI 10.1007/s00701-015-2545-y I would like to make the following comments:
In the ABSTRACT section: from the text, it is impossible to know how many patients did have tissue adhesions.
In the INTRODUCTION section, the sentence “In fact, in many cases ozone therapy is incorrectly used as a first approach or in case of failure after pharmacologic treatment.” has no reference support. The reader should suppose it is the author’s opinion.
In the MATHERIALS AND METHODS section, regarding the sentence “In most cases this therapy is even proposed as an alternative to surgery, although its effects are often only partial and temporary [3, 13].”, after a careful reading of both references, I have not been able to read such an assertion in any of them. I have sent this information to both reference’s authors so they can get it touch with you and with the correspondence author of the paper to clarify these references.
In the same section, the sentence “These patients received 16 applications in an 8-week period (standard therapy) [5].” points to a reference (2) that, as you can read in the title, is not related AT ALL with intraforaminal approach, but with intramuscular injections!!
Keeping in the same section, the sentence “Before the surgery, informed consent was obtained from all the patients, and they were subjected to an MRI evaluation as standard protocol. In eight patients a contrast enhanced MRsurgery, accomplished in order to perform a microdiscectomy or micro-decompression, several hard adhesions between the soft tissues and bony structures were unexpectedly discovered.” we discover that only 8 from 23 patients showed tissue damage, when according to the ABSTRACT section, the reader can understand that ALL the patients that were previously treated with ozone had this damage. Moreover, the authors don’t refer to MR studies before ozone treatment, so we actually don’t know if this adhesions were there before the ozone treatments. Some patients that come to my office have these kind of adhesions without any previous local treatment.
Following in the same section of the paper, regarding the sentence “This lesion was also detected during the preoperative MRI, but it appeared only after the ozone therapy treatment, about 9 months after the last cycle of infiltrations.”, the reader cannot know, from the information in the text, if there was an MR before ozone treatment for all patients, some patients or whatever, so it is impossible to make such an assertion.
In this section, the authors wrote “On the contrary, we did not find any pathological abnormalities in the patients who did not receive any injections or who received intraforaminal steroid injections”. It is astonishing that the authors did not find any problem in steroid injected patients, when local damage into the injected tissue is well documented (1, 3, 5, 6). Morover, as you surely know, there is an FDA alert regarding epidural steroid injections! (4)
In the CONCLUSION section, the sentence “However, in our opinion, it is even more important and necessary to be careful in the patient selection, because we must be aware that in Italy about 3000 treatments are performed every day, but about 34 % of the patients who undergo ozone therapy were not previously informed by a physician, but only by a friend or relative (Fig. 11) [5].” is, at least, tendentious. All patients that are treated with ozone are evaluated by a medical doctor and receive and informed consent prior to the treatment, so they are ACTUALLY INFORMED BY A PHYSICIAN, just the opposite of the text in this paper. You can read reference 5 in the paper to realize about this fact. (2)
After all the comments, in my humble opinion, this paper don’t reach the quality standard of your publication.
José Baeza-Noci, MD., PhD.
REFERENCES
- Articular and periarticular corticosteroid injections. Drug Ther Bull 1995, 33: 67-70.
- Coclite D, Napoletano A, Barbina D, Guerrera D, Guerra R, Paoloni M, Santilli V, Franzini M (2008) Conferenza di consenso: Ossigeno-ozono terapia nel trattamento delle lombosciatalgie da ernia discale con tecnica iniettiva intramuscolare paravertebrale. Rapporti ISTISAN 08/9, Italy
- Hardin JG. Controlled study of the long-term effects of steroid injection. Arthritis Rheum 1972, 22: 619.
- http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm394530.htm
- Gray RG, Tenenbaum J, Gottlieb NL. Local corticosteroid injection treament in rheumatic disorders. Semin Arthritis Rheum 1981; 10: 231-54.
- Stefanich RJ. Intraart;cular corticosteroids in treatment of osteoarthritis. Orthop Rev 1986; 15: 65-71.
