A Metaanalysis of the Effectiveness and Safety of Ozone Treatments for Herniated Lumbar Discs
Received 29 May 2009; received in revised form 20 October 2009; accepted 3 December 2009. published online 25 February 2010.
Purpose
To determine statistically significant effects of oxygen/ozone treatment of herniated discs with respect to pain, function, and complication rate.
Materials and Methods
Random-effects metaanalyses were used to estimate outcomes for oxygen/ozone treatment of herniated discs. A literature search provided relevant studies that were weighted by a study quality score. Separate metaanalyses were performed for visual analog scale (VAS), Oswestry Disability Index (ODI), and modified MacNab outcome scales, as well as for complication rate. Institutional review board approval was not required for this retrospective analysis.
Results
Twelve studies were included in the metaanalyses. The inclusion/exclusion criteria, patient demographics, clinical trial rankings, treatment procedures, outcome measures, and complications are summarized. Metaanalyses were performed on the oxygen/ozone treatment results for almost 8,000 patients from multiple centers. The mean improvement was 3.9 for VAS and 25.7 for ODI. The likelihood of showing improvement on the modified MacNab scale was 79.7%. The means for the VAS and ODI outcomes are well above the minimum clinically important difference and the minimum (significant) detectable change. The likelihood of complications was 0.064%.
Conclusions
Oxygen/ozone treatment of herniated discs is an effective and extremely safe procedure. The estimated improvement in pain and function is impressive in view of the broad inclusion criteria, which included patients ranging in age from 13 to 94 years with all types of disc herniations. Pain and function outcomes are similar to the outcomes for lumbar discs treated with surgical discectomy, but the complication rate is much lower (<0.1%) and the recovery time is significantly shorter.
bDepartment of Medical Imaging, University of Toronto, Fitzgerald Building, Room 112, 150 College Street, Toronto, Ontario M5S 3E2, Canada
cDepartment of Interventional Neuroradiology, Johns Hopkins School of Medicine, Baltimore, Maryland
dNeuroradiology Unit, A. Cardarelli Hospital, Naples, Italy
Address correspondence to K.J.M.
This study was funded in part by ActiveO (Salt Lake City, Utah), a company with a product that relates to the subject of this research. All of the authors acknowledge direct and/or indirect financial relationship(s) with ActiveO. J.S. and T.M. are salaried employees of ActiveO.
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