A Metaanalysis of the Effectiveness and Safety of Ozone Treatments for Herniated Lumbar Discs

ActiveO, Salt Lake City, Utah, USA.
Journal of vascular and interventional radiology: JVIR (Impact Factor: 2.41). 02/2010; 21(4):534-48. DOI: 10.1016/j.jvir.2009.12.393
Source: PubMed


To determine statistically significant effects of oxygen/ozone treatment of herniated discs with respect to pain, function, and complication rate.
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.
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%.
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.

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    • "In the past numerous intradiscal therapies were used to treat discogenic pain and symptomatic disc herniation by performing indirect decompression via disc volume reduction [1]. Many studies were published on the clinical results of chemonucleolysis with different substances [2], [3] and percutaneous laser disc decompression (PLDD) [4]. For some procedures, efficacy has been investigated [1], [5]. "
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    ABSTRACT: We assessed volume following nucleoplasty disc decompression in lower lumbar spines from cadaveric pigs using 7.1Tesla magnetic resonance imaging (MRI). To investigate coblation-induced volume reductions as a possible mechanism underlying nucleoplasty. We assessed volume following nucleoplastic disc decompression in pig spines using 7.1-Tesla MRI. Volumetry was performed in lumbar discs of 21 postmortem pigs. A preoperative image data set was obtained, volume was determined, and either disc decompression or placebo therapy was performed in a randomized manner. Group 1 (nucleoplasty group) was treated according to the usual nucleoplasty protocol with coblation current applied to 6 channels for 10 seconds each in an application field of 360°; in group 2 (placebo group) the same procedure was performed but without coblation current. After the procedure, a second data set was generated and volumes calculated and matched with the preoperative measurements in a blinded manner. To analyze the effectiveness of nucleoplasty, volumes between treatment and placebo groups were compared. The average preoperative nucleus volume was 0.994 ml (SD: 0.298 ml). In the nucleoplasty group (n = 21) volume was reduced by an average of 0.087 ml (SD: 0.110 ml) or 7.14%. In the placebo group (n = 21) volume was increased by an average of 0.075 ml (SD: 0.075 ml) or 8.94%. The average nucleoplasty-induced volume reduction was 0.162 ml (SD: 0.124 ml) or 16.08%. Volume reduction in lumbar discs was significant in favor of the nucleoplasty group (p<0.0001). Our study demonstrates that nucleoplasty has a volume-reducing effect on the lumbar nucleus pulposus in an animal model. Furthermore, we show the volume reduction to be a coblation effect of nucleoplasty in porcine discs.
    PLoS ONE 11/2012; 7(11):e50211. DOI:10.1371/journal.pone.0050211 · 3.23 Impact Factor
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    • "In the past a variety of different intradiscal procedures were used for treating symptomatic disc prolapse [7]–[10], many of which have now been abandoned [11]. Various studies have reported the clinical results of these treatments [8] [10] [12]–[14], and the effectiveness of some procedures has been demonstrated in high-quality studies [7] [10] [9] [15]. For many procedures, however, the mechanism of action remains to be demonstrated in an experimental setting. "
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    ABSTRACT: To evaluate changes in nucleus pulposus volume as a potential parameter for the effects of disc decompression. Fifty-two discs (T8 to L1) were extracted from 26 pigs and separated into thoracic (T8 to T11) and thoracolumbar discs (T12 to L1). The discs were imaged using 7.1 Tesla ultrahigh-field magnetic resonance imaging (MRI) with acquisition of axial T2-weighted turbo spin-echo sequences for determination of baseline and postinterventional nucleus pulposus volumes. Volumes were calculated using OsiriX® ( After randomization, one group was treated with nucleoplasty, while the placebo group was treated with an identical procedure but without coblation current. The readers analyzing the MR images were blinded to the kind of procedure performed. Baseline and postinterventional volumes were compared between the nucleoplasty and placebo group. Average preinterventional nucleus volume was 0.799 (SD: 0.212) ml. Postinterventional volume reduction in the nucleoplasty group was significant at 0.052 (SD: 0.035) ml or 6.30% (p<0.0001) (thoracic discs) and 0.082 (SD: 0.042) ml or 7.25% (p = 0.0078) (thoracolumbar discs). Nucleoplasty achieved volume reductions of 0.114 (SD: 0.054) ml or 14.72% (thoracic) and 0.093 (SD: 0.081) ml or 11.61% (thoracolumbar) compared with the placebo group. Nucleoplasty significantly reduces thoracic and thoracolumbar nucleus pulposus volumes in porcine discs.
    PLoS ONE 07/2012; 7(7):e41497. DOI:10.1371/journal.pone.0041497 · 3.23 Impact Factor
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    • "antioxidant enzymes, nitric oxide pathways, 2,3-diphosphoglycerate) as a consequence of applying low ozone doses. Those facts support some of the current clinical applications of ozone (Colombo et al., 2000; Re et al., 2008; Steppan et al., 2010). In an experimental model, rectal insufflation (a simple, easy and inexpensive method of delivering ozone) showed a sustained improvement in erythrocytes deformability suggesting its systemic effects (Seda Artis et al., 2010). "
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    ABSTRACT: Coronary artery disease (CAD) is the most common cause of sudden death, and death of people over 20 years of age. Because ozone therapy can activate the antioxidant system and improve blood circulation and oxygen delivery to tissue, the aim of this study was to investigate the therapeutic efficacy of ozone in patients with CAD, treated with antithrombotic therapy, Aspirin and policosanol. A randomized controlled clinical trial was performed with 53 patients divided into two groups: one (n=27) treated with antithrombotic therapy and other (n=26) treated with antithrombotic therapy plus rectal insufflation of O(3). A parallel group (n=50) age and gender matched was used as reference for the experimental variables. The efficacy of the treatments was evaluated by comparing hemostatic indexes and biochemical markers of oxidative stress in both groups after 20 day of treatment. Ozone treatment significantly (P<0.001) improved prothrombin time when compared to the antithrombotic therapy only group, without modifying bleeding time. Combination antithrombotic therapy+O(3) improved the antioxidant status of patients reducing biomarkers of protein and lipid oxidation, enhancing total antioxidant status and modulating the level of superoxide dismutase and catalase with a 57% and 32% reduction in superoxide dismutase and catalase activities respectively, moving the redox environment to a status of low production of O(2)(•-) with an increase in H(2)O(2) detoxification. No side effects were observed. These results show that medical ozone treatment could be a complementary therapy in the treatment of CAD and its complications.
    European journal of pharmacology 07/2012; 691(1-3):156-62. DOI:10.1016/j.ejphar.2012.07.010 · 2.53 Impact Factor
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