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Commentary and Perspective   |    
Primum Non NocereCommentary on an article by Shlomo Mandel, MD, MPH, et al.: “A Retrospective Analysis of Vertebral Body Fractures Following Epidural Steroid Injections”
Andrew J. Schoenfeld, MD1
1 William Beaumont Army Medical Center, El Paso, Texas
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The author received no payments or services, either directly or indirectly (i.e., via his institution), from a third party in support of any aspect of this work. Neither the author nor his institution has had any financial relationship, in the thirty-six months prior to submission of this work, with any entity in the biomedical arena that could be perceived to influence or have the potential to influence what is written in this work. Also, the author has not had any other relationships, or engaged in any other activities, that could be perceived to influence or have the potential to influence what is written in this work. The complete Disclosures of Potential Conflicts of Interest submitted by authors are always provided with the online version of the article.

Disclaimer: The author is an employee of the U.S. federal government and the United States Army. The opinions or assertions contained herein are the private views of the author and are not to be construed as official or reflecting the views of William Beaumont Army Medical Center, the Department of Defense, or the United States government.


Copyright © 2013 by The Journal of Bone and Joint Surgery, Inc.
J Bone Joint Surg Am, 2013 Jun 05;95(11):e78 1-2. doi: 10.2106/JBJS.M.00421
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Primum non nocere, or “first do no harm,” is the well-known maxim from the Hippocratic corpus advocating that a physician’s first priority should be to avoid precipitating further injury, or inadvertent worsening of conditions, in patients who are under his or her care. With this founding precept of the health-care tradition in mind, I commend the efforts of Dr. Mandel and his colleagues in bringing to our attention the potential for epidural steroid injections to elevate the risk of vertebral body fracture in elderly individuals. Although this association has been alluded to in previous publications, to the best of my knowledge the study by Mandel et al. is the first scientifically rigorous effort to quantify the fracture risk associated with epidural steroid administration.
The study was conducted with use of a propensity-matched cohort with an average age of sixty-six years. Comparison between the patients who received epidural steroid and the controls in the primary analysis revealed that the risk of fracture increased by 21% per episode of steroid administration. Moreover, in the secondary analysis in which the possibility of multiple fractures in a single patient was considered, a significant elevation in the risk of subsequent vertebral fracture following steroid administration was again demonstrated. The identification of this significant association, as well as the quantification of risk inherent with each injection event, represent novel contributions to the literature.
It is necessary to appreciate these findings, however, within the context of other works. As previously mentioned, many authors have surmised that the use of epidural steroids may increase the risk of fragility fractures, although the evidence for this contention has been scant up to this point. For example, although the recent work of Kang et al. showed that bone mineral density decreased following epidural steroid injection, no specific association was drawn between this apparent reduction in bone mass and the onset of fracture1.
Of greater concern, the definable fracture risk as documented by Mandel et al. should be set against the best available evidence regarding the long-term efficacy of these interventions, which is admittedly less than robust2,3. Early studies maintained that epidural injections had poor clinical effectiveness. A similar result was reported in the prospective randomized trial by Cuckler et al., in which the authors concluded that “…a decision to use epidural steroids must be made with the realization that we failed to demonstrate its clinical efficacy in this study…”3 Proponents of steroid injection frequently cite the work of Saal and Saal4, but it should be emphasized that that study involved patients with disc herniations, and the results are not necessarily translatable to an elderly population that is more likely to suffer from symptoms of lower-extremity claudication related to spinal canal stenosis. Furthermore, more current research, including that of Cosgrove et al.2, failed to show lasting effects of epidural injections in the majority of patients, let alone in individuals of advanced age.
Although the available literature fails to support a substantial effect of steroid injection beyond the short-term period, the impact of vertebral fractures on quality of life as well as mortality is well understood5. Puisto et al. and other researchers found that vertebral fractures were associated with a demonstrable elevation in the risk of mortality for both men and women5. These facts, particularly when combined with the reported 21% increase in fracture risk per injection episode, raise the concern for adverse fracture-related events occurring as a result of epidural steroid administration, especially in the elderly. Moreover, the importance of this 21% elevation in the risk of fracture can be appreciated when it is contrasted with the recent, and highly publicized, article on the potential for ischemic heart disease in women following radiation therapy for breast cancer, which indicated a 7.4% increase in risk per gray of radiation6.
The investigation by Mandel et al. has limitations that the reader should appreciate and that potentially diminish the breadth of the conclusions that may be drawn from the study’s findings. As the authors recognize, their study was a retrospective work that depended on data entered into a registry and a great deal of heterogeneity consequently existed in the indications for steroid administration. The database itself was also not comprehensive in scope, and it appears to me that patients who were treated with epidural steroid in the Henry Ford health-care system but subsequently treated elsewhere for a vertebral fracture would have escaped recognition in the data set. This fact in and of itself could potentially confound some of the findings, and the rate of vertebral fracture following epidural steroid injections may be underestimated as a result.
Given its design and limitations, I would caution against the utilization of the study by Mandel et al. as a rationale for curtailing epidural injection procedures among all patients at present. Such interventions have been shown to be effective in patients with acute disc herniation4, and the risk of vertebral fracture highlighted by Mandel et al. may not be inherent in all individuals, especially those who are younger in age and/or possess normal bone mineral density. At a minimum, this laudable effort should be considered to represent a first step in the scientific process, essentially a call for further prospective research on the influence of epidural steroids on the risk of subsequent vertebral fracture. In addition, the results of this investigation can be used to inform the discussions and consent process prior to epidural steroid administration, particularly with respect to the risk-benefit profile in patients of advanced age and reduced bone mineral density. Clearly, much more work on this issue remains to be performed before definitive conclusions regarding the influence of epidural steroids on vertebral body fractures can be made. In the interim, however, practitioners would do well to consider the results presented by Mandel et al., as well as the Hippocratic dictum primum non nocere, when recommending epidural steroid injections in elderly patients.
Kang  SS;  Hwang  BM;  Son  H;  Cheong  IY;  Lee  SJ;  Chung  TY. Changes in bone mineral density in postmenopausal women treated with epidural steroid injections for lower back pain. Pain Physician.  2012 May-Jun;15(  3):229-36.
 
Cosgrove  JL;  Bertolet  M;  Chase  SL;  Cosgrove  GK. Epidural steroid injections in the treatment of lumbar spinal stenosis efficacy and predictability of successful response. Am J Phys Med Rehabil.  2011 Dec;90(  12):1050-5.[CrossRef]
 
Cuckler  JM;  Bernini  PA;  Wiesel  SW;  Booth  RE  Jr;  Rothman  RH;  Pickens  GT. The use of epidural steroids in the treatment of lumbar radicular pain. A prospective, randomized, double-blind study. J Bone Joint Surg Am.  1985 Jan;67(  1):63-6.
 
Saal  JA;  Saal  JS. Nonoperative treatment of herniated lumbar intervertebral disc with radiculopathy. An outcome study. Spine (Phila Pa 1976).  1989 Apr;14(  4):431-7.[CrossRef]
 
Puisto  V;  Rissanen  H;  Heliövaara  M;  Impivaara  O;  Jalanko  T;  Kröger  H;  Knekt  P;  Aromaa  A;  Helenius  I. Vertebral fracture and cause-specific mortality: a prospective population study of 3,210 men and 3,730 women with 30 years of follow-up. Eur Spine J.  2011 Dec;20(  12):2181-6.  Epub 2011 May 25.[CrossRef]
 
Darby  SC;  Ewertz  M;  McGale  P;  Bennet  AM;  Blom-Goldman  U;  Brønnum  D;  Correa  C;  Cutter  D;  Gagliardi  G;  Gigante  B;  Jensen  MB;  Nisbet  A;  Peto  R;  Rahimi  K;  Taylor  C;  Hall  P. Risk of ischemic heart disease in women after radiotherapy for breast cancer. N Engl J Med.  2013 Mar 14;368(  11):987-98.[CrossRef]
 

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References

Kang  SS;  Hwang  BM;  Son  H;  Cheong  IY;  Lee  SJ;  Chung  TY. Changes in bone mineral density in postmenopausal women treated with epidural steroid injections for lower back pain. Pain Physician.  2012 May-Jun;15(  3):229-36.
 
Cosgrove  JL;  Bertolet  M;  Chase  SL;  Cosgrove  GK. Epidural steroid injections in the treatment of lumbar spinal stenosis efficacy and predictability of successful response. Am J Phys Med Rehabil.  2011 Dec;90(  12):1050-5.[CrossRef]
 
Cuckler  JM;  Bernini  PA;  Wiesel  SW;  Booth  RE  Jr;  Rothman  RH;  Pickens  GT. The use of epidural steroids in the treatment of lumbar radicular pain. A prospective, randomized, double-blind study. J Bone Joint Surg Am.  1985 Jan;67(  1):63-6.
 
Saal  JA;  Saal  JS. Nonoperative treatment of herniated lumbar intervertebral disc with radiculopathy. An outcome study. Spine (Phila Pa 1976).  1989 Apr;14(  4):431-7.[CrossRef]
 
Puisto  V;  Rissanen  H;  Heliövaara  M;  Impivaara  O;  Jalanko  T;  Kröger  H;  Knekt  P;  Aromaa  A;  Helenius  I. Vertebral fracture and cause-specific mortality: a prospective population study of 3,210 men and 3,730 women with 30 years of follow-up. Eur Spine J.  2011 Dec;20(  12):2181-6.  Epub 2011 May 25.[CrossRef]
 
Darby  SC;  Ewertz  M;  McGale  P;  Bennet  AM;  Blom-Goldman  U;  Brønnum  D;  Correa  C;  Cutter  D;  Gagliardi  G;  Gigante  B;  Jensen  MB;  Nisbet  A;  Peto  R;  Rahimi  K;  Taylor  C;  Hall  P. Risk of ischemic heart disease in women after radiotherapy for breast cancer. N Engl J Med.  2013 Mar 14;368(  11):987-98.[CrossRef]
 
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