- Medical Director, Pain Management Center of Paducah, Paducah, Clinical Professor, Anesthesiology and Perioperative Medicine, University of Louisville, Louisville, KY, Paducah, Kentucky, USA
- Department of Anesthesia, LSU Health Science Center, New Orleans, LA, USA
- Vice Chief of Interventional Care, Chief of Minimally Invasive Spine Surgery, Service Line Chief of Interventional Radiology, Director of Endovascular Neurosurgery and Neuroendovascular Program, Massachusetts General Hospital, Associate Professor, Harvard Medical School, Boston, MA, USA
Correspondence Address:
Laxmaiah Manchikanti
Vice Chief of Interventional Care, Chief of Minimally Invasive Spine Surgery, Service Line Chief of Interventional Radiology, Director of Endovascular Neurosurgery and Neuroendovascular Program, Massachusetts General Hospital, Associate Professor, Harvard Medical School, Boston, MA, USA
DOI:10.4103/2152-7806.129429
Copyright: © 2014 Manchikanti L. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.How to cite this article: Manchikanti L, Kaye AD, Hirsch JA. RE: The risks of epidural and transforaminal steroid injections in the spine: Commentary and a comprehensive review of the literature. Surg Neurol Int 25-Mar-2014;5:38
How to cite this URL: Manchikanti L, Kaye AD, Hirsch JA. RE: The risks of epidural and transforaminal steroid injections in the spine: Commentary and a comprehensive review of the literature. Surg Neurol Int 25-Mar-2014;5:38. Available from: http://sni.wpengine.com/surgicalint_articles/re-the-risks-of-epidural-and-transforaminal-steroid-injections-in-the-spine-commentary-and-a-comprehensive-review-of-the-literature/
Dear Editor,
We read with interest the comprehensive literature review and commentary by Dr. Epstein of the risks of epidural and transforaminal steroid injections in the spine.[
Dr. Epstein has selected all the negative studies and provided seemingly erroneous interpretations of other literature leading to what we believe are best termed inappropriate conclusions. It would appear that her focus may have been on the contaminated epidural steroid injections resulting in meningitis. However, she postulated a multitude of other issues based on incidence of infection from contaminated steroids, projecting that epidural injections are typically short-acting and ineffective over the long-term, exposing patients to major risks and complications, with delay in surgery. Even the very unusually high and unimaginable complications she is describing in these manuscripts of adhesive arachnoiditis of 6-16%, intravascular injections, etc., along with other life-threatening complications are not based on the literature she has reviewed. Even with the extraordinary statements re: Complications in interventional pain procedures, they may well be less when compared with the risks of intraspinous fusion devices in which Dr. Epstein described maximal complication rates of 38%, reoperation rates of 85%, poor outcomes in 77%, along with high costs of the device.[
The author, in the description of complications and outcomes of interlaminar and transforaminal epidural injections, seems to use the manuscript of facet joint nerve blocks by Manchikanti et al.[
An assessment of outcomes should describe at least all randomized trials. Instead Dr. Epstein appears to have picked only a few studies with negative results. Based on inadequate utilization of literature, she describes that patients are subject to major life-threatening risks, while delaying potential requisite surgery. Per above, prior reports by Dr. Epstein of surgical complications are enormous.[
Overall this manuscript would be appropriate for describing the infectious complications based on contaminated steroid injection. Multiple manuscripts in literature[
Multiple complications related to transforaminal epidural injections are justifiable;[
The author also describes two major types of epidural spinal injections, translaminar and transforaminal; however, there is also a caudal epidural injection. In assessment of the efficacy of epidural injections, one would review all the literature; however, this review is lacking focus on selective literature and using the literature related to the complications in the efficacy. She also described one study by Manchikanti;[
Overall, this manuscript is confusing. It is our opinion that it provides multiple elements of misinformation rather than evidence-based opinions.
Query
We read with interest the comprehensive literature review and commentary by Dr. Epstein of the risks of epidural and transforaminal steroid injections in the spine.[
Response from Dr. Epstein
The individual writing the letter to the editor comments that this manuscript just appears “to be comprehensive,” I would respond that it includes 43 references, and covers over 62 manuscript (prior to pdf) pages [
Query
We disagree with Dr. Epstein's understanding of the literature and makes unusual claims discrediting all interventional techniques even though the title says “epidural and transforaminal steroid injections in the spine.” Further, the author appears to not recognize that transforaminal injections and caudal epidural injections are in facet epidural injections.[
Response from Dr. Epstein:
I would ask the author of this query, where are the “unusual claims discrediting all interventional techniques? In each section, the data cited comes from the various studies written by multiple authors [
One example of this comes from the following section entitled: Increase of 160% of Steroid Injections Over 10 Years Driven by Aging/Desperate Patients and Monetary Considerations
Here, Dr. Manchikanti, Chairman of the American Society of Interventional Pain Physicians observed: “We are doing too many of these (spinal injections), and many of those don’t meet the proper criteria”.[
Query
Dr. Epstein has selected all the negative studies and provided seemingly erroneous interpretations of other literature leading to what we believe are best termed inappropriate conclusions.
Response from Dr. Epstein
Again, if you look at the article, there are many studies that presented both the pros and cons for performing these injections [
Presentation of Multiple Articles Supporting the Use of Epidural and Transforaminal Injection
For example, under the section Indications for Epidural and Transforaminal Injections, Dr. Epstein presented Landa et al. findings, citing two major types of epidural spinal injections employed in the cervical and lumbar regions; translaminar (TLESI) and transforaminal (TFESI) approaches.[
Query
It would appear that her focus may have been on the contaminated epidural steroid injections resulting in meningitis.
Response from Dr. Epstein
Indeed, one of the purposes of this commentary was to review the data surrounding the “epidemic” of contaminated epidural steroid injections performed in 2012 [
These data, as documented by the references, had already been published in major national newspapers and other medical journals prior to being presented in this commentary. The purpose of presenting this information to spine surgeons and others who read Surgical Neurology International Spine Supplement (a free downloadable internet journal) was to highlight what can happen if contaminated steroid material is injected in the spine, thus focusing attention on whether these “invasive” procedures are necessary, and whether the inherent risks warrant the benefits. Furthermore, attention was focused on the lack of uniform regulations for many of these compounding pharmacies, a shortfall which contributed to the epidemic of epidural steroid (ESI)-related infections. Under the title: The Failure to Adequately Regulate Specialty Pharmacies the failure to adequately regulate specialty pharmacies is the present focus of discussion, as “greenish black foreign matter” and “white filamentous tissue” have been found in contaminated vials of steroids.[
Additionally, Dr. Epstein cited OTHER authors who emphasized OTHER complications attributed to epidural steroid injections (ESIs) beyond contamination/infection. Under the section News of Meningitis Attributed to Epidural/Transforaminal Steroid Injections Plus Other Risks of Nerve Damage, Paralysis, and Strokes, Pollack noted that the recent outbreak of fungal meningitis resulted from epidural/transforaminal spinal injections, but also highlighted that these “same injections have also long been linked to other rare but devastating complications, including nerve damage, paralysis and strokes.”[
Query
However, she postulated a multitude of other issues based on incidence of infection from contaminated steroids, projecting that epidural injections are typically short-acting and ineffective over the long-term, exposing patients to major risks and complications, with delay in surgery.
Response from Dr. Epstein
Actually, in order to provide balance to this review article, Dr. Epstein included reviews/sections from at least 15 studies favoring epidural steroid injections. This “review article”, therefore, was hardly “one sided” [
Pros for Epidural Steroid Injections: References to 15 Articles With Summary of 3 of the 15
Under the section Benefits for the Efficacy of Epidural Injections, Utility of Epidural Steroid Injections in Averting Surgery in Patients Originally Deemed Surgical Candidates, Riew et al. designed a prospective, randomized, controlled, double-blind study to determine how effective selective nerve root injections utilizing steroids vs. bupivacaine alone could be in avoiding surgery for patients with demonstrated “surgical” disc herniations.[
A second study concerned the Minimal Complications of 10,000 Fluoroscopic-Guided Epidural Injections. It was authored by Manchikanti et al. and was a prospective, nonrandomized study involving 10,000 patients who over 20 months received: 39% caudal epidurals, 23% cervical interlaminar epidurals, 14% lumbar interlaminar epidurals, 13% lumbar transforaminal epidurals, 8% percutaneous adhesiolysis, and 3% thoracic interlaminar epidural procedures.”[
A third study by Ahadian et al. noted the Efficacy of Lumbosacral Transforaminal Steroid Injections: 30% or Greater Reduction in Radicular Pain with Transforaminal Epidural Injections Utilizing three Different Doses of Dexamethasone. Ahadian et al.'s prospective, randomized, double-blind trial, the relative efficacy of transforaminal epidural injections utilizing 4 mg (33 patients), 8 mg (33 patients), and 12 mg (32 patients) of Dexamethasone were studied at four time intervals: 1, 4, 8, and 12 weeks postinjection.[
There were many other sections/articles as cited below that reviewed additional “pros” for different types of spinal injections. These included:
Evidence-Based Literature Documents Efficacy of Lumbosacral Transforaminal Steroid Injections Performed Under Fluoroscopy or CT Guidance by Benny and Azari.[
Efficacy of Multiple Types of Spinal Injections, Including Transforaminal Epidural Steroids In Resolving Radicular Pain by Roberts et al.[
Better Outcomes with Transforaminal Epidural Steroid Injections vs. Interlaminar Injections for Lumbar Disc Disease by Schaufele et al.[
Greater Effectiveness of Bilateral Transforaminal Epidural Steroid Injections for Treating Patients with Spinal Stenosis by Lee et al.[
Comparable Efficacy of Different Spinal Injections; Comparable Efficacy of Epidural Steroid Injections vs. Intramuscular Injections of Steroids with a Local Anesthetic by Wilson-MacDonald et al.[
Relative Efficacy of Caudal Epidural Injections with Local Anesthetic With or Without Steroids by Manchikanti et al.[
Blind (without Fluoroscopy) Interlaminar Spinal Epidural Steroid Injections Provide Short-term Relief for Disc Herniations and Radiculitis But Not Spinal Stenosis by Parr et al.[
Comparable Long-term Efficacy of Cervical Epidural Steroid Injections Performed with/without Morphine by Castagnera et al.[
Minimal Complications of Cervical Epidural Steroid Spinal Injections Performed Under Fluoroscopy by Botwin et al.[
Few Complications of Cervical Epidural Steroid Injections by Abbasi et al.[
Efficacy and Safety (64%) of Cervical Epidural Steroids for Radiculopathy by Rowlingson and Kirschenbaum[
Few Complications Attributed to 1036 Extraforaminal Cervical Nerve Blocks by Ma et al.[
And there are other sections as well. Therefore the accusation that Dr. Epstein only “projected that epidural injections are typically short-acting and ineffective over the long-term, exposing patients to major risks and complications, with delay in surgery” was simply not true as the 16 articles cited above will attest to.
Under the section Risks of Epidural/Transforaminal Epidural Spinal Injections, Limited Efficacy of Injections, Dr. Epstein also presented the “cons” from other studies/articles. One article noted that ESI were “typically short-acting and ineffective over the long-term, exposing patients to major risks and complications, with delay in surgery.”[
In another section, Epidural Steroid Injections Provide No Additional Improvement, Valat et al.'s article compared the efficacy of epidural corticosteroid injections (2 mL prednisolone acetate (50 mg)) vs. 2 mL isotonic saline (both administered ×3) for patients with sciatica for between 15 and 180 postinjection days.[
Therefore, the “pros” and “cons” of ESI were presented from multiple articles as detailed above, indicating that this review article was indeed, not simply one-sided; that accusation is clearly spurious [
Query
Even the very unusually high and unimaginable complications she is describing in these manuscripts of adhesive arachnoiditis of 6-16%, intravascular injections, etc., along with other life-threatening complications are not based on the literature she has reviewed. Even with the extraordinary statements re: Complications in interventional pain procedures, they may well be less when compared with the risks of intraspinous fusion devices in which Dr. Epstein described maximal complication rates of 38%, reoperation rates of 85%, poor outcomes in 77%, along with high costs of the device.[
Response from Dr. Epstein
The complication rates that I cited in this review article were those drawn directly from the literature. Indeed, I have written over 300 original and/or review articles/chapters on multiple subjects that similarly provide careful assessment of the appropriate literature. I am glad, however, to see that the QUERY, author has read some of these articles. Nevertheless, I fail to see their relevance in the context of this discussion.
Query
The author, in the description of complications and outcomes of interlaminar and transforaminal epidural injections, seems to use the manuscript of facet joint nerve blocks by Manchikanti et al.[
Response from Dr. Epstein
I have already responded in prior sections regarding the complications of these injections, which do, however, include intravascular injuries resulting in quadriplegia [
There are multiple other sections that continue to review complications from other studies. In yet another section, Multiple Complications of Epidural or Transforaminal Injections
Multiple Complications of Epidural/Transforaminal Injections Are Often Underreported
Landa et al. noted that serious complications of epidural/transforaminal spinal injections are often underreported.[
Of interest, the multiple sections of this review article were overwhelmingly devoted to assessment of different articles, and were not simply my opinion pieces. I did offer, however, one short section Author's Personal Communication with Pediatric Neurosurgeons regarding personal communication with pediatric neurosurgeons regarding a16-year-old female who following a cervical epidural injection performed by an outside physician became quadriplegic. The MR immediately demonstrated a fluid signal within the cord itself, consistent with a direct intramedullary cord injection. Despite treatment with hyperbaric oxygen, she did not fully recover (personal communication).
Query
An assessment of outcomes should describe at least all randomized trials. Instead Dr. Epstein appears to have picked only a few studies with negative results. Based on inadequate utilization of literature, she describes that patients are subject to major life-threatening risks, while delaying potential requisite surgery. Per above, prior reports by Dr. Epstein of surgical complications are enormous.[
Response from Dr. Epstein
I have already demonstrated that I did not just “pick only a few studies with negative results” [
Query
Overall this manuscript would be appropriate for describing the infectious complications based on contaminated steroid injection.
Response from Dr. Epstein
Thank you for this comment.
Query
Multiple manuscripts in literature[
Response from Dr. Epstein
As indicated in the review article, there are many articles that demonstrate the lack of long-term effectiveness [
Query
Multiple complications related to transforaminal epidural injections are justifiable;[
Response from Dr. Epstein
The multiple sections and articles citing intravascular injections resulting in major neurological deficits have already previously been quoted [
Query
This trend extended to the clinical effectiveness, complications, and also costs and provides misinterpretations. She quotes Manchikanti et al.[
Response from Dr. Epstein
I have already responded to similar comments made earlier. However, for your reference look again under Increase of 160% of Steroid Injections Over 10 Years Driven by Aging/Desperate Patients and Monetary Considerations. You will find that Dr. Manchikanti, Chairman of the American Society of Interventional Pain Physicians observed: “We are doing too many of these (spinal injections), and many of those don’t meet the proper criteria”.[
Query
The author also describes two major types of epidural spinal injections, translaminar and transforaminal; however, there is also a caudal epidural injection. In assessment of the efficacy of epidural injections, one would review all the literature; however, this review is lacking focus on selective literature and using the literature-related complications in the efficacy. She also described one study by Manchikanti;[
Response from Dr. Epstein
I would recommend that the Query read the review article more carefully to find answers to these comments/questions/accusations [
Query
Overall, this manuscript is confusing. It is our opinion that it provides multiple elements of misinformation rather than evidence-based opinions.
Response from Dr. Epstein
First of all, I would question the source of this conclusion. Second, the information provided comes from a multitude of studies gleaned from the literature, and included data regarding the pros and cons of these injections [
Commentary
TO THE EDITOR
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