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.[ 5 ] While this manuscript appears to be comprehensive, we are concerned with the lack of evidence in the opinions offered. 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.[ 8 9 ]

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.[ 7 ] Additionally, per Dr. Epstein many operations that are recommended are not necessary or are too complex.[ 6 ]

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.[ 20 ] alleging 11.4% intravascular injury and 76.3% bleeding. This would be a gross misinterpretation of that study. There was no intravascular injury described in this manuscript by Manchikanti et al.,[ 20 ] which rather described intravascular entry, unrelated to epidural injections.

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.[ 7 ]

Overall this manuscript would be appropriate for describing the infectious complications based on contaminated steroid injection. Multiple manuscripts in literature[ 8 10 11 12 13 14 15 16 18 19 21 22 23 24 25 26 ] have shown equal effectiveness of epidural injections on a long-term basis, along with facet joint nerve blocks, even though that was not the subject of this review, and have shown significant improvement with outcomes of at least 50% pain relief with functional status improvement of 50% over a period of 2 years. A recent systematic review also confirmed these findings.[ 3 ]

Multiple complications related to transforaminal epidural injections are justifiable;[ 8 9 ] however, these complications are related to mainly cervical epidural injections and based on the radicular entry and injection of particulate steroids. The author seems to make multiple statements not substantiated by literature. This trend extended to the clinical effectiveness, complications, and also costs and provides misinterpretations. She quotes Manchikanti et al.[ 20 ] as providing a multitude of data, which was not related to this manuscript or to other manuscripts.[ 17 ] The author has also made multiple statements regarding financial incentives not described in any of the manuscripts.

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;[ 14 ] which was a positive study, and made no comments. Parr et al.[ 27 ] is cited in reference to short-term pain relief for disc herniation and radiculitis and evidence was lacking for both short- and long-term treatment from an earlier systematic review published in 2009 rather than using the manuscript published by Benyamin et al.[ 1 ] In fact, recent guidelines[ 8 ] and multiple systematic reviews[ 1 2 4 9 28 ] have provided similar evidence for interlaminar epidural injections, caudal epidural injections, and lumbar transforaminal epidural injections performed in interventional pain management settings under fluoroscopy with proper selection of patients. However, there is no evidence for transforaminal cervical epidural injections.

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.[ 5 ] While this manuscript appears to be a comprehensive, we are concerned with the lack of evidence in the opinions offered.

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 [ Table 1 ]. Furthermore, the data predominantly include a summary of different authors’ findings, rather than just Dr. Epstein's subjective conclusions. Therefore, there is no “lack of evidence” as the so called “opinions” offered are actually the data from multiple articles written by the various authors.

Table 1

Sections and summaries

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.[ 8 9 ]

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 [ Table 1 ].

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”.[ 25 ] He further observed, “about 20 percent of doctors who perform the procedures were not adequately trained.” When reviewing Medicare records, he found that the frequency of these injections increased by 160% from 2000 to 2010. He attributed this to the needs of older patients in desperate need of pain relief, and by financial incentives. “Medicare and private insurers pay $100 to several hundred dollars for an injection, and there are pain clinics that do almost nothing but injections.”[ 25 ] Here, an expert in the field is clearly stating that there has been a marked increase in the incidence of these injections performed, and that many are done that “don’t meet the proper criteria”. Those are the words of Dr. Manchikanti; they are they are not Dr. Epstein's words. Furthermore Dr. Manchikanti himself brings up the financial incentive. Perhaps a closer analysis/review of the article would change the mind of the author of this QUERY.

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 [ Table 1 ].

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.[ 19 ] The translaminar procedure is utilized to address more diffuse symptoms, while the transforaminal approach is employed to directly treat a single nerve root. Note that Dr. Epstein did not edit out Landa et al. positive conclusions. In fact she quoted Landa et al. who found that these injections demonstrated “efficacy for up to 6 months of pain relief, though long-term benefits are less reliable.”[ 19 ] Dr. Epstein also did not exclude Dr. Landa's acknowledgement that “.these injections can also result in severe complications.” Landa et al.'s words were included to present Landa's balanced views, and his statements/conclusions were not Dr. Epstein's “erroneous interpretations.”

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 [ Table 1 ]. In the manuscript, under News of Infections Attributed to Epidural/Transforaminal Steroid Injections, the Morbidity Mortality Weekly Report of the Centers for Disease Control and Prevention published on October 19, 2012 the following statement: Multistate outbreak of fungal infection associated with injection of methylprednisolone acetate solution from a single compounding pharmacy (United States, 2012).[ 12 ] The Tennessee Department of Health was alerted that a patient tested positive for Aspergillus fumigatus meningitis 46 days after an epidural steroid injection (preservative-free methylprednisolone acetate solution (MPA) that had been “compounded at New England Compounding Center (NECC) in Framingham, Massachusetts.” By October 10, 2012, the CDC, multiple health departments, and the Food and Drug Administration (FDA) found 137 cases and 12 deaths in 10 states. By October 29, 2012, the Center for Disease Control had identified 25 deaths due to epidural steroid-related meningitis (many due to Aspergillosis), with 337 patients sickened in 18 states, and an additional 14,000 patients likely exposed to contaminated steroids.[ 3 ]

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.[ 3 ] The New York Times also reported in October of 2012 “greenish-yellow residue on sterilization equipment, surfaces coated with levels of mold, and bacteria that exceeded the company's own environmental limits” in one of the specialty pharmacies.[ 29 ]

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.”[ 3 29 ] He specifically detailed that epidural injections utilizing steroids, “while approved for uses like relieving inflammation in joints, have not been approved by the FDA for epidural injections, next to the spinal cord.”[ 29 ] Also referring to those who died of meningitis, Dr. William Landau, professor of neurology at Washington University in St. Louis, Missouri, noted: “Not only were these people killed, but there was no ethical reason to give this treatment.”[ 29 ] So in short, Dr. Epstein cited other authors’ concerns regarding not only fungal meningitis associated with ESI, but also regarding ESI's other complications.

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” [ Table 1 ].

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.[ 30 ] All 55 patients had radiculopathy that correlated with radiographically documented surgical disease (e.g. herniated discs). Patients were randomly selected for selective nerve-root injection with bupivacaine vs. bupivacaine with betamethasone, and could choose to receive up to 4 injections. Over the follow-up duration of 13-28 months, 9 of 27 patients receiving bupivacaine alone, but a higher 20 of 28 receiving bupivacaine with the steroid, decided against surgery (defined as a “success”): this difference was significant (P < 0.004). The authors projected that in the future, more patients with radiculopathy (1-2 level discs) should first undergo selective nerve-root injections with corticosteroids before opting for surgery.

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.”[ 26 ] All procedures were performed in an Ambulatory Surgical Center (ASC) by three physicians. Intravascular complications were greater for adhesiolysis (11.6%) and lumbar transforaminal (7.9%) injections vs. 0.5% for lumbar, 3.1% for caudal, 4% for thoracic, and 4.1% for cervical epidurals. Dural punctures, observed in 0.5% of patients occurred in the following: 1% cervical, 1.3% thoracic, 0.8% lumbar, and 1.8% adhesiolysis. The authors concluded that major complications were rare, but minor side effects were common.

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.[ 2 ] A 30% or greater reduction in radicular pain utilizing the Visual Analog Scale (VAS) was considered a “success”. Other outcome measures included the: Oswestry Low Back Disability Index (ODI), Subject Global Impression of Change, Subject Global Satisfaction Scale, and adverse events (AE). Over the 4, 8, and 12 postprocedure weeks, the average reduction in radicular pain based on the VAS was 41.7%, 33.5%, and 26.6%, respectively. The ODI revealed minimal residual findings by the 12th week after injection, and no AE were encountered. They concluded that results were comparable for all three-dosage groups, and that Dexamethasone was both safe and effective for transforaminal injections.

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.[ 6 ]

Efficacy of Multiple Types of Spinal Injections, Including Transforaminal Epidural Steroids In Resolving Radicular Pain by Roberts et al.[ 32 ]

Better Outcomes with Transforaminal Epidural Steroid Injections vs. Interlaminar Injections for Lumbar Disc Disease by Schaufele et al.[ 37 ]

Greater Effectiveness of Bilateral Transforaminal Epidural Steroid Injections for Treating Patients with Spinal Stenosis by Lee et al.[ 20 ]

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.[ 42 ]

Relative Efficacy of Caudal Epidural Injections with Local Anesthetic With or Without Steroids by Manchikanti et al.[ 24 ]

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.[ 28 ] Safety of Cervical Epidural Steroid Injections

Comparable Long-term Efficacy of Cervical Epidural Steroid Injections Performed with/without Morphine by Castagnera et al.[ 11 ]

Minimal Complications of Cervical Epidural Steroid Spinal Injections Performed Under Fluoroscopy by Botwin et al.[ 9 ]

Few Complications of Cervical Epidural Steroid Injections by Abbasi et al.[ 1 ]

Efficacy and Safety (64%) of Cervical Epidural Steroids for Radiculopathy by Rowlingson and Kirschenbaum[ 35 ]

Few Complications Attributed to 1036 Extraforaminal Cervical Nerve Blocks by Ma et al.[ 23 ]

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.”[ 3 ] Dr. Epstein directly cited Dr. Deyo's comment that despite the increase in steroid spinal injections, “people with back pain are reporting more functional and work limitations, rather than less.”[ 3 ] Dr. Deyo further cited a University of Washington study in which “seven clinical trials.showed the injections were helpful, another seven.found them no better or even worse than a placebo, and three (had) unclear results.”[ 3 ] Dr. Deyo also observed other risks of these injections that included: Infection, injections into the spinal fluid, intravascular injections, nerve damage, hemorrhages, and arachnoiditis. Again, these were not my quotes, but rather quotes from others that did not reflect a purely one-sided view.

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.[ 39 ] In 42 patients in the control group (CG), and 43 in the steroid-treated cohort, finding “the efficacy of isotonic saline administered epidurally for sciatica cannot be excluded, but epidural steroid injections provide no additional improvement.”[ 39 ] In another section, Epidural Steroids Offer No Significant Functional Benefits or Reduction in the Need for Surgery, Carette et al., in a double-blind, randomized trial, determined that for 158 patients with herniated discs evaluated utilizing the ODI at 3, 6, 12 weeks, and 1 year following injections, that even if epidural methylprednisolone resulted in some short-term benefits, it “offers no significant functional benefit, nor does it reduce the need for surgery.”[ 10 ] In the section Epidural Steroids Offer No Sustained Benefits or Reduce the Need for Surgery. Arden et al. evaluated the efficacy of three ESI vs. interligamentous saline injections (3 weeks apart) in patients with unilateral sciatica for 1-18 months.[ 5 ] They found that ESI offered transient benefit in symptoms at 3 weeks in patients with sciatica, but no sustained benefits in terms of pain, function, or need for surgery. In the section Risks of Cervical Epidural Steroid Injections, No Long-standing Benefit of Epidural Steroids/Local Anesthetic vs. Sterile. Anderberg et al. found in their prospective randomized study of 40 patients undergoing either cervical ESI/local anesthetic vs. sterile saline/local anesthetic, that at 5 postinjection weeks, patients receiving steroid injections had less pain, but not over the long-term.[ 4 ] In the section Permanent Neurological Complications (e.g. Quadriplegia) Associated with Cervical Epidural or Transforaminal Steroid Injections. Scanlon et al. cited eight instances of inadvertent intravascular injections leading to brain and spinal cord injury and identified an additional four cases of major particulate corticosteroid embolic injury to the cerebellum and brainstem in the literature.[ 36 ] In their own survey of members of the American Pain Society, the 21.4% response rate (287 of 1340) revealed 78 complications including: 16 vertebrobasilar brain infarcts, 12 cervical spinal cord infarcts, and 2 combined brain/spinal cord infarcts, with 13 fatal outcomes. In yet another section entitled Risks of Inadvertent Intravascular Injections During Under Attempted Cervical Steroid Injections, Inadvertent “Vascular Injections” Result in Quadriparesis During Attempted Epidural Cervical Steroid Injections. Bose et al. presented a patient who developed quadriplegia and a respiratory arrest following an attempted cervical epidural steroid injection at the C6-C7 level, concluding that it was likely a “vascular event” that left the patient with a major permanent neurological deficit.[ 8 ] And like the “pros” section, many other “cons” were also presented.

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 [ Table 1 ].

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.[ 7 ] Additionally, per Dr. Epstein many operations that are recommended are not necessary or are too complex.[ 6 ]

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.[ 20 ] alleging 11.4% intravascular injury and 76.3% bleeding. This would be a gross misinterpretation of that study. There was no intravascular injury described in this manuscript by Manchikanti et al.,[ 20 ] which rather described intravascular entry, unrelated to epidural injections.

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 [ Table 1 ]. The sections relevant to this include the following; Under the section Permanent Neurological Complications (e.g. Quadriplegia) Associated with Cervical Epidural or Transforaminal Steroid Injections, Scanlon et al. cited eight instances of inadvertent intravascular injections leading to brain and spinal cord injury and identified an additional four cases of major particulate corticosteroid embolic injury to the cerebellum and brainstem in the literature.[ 36 ] In their own survey of members of the American Pain Society, the 21.4% response rate (287 of 1340) revealed 78 complications including: 16 vertebrobasilar brain infarcts, 12 cervical spinal cord infarcts, and 2 combined brain/spinal cord infarcts, with 13 fatal outcomes. The next section dealt with Risks of Inadvertent Intravascular Injections During Attempted Cervical Steroid Injections, Inadvertent “Vascular Injections” Result in Quadriparesis During Attempted Epidural Cervical Steroid. Injections in which Bose et al. noted that 64-76% of patients undergoing cervical epidural steroid injections for pain/radiculopathy subjectively improved, and major adverse events (AE) attributed to these injections were rarely reported in the literature.[ 8 ] They felt that few clinicians report AE (due the risk of medicolegal suits and other factors), but also that few journals accept such case reports, much less those with negative outcomes. Bose et al.’s patient developed quadriplegia and respiratory arrest following an epidural steroid injection at the C6-C7 level and remained unchanged at 6 postinjection months. The injection was performed by “a fellowship-trained pain management specialist in an outpatient surgicenter using C-arm fluoroscopic guidance.”[ 8 ] Despite the patient's quadriplegia, Magnetic resonance (MR) studies performed 6 h after the injection and 6 months later failed to show any significant radiographic findings. The authors attributed the deficit/quadriplegia to an intravascular injection (“vascular event”). In another section, Transforaminal Cervical Injection Resulted in Vascular Infarction to Cord, following a left C6 transforaminal epidural steroid injection, Ludwig's 53-year-old patient developed left arm and bilateral lower extremity weakness, and MR confirmed intramedullary cord signal changes within 24 h from the odontoid to the C4-C5 levels consistent with diffuse vascular infarction.[ 22 ] In the section Inadvertent “Intravascular Injections” of Cervical Local Anesthesia Result in Transient Quadriplegia, Karasek and Bogduk noted the adverse consequences of performing a C6-7 transforaminal injection utilizing local anesthesia that resulted in an inadvertent injection into a cervical radicular artery.[ 17 ] Their patient's immediate quadriplegia resolved within 20 min; however, had this been a steroid injection, particulate matter may have acted as an embolus and caused a permanent injury. In another section: Cardiac Arrest Due to Cervical Epidural Steroid Injection Stabuer and Nazair's 67-year-old female patient following a C6-C7 epidural cervical steroid injection sustained pneumocephalus and a cardiopulmonary arrest.[ 38 ] The latter was likely attributed to blockade of the sympathetics resulting in bradycardia/arrest.

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.[ 7 14 15 19 41 43 ] Risks of epidural/transforaminal injections include: infection, epidural hematoma (0-1.9%), intravascular injections, nerve damage, cerebrospinal fluid (CSF) fistulas/headaches, air embolism, urinary retention, allergic reactions, seizures, blindness, and others.[ 7 14 15 19 41 43 ]

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.[ 7 ]

Response from Dr. Epstein

I have already demonstrated that I did not just “pick only a few studies with negative results” [ Table 1 ]. If the QUERY individual believes this, then he/she has not read the article carefully. Furthermore, I already presented the multitude of articles reflecting both the pros as and cons of ESI. Finally, the QUERY individual's last comment is not even relevant to the discussion.

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[ 8 10 11 12 13 14 15 16 18 19 21 22 23 24 25 26 ] have shown equal effectiveness of epidural injections on a long-term basis, along with facet joint nerve blocks, even though that was not the subject of this review, and have shown significant improvement with outcomes of at least 50% pain relief with functional status improvement of 50% over a period of 2 years. A recent systematic review also confirmed these findings.[ 3 ]

Response from Dr. Epstein

As indicated in the review article, there are many articles that demonstrate the lack of long-term effectiveness [ Table 1 ].

Query

Multiple complications related to transforaminal epidural injections are justifiable;[ 8 9 ] however, these complications are related to mainly cervical epidural injections and based on the radicular entry and injection of particulate steroids. The author seems to make multiple statements not substantiated by literature.

Response from Dr. Epstein

The multiple sections and articles citing intravascular injections resulting in major neurological deficits have already previously been quoted [ Table 1 ]. These sections accurately report/summarize the data from the different references, and are not just the musings/opinions of the author. I invite you to read the primary sources, which will substantiate the summaries I have provided in this review article.

Query

This trend extended to the clinical effectiveness, complications, and also costs and provides misinterpretations. She quotes Manchikanti et al.[ 20 ] as providing a multitude of data, which was not related to this manuscript, nor other manuscripts.[ 17 ] The author has also made multiple statements regarding financial incentives not described in any of the manuscripts.

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”.[ 25 ] He further observed, “about 20 percent of doctors who perform the procedures were not adequately trained.” When reviewing Medicare records, he found that the frequency of these injections increased by 160% from 2000 to 2010. He attributed this to the needs of older patients in desperate need of pain relief, and by financial incentives. “Medicare and private insurers pay $100 to several hundred dollars for an injection, and there are pain clinics that do almost nothing but injections.”[ 25 ] It was clearly his statements above rather than my own as the quotes indicate. His concern regarding adequate training, adequate indications, and financial considerations are rather clear. This clearly, therefore, documents the inaccuracy of the Query's last sentence.

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;[ 14 ] that was a positive study, and made no comments. Parr et al.[ 27 ] is cited in reference to short-term pain relief for disc herniation and radiculitis and evidence was lacking for both short- and long-term treatment from an earlier systematic review published in 2009 rather than using the manuscript published by Benyamin et al.[ 1 ] In fact, recent guidelines[ 8 ] and multiple systematic reviews[ 1 2 4 9 28 ] have provided similar evidence for interlaminar epidural injections, caudal epidural injections, and lumbar transforaminal epidural injections performed in interventional pain management settings under fluoroscopy with proper selection of patients. However, there is no evidence for transforaminal cervical epidural injections.

Response from Dr. Epstein

I would recommend that the Query read the review article more carefully to find answers to these comments/questions/accusations [ Table 1 ].

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 [ Table 1 ]. I would strongly recommend that the Query author undertake a more concerted review of this article to fully glean its benefits.

References

1. Benyamin RM, Manchikanti L, Parr AT, Diwan SA, Singh V, Falco FJ. The effectiveness of lumbar interlaminar epidural injections in managing chronic low back and lower extremity pain. Pain Physician. 2012. 15: E363-404

2. Benyamin RM, Wang VC, Vallejo R, Singh V, Helm S. A systematic evaluation of thoracic interlaminar epidural injections. Pain Physician. 2012. 15: E497-514

3. Bicket M, Gupta A, Brown CH, Cohen SP. Epidural injections for spinal pain: A systematic review and meta-analysis evaluating the “control” injections in randomized controlled trials. Anesthesiology. 2013. 119: 907-31

4. Diwan SA, Manchikanti L, Benyamin RM, Bryce DA, Geffert S, Hameed H. Effectiveness of cervical epidural injections in the management of chronic neck and upper extremity pain. Pain Physician. 2012. 15: E405-34

5. Epstein NE. The risks of epidural and transforaminal steroid injections in the spine: Commentary and a comprehensive review of the literature. Surg Neurol Int. 2013. 4: S74-93

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