PPM Editorial Board Discusses Epidural Steroid Injections and Blindness
Question: When I picked up the September issue of Practical Pain Management,1 I went straight to Dr. Tennant's editorial and it was a good thing that I did! My brother went blind this summer. It was a mystery, at least to his family, until I read the first paragraph of the editorial. I went to my brother and inquired about epidural steroid injections. Sure enough the blindness (hemorrhagic optic neuritis) occurred a few days after he completed a series of lumbar epidural injections.
Why is this horrific carnage allowed to continue, despite Food and Drug Administration warnings and the drugs being unapproved for epidural injections? I trained to perform spine injections at a weekend seminar several years ago but chose not pursue this practice because no clear evidence of efficacy was presented.
My brother is an artist with a caulking gun and keeps 25 to 30 men and women employed performing this craft. He has a beautiful wife, a daughter, and a host of beautiful granddaughters who he will never be able to see again. He is not just a statistic. We were saddened to learn of the tragedy that occurred within your family after an epidural steroid injection. This and other such outcomes have raised concerns about the safety of epidural steroid injections. Indeed, there have been reports in the literature of rare but serious complications after epidural steroid injections including stroke, blindness, paralysis, and death. (see Editor's Note).
Editor's Note: In April 2014, the Food and Drug Administration ordered a label warning for epidural injections to include the risks of severe adverse events (death, stroke, permanent blindness, and paralysis). While these events are considered rare, the agency noted that the severity of potential outcomes warranted a written caution.2
In October 2014, the FDA’s department of pharmacovigilance published a review of injectable steroids. A summary of its findings found 131 cases of serious adverse neurological events including 41 cases of arachnoiditis. Particulate steroids have more adverse events, but the agency noted at that time: “it is not know whether this difference reflects greater utilization of particulate steroid or greater toxicity.”3
In November 2014, after convening a two-day meeting to discuss the risk of serious neurologic adverse reactions associated with epidural steroid injections, the Anesthesia and Analgesic Drug Products Advisory Committee voted 15-7 in favor of calling particulate steroids “contraindicated for transforminal cervical injections” because they appear to carry greater risk of adverse neurological effects than nonparticulate agents. As of press time, the FDA has not made a final ruling.
Consider the Benefits of ESI
As pain medicine physicians, we have a vested interest in making sure that all the procedures we offer to our patients are safe and effective enough to justify the risks. As with all treatments, there are both risks and benefits to epidural steroids. However, we believe the debate about epidural steroids has thus far been focused on the risks of the treatment without accurate or adequate consideration of the benefits.
To begin, the question of efficacy of epidural steroids is of vital importance, as the performance of any procedure in the absence of efficacy would certainly be irresponsible. There are a number of high quality studies showing epidural steroid injections do indeed benefit patients.
Studies Supporting Efficacy
Ghahreman et al carried out a prospective, double-blind, randomized control trial comparing the efficacy of transforaminal epidural steroid injection with a variety of control treatments including transforaminal injection of local anesthetic alone, transforaminal saline, intramuscular injection of steroid and intramuscular saline for the treatment of lumbar radicular pain.4 The primary outcome measure in this study was the proportion of patients who achieved at least 50% pain relief at 1 month and secondary outcomes included measurements of function and disability. The study found a statistically significant difference between the epidural steroid group and any other group—54% of the epidural steroid patients achieved the desired relief (95% CI +/- 18%) while patients receiving any of the other treatments were statistically indistinguishable from each other with an average of only 15% achieving the desired relief (95% CI +/- 7%). In addition, the proportion of those receiving relief from epidural steroids remained significantly higher than the other groups at 12 month follow up. Secondary outcomes were also favorable in the epidural steroid group.4
In a prospective, randomized, controlled, double-blind trial, Riew et al demonstrated a highly significant difference in surgical rates for patients suffering from radicular pain who were treated with transforaminal epidural steroid and local anesthetic versus those treated with local anesthetic alone.5 During the 13 to 28 month post-procedure follow up period, only 29% of the patients treated with steroid and anesthetic underwent surgery while 66% of those treated with anesthetic alone required surgery.5
In a prospective, randomized control trial, Vad et al compared a transforaminal epidural steroid injection to a deep paraspinal trigger point injection with saline. Measurement outcomes included an improvement in the Roland-Morris back pain score, improvement in a visual numeric pain scale, improvement in a measure of hip flexion tolerance and a positive patient satisfaction score. At an average follow up of 16 months, the patients receiving the ESI had an 84% success rate compared to 48% in those receiving the saline injection.6 With this as a background, systematic reviews and meta-analysis summarizing the research done on this topic7,8 have found that up to 70% of patients receive 50% pain relief for 1-2 months while 30% receive complete pain relief.8 For those with disc herniation, up to 70% receive 50% relief for 6 months.9
From the preponderance of the evidence, it seems reasonable to conclude that, when preformed on patients with appropriate indications, epidural steroid injections have demonstrated efficacy in reducing pain, improving function, and lessening the need for more invasive treatments such as surgery.
Safety Risk of ESI
With a robust amount of literature supporting the efficacy of epidural steroids, we must also consider the safety of these procedures, for even in procedures with demonstrated efficacy, safety must be of the highest concern. This begs the question, what are the safety risks of epidural steroid injections and how are they addressed?