I am writing in response to an advertisement I read in your publication on October 11, 2017 by Dr. Wayne M. Fichter Jr.: Do Epidural Corticosteroid Shots Work? In the “advertorial”, he attempted to tackle a very complex question. Unfortunately, intentionally or unintentionally, he used limited data and presented it in a misleading way.
As I stated above, this is a very complex question to answer. In clinical medicine, the best way to answer a question is with what is termed randomized controlled trials, or RCTs. RCTs try to limit the variables in a study to just what is being asked so as to get the clearest picture possible. Unfortunately, RCTs for procedures are extremely difficult to do. Part of an RCT is to include a group that receives a placebo treatment. When doing medication studies, people can just be given a pill that looks the same as the treatment medication. In other words, they are “blinded” to the treatment they are receiving. As you can imagine, doing RCTs for any kind of procedure is challenging, if not impossible. In addition, there are multiple variables involved in performing epidural steroid injection (ESI) including when they are performed, the approach that is used, the medication that is used, whether or not fluoroscopy is used and why they are used. Dr. Fichter refers to one study from a journal that is not a major journal in the field of pain management and uses limited data for their analysis. This article tries to summarize data from several studies but only picks two time points at which to measure the outcomes they are looking for: pain relief 2-6 weeks after an epidural steroid injection (ESI) and pain relief greater than 12 months after an ESI. Not surprisingly, the study supported good pain relief for the 2-6 week time point, but did not see great evidence for pain relief 12 months after the injection. ESIs are not “curative” treatments. They are a tool to manage pain and allow people to function better, participate in a physical therapy program, and avoid medications that potentially can be harmful. The American Society of Interventional Pain Management convened a group of 51 experts to review the entire body of literature around ESIs and used criteria set forth by the Institute of Medicine to help answer when ESIs are appropriate to use. This group of experts included multiple different types of healthcare providers, not just interventional pain physicians. This was to help minimize any potential bias in the review. They found that overall, using the grading system from the Institute of Medicine, there was good to strong evidence for the use of ESIs in patients with back and leg pain for intermediate pain relief (months). Dr. Fichter also cites the American Academy of Neurology guidelines regarding ESIs. However, these guidelines are 10 years old and do not encompass the latest literature. In addition, there is a growing body of evidence that suggests that epidural injections help some patients to avoid back surgery.
Dr. Fichter also brings up the FDA warning on the use of corticosteroids in the epidural space. The FDA requiring special labeling on medications is not unique to corticosteroids and does not mean that they cannot be used appropriately. In addition, the FDA warning was broadly applied to all corticosteroids. Corticosteroids can be roughly divided between what is called particulate vs nonparticulate steroids. All reported cases of severe neurologic complications from steroids in the epidural space have been associated with particulate steroids. We use nonparticulate steroids for our injections, which have not been associated with these complications. In addition, severe neurologic complications from ESIs are a very rare complication, much like the risk of severe neurologic complications from chiropractic therapy.
The last point that Dr. Fichter brings up is the potential increased risk of vertebral compression fractures after ESIs. The study that he cites has been faulted for having multiple limitations and the best conclusion that can be drawn from the study is that epidural steroid injections may increase the risk of vertebral fracture in patients who already have osteoporosis, although clear conclusions cannot be drawn. Other studies have found increased risk of compression fracture in older patients and those with poor bone mass, but have not seen a clear link to ESIs. A board-certified interventional pain management physician would be able to determine whether or not an ESI would be indicated in a patient with osteoporosis.
Finally, I would like to point out that this article was in a section of the paper called “advertorials” in which individuals or companies pay an advertising rate and write an “article” which generally promotes their goods or services. They are writing about what they do and why it is beneficial. This article was written by a chiropractor who has no experience or expertise with ESIs. I feel this is misleading. Whether knowingly or not, Dr. Fichter’s comments potentially could cause harm to people who may truly benefit from this therapy delivered in an appropriate manner. If someone truly has a question on whether or not ESIs may benefit them, I would hope that in the future Dr. Fichter would point them in the direction of a Fellowship trained, Board Certified interventional pain management physician who would be more capable of answering that question.
Scott Magnuson, MD
Pain Management of North Idaho, Coeur dAlene