Epidural steroid injections turned deadly raise pointed controversy over poor oversight of compounding pharmacies. But tainted or not, are the injections a valid therapy for back pain at all? Here, one expert’s opinion.
Epidural steroid injections (ESIs) have been in the news recently-and not in a good way. More than 30 people who received ESIs have died, virtually all from meningitis, and another 400 have been sickened after having the procedure. These problems have been traced to a fungal contamination of the steroid used that was produced by a Massachusetts pharmacy.
Questions have been raised about this pharmacy’s sanitary procedures and whether its widespread distribution of the drug was allowed under the laws that permit pharmacies to compound medications for individual patients. State and federal regulatory and law enforcement agencies will have to decide on the penalties, and also whether prosecution is warranted.
Obviously, contamination is an issue that physicians could face with any medication, and there is no suggestion that any of the physicians who used the steroid involved had any idea that it was contaminated. However, there is the very real question of whether ESIs are likely to confer benefit to many of those who receive them, including those who are given contaminated drug.
A recently published meta-analysis of 23 clinical studies published from 1970 to 2012 on ESI for sciatica calls into question just how efficacious ESIs really are for this disorder.1 Sciatica is probably the most common reason for which the procedure is performed and for which there is believed to be the most support for its use. The review found that compared with placebo, ESIs provided a small but statistically significant short-term improvement in pain and disability but not in long-term improvement (ie, after 1 year).1
These results are very similar to those found in a review of the literature by an American Academy of Neurology committee in 2007 that also highlighted the lack of evidence of long-term benefits of ESIs.2 This review not only noted the very limited literature supporting ESIs, but also the controversies regarding the best anatomic approach for these injections, the best medications and the optimal dosages to use, and the frequency of the injections.2
To say that there is something discordant between dearth of research demonstrating benefits of ESIs and the controversies that surround their use and the fact that an estimated 9 million are performed in the US each year could be considered an understatement.
The limited support for ESIs should not be too surprising. The theoretical basis for their use-that the pain they are being used to treat is primarily related to an inflammatory process associated with irritation of the nerve roots-has never been demonstrated to be the primary underlying pathologic process in most cases of sciatica or back pain.
Multiple studies have shown that for most people, abnormal findings on MRIs and other tests do not correlate with the presence or severity of back pain or sciatica. Furthermore, many patients who have actual disc herniation and who undergo surgery that would be expected to free the nerves from any irritation or impingement do not gain relief. Thus, the use of ESIs is based largely on a theory for which there is little support.
It is true that there are many anecdotal cases of patients who do benefit from ESIs. However, we can say the same of virtually everything ever used to treat back pain. And, sadly, the widespread use of ESIs calls into question of how carefully many of the physicians who perform them are screening patients to determine how likely the procedure is to provide benefit.
In an article on the contaminated steroid, the New York Times described the case of one of the people who received it.3 According to the article, the person had originally had received ESIs for “disc disease.” When the injections failed to relieve her pain, she had 2 back surgeries, which also did nothing for the pain. She again received steroid injections for the pain, this time with the contaminated drug. Because she subsequently developed a severe headache, a lumbar puncture was performed to rule out meningitis. Fortunately, the test was negative.
In light of the fact that ESI had previously failed to relieve this patient’s pain, I am not aware of any reason why repeating the injections after back surgery would be more likely to be successful. I would love to hear the physician’s explanation as to why he or she felt they were indicated.
Surely there are people with sciatica-and probably those with back pain without sciatica-who may benefit from ESIs. But it appears that there are many for whom there is little indication of a positive outcome; yet many are still undergoing this procedure at the recommendation of their physicians.
If there is anything positive to come out of the meningitis outbreak with regard to pain management, it should be this lesson. More conservative treatment modalities need to be exhausted before ESIs are considered.
1. Pinto RZ, Maher CG, Ferreria ML, et al. Epidural corticosteroid injections in the management of sciatica: a systemic review and meta-analysis. Ann Intern Med. 2012; doi:10.7326/0003-4819-157-12-201212180-00564
2. Armon C, Argoff CE, Samuels J, et al. Assessment: use of epidural steroid injections to treat radicular lumbosacral pain. Neurology. 2007;68:723-729
3. Grady D. ‘Worried Sick’: meningitis risk haunts 14,000. New York Times.http://www.nytimes.com/2012/10/22/health/meningitis-risk-haunts-14000-people.html?_r=0. Accessed December 17, 2012.