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Rapid Responses: Rapid Responses published:
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Potemkin would have used steroids
- Dr. Herbert H. Nehrlich (25 June 2004)
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Unannounced side effect of epidural steroids
- Zana A Gentle, Charles Burton, Dr. Antonio Aldrete, Dr. Sarah Smith (25 June 2004)
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Can the NHS Afford Quality Epidural Steroid Injections
- Cynthia M Lewis (25 June 2004)
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Need of a clinical trial for epidural steroid inection in low back pain.
- Milind S Deogaonkar (25 June 2004)
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Epidural - problems
- Jon Madura (25 June 2004)
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epidural steroid injections
- linda coleman (28 June 2004)
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Epidural Steroids for Low Back Pain: No Evidence
- Edward M. Walsh (28 June 2004)
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Epidural Steroids Dangerous and Full Disclosurre Rarely Given
- Jeff Felicetti (28 June 2004)
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Depo Medrol DID Harm Me
- Mary J Reyerson (28 June 2004)
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More importantly what are the risks of epidural steroid injections?
- Gary A Snook (28 June 2004)
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Epidural steroids and arachnoiditis
- Bob Smith (28 June 2004)
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Since When?
- Barbara S Welch (28 June 2004)
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Royal Society of Anaesthetists / Pain Society Recommendations
- Sue G. Clayton (29 June 2004)
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Epidural
- Isobel Knight (29 June 2004)
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Do epidural steroid injections help low back pain?
- Kieran M Walsh (30 June 2004)
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The Epidurals Changed My Life Forever
- Martha E Lyles (30 June 2004)
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Blood unseen
- Lina J Talbot (2 July 2004)
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My Epidural steroid experience
- Richard Bachrach (2 July 2004)
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Sacral Epidurals should not be negelcted from trials
- Guy S Wildy (3 July 2004)
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Multiple Dangers from Epidural Steroids
- William M. Landau, Dewey A. Nelson, MD (6 July 2004)
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Epidural Steroid Injections: Technique is Important
- Keith Bush, Ellis Richard (9 July 2004)
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ESI's with Depo-Medrol / Efficacy & Safety Issues
- Dennis J. Capolongo (11 July 2004)
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making a diagnosis
- Judith Neaves (11 August 2004)
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Dr. Herbert H. Nehrlich, Private Practice Bribie Island, Australia 4507
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In my opinion epidural injection of steroids for back pain is a cop- out. You can accomplish the same thing by cutting the afferent nerves, thus preventing the brain from 'finding out' that there is a problem. Of course, this is akin to cutting the telephone wire to the fire department. The firemen will never know that they were needed, thus there couldn't have been a fire. Personally, I figure that a thorough work-up and accurate diagnosis should precede the referral to a properly trained chiropractor if one desires a good outcome for the patient. Chiropractors have shown again and again, in study after study, that they obtain superior results, in less time and at less cost. Injecting steroids, even though Dr. Cyriax, an orthopedist of note, 'pioneered' it is no better than cutting the vagus nerve for sweaty hands. Competing interests: None declared |
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Zana A Gentle, disabled 37205 USA, Charles Burton, Dr. Antonio Aldrete, Dr. Sarah Smith
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Sir, I would like to point out one item of interest in your article. It is widely reported that there are no adverse side effects of epidural steroid use. This misconception is not entirely true. There are well over a million of us in the US alone, who react either to contrast materials used in the procedure, have a septic reaction, or experience a strong reaction to the agent, such as depo-medrol or celestone soluspan. The result for us is an obscure, but nevertheless devastating condition known as arachnoiditis. Adhesive arachnoiditis. I would hardly call arachnoiditis non-adverse. There is no cure for it. Common symptoms? Extraordinary pain, at times, suicide level pain and neuralgia. Clumping of dural roots, clumping or adhering of cauda equina, etc., paralysis, paraplegia, on and on. Brain and spinal cord lesions and/or deteriorization. This hits only a few percent of ESI injectees, however, a lifetime of these symptoms is a substantial risk. A risk we are not advised of, nor do we consent to, in common epidural procedures. In my 19 years of spine problems, I have had nearly 30 epidural steroid shots. The first 10 or so were effective; the last dozen or so have been disastrous, and resulted in, or were greatly involved in arachnoiditis tagging me. It is true, it works for some people, and some circumstances, and does nothing for others. Some conditions it helps, for others, again, epidural steroids do nothing. However, the preservatives in the agent, namely glycol, or the others, are full of risks, and many steroid makers specifically advise against use of the steroids epidurally, despite the fact that is exactly how they are used (see references)... Another reason their use should be more closely scrutinized. Thank you for bringing this topic to your readers. Competing interests: None declared |
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Cynthia M Lewis, Retired DE4 5HS
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Drs Ash and Jo Samanta are to be congratulated
for opening up discussion about the controversial treatment of epidural steroid
injection for low back pain. They cite the paper by Carette et al 1
as evidence for the procedure being "safe" but they do not discuss in
whose hands such injections are "safe". Neither do the authors
mention some of the cautions that have been issued in relation to particular
preparations. For example, the product information
for Depo-Medrone 2 (methylprednisolone - a steroid widely
used for ESI) states, "Due to its potential for
neurotoxicity, Depo-Medrone must not be given by the intrathecal route.
Depo-Medrone is not recommended for
epidural, intranasal, intra-ocular, or any other unapproved route of
administration". The authors also do not mention the
"Adverse Reports" already collected by the FDA. For this particular
preparation, the incidence of arachnoiditis and paralysis is high on the list
(arachnoiditis is in10th place, paralysis 56th, from a total of 1,049). For a
drug that has many other applications and is not recommended for epidural use,
this is worrying. Safe
hands and missed targets
Many papers show that
"blind" epidural steroid injections are frequently misplaced 3
4 5. In fact, given the figures available, it is likely
that a significant number - possibly greater than 60% - miss the target.
Epidural injection is an acquired skill and in inexperienced hands it can pose
risks for the patient. The hazards of
"blind" ESI are somewhat greater than those accepted for epidural
anaesthesia. There is ever-present risk of infection, pneumocephalus and dural
puncture (a figure of around 5% dural puncture is usually quoted for ESI 6)
and there is the additional hazard of the substance injected. Toxic
drugs Hazards associated
with intrathecal administration of steroid were recognised years ago and the
procedure was then withdrawn. And with such a relatively high incidence of
dural puncture, is it surprising that arachnoiditis ranks high in the reports
of adverse effects? The authors do not discuss the toxicity of
steroid preparations: the fact that most contain neurotoxic preservatives 7.
In addition to this, the particulate nature of the formulation poses a hazard -
the "depo" property that (supposedly) gives the injection its
long-term action. Warnings about the potential of tissue destruction by such
"crystals" are found in the manufacturer's data sheet: they have the
potential to block blood vessels and to cause arachnoiditis. A
safer way.
It is surprising that
the authors did not mention another paper where 5334 patients receiving
epidural steroid injection suffered little harm 8. BUT, it should be pointed out that these injections
were qualitatively different from the quick "shot in the back" that
most NHS patients receive. These patients received an injection that was
performed using epidurography, where X-ray imaging and a small amount of
radio-opaque dye is first injected to ensure the needle is in the correct
position. It is then virtually impossible for the practitioner to
penetrate the dural membrane and inject steroid intrathecally. In this
particular study, although only a small number of patients were followed for
two years, there were no cases of persistent neurological complications. I note that the Drs
Samanta are rheumatologists and I wonder if their patients have the benefit of
this procedure? Do
we need more studies? The authors say, "A
need exists for well designed trials of adequate size to determine the
effectiveness of epidural injection in back pain." But I wonder why
they did not cite recent trials (2003 –2004), for example that funded by the NHS R&D Health
Technology Assessment where 228 patients were studied 9. The
authors concluded, "Ten randomised
trials, a systematic review and meta analysis have failed to answer whether it
is worthwhile performing epidural steroid injections for sciatica." These authors did find slight
evidence for benefit but wondered, "Whether
the limited benefit conferred by epidural steroid injection is significant
enough to purchasers so that they continue to support this procedure remains to
be seen." A smaller randomised controlled trial from
France also concluded that steroid was no better than isotonic saline 10:
and in addition, similar findings were presented at a meeting in San Francisco
(March 2004) 11. I would suggest that any evidence for benefit is
slowly being eroded and do not understand why the authors did not mention these
recent studies. Conclusions
Epidural steroid injection
is perceived as being useful, it is also perceived as being safe. I believe it
is neither of these things. The Drs Samanta conclude, "Evidence for
and against epidural steroid injection should be clearly explained to allow
patients to make an informed choice regarding their treatment." If the content of their article is the
information a patient is normally given, I believe it is wholly inadequate? In recommendations issued by the Royal College
of anaesthetists we read, "Historical precedence and tradition can no
longer be regarded as justification for practices that are perceived to fall
below the standards acceptable to a responsible body of doctors. If one patient
is harmed by sub-standard practice then that is one too many.” 12 A significant number of patients have been
harmed and the tradition of "shot in the back" is probably
responsible. With present queries about effectiveness, I believe epidural
steroid injection should only be carried out if the procedure is performed by a
skilled person and with epidurography, if it can not be done in this way, I
believe it should not be done at all. Can the NHS afford epidural steroid injection
with epidurography? References.
Competing interests: None declared |
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Milind S Deogaonkar, Fellow, Cleveland Clinic Foundation, Cleveland, OH 44195, USA
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Low back pain forms a large chunk of neurosurgical practice. I have always followed a set algorithm in my practice. When the patients with low back pain come to my clinic I tend to divide them into ‘surgical’, ‘non-surgical’ and ‘borderline'. Surgical cases usually include those with eminent sphincter problems, large discs on MRI with radicular pain or with progressive motor deficit. Borderline are those with radiculopathy and small disc prolapses whom I give a trial of physiotherapy and rest. Non-surgical cases where the MRI only shows degeneration and there is no radicular pain, I do use epidural injections of steroids along with physiotherapy. Another group of patients I use epidural steroids are those of ‘failed back syndrome’ who still have lot of back pain even after back surgery and post-operative imaging is unimpressive. Having said that, this whole practice is based on little scientific inputs and more on surgical tradition in units where I did my training. I fully agree with the authors [1] that a technique so extensively used by rheumatologists, anesthesiologists, pain specialists, neurosurgeons, and rehabilitation specialists should be validated by a proper randomized, multicentric, double blind trial. There is very little scientific evidence of its usefulness [2] but those of us using it know it works in some patients. A trial like this will be able to show us the exact subgroup of patients in whom it will be most effective References: 1. Samanta A, Samanta J: Is epidural injection of steroids effective for low back pain? ; BMJ 2004;328:1509-1510 2. Watts RW, Silagy CA. Meta-analysis and the efficacy of epidural corticosteroids in the treatment of sciatica. Anaesthesia Intens Care 1995;223: 564-9 Competing interests: None declared |
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Jon Madura, n/a New Jersey USA 08859
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I have had three sets of epidural injections for back pain and along the way have come accross many other patients with similar happenings. Back pain was the primary concern butleg pain and subsequent numbness has now joined in. The epidurals at first gave short lived relief but the last set was a waste of time. Locally, they are administered by anesthesiologists who are not otherwise involved in pain management cases. I also had L5-S1 operated on. These named instances were my ONLY contact with steroids yet within a year of having these, I developed OSTEOPOROSIS at a value of -4.2 (verified). NOT a single person ever advised me of this possibility but now that i am under long term treatment, the connection is very evident. Also there seems to be no or very minimal written guidelines for the use of steroids by medical personal and everyone pointed out to me that usage varied widely by patient/physician. I believe that this needs to be addressed by the medical community. Competing interests: None declared |
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linda coleman, editor jeremiahjunction, 18944 USA
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I was rendered disabled by epidural steroid injections. Also the routinely prescribed use of steroids has left me with an avascular necrosis of the right hip. I was told by my Drs. that all of the above were considered "safe". In light of my experience, please do not imply that any of these are "safe". The patient should be informed of the catastrophic effects these procedure can and do cause. thank you Competing interests: None declared |
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Edward M. Walsh, Consultant in Anaesthesia and Chronic Pain Southmead Hospital, Bristol, BS10 5NB UK
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This is a dangerously flawed editorial. The title states “Is epidural injection of steroids effective for low back pain?” Now it could be, as in many other such articles, that the authors either have failed to distinguish between low back pain, low back pain with leg pain, and sciatica on its own, or they are using the term “low back pain” as shorthand for sciatica. We should not expect such imprecision from two rheumatologists with “longstanding clinical experience”, but they have put low back pain unqualified by any more specific term in their title. Indeed they make it quite clear in their text that they are discussing specifically low back pain and whether epidural steroid injection can help low back pain. The authors distinguish between leg pain dominant and back pain dominant cases of low back pain and their article plainly deals with the latter type, which they say is caused by biomechanical factors but may also be associated with some nerve root irritation. What is not clear is how clinicians should distinguish between the majority of back pain cases with some referred leg pain which have biomechanical causes, and the few with nerve root irritation. The fact is there is no satisfactory way; it is usually a clinical guess. My patients who have proven disc prolapse if assessed for surgery are told by surgeons that removing the disc may relieve their leg pain but is unlikely to help their low back pain, which is what usually happens. So the idea that nerve root irritation alone may lead to low back pain is probably unfounded. Yet on the assumptions that such cases exist and that a reliable diagnosis can be made, the authors are proposing the use of a potentially dangerous technique. Elsewhere in the editorial, the distinction between low back pain with “nerve root irritation” and biomechanical low back pain is not made clear. That is why I think this editorial is dangerous: other less experienced physicians may think, as the authors actually propose in their conclusion, that epidural steroid injection is worth trying in any case of low back pain that fails to resolve. But does the evidence they cite have any relevance to low back pain and epidural steroid injections? Koes et al’s systematic review concludes by stating that “there are no indications that epidural steroid injections might be effective in patients with (chronic) back pain without sciatica” 1. The conclusion of Watts and Silagy’s meta-analysis only refers to “lumbosacral radicular pain” not low back pain.2 So quoting numbers needed to treat based on these analyses of nerve root pain cases is flawed if applied to low back pain, as the authors have done. The Cochrane review that the authors quote was on the injection treatment of low back pain.3 However, the four papers quoted in the editorial were all about patients who had nerve root pain not low back pain, so should not have been quoted in an editorial on the treatment of low back pain. Nelemans et al in fact state that “convincing evidence is lacking regarding the effects of injection therapy on low back pain.”4 Given the lack of evidence in the literature, all the authors can advance to establish their argument is their “longstanding clinical experience”. In my opinion, their proposal to give epidural steroids to patients with “low back pain that has not resolved within three months ….. and who may have radicular symptoms”, presumably whatever the cause, is ludicrous on economic and safety grounds. Personally5, along with several other authors6, I have long rejected low back pain as an indication for epidural steroid injection and now only inject those cases with a proven disc protrusion not suitable for surgery. As for its efficacy even in nerve root pain, I have not been able to reach a definite decision after some 20 years of consideration. What hope therefore for the poor patient coming to an “informed choice” on epidural steroids and low back pain? I hope also anyone inspired by this editorial to treat low back pain with epidural steroids will not forget to tell their patients that the steroid being used is neither licensed for low back pain nor for the epidural route and that the British Society for Rheumatology guideline states that “epidural steroid injections are an evidence-based treatment for sciatica” not low back pain.7 References: 1. Koes BW, Scholten RJ, Mens JM, Bouter LM. Efficacy of epidural steroid injections for low back pain and sciatica: a systematic review of randomized clinical trials. Pain 1995;63: 279-88. 2. Watts RW, Silagy CA. Meta-analysis and the efficacy of epidural corticosteroids in the treatment of sciatica. Anaesthesia Intens Care 1995;223: 564-9. 3. Nelemans PJ, de Bie RA, de Vet HCW, Sturmans F. Injection therapy for subacute and chronic benign low back pain. Cochrane Database Syst Rev 2000;(2): CD001824. 4. Nelemans PJ, de Bie RA, de Vet HCW, Sturmans F. Injection therapy for subacute and chronic benign low back pain. Spine 2001;26:501-515 5. Walsh EM. Epidural steroid injections for back pain and sciatica. In: Breivik H, Campbell W, Eccleston C, eds Clinical Pain management: Practical Applications and Procedures. London: Arnold 2003; 417 - 427 6. Epidural Use of Steroids in the Management of Back Pain. National Health and Medical Research Council of Australia, Canberra, 1994 7. British Society for Rheumatology 2001. https://www.msecportal.org/portal/editorial/PublicPages/bsr/536883013/2.doc Competing interests: None declared |
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Jeff Felicetti, None Beecher, IL 60401
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As a result of repeated epidural steroid injections, I now have Adhesive Arachnoiditis. The possibility of the scarring on the nerves and nerve roots had never been disclosed as a possibility. I am now permanantly disabled with a condition that will only progressively worsen. The end result could even be as severe as paralysis from the waist down, loss of bowel control, etc... I'm 43 years old anf live with horrible pain every day. The only way I function at all is with rather high doses of narcotic pain medications, and even those just lessen the pain somewhat. I can barely manage to take care of my basic needs on a good day. Without medication I could not even get out of bed. The sad thing is, it can ONLY get worse. Half the Man I Used to Be, Jeff F.Felicetti Competing interests: None declared |
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Mary J Reyerson, none USA 56009
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I had an epidural steroid injection done in Oct. 2003 using the drug depo medrol. I had multiple lumbar punctures resulting in adhesive arachnoiditis. Epidural injections may be good for some people, but I don't think it is worth the risk to have this done. Having this procedure done is like playing russian roulette, who will be next.....maybe it will be you and believe me, this is a hideous disease with no cure and the prognosis is not good. Thank you for letting me voice my opinion. Competing interests: None declared |
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Gary A Snook, patient Lolo, Montana 59847 USA
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I read with interest your article on epidural steriod injections. I was happy to see that someone had the courage to ask such a timely question.After all epidural steroid injections have been a cash cow of the medical community for years.Literally billions of dollars are spent by millions of people trying to find relief for back pain every year. I did find one thing lacking however. Do you know what that was? You failed to mention anything about the severe risks of epidural steroids,but more that that your paper states that "epidural steroid injections are relativly straightforward and safe". It has been known for years that some very severe reactions have been associated with them, even DEATH! For those who are unfortuneate enough to survive the procedure, and then find they now have an incurable disease like Arachnoiditis from that "safe"procedure, well, their life is a life of pain, 24/7 pain, pain so unimaginable that even the raging fires of Christendoms Hell fire pale in comparison. I applaud their courage to face another day. My doctor told me before my epidural steroid injection of Depo Medrol that it was safe.That was more than the doctor did who bathed my spinal cord in Depo Medrol before closing after surgury did.I guess he felt that it wasn't even worth telling me the risks at all. Had either one of them done so.Had they explained to me the risks accociated with epidural steroids I wouldn't be writing this letter today because I would have refused the procedure and would not now suffer from Arachnoiditis. Because you don't just catch this disease from a toilot seat,it is a severe reaction to epidural steroids. What reason does the medical community have for ignoring the risks? Why do so many of her finest doctors fail to inform the patient of those risks? Since epidural steroid injections have not been proven effective. Would not the prudent thing to do, be to discontinue their use until they are proven safe? How can any discussion of the effectiveness of epidural steroids have any merit if it does not address the victims in the game of epidural steroid roulette? From my point of view a failure to do so would be like throwing out the baby with the bathwater. Thank you so much for raising such a thought provoking question and letting me express my view. Gary Snook Competing interests: None declared |
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Bob Smith, GP Galashiels Health Centre TD1 2UA
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I remember being told by a senior colleague one time that arachnoiditis has only been reported with methylprednisolone (Depo- Medrone) injection and not with triamcinolone preparations (e.g.Kenalog).Is this correct and if so, shouldn't Drs who use epidural steroids only use triamcinolone? Competing interests: None declared |
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Barbara S Welch, Victim Anna, Texas 75409
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I received an email from a person who deals with the same things that I do on a daily basis and I am here to raise a question with regards to epidurals and low back pain. Since when did the label on the steroids EVER say that they were safe to use in the spinal area. The answer to that is...NEVER!!! How dare you doctors out there sentence us to death, all the while collecting money from us, causing us pain, more illnesses and then to top it off...telling us that it is good for us??? SINCE WHEN? The ingredients in these steroids are LETHAL to the spinal cord and the nerves. When you bathe those nerves and inject that steroid, you are committing a crime. A crime against other humans and also a crime in using the steroids incorrectly as WRITTEN ON THE MANUFACTURER'S LABELLING. How many of you would like to let me take a long needle, let me poke it into your back while trying to make sure that I do not hit the spinal cord itself, and when I do reach the space, if I don't have to try it more than a few times, let me inject a lethal substance into your body that is going to first off cripple you, cause you immense amounts of pain, paralyse you, cause other diseases and conditons such as Cauda Equina Syndrome, Adhesive Arachnoiditis and a host of other medical issues that will eventually kill you? Oh and on top of that...how about I tell you that it is SAFE and EFFECTIVE when I know that is not a proven fact. And one last thing...I will lie to you and tell you that any symptoms you may have after I do this, is all in your head. Not many of you I bet. The Hippocratic oath says that you are to CAUSE NO HARM in your care of another human being...guess what? You do great harm and you take life instead of saving them all because you do not read nor accept what people are telling you. SINCE WHEN did I want this? SINCE WHEN did I ask you to do this to me and my family? SINCE WHEN did I ask you to cause a miscarriage of a wanted child? What sane person would? NOT A ONE OF US...you included. So before you stick that needle in the next person's back, take the time to blink and let the dollar signs go away so you can read, understand and comprehend what you are about to do and the seriousness of your actions. There are many of us out here who have been subjected to these injections and NOT A ONE OF US were ever informed of these consequences. I call upon you now to wake up and pull your heads out of the mud. Stand up and say YES, I made a mistake and am willing to accept the consequences of my actions. I will not do this again as I see the harm I am doing to people instead of helping them as I stated I would do when I graduated from medical school. I know this won't make a difference to many of you and most of you will write me off as a crackpot or some weirdo but if even just one of you goes and reads that label and takes a few seconds to think about what you are doing...maybe there will be one less of us out here who is going to die early, maybe one of us who will be here to see our children grow up, maybe one of us will be able to have more children, maybe...just maybe we will live life to the fullest instead of each day taking more and more medications to try and alleviate the ever increasing pain and the ever increasing conditions that are the consequences of YOUR actions. Then again...maybe not. Competing interests: None declared |
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Sue G. Clayton, Lay patient member of the Patient Liasion Committe of the Pain Society Ladywell House, Fordwich, Canterbury CT2 ODL
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The Royal Society of Anaesthetists and the Pain Society have issued "Recommendations on the use of epidural injections for the treatment of back pain and leg pain of spinal origin (March 2002)" These are concerned with the competencies of doctors who perform ESIs and the clinical environment in which they are performed. They do not endorse or recommend the use of particular medication or product for epidural injection and state that the choice of these is the responsibility of the individual practitoner. At a purely personal level, the series of three ESIs ordered to try to alleviate my intractable pain due to failed back surgery syndrome after four spinal operations had to be abandoned. The anaesthetist was not able to insert the injection into the epidural space due to dense scarring. The pain was greatly exacerbated and I was later diagnosed with adhesive arachnoiditis. If epidurography had been available there might have been a much better outcome. How widely available is epidurography today and is it being used by all practitioners? Sue Clayton Competing interests: None declared |
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Isobel Knight, Life Coach Cambridge
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I have read all the responses to the article 'Is epidural injection of steroids effective for low back pain? and I have to say that in my case it has been highly effective. I have suffered from chronic back pain (disc prolapse L4/5) for over ten years and tried everything from physiotherapy, rest, exercise, drugs, spinal manipulation (chiropractics etc) and the epidural has given me long periods of pain relief. The only problem is that I am quite young (29) and I don't know how many more epidurals I will be able to have safely. I have had three so far with longer periods or relief in between (e.g. more than nine months). I have been treated at one of the leading pain units and I feel that I have been treated carefully with all risks explained to me. For me the decision to have epidurals has paid off and I have got my life back. Nevertheless I am cautioned by the other responses to this article and know that it will not be possible to have epidural injections indefinitely. Competing interests: None declared |
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Kieran M Walsh, Editorial Registrar, bmjlearning.com BMA House, Tavistock Square, London WC1H 9JR.
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Dear Sir, Do epidural steroid injections help low back pain? Not on the basis of current evidence. (1) I was surprised by the conclusions of the editorial by Samanta et al. (2) The recent Cochrane review quoted in the editorial found that there was no significant difference between epidural steroid injections and placebo after 6 weeks or 6 months. (1) Adverse effects were infrequent but did include headache, fever, subdural penetration and rarely, epidural abscess and respiratory depression. (1) The conclusions in the editorial have a tenous link with the evidence. Surely you should only give epidural steroid injections for low back pain in the context of a randomised double-blind placebo controlled trial. We would then quickly have a conclusive answer to the above question. Yours Sincerely, Dr. Kieran Walsh. 1. Nelemans PJ, de Bie RA, de Vet HCW, Sturmans F. Injection therapy for subacute and chronic benign low back pain. Cochrane Database Syst Rev 2000;(2): CD001824. 2. Samanta A, Samanta J: Is epidural injection of steroids effective for low back pain? ; BMJ 2004;328:1509-1510 Competing interests: None declared |
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Martha E Lyles, patient with arachnoiditis 38401
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I was told by my neurologist that a series of epidurals would help my sciatic pain after I had bee rear ended in an auto accident. I took a series of three epidurals in July. I received minor relief for a short period of time. Six weeks later I started to show some symtoms of arachnoidits. By Christmas I had a mylegram which showed arachnoiditis. While I had been able to walk two miles every day before the epidurals, my walking ability suddenly started to decline and by Febuary I was unable to walk 100 yards. I was placed on a narcotic pain patch and other drugs to deaden the nerve pain. I now struggle to keep myself out of a wheel chair. My life suddenly changed due to the epidurals. Competing interests: None declared |
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Lina J Talbot, Retired general medical registrar TQ1 3TB
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There is a further point to add to the list of serious concerns regarding the use of epidural steroid injections for “low back pain”. It may frequently remain unseen, but the risk of blood leakage into the three intraspinal spaces should not be underestimated by either practitioners or patients. Intravascular injection occurs with caudal and transforaminal epidural steroid injection in over 10%, and with interlaminar injections in 1.9% of procedures: the incidence of laceration of blood vessels by the needle tip will not be less (1). Indeed, Igarashi et al visualized blood vessel trauma at the tip of the Tuohy needle in approximately 20% of pregnant women undergoing lumbar epidural anaesthesia, irrespective of trimester (2). 14% of punctures for spinal anaesthesia are associated with significant vascular trauma (3). Blood in the subarachnoid, subdural and epidural spaces opens the door to inflammatory scarring around the nerve roots. Ten per cent of patients receiving “blind”epidural steroid injection hopefully do not develop a mesh of scar tissue around a nerve root, where blood has gravitated into and/or around the nerve root sleeve …….. or do they? Blood unseen, pathology unseen. The critical concerns regarding epidural steroid injections are: 1. Indications for use are ambiguous and vary with practitioner 2. Recent clinical trials demonstrate poor to no effectiveness even at three or six weeks (4,5) 3. “Blind” epidural injections performed without fluoroscopy and injection of radiographic contrast miss their target over 25% of the time (6,7,8) 4. There is potential risk of major adverse harm, not only from intraneural and dural puncture, but also as a result of the significant rate of intraspinal haemorrhage. This may well pass unnoticed at the time of injection. Patients in clinical trials whose radiculopathy worsens in the months following epidural steroid injection need to be adequately followed up in order to ascertain the true magnitude of this risk. 1. Sullivan WJ, Willick SE, Chira-Adisai W, Zuhosky J, Tyburski M, Dreyfuss P, et al. Incidence of intravascular uptake in lumbar spinal injection procedures. Spine 2000;25: 481-6. 2. Igarashi T, Hirabayashi Y, Shimizu R, Saitoh K, Fukuda H, Suzuki H. The fiberscopic findings of the epidural space in pregnant women. Anesthesiology 2000;92: 1631-6. 3. Knowles PR, Randall NP, Lockhart AS. Vascular trauma associated with routine spinal anaesthesia. Anaesthesia 1999;54: 647-50. 4. Carette S, Leclaire R, Marcoux S, Morin F, Blaise GA, St-Pierre A, et al. Epidural corticosteroid injections for sciatica due to herniated nucleus pulposus. The New England Journal of Medicine 1997;336: 1634-40. 5. Arden NK. Corticosteroid injections result in only limited short- term benefits for sciatica patients. American College of Rheumatology 66th Annual Scientific Meeting 2002; Abstract 530. Reviewed for Medscape Medical News, 28 Oct 2002, by Vogin GD. 6. Broadbent CR, Maxwell WB, Ferrie R, Wilson DJ, Gawne-Cain M, Russell R. Ability of anaesthetists to identify a marked lumbar interspace. Anaesthesia 2000;55: 1122-6. 7. Renfrew DL, Moore TE, Kathol MH, el-Khoury GY, Lemke JH, Walker CW. Correct placement of epidural steroid injections: fluoroscopic guidance and contrast administration. American Journal of Neuroradiology 1991;12: 1003-7. 8. White AH, Derby R, Wynne G. Epidural injections for the diagnosis and treatment of low-back pain. Spine 1980;5: 78-86. Competing interests: None declared |
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Richard Bachrach, NY College of Osteopathic Medicine Associate Professor 317 Madison Ave Ste 200 New York, NY 10017
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Oct 4 2002. Planning hiking trip in Nova Scotia. for several weeks Right L5 radiculopathy which has responded 2 and 3 years previously to single epidural steroid injections. Can't go hiking in this condition so opt for another epidural steroid injection under radiographic guidance. just after insertion of the needle, commencement of injection, I feel a deep ache across my thoracolumbar junction. Does not subside. No change radiculopathy. Thoracolumbar junction pain persists Following injection and becomes more severe particularly on coughing. off to Nova Scotia anyway.progressively increasing leg pain, bilateral leg weakness. Then develop what appears to be L4 radiculopathy left lower extremity.progressively increasing leg weakness, unable to climb even two steps. Severe constipation, unable to urinate without great difficulty. Saddle hypaesthesia, paraesthesias, allodynia both legs. Needless to say, no hiking. Back to New York, MRI spinal cord hematoma at the conus. Weakness, bladder and bowel difficulties progressively increasing. Second MRI demonstrates syrinx. Neurologist, neurosurgeon suspect AV fistula. angiogram fails to reveal AV fistula. Weakness, etc. persists, getting worse. MRI shows resolution hematoma, recession of syrinx, but symptoms persist. Second angiogram January 03 demonstrates AV fistula at S1-S2. Embolized. Slow regression of bladder, bowel symptoms but persistent lower extremity weakness, pain. During that period from January 03 through March 04, unable to lie down to sleep because of back pain. Constipation severe. Bladder control erratic. By May 04, with the aid of a body pillow, finally able to lie down to sleep. Still unable to walk > half a block. Must use wheelchair in order to practice in my office. Poor response to attempted physical therapy exercises,directed by extremely knowledgeable PT, increased pain, weakness. Still have all sensory symptoms, most annoying constant sensation rectal fullness. In spite of reassurance on many occasions by my physicians, I am extremely skeptical about every recovering my ability to walk. needless to say I am now very discriminating about referring for epidurals even under fluoroscopic guidance. No reservations about caudal epidurals, yet, although reservations about efficacy. More information available on request. Richard Bachrach, DO, FAOASM Competing interests: None declared |
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Guy S Wildy, General Practitioner Jersey JE2 3QQ
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Editor - Trials for epidural steroid injection for low back pain and sciatica are mostly from trials involving epdiurals given by the lumbar route. This makes the treatment only suitable for in patient hospital based administration. Many doctors in the field of primary care and musculoskletal medicine will access the epidural space via the sacral hiatus (caudal route). The advantages of this are simplicity of adminstartion, safety and minimal delay in offering treatment. Benefits from cost savings and bypassing the referral system to secondary care are self evident. In addition to the recommendations for future trials in assessing efficacy of epdiural injection I would recommend that they should compare the efficacy between administration via the lumbar and sacral route. If favourable then selected unresolved back pain and sciatica treatment could be devolved to inexpensively trained willing docotrs in primary care and musculoskeltetal medicine. 1. Samants A, Samanta J. BMJ Vol 328. 26 June 04 Competing interests: None declared |
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William M. Landau, Professor of Neurology Neurology Dept. Washington Univ. Med. School 600 S. Euclid Ave. St Louis, MO 63110, Dewey A. Nelson, MD
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Unfortunately the Samantas’ editorial about epidural steroid injection missed our recent review, Intraspinal steroids: history, efficacy, accidentality, and controversy with review of United States Food and Drug Administration reports (published in both the Journal of Neurology, Neurosurgery and Psychiatry1 and Neurosurgery Quarterly2). Having reviewed the 7 extant controlled trials of epidural spinal injection (ESI), including 468 subjects, we concluded, “Intraspinal steroid therapy is not effective therapy for back pain or radicular syndromes, because steroid formulations, placebos, and sham injections have similar outcomes.” More recently, Arden et al3 reported similar conclusions from a controlled study of 228 patients. They stated, “We used the highest dose and the most potent steroid possible, even powered it so that we could pick up a nonclinically significant effect. There is no quick fix or magic injection.” No cure. Whether short term improvement is due only to the placebo effect or possibly also to toxic effects from the usual ad hoc hypertonic injectate containing steroid, steroid preservative agents, local anesthetic, and often a radiological contrast agent, is unknown. We found no supportive evidence to confirm the theory that spinal pathological processes associated with herniated nucleus pulposus are inflammatory, as was proved to be the case in studies of rheumatic joints. No pathological rationale. In regard to the dangers of ESI, there are no certain epidemiological data. It is estimated that no more than 0.2% of adverse drug reactions are ever reported to the Federal Drug Administration (FDA). Serious complications among 17 backache and radiculopathy patients reported to the FDA between 1992 and 1996 included extensive adhesive arachnoiditis, pneumocephalus, accidental vertebral artery injection, fatal brain stem infarction, meningitis, and permanent paraplegia. It is likely that there are 400-600 unreported cases for every one whose description reaches the FDA. It has become widely accepted that intrathecal infusion of steroid medication is dangerous. Neurotoxic effects of hydrocortisone, preservative agents, myelographic contrast agents, and local anesthetics have been demonstrated. Manufacturers’ statements in the 1989 Physician’s Desk Reference include: “Depo-Medrol aqueous suspension is contra- indicated for intrathecal administration. This formulation of methylprednisolone acetate has been associated with severe medical events when administered by this route… Adverse reactions reported with the following routes of administration: intrathecal/epidural: arachnoiditis, meningitis, paraparesis/paraplegia, sensory disturbances, bowel/bladder disfunction, headache, seizures.” In 1991 the manufacturer of betamethasone sodium phosphate (CelestoneR) stated, “Under no circumstances do we recommend that Celestone Chronodose [Australian trademark)] be administered by epidural injection.” Accidental intrathecal injection as a complication of purposeful epidural administrationhas been reported in 5% - 6% percent of treated patients, and this percentage is likely higher in the hands of less experienced therapists. Whatever be the precise prevalence of serious complications from ESI, several of the RAPID RESPONSE email submissions speak of the tragic permanence of chronic pain and movement disability resulting from arachnoiditis, radiculopathy, and myelopathy. Obviously, there is no guarantee against such risks. We conclude that ethical considerations require that informed consent be obtained from patients to whom ESI is recommended. The incidence of therapeutic cure and the prevalence of catastrophic complication risk should be defined and accepted. Dewey A. Nelson, MD, FACP
1. Nelson DA, Landau WM. Intraspinal steroids: history, efficacy, accidentality and controversy with review of U.S. Food and Drug Administration (FDA) reports. J Neurol Neurosurg Psychiatry 2001;70:433- 443. 2. Nelson DA, Landau WM. Intraspinal steroids: history, efficacy, accidentality and controversy with review of U.S. Food and Drug Administration (FDA) reports. Reprinted from J Neurol Neurosurg Psychiatry 2001;70:433-443 to: Neurosurg Quart 2001;11:276-289. 3. Arden NK et al. Oct. 26, 2002 Annual ACR meeting. Program Abstract 530. Medscape Medical News 11/11/02. Competing interests: None declared |
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Keith Bush, Honorary Clinical Lecturer Imperial College 6 Harley Street, London W1G 9PD, Ellis Richard
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Dear Editor Samanta and Samanta are to be congratulated for their succinct review of Epidural Steroids in the Management of Low Back Pain. We would just like to expand on two issues which might be of particular interest to those considering further research. We agree that the heterogenicity of sample populations will reduce the chance of demonstrating efficacy. Patients who are likely to respond to epidural steroids, for anatomical reasons, are those whose pain is arising from structures adjacent to the epidural space: classically sciatica with nerve root compromise or low back pain due to dural irritation, as a consequence of discogenic pathology. Positive dural tension signs, in the form of a limited straight leg raise, increasing the usual leg or back pain respectively, in conjunction with correlating imaging, serve to distinguish these patients. This was one of five possible reasons for not demonstrating efficacy. A sixth is the high incidence of technical failure. White et al1 drew attention to the fact that up to 25% of caudal epidural injections could be extrasacral. More recent studies have demonstrated an overall 11.2% rate of inadvertent intravascular injection2. For those of us who use imaging control on a regular basis, it is commonplace to visualise inappropriate spread of contrast requiring further needle adjustment in order to reach the target. In the future, studies must be conducted utilising imaging control with the use of contrast. Dr Keith Bush Honorary Clinical Lecturer
Department of Musculo-Skeletal Surgery, Charing Cross Hospital, Imperial College Department of Rheumatology, University of Southampton References - 1 White AH, Derby R, Wynne G. Epidural injections for the diagnosis and treatment of low back pain. Spine 1980; 5: 78-86. 2 Michael B, Furman MD, Erin M. O’Brien, Timothy M. Zgleszewski. Incidence of intravascular penetration in transforaminal lumbosacral epidural steroid injections. Spine 2000; 25: 2628-32. Competing interests: None declared |
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Dennis J. Capolongo, Director EDNC, Washington, DC - USA
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We recently obtained documents about the efficacy and safety of steroid epidural injections using Depo-Medrol from Pfizer/Pharmacia and the United States Food and Drug Administration. This steroid is widely used "off-label" to treat chronic neck and back pain. But according to these documents, Depo-Medrol is "not FDA approved" for this use and "not recommended" by the manufacturer, yet it remains the preferred steroid by doctors! We believe that these documents can successfully challange the widespread practice of epidural steroid injections using this unapproved and non-recommended steroid suspension. Our research clearly indicates that patients who have complained and suffered as a result of their Depo- Medrol epidurals, were widely ignored by their physicians who suppressed the data from the manufacturer. The potential for this abuse appears to be global in scale and for the lack of a better term; it's downright criminal in our opinion. There are NO INJECTABLE STEROIDS that are FDA approved for spinal epidural use. Currently, the most common steroid is Depo-Medrol, manufactured by Pfizer/Pharmacia & Upjohn, (PP&U). As early as 1995, PP&U strongly stated, in an internal document, that they have received reports of SEVERE MEDICAL EVENTS associated with epidural injections of Depo-Medrol. Because of these reports, they posted a warning in the package insert declaring that the "epidural administration of Depo-Medrol is NOT RECOMMENDED"! But in 1997, PP&U quietly removed this statement from their Depo-Medrol package insert and buried it an internal document for limited distribution. No one yet knows exactly why this was done, but we feel they caved to industry pressure! PP&U withdrew the warning from the drug insert with FDA approval, but it soon reappeared in an internal company document. This document is titled: "Depo-Medrol - Reformulation / Epidural Use". This document ups the package insert WARNING from "adverse effects" to "SEVERE MEDICAL EVENTS"! It's a quantum leap in grammatical terms. The manufacturer also warns against mixing the steroid with any other chemical solution such as an anesthetic like Marcaine or Lidocaine.. These "bedside toxic brews" can be dangerously “incompatible”, thus increasing the risks of severe side effects, even when used as directed! When Depo-Medrol is injected epidurally, mixed or not with Marcaine or Lidocaine before it’s administered, this volatile mixture has been linked to many severe adverse effects such as, Adhesive Arachnoiditis, Severe Sensory Nerve Disturbance, CNS Disturbances, Severe Infectious and Noninfectious Nerve Root Inflammation, Toxic Meningitis and Paraplegia. So why hasn't this important information gotten out? Why is it that doctors ignore the manufacturer's WARNINGS and continue to misinform their patients of these posted drug-risk alerts? Keep in mind that it’s not the steroid component of Depo-Medrol that prompted Pharmacia's medical ALERT. It's the KNOWN NEUROTOXIC COMPOUNDS found within Depo-Medrol, such as Polyethylene Glycol, Benzyl Alcohol, and Myristyl Gamma Picolinium Chloride, (MGPC) etc., which causes the harm associated with so many worldwide complaints! Their internal documents claim that the preservative MGPC is “not even necessary in the single dose vials”, yet they have decided to keep it in the formulation as a suspension agent. This is highly suspicious because the drug already has a suspending agent, Polyethylene Glycol! It's clear that there must be another reason for keeping MGPC in the formulation if it's not necessary! PP&U left MGPC in their single dose vials because they know it's being used for epidural injections. This supports the theory that they must privately endorse Depo-Medrol for epidural administration since they are formulating it for this "non- recommended" application! They decided to keep MGPC in the steroid compound to act as a preservative against pathogen contamination when administered epidurally, and not merely as a suspension agent! If they're secretly formulating the steroid for epidural injections by keeping MGPC in their single dose vials, they will be held accountable. Otherwise, they could not substantiate why they left MGPC in the formulation if doctors were using Depo-Medrol only as indicated by the FDA! The mechanism by which Depo-Medrol and its neurotoxic components can go wrong has yet to be completely uncovered by a sluggish medical establishment. It’s highly suspicious that there’s very little research to substantiate the causes of so many worldwide complaints. But what is clear is that thousands of patients are needlessly suffering as a direct result of their Depo-Medrol epidurals whose complaints have generally fallen on deaf ears. *(Between 1998 and 2002, 350 deaths and over 15,500 adverse events were reported to the US-FDA) Doctors have conveniently diverted blame for these new complaints on the worsening state of their patient’s original condition. These cases have been globally documented by the manufacturer and are available for anyone's review! Nothing is currently being done to educate the public about the true dangers associated with this treatment. Astonishing! In fact, we discovered that many in the health care profession have either chosen to ignore the growing controversies and still fail to properly inform their patients of the true risks prior to the procedure, or have decided to quietly phase-out the practice altogether without explanation. Puzzling? The steroid is currently contraindicated for intrathecal use and strongly "not recommended" for epidural use by the manufacturer, YET THE LISTED DANGERS ARE IDENTICAL FOR BOTH ROUTES OF ADMINISTRATION! Why then hasn’t Depo-Medrol been contraindicated for epidural injections since it carries the same risks as intrathecal injections? Is it simply a matter of medical politics, or are the financial fortunes for both the manufacture and those who continue to perform Depo-Medrol epidurals at stake? To see these documents or for more information, please go to our website: http://groups.msn.com/DepoMedrolDidItHarmYou To read the latest trial reports on the efficacy of ESI’s: http://wwwaaos.org/wordhtml/anmt2004/sciprog/188.htm I can be contacted at: EndDepoNow@msn.com Kindest regards, Dennis James Capolongo / Director EDNC - The End-Depo-Now Campaign Washington, DC (c) 2004 - THE E N D - D E P O - N O W CAMPAIGN *FDA MedWatch Database - Freedom Of Information Act Competing interests: None declared |
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Judith Neaves, musculoskeletal physician and osteopath norfolk
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It would not be logical to trial a treatment for "abdominal pain", because it is not a diagnosis. The same applies to "low back pain", it is also not a diagnosis. In order to treat low back pain, those seeing patients need to improve their clinical diagnostic skills significantly, in order to make a diagnosis before embarking on a treatment plan. The training to acquire these skills is available, both for medical professional and non medical therapists. At present those who have these skills are few and far between in the NHS. Let the profession move forward in our diagnostic skills and thus be able to treat more patients more effectively. Competing interests: None declared |
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