Rafael Zambelli Pinto, MSc; Chris G. Maher, PhD; Manuela L. Ferreira, PhD; Mark Hancock, PhD; Vinicius C. Oliveira, MSc; Andrew J. McLachlan, PhD; Bart Koes, PhD; Paulo H. Ferreira, PhD
This article was published at www.annals.org on 13 November 2012.
Financial Support: Mr. Pinto is a PhD student supported by Capes Foundation, Ministry of Education of Brazil. Dr. Maher is supported by a research fellowship funded by the Australian Research Council.
Potential Conflicts of Interest: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M12-1381.
Requests for Single Reprints: Rafael Zambelli Pinto, MSc, PO Box M201, Missenden Road, Camperdown, Sydney, New South Wales 2050, Australia; e-mail, firstname.lastname@example.org.
Current Author Addresses: Drs. Pinto, Maher, and M.L. Ferreira: The George Institute for Global Health, PO Box M201, Missenden Road, Camperdown, Sydney, New South Wales 2050, Australia.
Dr. Hancock: Faculty of Human Sciences, Macquarie University, 75 Talavera Road, Macquarie Park, Sydney, New South Wales 2109, Australia.
Drs. P.H. Ferriera and Oliveira: Faculty of Health Sciences, University of Sydney, 75 East Street, Lidcombe, Sydney, New South Wales 2141, Australia.
Dr. McLachlan: Pharmacy Building (A15), Science Road, Faculty of Pharmacy, University of Sydney, Sydney, New South Wales 2006, Australia.
Dr. Koes: Department of General Practice, Erasmus Medical Centre, P.O. Box 2040, 3000 CA Rotterdam, the Netherlands.
Author Contributions: Conception and design: R.Z. Pinto, C.G. Maher, M.L. Ferreira, M. Hancock, V.C. Oliveira, B. Koes, P.H. Ferreira.
Analysis and interpretation of the data: R.Z. Pinto, C.G. Maher, M.L. Ferreira, V.C. Oliveira, A.J. McLachlan, B. Koes, P.H. Ferreira.
Drafting of the article: R.Z. Pinto, C.G. Maher, A.J. McLachlan.
Critical revision of the article for important intellectual content: R.Z. Pinto, C.G. Maher, M.L. Ferreira, M. Hancock, V.C. Oliveira, A.J. McLachlan, B. Koes, P.H. Ferreira.
Final approval of the article: R.Z. Pinto, C.G. Maher, M.L. Ferreira, M. Hancock, V.C. Oliveira, A.J. McLachlan, B. Koes, P.H. Ferreira.
Statistical expertise: R.Z. Pinto, C.G. Maher, M.L. Ferreira.
Administrative, technical, or logistic support: C.G. Maher, P.H. Ferreira.
Collection and assembly of data: R. Zambelli Pinto, C.G. Maher, M. Hancock, V.C. Oliveira.
Pinto R., Maher C., Ferreira M., Hancock M., Oliveira V., McLachlan A., Koes B., Ferreira P.; Epidural Corticosteroid Injections in the Management of Sciatica: A Systematic Review and Meta-analysis. Ann Intern Med. 2012;157:865-877. doi: 10.7326/0003-4819-157-12-201212180-00564
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Published: Ann Intern Med. 2012;157(12):865-877.
Existing guidelines and systematic reviews provide inconsistent recommendations on epidural corticosteroid injections for sciatica. Key limitations of existing reviews are the inclusion of trials with active controls of unknown efficacy and failure to provide an estimate of the size of the treatment effect.
To determine the efficacy of epidural corticosteroid injections for sciatica compared with placebo.
International Pharmaceutical Abstracts, PsycINFO, MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, and CINAHL.
Randomized, placebo-controlled trials assessing the efficacy of epidural corticosteroid injections in participants with sciatica.
Two independent reviewers extracted data and assessed risk of bias. Leg pain, back pain, and disability were converted to common scales from 0 (no pain or disability) to 100 (worst possible pain or disability). Thresholds for clinically important change in the range of 10 to 30 have been proposed for these outcomes. Effects were calculated for short-term (>2 weeks but ≤3 months) and long-term (≥12 months) follow-up.
Data were pooled with a random-effects model, and the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach was used in summary conclusions. Twenty-five published reports (23 trials) were included. The pooled results showed a significant, although small, effect of epidural corticosteroid injections compared with placebo for leg pain in the short term (mean difference, −6.2 [95% CI, −9.4 to −3.0]) and also for disability in the short term (mean difference, −3.1 [CI, −5.0 to −1.2]). The long-term pooled effects were smaller and not statistically significant. The overall quality of evidence according to the GRADE classification was rated as high.
The review included only English-language trials and could not incorporate dichotomous outcome measures into the analysis.
The available evidence suggests that epidural corticosteroid injections offer only short-term relief of leg pain and disability for patients with sciatica. The small size of the treatment effects, however, raises questions about the clinical utility of this procedure in the target population.
Herbert I, Rothenberg, M.D.
University of Colorado Medical School, Denver, CO
December 20, 2012
More Research Needed
To the Editor:
In the 18 December 2012 issue of the Annals, Pinto et al. conclude that epidural steroid injections offer only slight and only short term relief for patients with sciatica, and they question the utility of this procedure. This is an unsurprising conclusion in view of the fact that they review 24 studies and a total of 83 published articles all of which support the validity of their conclusion. This for a procedure which they state is performed between 740,845 and 1,457,962 times annually at great cost and some risk (see the current epidemic of iatrogenic fungal meningitis—infrequent but catastrophic). The authors laudably suggest the need for more research on sciatica itself.Isn't it time for some reputable individual, agency, or organization, like the ACP, committed to the principle of evidence-based medical practice to make a clear statement as to the uselessness of this procedure in which minor and temporary gains are far outweighed by the hazard and cost?
Herbert I. Rothenberg, MD
Laxmaiah Manchikanti, MD, Frank JE Falco, MD, and Joshua A. Hirsch, MD
Clinical Professor of Anesthesiology and Perioperative Medicine, University of Louisville, KY, Medical Director, Pain Management Center of Paducah, Paducah,KY: Medical Director, Midatlantic Spine, Dir
March 29, 2013
Epidural Corticosteroid Injections in the Management of Sciatica
Re: Epidural Corticosteroid Injections in the Management of Sciatica Epidural corticosteroid injections in the management of sciatica by Pinto et al (Ann Intern Med 2012;157:865-877) represents significant progress in systematic review and metaanalysis of epidural injections. The major improvement over the previous reviews is the evaluation of 3 separate approaches, namely, caudal, interlaminar, and transforaminal. Despite this important methodological improvement, multiple deficiencies are present in this manuscript as well. Importantly, authors have considered placebo interventions as administration of an inert or innocuous substance either into the epidural space or adjacent spinal tissue. Consequently, they missed the major issue in relation to the placebo that administration of an inert or innocuous substance into an active structure leads to clinical activity along with clinical effectiveness – a different response from the placebo (1). Moreover, the authors have not considered nocebo experiences in this manuscript.
Another major issue is that authors have considered local anesthetic injections, what they defined as short duration of action as placebo utilized in active treatment and control groups. It has been repeatedly demonstrated that local anesthetics either in the form of a short acting agent such as lidocaine (2,3), or long acting agent (4,5) such as bupivacaine provide clinically meaningful effects in multiple randomized trials. Mechanism of action of long-term improvement with local anesthetics has been well described in multiple manuscripts (1-5). In addition, while authors have meticulously separated caudal, interlaminar, and transforaminal, they have not separated procedures performed under fluoroscopy and others without fluoroscopy.
Finally, long-term effectiveness may not be assessed unless procedures are repeated after dissipation of their activity. Failing to do so, would be equivalent to assessing insulin to control blood sugar levels after one year, or for that matter even after 2 days. Based on the above, the manuscript necessarily results in inappropriate conclusions comparing the effect size between 2 groups rather than baseline to after treatment effect. Consequently, the results will be different showing significant effect size on a short-term as well as long-term basis, if contemporary interventional pain management practices and duration of effectiveness taken into consideration. If authors considered only fluoroscopically performed studies utilizing proper placebo design.
Laxmaiah Manchikanti, MD
Clinical Professor of Anesthesiology and Perioperative Medicine,
University of Louisville, Kentucky,
Medical Director, Pain Management Center of PaducahPaducah, Kentuckydrlm@thepainmd.com
Frank Falco, MD
Medical Director, Midatlantic SpineDirector, Pain Medicine Fellowship Program,
Temple University Hospita lAssociate Professor,
Temple University Medical School Philadelphia, PA email@example.com
Joshua A. Hirsch, MD
Chief of Minimally Invasive Spine SurgeryVice Chief:
Interventional CareMassachusetts General Hospital
Associate Professor of Radiology,
Harvard Medical School Boston, MA, HIrsch@snisonline.org
1. Manchikanti L, Benyamin RM, Falco FJE, Caraway DL, Datta S, Hirsch JA. Guidelines warfare over interventional techniques: Is there a lack of discourse or straw man? Pain Physician 2012;15:E1-26
.2. Manchikanti L, Cash KA, McManus CD, Pampati V. Fluoroscopic caudal epidural injections in managing chronic axial low back pain without disc herniation, radiculitis or facet joint pain. J Pain Res 2012;5:381-90.
3. Manchikanti L, Singh V, Cash KA, Pampati V, Damron KS, Boswell MV. Effect of fluoroscopically guided caudal epidural steroid or local anesthetic injections in the treatment of lumbar disc herniation and radiculitis: A randomized, controlled, double blind trial with a two-year follow-up. Pain Physician 2012;15:273-86.
4. Manchikanti L, Singh V, Falco FJE, Cash KA, Pampati V. Evaluation of lumbar facet joint nerve blocks in managing chronic low back pain: A randomized, double-blind, controlled trial with a 2-year follow-up. Int J Med Sci 2010;7:124-35.5. Manchikanti L, Singh V, Falco FJE, Cash KA, Pampati V, Fellows B. The role of thoracic medial branch blocks in managing chronic mid and upper back pain: A randomized, double-blind, active-control trial with a 2-year follow-up. Anesthesiol Res Pract 2012;2012:585806.
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