Correspondence
the results of a controversial study not a disease and can result from prevention of dementia appears not to
should overrule the recommendations several different known or unknown be one of them.
from a comprehensive evidence-based abnormalities or diseases.1 When it is Jan Van Zundert and colleagues
guideline that was based on eight ran possible to define additional specific challenge our portrayal of epidural
domised controlled trials. nociceptive causes for low back pain injections and radiofrequency de
A more balanced recommendation with effective treatments then we will nervation. The authors dispute our
would have been appropriate, since be able to address this major health statement that epidural glucocorticoid
Kritchanut / iStockPhoto
withholding patients a potentially issue, as Germon and colleagues injection for herniated disc with
effective treatment, integrated into a suggest. There is insufficient evidence radiculopathy has only a small short-
multidisciplinary approach, cannot be to support the existence of any such term effect.5 However, the review
considered as good clinical practice. specific causes of low back pain beyond they cite in support of their argument
We declare no competing interests. those we mentioned in the Series— actually concluded: “the available
ie, malignancy, fracture, infection, evidence suggests that epidural
*Jan Van Zundert, Guy Hans,
Sander van Kuijk, Koen Van Boxem, or inflammatory disorders such as corticosteroid injections offer only
Kris Vissers ankylosing spondylitis.1 Nguyen and short-term relief of leg pain and
[email protected] colleagues draw attention to their work disability for patients with sciatica.
on intradiscal glucocorticoid injections The small size of the treatment effects,
Department of Anesthesiology, Critical Care and
Multidisciplinary Pain Center, Ziekenhuis Oost- to support their case for including however, raises questions about the
Limburg, 3620 Lanaken, Belgium (JVZ, KVB); discopathy as a specified nociceptive clinical utility of this procedure in the
Department of Anesthesiology and Pain Medicine pain source. In a highly selected patient target population”.6 The authors also
(JVZ), Department of Clinical Epidemiology and
Medical Technology Assessment (SvK), Maastricht group the authors found a reduction in question our summary of the place
University Medical Center, Maastricht, Netherlands; pain but not disability at 1 month and of radiofrequency denervation for
Multidisciplinary Pain Center, University Hospital no long-term benefits. We agree with chronic low back pain. Although the
Antwerp, Edegem, Belgium (GH); and Department
of Pain and Palliative Medicine, Radboud University their conclusions, that the efficacy of National Institute for Health and Care
Medical Center, Nijmegen, Netherlands (KV) glucocorticoid intradiscal injection as a Excellence7 recommended use of the
1 Foster NE, Anema JR, Cherkin D, et al. possible treatment for chronic low back treatment for patients with moderate
Prevention and treatment of low back pain: pain associated with active discopathy to severe chronic low back pain who
evidence, challenges, and promising
directions. Lancet 2018; 391: 2368–83. is questionable, given the lack of long- have had insufficient improvement
2 Bernstein IA, Malik Q, Carville S, Ward S. term benefit.2 We agree with Paraskevas despite comprehensive conservative
Low back pain and sciatica: summary of NICE on the importance of recognising management including a combined
guidance. BMJ 2017; 356: i6748.
3 Pinto RZ, Maher CG, Ferreira ML, et al. ruptured aortic aneurysm, and indeed physical and psychological programme,
Epidural corticosteroid injections in the other intra-abdominal emergencies they also listed radiofrequency
management of sciatica: a systematic review
and meta-analysis. Ann Intern Med 2012;
and malignancies, as causes of acute denervation as one of their five future
157: 865–877. low back pain. These conditions are, research recommendations because
4 Provenzano DA, Buvanendran A, however, uncommon causes of low of the absence of conclusive evidence
de Leon-Casasola OA, Narouze S, Cohen SP.
Interpreting the MINT randomized trials back pain, and poor explanations for for effectiveness. The results of a 2015
evaluating radiofrequency ablation for lumbar long-term low back pain and disability. Cochrane review 8 examining the
facet and sacroiliac joint pain: a call from ASRA
for better education, study design, and
Until recently, we might have agreed same research showed that there was
performance. Reg Anesth Pain Med 2018; with Damian M Bailey and colleagues no high-quality evidence to suggest
43: 68–71. that promotion of exercise might that radiofrequency reduced pain or
5 van Kuijk SMJ, Van Zundert J, Hans G, et al.
Flawed study design and incorrect presentation help reduce cognitive decline in older improved function in people with
of data negatively impact potentially useful people. However, there are now good chronic low back pain. The UK National
interventional treatments for patients with low
back pain: a critical review of JAMA’s Mint study.
quality prospective data to show that, Institute for Health Research Health
Pain Pract 2018; 18: 292–95. although physical activity declines in Technology Assessment Programme
the years preceding diagnosis, there is is seeking to commission a new trial in
Authors’ reply no neuroprotective effect of physical the UK comparing this procedure versus
Christelle Nguyen and colleagues, activity on cognitive function. 3 sham radiofrequency denervation. The
Tim Germon and colleagues, and Furthermore, a randomised controlled evidence from the Dutch Mint trials
Kosmas I Paraskevas argue that we trial of exercise for people with mild suggested that radiofrequency did not
did not pay sufficient attention to to moderate dementia found exercise provide greater benefit than an exercise
the specific nociceptive causes of training had a detrimental effect on programme.9 We acknowledge that
low back pain in our Lancet Series on cognitive function.4 Although there the Mint trials have been controversial.
low back pain. We were quite explicit might be many reasons to promote The same level of critical appraisal also
that low back pain is a symptom physical activity and exercise, the needs to be applied to previous studies
www.thelancet.com Vol 392 December 15, 2018 2549
Correspondence
that appear to support use of the Discrepancies in guidelines this guideline,1 reports a pooled relative
procedure. We therefore are of the firm, risk (RR) of 0·62 with a 95% CI of
and balanced, view that radiofrequency
for acute respiratory 0·23–1·26.4 This point estimate includes
denervation should be withheld from distress syndrome trials at both high and low risk of
patients unless within the context of bias, and does not include a recent
a high quality research trial that can In July, 2018, the Faculty of Intensive RCT of 197 patients.5 As part of the
reduce the uncertainty about value of Care Medicine (FICM) and the Intensive 2017 Society of Critical Care Medicine
the procedure. Care Society (ICS) released their (SCCM) and European Society of Critical
See Online for appendix Please see appendix for authors’ declaration of guidelines on the management of acute Care Medicine (ESICM) Corticosteroid
interests. respiratory distress syndrome.1 These Guideline Task Force, we updated the
*Nadine E Foster, Martin Underwood, guidelines used GRADE methodology evidence summary examining the
Chris G Maher, Jan Hartvigsen, to develop evidence based recom efficacy of corticosteroids in acute
Maurits van Tulder, Rachelle Buchbinder mendations for the management of respiratory distress syndrome. In
[email protected] acute respiratory distress syndrome in an updated systematic review and
Arthritis Research UK Primary Care Centre, Research adult patients in intensive care. Overall, meta-analysis,2 specifically designed
Institute for Primary Care and Health Sciences, Keele the guideline provides useful guidance to support this guideline effort, we
University, Staffordshire ST5 5BG, UK (NEF); Warwick to stakeholders. identified nine RCTs (as compared
Clinical Trials Unit, Warwick Medical School,
University of Warwick, Coventry, UK (MU); Sydney Our main concern with the guidelines1 with the five identified by the 2008
School of Public Health, University of Sydney, NSW, is that the evidence summaries systematic review). Five of these RCTs
Australia (CGM); Department of Sports Science and rely on previously completed sys were rated as having a low risk of
Clinical Biomechanics, University of Southern
Denmark, Odense, Denmark (JH); Department of tematic reviews and meta-analyses, bias, and subsequent meta-analysis of
Health Sciences, Faculty of Science, Vrije Universiteit rather than performing an updated these five studies showed a pooled RR
Amsterdam, Amsterdam, Netherlands (MvT); analysis specifically for this guideline estimate of 0·76 (95% CI 0·58–0·99)
and Cabrini-Monash Department of Clinical
Epidemiology, Cabrini Institute and Monash
effort. The result is that many of for hospital mortality when using
University, Malvern, VIC, Australia (RB) the recommendations are based on corticosteroids. This estimate includes
1 Hartvigsen J, Hancock MJ, Kongsted A, et al. evidence summaries that are outdated, only studies with low risk of bias and
What low back pain is and why we need to pay not entirely relevant, or do not include includes all recent trial data (up until
attention. Lancet 2018; 391: 2356–67.
2 Nguyen C, Boutron I, Baron G, et al. Intradiscal
the most recent trial data. This greatly the time of publication). The net effect,
glucocorticoid injection for patients with lowers the trustworthiness of the compared with the 2008 review, 2
chronic low back pain associated with active recommendations. For example, the is a decrease in imprecision (upper
discopathy: a randomized trial. Ann Intern Med
2017; 166: 547–56. evidence profile addressing corti end of the CI now excludes harm),
3 Sabia S, Dugravot A, Dartigues JF, et al. costeroids in acute respiratory distress and a decrease in concerns related
Physical activity, cognitive decline, and risk of
dementia: 28-year follow-up of Whitehall II
syndrome synthesises the results of to risk of bias producing moderate-
cohort study. BMJ 2017; 357: j2709. three meta-analyses published in 2008,2 quality evidence of benefit with
4 Lamb SE, Sheehan B, Atherton N, et al. 2009,3 and 2014.4 Two of these meta- corticosteroids.
Dementia and physical activity (DAPA) trial of
moderate to high intensity exercise training analyses2,4 incorporate randomised Armed with this higher-certainty
for people with dementia: randomised controlled trials (RCTs) from the evidence, and combined with our
controlled trial. BMJ 2018; 361: k1675.
1980s that investigated short-term updated review that showed an
5 Foster NE, Anema JR, Cherkin D, et al.
Prevention and treatment of low back pain: (24–48 h) and large-dose corticosteroids increase in mechanical ventilator-
evidence, challenges, and promising (up to 120 mg/kg methylprednisolone free days with corticosteroids
directions. Lancet 2018; 391: 2368–83.
6 Pinto RZ, Maher CG, Ferreira ML, et al. Epidural
equivalent), an intervention that is (mean difference 7·06 days fewer,
corticosteroid injections in the management of obsolete and discredited by the present 95% CI 3·19–10·93, high certainty
sciatica: a systematic review and meta-analysis. pathophysiological understanding of evidence), the 2017 SCCM and ESICM
Ann Intern Med 2012 157: 865–77.
7 National Institute for Health and Care acute respiratory distress syndrome. guideline panel made a conditional
Excellence. Non-specific low back pain and Using this evidence summary that recommendation for corticosteroids in
sciatica: management. NICE guideline: short
version. November 2016. https://www.nice.org.
was judged to be very low quality, the acute respiratory distress syndrome.6
uk/guidance/ng59 (accessed Sept 28, 2018). FICM–ICS guideline panel did not feel We suggest that the FICM and ICS
8 Maas ET, Ostelo RWJG, Niemisto L, et al. confident in making a recommendation consider updating their guideline
Radiofrequency denervation for chronic low back
pain. Cochrane Database Syst Rev 2015; for or against corticosteroids in acute development processes. Although there
10: CD008572. respiratory distress syndrome and are time and resource implications
9 Juch JNS, Maas ET, Ostelo RWJG, et al. Effect of instead made a research recom for societies contemplating updating
radiofrequency denervation on pain intensity
among patients with chronic low back pain: mendation. systematic reviews, the investment is
the Mint randomized clinical trials. JAMA 2017; Hospital mortality, extracted from necessary if the goal is to provide the
318: 68–81.
the 2008 meta-analysis and used in most up-to-date and comprehensive
2550 www.thelancet.com Vol 392 December 15, 2018
