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Randomised controlled trial
Oral steroids for improved function but not pain in acute radiculopathy due to disc herniation
  1. Steven P Cohen
  1. Johns Hopkins Medical Institutions & Walter Reed National Military Medical Center, Baltimore, Maryland, USA
  1. Correspondence to : Dr Steven P Cohen, Johns Hopkins Medical Institutions, 550 North Broadway, Suite 301, Baltimore, MD 21205, USA; scohen40{at}jhmi.edu

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Context

The toll low back pain (LBP) exerts on society is enormous. Approximately 40% of cases of chronic LBP are primarily neuropathic in nature,1 which may make them responsive to corticosteroids. A randomised trial performed in 208 patients with acute radiculopathy found that 30% of those who received piroxicam or placebo continued to experience symptoms at 3 months, with few people reporting resolution afterwards.2 These results are consistent with other studies suggesting that radicular pain that persists for longer than 3 months after injury is likely to become chronic. For systemic steroids, most but not all studies have failed to demonstrate significant benefit.3

Methods

The authors performed a randomised, double-blind, placebo-controlled trial comparing oral prednisone (5 days each of 60 mg, then 40, then 20 mg/day) to placebo in 269 patients with acute (<3 months) lumbosacral radiculopathy. Participants were allocated to receive either steroids or placebo in a 2:1 ratio. Inclusion criteria included MRI confirmation of a herniated lumbar disc, and a score >30 on the Oswestry Disability Index (ODI), indicating moderate disability. Those with symptoms >3 months, previous low back surgery, prior epidural or oral steroid treatment, diabetes, secondary gain and significant motor deficits were excluded. The primary outcome measure was ODI score 3 weeks after treatment; secondary outcome measures included 0–10 numerical rating scale pain scores for average and worst pain above (back) and below (leg) the waist, Short Form-36 (SF-36) and satisfaction. Follow-up visits were performed in person or by phone through 1 year.

Findings

For the primary outcome measure, ODI scores declined from baseline in both groups, with the mean reduction being greater in the steroid group (mean 51.2–32.2 in the steroid vs 51.1–37.5 in the control group at 3 weeks; adjusted mean 6.4 point difference; p=0.006). One year posttreatment, the mean between-group difference continued to favour the treatment group (adjusted mean difference 7.4 points, 95% CI 2.2 to 12.5; p=0.005). For pain scores, no significant differences were observed at any time point, although those treated with steroids had non-significantly lower ‘below waist’ (ie, radicular) pain scores (adjusted difference between groups −0.6 for average; p=0.15 and −0.7 for worst; p=0.09) at 1 year. Statistically significant benefits were also observed for the physical and mental components of the SF-36.

Commentary

The findings suggest that oral steroids may provide long-term improvement in function in individuals with acute radiculopathy due to herniated disc. The results are in contrast to a meta-analysis and systematic review that included seven studies and 383 patients, which found no evidence that systemic steroids reduce pain, improve function or decrease the need for surgery or analgesic consumption. Whereas, the current study limited the selection to those with symptoms <3 months in duration, five of the studies in the meta-analysis included only patients with <8 weeks of symptoms. However, none extended treatment longer than 1 week and all were underpowered.

The findings by Goldberg and colleagues also diverge from what we know about epidural steroid injections (ESI), which directly deposit high concentrations of steroids over the affected nerve root(s). Unlike oral steroids, ESI have mostly been studied in subacute or chronic radiculopathy. Although they clearly provide short-term improvement in symptoms, unless they are repeated the beneficial effects tend to recede after 6 weeks.1

The use of ODI as the primary outcome measure is surprising, as ODI measures function at a cross-section in time, rather than over a period of time (as SF-36 and pain scores can) and therefore may be more affected by transient changes in status. However, the effects observed in the study were also noted in SF-36 and global patient assessment. Similar to the meta-analysis, more side effects were noted in the steroid group, which may have contributed to inadequate blinding.

Implications for practice

Although the results demonstrate that a 15-day course of oral steroids may improve intermediate-term outcomes in individuals with acute radiculopathy due to herniated disc, they must be viewed cautiously, given their divergence with other studies examining steroids given systemically or by injection. Nevertheless, in individuals with acute symptoms at high risk for developing chronic pain (eg, those with coexisting psychosocial issues) and at low risk for side effects, a course of oral steroids seems like a reasonable treatment option.

References

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Footnotes

  • Competing interests SPC served as a consultant for Semnur Pharmaceuticals, which is trying to develop an FDA-approved steroid for epidural injection.

  • Provenance and peer review Commissioned; internally peer reviewed.