FROM JAMA
A 15-day course of oral steroids modestly improved function but not pain in patients with acute radiculopathy due to a herniated lumbar disk, according to a report published online May 19 in JAMA.
Compared with epidural steroid injections, oral steroids provide similar anti-inflammatory activity but avoid MRI, can be delivered quickly by primary care physicians, avert the risks of spinal injection, and are much cheaper. “Oral steroids are used by many community physicians, have been included in some clinical guidelines, and are noted as a treatment option by some authors,” yet no adequately powered clinical trials of the therapy have been performed until now, said Dr. Harley Goldberg of the department of physical medicine at the Kaiser Permanente Northern California Spine Care Program, San Jose, and his associates.
Their study involved 269 adults at three primary care practices who had leg pain extending below the knee in a nerve root distribution, confirmation of a herniated disk on MRI, and scores of 30 or higher on the 100-point Oswestry Disability Index (ODI). These participants were randomly assigned to receive either daily prednisone capsules (cumulative dose, 600 mg) or matching placebo in addition to usual care and were followed for 1 year.
The primary outcome measure was self-reported score on the ODI at 3 weeks. After adjustment for potential confounders, the mean score was 6.4 points higher with prednisone than with placebo, a significant but modest difference. This benefit persisted at 1-year follow-up, with a mean difference of 7.4 points between the two study groups. In addition, the active-treatment group was significantly more likely to achieve at least a 30-point or 50% improvement in ODI score at 3 weeks (RR, 1.7) and at 1 year (RR, 1.3), and showed significantly greater improvement in the physical component summary score on the Short Form 36 at 3 weeks and on the mental component summary score at 1 year, the investigators said ( JAMA 2015;313:1915-23 ).
There were no differences between the active treatment and the placebo groups in measures of below-the-waist pain at either 3 weeks or 1 year, however, and no differences in the proportion of patients achieving 2- to 5-point improvements in pain scores on a 10-point numerical rating scale at either follow-up assessment. Most importantly, there was no significant between-group difference in the likelihood of undergoing spine surgery during the year following treatment; rates of spine surgery were 9.9% among patients who received prednisone and 9.1% among those who received placebo.
Patients who received active treatment were significantly more likely to report adverse effects (49.2%) than those who received placebo (23.9%), but these were minor and transient. No serious treatment-related adverse events occurred.
“Whether the observed improvement in function (without concomitant improvement in pain) merits use of oral steroids for patients with an acute radiculopathy is a difficult decision and, ultimately, becomes a personal one that must be weighed by individual patients and their physicians,” Dr. Goldberg and his associates said.
This study was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Goldberg reported having no financial disclosures; one of his associates reported ties to the Orthopaedic Research and Education Foundation, AOSpine, Simpirica, and Intrinsic Orthopedics.
