Oral Steroids Provide Little Pain Relief Over Placebo in Acute Radiculopathy Due to Disc Herniation
Despite the widespread use of oral corticosteroids for acute radiculopathy resulting from a herniated lumbar disc, this treatment did not significantly improve pain levels compared with placebo in a randomized controlled trial published in the May 19 issue of JAMA. Oral steroids were linked to a modest improvement in function in this study.
“For many years, physicians have given their patients these short courses of steroids under the assumption that they are highly effective for many or most patients,” said lead author of the study Harley Goldberg, DO, Director of Spine Care Services, Kaiser Permanente San Jose, CA. “We now know that may not be true and that most patients given oral steroids will do just as well with a placebo,” Dr. Goldberg said.
“Each patient with acute radiculopathy (sciatica) will need to weigh the benefits and risks of taking a short course of oral steroids with their physician,” Dr. Goldberg said. “The value of this research lies in being able to provide patients and physicians with hard evidence so that they can have a meaningful and informed discussion about balancing the relative benefits and risks associated with using a short course of oral steroids for acute radiculopathy in the context of other treatment options,” said Dr. Goldberg, who is also Co-Chair of Spine Surgery Program, Northern California Kaiser Permanente Medical Care Program, Oakland, CA.
Study Enrolled Patients With Radiculopathy for 3 Months or Less
The study enrolled 269 adults (age 18 to 70 years) who presented with a ≤3 month history of radiculopathy, score of ≥30 on the Oswestry Disability Index (ranges from 0-100 with higher scores indicating greater dysfunction), and a herniated disc confirmed on magnetic resonance imaging. The patients were recruited from primary care practices of Kaiser Permanente Northern California facilities. The patients had not received oral or epidural steroid treatments in the previous 3 months, previous lumbar surgery, substantial or progressive motor loss, or an ongoing litigation or workers compensation claim.
Study participants were given either a tapering 15-day course of oral prednisone (n=181) or a placebo (n=88). Prednisone was given as 5 days each of 60 mg, 40 mg, and 20 mg for a total cumulative dose of 600 mg.
Improvement in Functioning but Not Pain Found in Prednisone Group
A small, statistically significant improvement in function (change in baseline ODI) at both 3 weeks and 52 weeks favored the prednisone-treated group (Table). In contrast, no statistically significant difference in lower extremity pain scores was found at any time point (Table). Several secondary outcomes showed small but inconsistent improvements in the active treatment group relative to the placebo group.
Dr. Goldberg said he was surprised that oral prednisone did not significant improve pain levels over placebo. “It was my clinical impression that steroids were helpful in these patients, which is why we conducted the trial,” he said. “This demonstrates the value of well-conducted trials. Patients were getting better, just no different from those that received placebo,” Dr. Goldberg said.
Future Research Planned on Non-interventional Treatments for Radiculopathy
“There is more to discover from our data set, and we’ll starting that work now,” Dr. Goldberg explained. “We may find interesting indications that prioritize other research into what non-interventional treatments help which patients,” he said.
“The value of well designed trial is the production of a sound base to take the next step forward,” Dr. Goldberg added. “This isn’t the end of the discussion, but it provides meaningful evidence that is folded into what we already know about treatment effects in this population,” he concluded.
Commentary From NASS Expert
“This study is well done, using appropriate blinding, validated outcome measures, and a large enough group of patients to show a difference in the outcome measure,” commented Scott Kreiner, MD, who was Chair of the Committee that oversaw development of the North American Spine Society’s (NASS) guideline on lumbar disc herniation with radiculopathy. “This randomized controlled study shows that oral steroids tend to provide some relief over placebo in the treatment of lumbar radiculitis related to disc herniation at 3 weeks. When assessing the ODI, while the difference P value is statistically significant, the 95% confidence intervals between the 2 groups overlap raising a concern that a true significant difference in the groups does not exist,” Dr. Kreiner said.
“Regardless of this shortcoming, there is clearly a trend toward faster relief in the steroid group as compared with the placebo group. This outcome is expected and what most practitioners see their practice,” said Dr. Kreiner, who is also is a physiatrist at Ahwatukee Sports & Spine, Phoenix, AZ.
“The use of oral steroids for the treatment of pain related to lumbar disc herniation is common, even though it is off-label,” Dr. Kreiner said. “This practice is typical and appropriate for practitioners seeing the patient early in the course of treatment. I believe that this study justifies the use of steroids early in the treatment of patients with lumbar radiculitis, and physicians who are providing early care to this group of patients should consider this as an initial form of treatment,” he added.
“This study does not compare the effectiveness of oral steroids to transforaminal epidural steroid injections, which are also known to be effective in the treatment of this problem.” Dr. Kreiner added. “Spine specialists may choose to inject the medication as it will place the medication at the site of pathology as opposed to relying on the response to an oral medication,” he said.