麻豆传媒

A short course of oral steroids moderately improved function in patients with herniated lumbar disc, but did not improve pain, according to a randomized,controlled trial.

After 3 weeks of treatment with prednisone, patients experienced an adjusted mean 6.4 point improvement in Oswestry Disability Index (ODI) scores (95% CI 1.9-10.6, P=0.006) with marginal improvements in Short Form 36 Health Survey Physical Component Scores (SF-36 PCS) compared with placebo (mean 3.3, 95% CI 1.3-5.2, P=0.001), reported , of Kaiser Permanente Northern California in San Jose, and colleagues.

But no improvement was seen in the SF-36 Mental Component Scores at 3 weeks (mean 2.2, 95% CI -0.4 to 4.8, P=0.10), they wrote in the.

The group also reported that patients in the prednisone group more commonly had one or more adverse events at 3-week follow-up versus the placebo group (49.2% versus 23.9%, P<0.001).

"Oral steroids are used by many community physicians ... however, no appropriately powered clinical trials of oral steroids for radiculopathy have been conducted to date," the authors explained.

of Oregon Health and Science University in Portland, agreed, adding that "oral prednisone is widely used for treating sciatica, but with only weak evidence to date. This study gives us the best evidence so far about its real effects, and like so many treatments for back conditions, the effects are modest."

, of the University of Alberta, said that "I'd put this one in the middle on the 'important study' versus 'nothing new' scale. It's a well done [randomized, controlled trial] and it reported on outcomes that matter. The effect was positive but modest, as the authors point out, and there were some side effects issues, though not severe."

Goldberg and colleagues enrolled adults with radicular pain lasting 3 months or less, an ODI score of 30 or higher, and a herniated disc confirmed by MRI. They were randomly assigned to a tapering 15-day course of oral prednisone or placebo from 2008 to 2013. The dosing course was 5 days each of 60 mg, 40 mg, and 20 mg, for a total cumulative dose of 600 mg.

The primary outcome was ODI change at 3 weeks. Secondary outcomes included ODI change at 1 year and change in lower extremity pain.

The observed baseline and 3-week mean ODI scores were were 51.2 and 51.1 for the prednisone group and 32.2 and 37.5 for the placebo group.

At 52 weeks, those in the study arm had a mean 7.4-point improvement in ODI scores (95% CI 2.2-12.5, P=0.005) compared with the placebo group.

In terms of pain, the prednisone group had a mean 0.6-point (95% CI -0.2 to 1.3, P=0.15) greater reduction at 52 weeks versus placebo.

The authors found no statistically significant difference between groups in changes in patients' below-waist pain rating either at 3 weeks or 52 weeks.

Over the 1-year follow-up period, there was no significant between-group difference in the likelihood of undergoing spine surgery (9.9% versus 9.1%, RR 1.2, 95% CI 0.5-2.6, P=0.68), the group reported.

Mild adverse events included insomnia, nervousness, and increased appetite, all of which are common with prednisone therapy, the authors said. At 1 year, there were no significant differences in the proportion of participants in each group reporting at least one adverse event (80.1% versus 71.6%, P=0.12).

While there were five serious adverse events overall with three occurring in the study arm -- appendectomy, suicide attempt, and deep venous thrombosis -- none were deemed related to prednisone, Goldberg's group stated.

Study limitations included a potentially inadequate prednisone dosing schedule and partially successful blinding because of common adverse events with the oral steroid. Also, the results may be limited to patients with a positive MRI finding and a baseline ODI score of 30 points or higher.

Green agreed that the latter criteria limits the applicability of the results. "The results in routine practice will almost certainly be somewhat less," he said. "They carefully chose people with the type of back pain most likely to respond, people with clear-cut, pure disc disease, symptoms and anatomical findings matching, not chronic, and no secondary gain issues. The reality of back pain in primary care is much messier. In real-world practice, this treatment will get used for patients who are, and who really aren't good candidates. So the results will be rather mixed."

of the University of Nevada School of Medicine in Reno commented that using oral steroids for lumbar disc pain is "an example of a widely accepted practice that has indeed not been studied well on a controlled basis, and turns out to be modest at best."

"What this study says is that the results probably barely rise to the level of clinical importance," he said but added that the distinction between pain and motor improvement was interesting.

"The other issue is that sciatic pain is not always caused by a herniated disc so the patient population is somewhat heterogeneous," in terms of whether oral steroids will work. "Piriformis syndrome, for example, which is common, would not be expected to respond," he said.

Deyo said that he'd like to see a head-to-head comparison between oral prednisone and injected steroids in this patient population. Goldberg's group pointed out that, despite conflicting evidence, epidural steroid injections are offered to patients "under the assumption that radicular symptoms are caused by inflammation of the affected lumbar nerve root."

"Another question that the trial raises is whether oral prednisone is any more effective than nonsteroidal anti-inflammatory drugs like ibuprofen or naproxen," Deyo stated.

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