By Gene Emery
NEW YORK (Reuters) - Steroid injections widely used to treat back pain offer little or no real benefit, according to a new study of 400 patients.
Those who received the drug mixed with the painkiller lidocaine scored no better on measures of disability and leg pain after six weeks than patients in a control group who received lidocaine injection alone.
"These (injections) are so commonly used and the steroids do pose an added risk to patients without much benefit," the study’s lead author Dr. Janna Friedly of the University of Washington in Seattle told Reuters Health. "I do hope patients and their doctors will be more cautious about using them” for spinal stenosis, she said.
Lumbar spinal stenosis is a narrowing of the passageway surrounding spinal nerves in the lower back. The resulting nerve compression is painful and the number one reason older adults have spinal surgery. The combination of glucocorticoid steroids and an anesthetic is supposed to reduce nerve inflammation and swelling in the surrounding tissue.
Roughly 550,000 procedures - at a cost ranging from $500 to $2,000 per injection - are done each year just among Medicare recipients.
"Certainly, this study raises serious questions about the benefits of epidural glucocorticoid injections for spinal stenosis," Dr. Gunnar Andersson of Rush University Medical Center in Chicago writes in an accompanying editorial in the New England Journal of Medicine.
“It's looking like it may be a little harder to justify doing those injections for spinal stenosis in patients. But it doesn't show it's not effective at all," said Dr. D. Scott Kreiner, co-chairman of the guidelines committee of the North American Spine Society, who was not involved in the research.
He told Reuters Health that the treatment "is moderately effective, not curative, and that may or may not be enough for some patients to avoid surgery."
Because evidence for the effectiveness of the injections is lacking, the study team involved doctors at 16 sites in the U.S., who gave half the patients injections of lidocaine followed by one of four glucocorticoid drugs: triamcinolone, betamethasone, dexamethasone or methylprednisolone.
The remaining patients got lidocaine alone, and all patients had the option of a second round of treatment.
Before the injections, three weeks later and again at the six-week point, patients scored their pain level on a 25-point scale, with 25 being the worst pain.
At the three-week mark, average pain scores among patients in the lidocaine group had dropped from 15.7 down to 13.1, and down to 12.5 after six weeks. People in the lidocaine-glucocorticoid group started out with a bit more pain - their average score was 16.1 - and they showed most of their improvement at the three-week mark, scoring 11.7 at that point and 11.8 at the six-week mark.
The difference between the groups was not statistically significant, meaning it could have been due to chance. A similar pattern was seen for leg pain, where there was a slight difference at three weeks, but that disappeared by week 6.
On a satisfaction survey, 67 percent of patients who received steroids plus lidocaine reported being very or somewhat satisfied with their treatment, as compared with 54 percent of those who received lidocaine alone, the researchers note in their report. The steroid recipients showed more improvement on a scale that measured depression, as well.
But they also reported more adverse events per person than the control group. The most pronounced difference in side effects was in the category of fever, infection or both. The problem was seen in two patients in the lidocaine-only group but 10 patients who got lidocaine plus a steroid.
"It certainly is a nudge for not using epidural injections for spinal stenosis," Kreiner told Reuters Health.
In the editorial, Andersson said if patients decide to have injections anyway, a second one should be avoided if there is no effect from the first.
Because many insurance companies require the injections before surgery is approved, the new finding, combined with the U.S. Food and Drug Administration's warning that they can cause paralysis, nerve damage or death, "suggest that this requirement should be reconsidered," he said.
Friedly predicted that the findings will meet with some resistance among doctors because "these are injections that are commonly performed and people believe that they work," which is why the results were surprising.
"There are not a lot of effective treatments for pain and symptoms associated with spinal stenosis," she said. "We still have a lot of unanswered questions about what alternative treatments are effective."
SOURCE: http://bit.ly/1jVLSz9 New England Journal of Medicine, July 3, 2014.