A widely used method of treating back and leg pain, steroid injections for spinal stenosis — may provide little benefit for many patients, according to a new research that experts said should make doctors and patients think twice before the treatment.
But
the study, the largest randomized trial evaluating the treatment, found
that patients receiving a standard stenosis injection — which combine a
steroid and a local anesthetic — had no less pain and virtually no
greater function after six weeks than patients injected with anesthetic
alone. The research, involving 400 patients at 16 sites, was published Wednesday in The New England Journal of Medicine.
“Certainly there are more injections than actually should happen,” said Dr. Gunnar Andersson,
the chairman emeritus of orthopedic surgery at Rush University Medical
Center in Chicago, who was not involved in the research. “It’s sort of
become the thing you do.
You see this abnormality on the M.R.I. and the
patient complains, and immediately, you send the patient for an epidural
injection.”
Some
people can still benefit from injections, he said, but now physicians
“will be more cautious” and patients should ask, “Should I really do
this?’ ”
Mostly,
steroid injections are safe, carrying small risks of infection,
headaches and sleeplessness. But in April, the Food and Drug
Administration warned
that they may, in rare cases, cause blindness, stroke, paralysis or
death, noting that injections have not been F.D.A.-approved for back
pain and their effectiveness has “not been established.”
Often
caused by wear and tear, spinal stenosis occurs when spaces within the
spine narrow, putting pressure on nerves and causing pain or numbness in
the back and the legs. More than a third of people over 60 have some
narrowing, research suggests.
Steroid
injections, which reduce inflammation, are often tried when physical
therapy or anti-inflammatory medication fails, with the aim of avoiding
expensive surgery. Some insurance companies require injections before
approving surgery.
The
study provides evidence to tell some patients, “This probably isn’t
going to work very well for you,” said Dr. Ray Baker, a past president
of the North American Spine Society and the International Spine
Intervention Society, who was not involved in the study.
And because
some participants received two injections without greater benefit, “it
strongly speaks against the practice of performing multiple injections.”
Spinal
injections are considered effective for other conditions, like
herniated discs. But of the 2.2 million given annually to people on
Medicare, about a quarter are for spinal stenosis, said Dr. Janna
Friedly, a professor of rehabilitation medicine at the University of
Washington and the study’s lead author. She said injections cost $500 to
$2,000 each.
The study helps answer questions raised by the Spine Society and the Cochrane Collaboration,
a group of medical experts. Both issued reviews last year finding
insufficient evidence to recommend injections for some types of
stenosis.
“If
the benefit really isn’t there and you do the procedure more and more,
then all you’re doing is compounding the risk,” said Dr. Christopher
Standaert, a co-author of the study and a professor at the University of
Washington.
Dr.
Scott Kreiner, a co-chairman of the Spine Society’s evidence-based
guidelines committee, said the new research should “influence future
guidelines.”
A
rehabilitation medicine specialist in Phoenix who was not involved in
the study, Dr. Kreiner says he will give fewer second injections and may
refer some patients to surgery sooner. “This is probably a step toward
eliminating or minimizing the use of epidural steroid injections for
this problem,” he said.
Still, the research, funded by the federal Agency for Healthcare Research and Quality, leaves questions unanswered.
Because
every patient received injections, and both groups reported similar
improvement six weeks later, researchers cannot tell if patients would
do as well without any injections at all.
Also unclear is whether the
anesthetic, lidocaine, did anything helpful when injected alone. Some
experts said the benefits patients reported seemed larger than typical
placebo effects.
“To
me it’s unlikely that the lidocaine has a long-term effect,” Dr.
Friedly said, “but there are people who think that it could.”
The
study also did not represent all types of stenosis, involving patients
with central stenosis, not stenosis on one side, which Dr. Andersson
said was more localized and therefore possibly more treatable by
injection.
Stenosis, Dr. Standaert said, “can be caused by all sorts of things.”
While
some of his patients have done well with steroids, he said, “if the
pain isn’t primarily due to inflammation, then maybe it’s not going to
help.”
Still,
two patients recently tried lidocaine-only injections and “didn’t get
better,” he said. Some results suggest the issue is complex. Three weeks
after injection, patients receiving steroids reported slightly greater
function and less pain than the lidocaine-only group.
By six weeks, the
difference evaporated. When results were adjusted for how long patients
had had stenosis, the steroid group had only tiny advantages in
function.
The
steroid group had slightly less depression and more satisfaction with
treatment, possibly because of steroids’ mood-lifting effect, experts
said. But those patients had more negative effects, like headaches,
fever, infection and lower levels of the protective stress hormone
cortisol.
Afterward,
patients and their doctors were told which injection they received, and
then offered another injection, the same or different. William Johnson,
58, of Plano, Tex., a former Air Force and postal employee now
attending college, initially received the steroid.
He said his pain
“immediately went away,” he did not need another injection and, 18
months later, remained pain-free.
His
doctor, Dr. Thiru Annaswamy of the Dallas Veterans Medical Center, said
by email: “There are patients who clearly respond to steroid injection.
However, it is unclear why some do, and others don’t.” And Mr. Johnson
“may have responded to the lidocaine-only injection, too.”
Another
participant, Bonnie Merenstein, 73, a retired teacher in Denver,
received lidocaine-only injections and requested another. Years ago, she
said, steroid injections provided minimal improvement, and before the
study, “I really could not walk for more than eight minutes without my
legs going numb.”
Afterward,
numbness lessened, grocery shopping and museum-going became easier, and
she recently biked and canoed with her granddaughter.
“I believe that the lidocaine may have been as effective as a steroid,” she said.
Source: ww.nytimes.com
0 comments:
Post a Comment