People with ruptured
disks in their lower backs usually recover whether or not they have
surgery, researchers are reporting Wednesday. The study, a large
trial, found that surgery appeared to relieve pain more quickly but
that most people recovered eventually and that there was no harm in
waiting.
And that, surgeons
said, is likely to change medical practice.
The study, published
in The Journal of the American Medical Association, is the only
large and well-designed trial to compare surgery for sciatica with
waiting.
The study was
controversial from the start, with many surgeons saying they knew
that the operation worked and that it would be unethical for their
patients to participate in such a study.
In the end, though,
neither waiting nor surgery was a clear winner, and most patients
could safely decide what to do based on personal preference and
level of pain. Although many patients did not stay with their
assigned treatment, most fared well with whatever treatment they
had.
Patients who had
surgery often reported immediate relief. But by three to six months,
patients in both groups reported marked improvement.
After two years,
about 70 percent of the patients in the two groups said they had a
"major improvement" in their symptoms. No one who waited had serious
consequences, and no one who had surgery had a disastrous result.
Many surgeons had
long feared that waiting would cause severe harm, but those fears
were proved unfounded.
"I think this will
have an impact," said Dr. Steven R. Garfin, chairman of the
department of orthopedic surgery at the University of California,
San Diego. "It says you don't have to rush in for surgery. Time is
usually your ally, not your enemy," Garfin added.
As many as a million
Americans suffer from sciatica, said Dr. James Weinstein, a
professor of orthopedic surgery at Dartmouth who led the study. The
condition is characterized by an often agonizing pain in the
buttocks or leg or weakness in a leg.
It is caused when a
ruptured disk impinges on the root of the sciatic nerve, which runs
down the back of the leg. And an estimated 300,000 Americans a year
have surgery to relieve the symptoms, Weinstein said.
Patients are often
told that if they delay surgery they may risk permanent nerve
damage, perhaps a weakened leg or even losing bowel or bladder
control. But nothing like that occurred in the two-year study
comparing surgery with waiting in nearly 2,000 patients.
The study did not
include people who had just lower back pain, which can have a
variety of causes. Nor did it include people with conditions that
would require immediate surgery like losing bowel or bladder
control.
Instead, they were
typical of a vast majority of people with sciatica who are made
miserable by searing pain. For such patients, fear that delaying an
operation could be dangerous "was the 800-pound gorilla in the
room," said Dr. Eugene J. Carragee, professor of orthopedic surgery
at Stanford.
Carragee said that he
had never believed it himself, but that the concern was widespread
among patients and doctors.
"The worry was not
knowing," he added. "If someone had a big herniated disk, can you
just say, 'Well, if it's not bothering you that much, you can wait?'
It's kind of like walking on eggshells. What if something terrible
did happen?"
With the new results,
it is clear that the risk of waiting "is, if not extraordinarily
small, at least off the radar screen," Carragee said.
The study involved 13
spine clinics in 11 states. All the participants had pain from
herniated disks and leg pain. The patients were asked whether they
would allow the researchers to decide their treatment at random.
Those who did not have surgery generally received physical therapy,
counseling and anti-inflammatory drugs.
In the end, the study
could not provide definitive results on the best course of treatment
because so many patients chose not to have the treatment that they
had been randomly assigned.
About 40 percent of
those assigned to surgery decided not to have it, often because
their conditions improved while they awaited the operations. A third
of patients assigned to wait decided to have operations, often
because their pain was so bad that they could not endure it any
longer.
Others asked not to
be assigned at random and were followed to see what treatment they
chose and how they fared.
The
researchers are also conducting a separate analysis on the cost
effectiveness of surgery compared with waiting. Although that
analysis has not been published, Dr. Anna N. A. Tosteson of
Dartmouth, an author of the study, said that Medicare paid a total
of $5,425 for the operation and that private insurers might pay
three to four times that.
Although the results
answered one question, about the safety of waiting, they were also,
in a sense, disappointing, said Dr. David R. Flum, a contributing
editor at The Journal of the American Medical Association and an
associate professor of surgery at the University of Washington.
"Everyone was hoping
the study would show which was better," Flum said.
"And everyone was
surprised by the tremendous number of crossovers in both
directions," he added, referring to the large number of participants
who changed from surgery to waiting and vice versa.
That muddied the
data.
Sciatica tends to run
in families and occurs when the soft gel-like material inside a
spinal disk protrudes through the outer lining of the disk like a
bubble on a bicycle tire. That compresses and inflames a nerve root
that forms the sciatic nerve.
The resulting pain
can feel like a burning fork in the buttocks, Weinstein said. Or it
can be a searing pain down the back of a leg. The pain can be so
intense that some people cannot walk. Some cannot sit. Some,
Weinstein said, "can barely crawl."
The operation is
quick and generally effective, Garfin said. It involves gently
pushing the compressed nerve root away from the herniated disk. Then
the surgeon makes an incision in the disk and deflates it. The nerve
returns to its normal position, the inflammation goes away, and the
pain often disappears.
The Journal of the
American Medical Association published two papers on the study, one
reporting on the randomized trial and the other on the patients who
chose not to be randomized. It also published editorials by Carragee
and Flum.
The reason for all
the attention, Flum explained, was that the study was large and well
designed, that its authors had no conflicts of interest, and, "We
can learn a lot."
The message, in the
end, Weinstein said, was that no matter which treatment a patient
received, "nobody got worse."
He added, "We never
knew that until we did the study."