Dartmouth-led studies show benefit of surgery and non-operative
treatments
The first in a series of groundbreaking papers that look at the efficacy of
common back surgery over non-surgery shows that in cases of disk herniation
with severe pain, patients who have surgery experience better outcomes than
patients who undergo non-operative treatment. However, both surgical and
non-surgical patients show considerable improvement in their functionality and
quality of life one and two years after their initial symptoms.
James N. Weinstein, MD (Photo by Joseph Mehling '69)
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The findings are part of the five-year, $15 million, 11-state Spine Patient Outcomes Research
Trial (SPORT), funded by the National
Institutes of Health (NIH). They are significant because they mark the
first time the effectiveness of disk surgery has been measured in a unique
trial involving both randomized and observational cohorts. They appear in the
Nov. 22 issue of the Journal of the
American Medical Association (JAMA).
"What we found is that for patients who come to us with severe back and
leg pain and have surgery, there is an advantage in terms of how they feel
overall one and two years out from the surgery," says James N. Weinstein,
lead author and chairman of the orthopaedics departments at Dartmouth Medical School and Dartmouth-Hitchcock Medical Center.
However, he says, in cases where pain is tolerable and a patient's lifestyle
allows it, non-surgical treatment can be very effective.
"In those cases, we saw that patients who did not have surgery, but
treated their symptoms with physical therapy, over-the-counter pain medications
and other non-surgical treatments, also improved substantially, reporting a
quality of life close to what the surgical patients reported a year after their
surgery. This new information will make it possible for physicians to share
outcomes with their patients and allow them to make more informed choices about
whether to have the surgery or not," he says.
Lumbar diskectomy is the most common surgical procedure in the United States
for patients with back and leg pain. And back pain is one of the most frequent
ailments in America, second only to the common cold as the cause of doctor
visits and absences from work. Thirty percent of Americans experience back pain
on any given day; 80 percent will experience back problems at some time in
life. The overall cost of back pain in direct medical charges and lost
productivity is estimated to be $30 to $70 billion a year in the United
States.
And yet, up until now, there was very little scientific evidence
specifically addressing whether diskectomy and two other of the most commonly
performed back surgeries actually make a positive difference for patients over
more conservative, non-surgical treatments. In 1999, the National Institute of Arthritis and
Musculoskeletal and Skin Diseases (NIAMS) of the NIH funded the SPORT study
in hopes of measuring the efficacy and cost effectiveness for these procedures.
The disk herniation study results are the first to be published.
"As a surgeon who works with disk herniation patients, this research is
extremely valuable," Weinstein says. "Clearly, those patients
experiencing severe back and leg pain as a result of pressure on the nerve will
benefit immediately and substantially from surgery. But for those patients
where the pain is tolerable, they need to know that non-surgical treatment can
yield long-term results that are close to what surgical patients experience.
What it comes down to are patients' values, preferences, and what works for
them in their life situations-an informed choice."
The trial is unusual in that it followed a group of patients who allowed
themselves to be "randomized" in traditional fashion (meaning that
they agreed that a flip of the coin would decide if they received surgery or
not), as well as an "observational" group, who did not agree to be
randomized, but did agree to be followed and have their results reported as
part of the trial. This unprecedented structure allowed the researchers to
compare real-life patterns and outcomes with those of the randomized group.
What scientists found was that the trends and results were remarkably
similar for the two groups. This is important because although randomized
trials are considered to be the "gold standard" in clinical trials,
some have questioned whether the population that will agree to be randomized is
indeed representative of the population at large. The similarities between the
two groups in this study add credibility to the findings, according to the
authors.
Of the 1,244 patients enrolled in the two groups, 760 had surgery and 484
did not. Because of crossovers-patients randomized to one arm of the study
choosing to move to the other, largely because of changes in their
condition-the findings are not considered conclusive. However, at every stage,
the authors observed that patients who had surgery reported better
outcomes.
Papers on the two other back conditions being studied-spinal stenosis and
spinal stenosis with degenerative spondylolisthesis-are expected to be
published in 2007.
Coauthors on the disk herniation study papers are Jon D. Lurie, Tor
Tosteson, Jonathan A. Skinner, Anna N.A. Tosteson, Brett Hanscom, and William
A. Abdu, all of Dartmouth; Richard Deyo, University of Washington; Todd Albert
and Alan S. Hilibrand, Rothman Institute at Thomas Jefferson University; Scott
D. Boden, Emory University; Harry Herkowitz and Jeffrey Fischgrund, William
Beaumont Hospital; and Frank Cammisa, Hospital for Special Surgery.
By SUSAN KNAPP
CENTERS PARTICIPATING IN THE STUDY (IN ADDITION TO DARTMOUTH)
- William Beaumont Hospital, Royal Oak, Mich.
- Emory University, Atlanta, Ga.
- New York University/Hospital for Joint Diseases, New York, N.Y.
- Hospital for Special Surgery, New York, N.Y.
- Kaiser Permanente, Oakland, Calif.
- Nebraska Foundation for Spinal Research, Omaha, Neb.
- Rothman Institute at Thomas Jefferson Hospital, Philadelphia, Pa.
- Rush Presbyterian-St. Luke's Medical Center, Chicago, Ill.
- University California-San Francisco, San Francisco, Calif.
- University Hospitals of Cleveland/Case Western Reserve University,
Cleveland, Ohio
- Washington University, St. Louis, Mo.
- Maine Spine and Rehabilitation, Scarborough, Maine
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