23.1.2004
This page is a mirror. The original URL is: http://www.eurekalert.org/pub_releases/2002-07/bcom-sfc070802.php
Diese Seite ist ein Mirror. Die originale URL ist : http://www.eurekalert.org/pub_releases/2002-07/bcom-sfc070802.php
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Public release date: 10-Jul-2002
Contact: Anissa Anderson Orr
anissaa {at} bcm.tmc.edu
713-798-7973
Baylor College of Medicine
Study finds common knee surgery no better than placebo
HOUSTON--(July 10, 2002)--Patients with osteoarthritis of the knee who
underwent placebo arthroscopic surgery were just as likely to report
pain relief as those who received the real procedure, according to a
Department of Veterans Affairs (VA) and Baylor College of Medicine
study published in the July 11 New England Journal of Medicine.
The researchers say their results challenge the usefulness of one of
the most common surgical procedures performed for osteoarthritis of
the knee.
"The fact that the effectiveness of arthroscopic lavage or debridement
in patients with osteoarthritis of the knee is no greater than that of
placebo surgery makes us question whether the dollars spent on these
procedures might not be put to better use," said lead investigator Dr.
Nelda P. Wray, a health services researcher at the Houston VA Medical
Center and Baylor College of Medicine in Houston.
In the study, 180 patients with knee pain were randomized into three
groups. One group received debridement, in which worn, torn, or loose
cartilage is cut away and removed with the aid of a pencil-thin
viewing tube called an arthroscope. The second group underwent
arthroscopic lavage, in which the bad cartilage is flushed out. The
third group underwent simulated arthroscopic surgery; small incisions
were made, but no instruments were inserted and no cartilage removed.
Dr. Bruce Moseley, a clinical associate professor of orthopedics at
Baylor, recruited all the patients in the study and performed all
surgeries both real and placebo. Dr. Baruch Brody, director of the
Center for Medical Ethics and Health Policy at Baylor, was
instrumental in critically assessing the ethical issues involved in
the study and in developing the stringent consent process for the
study.
Of the 324 participants who met inclusion criteria for the study, 44
percent declined to participate, demonstrating they understood that
they might not receive the actual surgery. Before undergoing surgery,
participants also wrote in their chart, "On entering this study, I
realize that I may receive only placebo surgery. I further realize
that this means that I will not have surgery on my knee joint.
This placebo surgery will not benefit my knee arthritis."
During two years of follow-up, patients in all three groups reported
moderate improvements in pain and ability to function. However,
neither of the intervention groups reported less pain or better
function than the placebo group. Indeed, the placebo patients reported
better outcomes than the debridement patients at certain points during
follow-up. Throughout the two years, the patients were unaware of
whether they had received real or placebo surgery.
In past clinical trials of arthroscopic knee surgery, the majority of
patients reported pain relief. Though others have suggested that
improvement results from flushing out of the knee joint or the removal
of cartilage, these studies did not compare the actual procedures to
placebo. The authors of the new study say their findings raise
questions about what really causes the improvements seen with lavage
or debridement. Their results suggest the same therapeutic benefits
may be achieved through non-invasive placebo surgery.
Osteoarthritis, a degenerative joint disease, is the most common form
of arthritis, and commonly occurs in the knee. Symptoms include pain,
stiffness, and swelling. Treatment typically involves pain-relieving
and anti-inflammatory drugs, along with heat-therapy and exercise.
When these fail, surgery is often recommended.
In the United States, it is estimated that more than 650,000
arthroscopic debridement or lavage procedures are performed each year,
many of these for arthritis, at a cost of about $5,000 each.
"This study has important policy implications," Wray said. "We have
shown that the entire driving force behind this billion dollar
industry is the placebo effect. The health care industry should
rethink how to test whether surgical procedures, done purely for the
relief of subjective symptoms, are more efficacious than a placebo."
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The research was funded by VA and conducted through the agency's
Houston Center for Quality of Care and Utilization Studies, based at
the Houston VA Medical Center. The Center is co-funded by the
department of medicine at Baylor.
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