A Knee Surgery for Arthritis Is Called Sham
By: Gina Kolata
NY Times, July 11, 2002
The operation — arthroscopic surgery for the pain
and stiffness caused by osteoarthritis — is done on at least 225,000
middle-age and older Americans each year at a cost of more than a billion
dollars to Medicare, the Department of Veterans Affairs and private
insurers.
It involves making three small incisions in the knee;
inserting an arthroscope, a thin instrument that allows surgeons to see
the joint; and then flushing debris from the knee or shaving rough areas
of cartilage from the joint and then flushing it.
In the study, to be published today in The New
England Journal of Medicine, investigators at the Houston Veterans Affairs
Medical Center and Baylor College of Medicine report that while patients
often said they felt better after the surgery, their improvement was just
wishful thinking. Tests of knee functions revealed that the operation had
not helped, and those who got the placebo surgery reported feeling just as
good as those who had had the real operation.
"Here we are doing all this surgery on people
and it's all a sham," said Dr. Baruch Brody, an ethicist at Baylor
who helped design the study.
The study dealt only with arthroscopic surgery for
osteoarthritis, not with other common knee operations.
After learning of the results, Anthony J. Principi,
the secretary of veterans affairs, said yesterday that the study would
"change the practice of orthopedic medicine in the United
States."
But Veterans Affairs Departmentofficials stopped
short of saying they would no longer pay for the surgery. Medicare and
private insurers typically review such studies before deciding whether to
change their reimbursement practices.
The 180 participants in the study were randomly
assigned to have the operation or to have placebo surgery in which
surgeons simply made cuts in their knees so the patients would not know if
they had the surgery.
After they recovered from the procedures, most
patients said their knee pain had improved, and they continued to say they
were better for the two years that the researchers followed their
progress. But Dr. Nelda P. Wray, who is chief of the section of health
services research at Baylor, said, "On the objective scale, no one
was better at any time point."
Some orthopedists interviewed about the study said
they had wondered for some time about the operation's effectiveness. Dr.
Kenneth Fine, an orthopedic surgeon at the George Washington University
School of Medicine, said the procedure had long seemed to do nothing for
patients' underlying arthritis.
"There are pretty good success rates in terms of
patient satisfaction," Dr. Fine said, "but I have always been
skeptical."
Dr. William J. Tipton Jr., executive vice president
and chief executive of the American Academy of Orthopedic Surgeons, also
said he had questioned the operation.
"I'm both a patient and a physician," Dr.
Tipton said, explaining that he has osteoarthritis. "My knee is
buckling now, but I'm not going to have arthroscopy done. I recognize that
it's not going to help."
Still, he said he would like to see the study
repeated before doctors decided whether to do the operation.
"Gradually," Dr. Tipton speculated,
"physicians would say to their patients: `I know you've seen a lot
about arthroscopy, but you know what? It doesn't work very well for
osteoarthritis of the knee.' "
But a past president of the orthopedic surgeons'
academy, Dr. Douglas Jackson of Long Beach, Calif., said that the study's
population, mostly men in a veterans' hospital, was not typical of what he
had seen in his private practice, but that he would tell his patients
about their experience.
The research began when an orthopedic surgeon at the
Houston veterans' hospital, Dr. J. Bruce Moseley, who is now the team
physician for Houston's two professional basketball teams, approached Dr.
Wray suggesting a study that would compare washing the knee joint with
washing and scraping in patients with arthritis.
Dr. Wray had a bolder idea.
"She said, `How do you know that what you are
seeing is not a placebo effect?' " Dr. Moseley recalled. "My
response was, `This is surgery.' She said, `I hate to tell you this, but
surgery may have the biggest placebo effect of all.' "
Placebo studies of surgery are almost never done.
Many doctors consider them unethical because patients could undergo risks
with no benefits. Working with Dr. Brody, the ethicist, the group tried to
make the placebo treatment no more dangerous than daily life. Still, of
324 consecutive patients who were asked to participate, 144 declined.
For those who agreed, the day of surgery meant being
wheeled into an operating room while neither they nor any of the medical
staff knew what their treatment would be. When they were on the operating
table, Dr. Moseley, who did all the operations, opened a sealed envelope
telling him whether the patient was to have the surgery or not.
Those in the placebo group received a drug that put
them to sleep. Unlike those getting the real operation, they did not have
general anesthesia.
Dr. Moseley made small cuts in their knees to
simulate an operation. He bent and straightened the knee and asked for
surgical instruments, just in case the patient was partly conscious. An
assistant sloshed water in a bucket to make the sound of a knee being
flushed clean.
The paper in The New England Journal is accompanied
by two editorials. One, by Sam Horng and Dr. Franklin G. Miller of the
National Institutes of Health, asks whether placebo surgery is unethical.
The controversy, they wrote, comes because doctors assume that patients in
clinical research should not be put at risk if they cannot benefit, and
placebo surgery involves risk.
But, they say, clinical research is different from
medical therapy; its aim is not to help those in the study but to help
future patients.
To be ethical, they say, a study with placebo surgery
must meet three criteria: it must not place patients at undue risk; the
benefits of learning whether the surgery works must be worth any potential
risk to the patients; and the patients must give informed consent.
In the current case, they wrote, all those objectives
were met and the study "exemplifies the ethically justified use of
placebo surgery."
In the second editorial, Dr. David T. Felson of
Boston University and Dr. Joseph Buckwalter of the University of Iowa note
that if there were large beneficial effects from the surgery, the study
should have found them.
"Although the study may not have been large
enough to permit the detection of any small effects," they wrote,
"the data presented do not suggest that there were any.,"
In a telephone interview this week, Dr. Felson, a
professor of medicine and a rheumatologist by training, praised the
research but said it remained to be seen whether doctors and patients
would abandon the procedure.
"There's a pretty good-sized industry out there
that is performing this surgery," Dr. Felton said. "It
constitutes a good part of the livelihood of some orthopedic surgeons.
That is a reality."
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