Cellulite is a dimpled, uneven appearance of skin caused
by fat underneath. It affects some 85% of women and about 5% of men. Until
recently, the main treatments to battle cellulite have been external treatments
such as creams and radio-frequency and massage devices. The creams are largely
ineffective and the devices have a modest effect that typically lasts about six
months, doctors say.
A therapy called Cellulaze, which uses a laser machine
sold by Cynosure Inc. in Westford, Mass., hit the U.S. market in February. Some
doctors say the results are impressive. "The results are nothing short of
remarkable," says Los Angeles plastic surgeon Grant Stevens, a clinical
professor of surgery at the University of Southern California's Keck School of
Medicine in Los Angeles. Dr. Stevens, who isn't affiliated with Cynosure, said
he and another doctor in his practice together have treated about 40 patients
with Cellulaze.
Based on the published scientific data, Cellulaze is
"promising," says Mathew M. Avram, director of the Dermatology Laser
& Cosmetic Center at Massachusetts General Hospital in Boston. But "we
need more clinical experience before we can make any definitive statements as
to the efficacy of the device."
Cellulaze is different from earlier treatments in that it
tackles the root causes of cellulite, including thinning skin and connective
fibers called septae that are believed to create tension by pulling down the
skin, contributing to an uneven appearance, says Gordon H. Sasaki, a clinical
professor of plastic surgery at Loma Linda University Medical University Center
in Loma Linda, Calif. Dr. Sasaki is a paid consultant to Cynosure.
Cellulaze is done by plastic surgeons in their offices
under local anesthetic. It typically costs $5,000 to $7,000 for a bilateral
area, such as the thighs, and another $2,500 or more for each additional area.
One or more tiny incisions are made so a narrow tube called a cannula can be
inserted into the skin. Laser light, delivered through the cannula, cuts the
septae and melts small amounts of fat, Dr. Sasaki says. It heats the underside
of the skin, which stimulates collagen production and makes skin thicker and
more elastic, he adds.
Cellulaze leaves tiny scars—about two millimeters
long—which fade with time, surgeons say. Typically, compression garments are
recommended for at least two or three weeks to prevent fluid buildup. And there
will be bruises, so patients typically need to wait three to six weeks before
venturing out in a bathing suit, surgeons say.
The procedure can cause a buildup of fluid in the area
that has been treated, which can last for months and needs to be drained
regularly by a doctor.
In a written statement, Cynosure says "a few"
patients in early trials had the buildups, called seromas, adding that they
need to be drained to prevent infections and other complications. The company
says it has since lowered the recommended laser dosage and it isn't aware of
any seromas since the device hit the U.S. market.
According to a company-funded study of 10 women published
last year in Aesthetic Surgery Journal, Cellulaze resulted in skin that was 25%
thicker after a year. Cellulite reduction was "good" to
"excellent" as graded by physicians.
Dr. Sasaki, in data obtained as part of a
company-financed trial that has yet to be published, says 80% of 25 patients he
treated are still enjoying "substantial improvement" two years after
the surgery.
Lawrence Bass, director of the minimally invasive
plastic-surgery program at New York University Langone Medical Center in New
York, says the procedure appears to reduce the depth of cellulite dimples. A
person with less-pronounced dimples is "most likely to get a home
run" out of the procedure, says Dr. Bass, who has attended scientific
presentations of the data but hasn't performed the procedure. But if you have
really deep ones, he adds, "it might not be enough to make the lifestyle
change you want to make, such as wearing shorts in the summertime."
If a deep dimple is still visible, fat can be injected
with a syringe later to even it out, Dr. Sasaki says.
Another new laser treatment both for cellulite and body
contouring is i-Lipo, i-Lipo, from Chromogenex Technologies Ltd., South Wales,
England. The laser, which hit the U.S. market in December, is noninvasive and
involves pads placed externally on the skin. I-Lipo provokes a chemical
reaction that breaks down fat into its components, says company clinical
manager Donna Freeman. After the treatment, a cardiovascular workout of 30 to
40 minutes is recommended to burn off the components.
The "Ultra" model of the device comes with a
vacuum-massage device aimed at smoothing cellulite, but the effects on
cellulite haven't yet been tested in a clinical trial, the company says. A
34-patient study, unpublished, found eight 20-minute sessions with the device
reduced midsection size by 1.8 inches, measured by a tape measure, compared
with only a third of an inch for a sham therapy, which looked the same to
patients.
Dr. Bass says he is "skeptical" because
measuring-tape data has a large margin of error. Chromogenex says the measurements
used scientifically accepted standards.
New Laser Aims to
Zap Cellulite at the Source – Review
Disease-mongering.
Failure to evaluate the laughably limited data that were cited. Failure to quantify benefits or harms in a
meaningful way. Enough said? If not, read on.
Our Review Summary
For a column entitled “Aches & Claims,” this entry
caused us many aches because it didn’t adequately evaluate claims, such as:
- “The
results are nothing short of remarkable.”
- “Cellulite
reduction was good to excellent as graded by physicians.”
- “Substantial
improvement two years after surgery.”
Why This Matters
It’s ironic that one week after the big brouhaha over the
Supreme Court decision on the Affordable Care Act, a story like this about a
cosmetic treatment that costs a minimum of $5,000 – 7,500 never mentioned
insurance coverage.
There are many reasons Americans spend a far greater
percentage of the GDP on health care than anyone else on the face of the
Earth. And stories like this capture
just one little slice.
Cosmetic dermatology is one of the few domains in
medicine where the “free market” reigns.
Although devices such as the laser highlighted in this story are
approved by the FDA, the approval process does not guarantee the results. That’s why it is so important to provide
readers with as much information about new devices and new approaches as
possible.
Criteria
SATISFACTORY
Costs were discussed. But the story didn’t discuss
insurance coverage. One online reader did, though, writing:
“Interesting how while plastic surgery isn’t covered by
health insurance, the follow-up care and complications often are. The side
effects of this procedure sound horrific, and we all get to pay for it.”
NOT SATISFACTORY
Deep in the story, a company-funded study of 10 (!) women
was discussed – resulting in “skin that was 25% thicker after a year.”
What does that mean? What is the true benefit of that? The story
says doctors graded cellulite reduction as “good to excellent.” In all 10
women? Was this a subjective judgment?
Then the story cites unpublished data from a
company-financed trial trial. Might as well have been a news
release. Hardly a good source of evidence to cite at this point.
By the end, there really was no good quantification of
benefit.
Interestingly, the story provides no information about
what the subjects thought about the results.
NOT SATISFACTORY
Potential harms were mentioned:
- Cellulaze
leaves tiny scars—about two millimeters long—which fade with time, surgeons
say. Typically, compression garments are recommended for at least two or three
weeks to prevent fluid buildup. And there will be bruises, so patients
typically need to wait three to six weeks before venturing out in a bathing
suit, surgeons say.
- The
procedure can cause a buildup of fluid in the area that has been treated, which
can last for months and needs to be drained regularly by a doctor.
- In
a written statement, Cynosure says “a few” patients in early trials had the
buildups, called seromas, adding that they need to be drained to prevent
infections and other complications. The company says it has since lowered the
recommended laser dosage and it isn’t aware of any seromas since the device hit
the U.S. market.
But none of these harms was quantified, so the scope of
the potential harm wasn’t clear. What does it actually mean when the
story uses vague terms such as “typically”…”can cause”…”a few patients” ?
NOT SATISFACTORY
One independent perspective came from a dermatologist who
said “”we need more clinical experience before we can make any definitive
statements as to the efficacy of the device.”
But the rest of the story was cheerleading in its failure
to explain or evaluate the evidence:
- failing
to point how laughably small is a company-funded study of 10 women
- failing
to point out the folly of citing data from a company-funded trial that is not
published
NOT SATISFACTORY
Pretty egregious disease-mongering – both in what the
story said and it what it didn’t say.
What it said:
Bathing-suit season is here and with it, anxiety over
cellulite. A new laser device that burrows under the skin is getting praise
from some doctors who say it gives more dramatic and longer-lasting results
than previous treatments, but others caution that more research is needed.
Cellulite is a dimpled, uneven appearance of skin caused
by fat underneath. It affects some 85% of women and about 5% of men.
What it didn’t say:
- It
didn’t have one word about why/whether cellulite needs to be treated.
- It
didn’t cite the source of the data for how many people are affected. And
of those supposed 85% of women and 5% of men, are they ALL considered
candidates for treatment? And if so, by whom? With what vested
interest?
Finally, the story described the “battle” with
cellulitis, which conjures up images of fat cells being taken on by light
sword-armed dermatologists to save humanity from the scourge of dimpled thighs.
Battle? Really?
SATISFACTORY
There were two apparently independent sources quoted.
NOT SATISFACTORY
In a practice that is far too common in such stories,
this one mentioned alternatives but waved them off as ineffective without
citing any data.
Until recently, the main treatments to battle cellulite
have been external treatments such as creams and radio-frequency and massage
devices. The creams are largely ineffective and the devices have a modest
effect that typically lasts about six months, doctors say.
Meantime, this entire story was based on two
company-funded studies – one tiny and one unpublished!!!
SATISFACTORY
The story stated that the laser approach “hit the US
market in February.”
SATISFACTORY
The story at least mentioned one other “new laser
treatment for cellulite and body contouring.” (Although the only data cited on
that approach also came from a tiny, unpublished study.)
SATISFACTORY
Because two apparently independent experts were quoted,
it does not appear that the story relied solely on a news release.
Total Score: 5 of 10 Satisfactory
No comments:
Post a Comment