There is no quick fix for lymphedema.
Unfortunately, there are untested medical devices out there
promising this quick fix. We have the emphatic opinion of
"buyer beware."For some of the same
reasons that we do not endorse or recommend the Acuscope or endorse
or recommend the Laser as any type of effective treatment of
lymphedema, we are including it here for those who have questions
about its use in lymphedema.
Again, we do not in any way endorse this
treatment.
The
studies below included very small numbers of
patients, which we do not believe produces reliable
evidenced-based results.
Low level
laser therapy (LLLT) has been introduced into the US market for
lymphedema. In 2006 the FDA cleared the Riancorp low level laser
device for lymphedema treatment.* The
Riancorp LTU-904
laser therapy units
are infra-red lasers operating at a wavelength of 904 nanometers.
This invisible wavelength penetrates deeply into tissue where it is
absorbed by cells and converted into energy that apparently aids in
reducing the swelling of post mastectomy lymphedema.
Very small
studies suggest that low-level laser therapy may be effective in
reducing lymphedema in a clinically meaningful way for some women.
Two cycles of laser treatment were found to be effective in reducing
the volume of the affected arm, extracellular fluid, and tissue
hardness in approximately one-third of patients with post-mastectomy
lymphedema at three months post-treatment. Suggested rationales for
laser therapy include a potential decrease in fibrosis, stimulation
of macrophages and the immune system, and a possible role in
encouraging lymphangiogenesis.
We researched
these studies and found the laser has been tested in one trial on 64
women with either one or two cycles, delivered by therapists, and
the women were followed for 3 months. This is the placebo
controlled, double blind study that was the basis for granting FDA
approval. Unfortunately, we can not find any studies in the world
literature where larger numbers of women were followed for longer
periods of time.
Treatment of postmastectomy
lymphedema with low-level laser therapy: a double blind,
placebo-controlled trial.
Carati
CJ,
Anderson
SN,
Gannon BJ,
Piller NB.
Department of Anatomy, School of Medicine, Flinders University,
Adelaide, South Australia, Australia.
colin.carati@flinders.edu.au
BACKGROUND: The current study describes the results of a double
blind, placebo-controlled, randomized, single crossover trial of
the treatment of patients with postmastectomy lymphedema (PML)
with low-level laser therapy (LLLT). METHODS: Participants
received placebo or one cycle or two cycles of LLLT to the
axillary region of their affected arm. They were monitored for
reductions in affected limb volume, upper body extracellular
tissue fluid distribution, dermal tonometry, and range of limb
movement. RESULTS: There was no significant improvement reported
immediately after any of the treatments. However, the mean
affected limb volume was found to be significantly reduced at 1
month or 3 months of follow-up after 2 cycles of active laser
treatment. Approximately 31% of subjects had a clinically
significant reduction in the volume of their PML-affected arm (>
200 mLs) approximately 2-3 months after 2 cycles of treatment.
There was no significant effect of placebo treatment, or one
cycle of laser treatment, on affected limb volume. The
extracellular fluid index of the affected and unaffected arms
and torso were reported to be significantly reduced at 3 months
after 2 cycles of laser therapy, and there was significant
softening of the tissues in the affected upper arm. Treatment
did not appear to improve range of movement of the affected arm.
CONCLUSIONS: Two cycles of laser treatment were found to be
effective in reducing the volume of the affected arm,
extracellular fluid, and tissue hardness in approximately 33% of
patients with postmastectomy lymphedema at 3 months after
treatment. Copyright 2003 American Cancer Society.DOI
10.1002/cncr.11641
We have
found another study
where it was tested on ten woman:
Treatment of chronic postmastectomy lymphedema with low level
laser therapy: a 2.5 year follow-up.
Piller NB,
Thelander
A.
Department of Public Health, School of Medicine, Flinders
Medical Centre, Bedford Park, South Australia. binbp@flinders.edu.au
Ten
women with unilateral arm lymphedema after axillary clearance
(radical mastectomy) and radiotherapy for breast cancer received
16 treatment sessions with Low Level Laser Therapy (LLLT) over
10 weeks and seven patients were followed for 36 months. The
effect of LLLT was monitored by arm circumference,
plethysmography, tonometry, bioimpedance and a questionnaire
dealing with subjective symptoms. After treatment, edema volume
(both extracellular and intracellular) was decreased, the tissue
(except for the upper arm) progressively softened or approached
a normal texture, and the patients reported improvement in
aches/pains, tightness, heaviness, cramps, pins/needles, and
mobility of the arm. Skin integrity was also improved and the
index for risk of infection decreased. Follow-up assessment at
1, 3, 6, and 30-36 months showed varying trends although at
30-36 months most subjective parameters and bioimpedance derived
data on ECF and ICF tended to return toward pre-treatment
levels. Arm circumference continued to show overall improvement,
however, with a volume reduction of the affected arm reaching
29%. Tonometry also showed maintenance of near normal values for
the involved forearm and anterior and posterior chest; however,
the upper arm showed progressive induration. The data suggest
that laser treatment, at least initially, improved most
objective and subjective parameters of arm lymphedema
The laser is
available for purchase by individuals to use in their home: please
note the caution on their
brochure.
Precautions
As
with any clinical modality for treatment of lymphedema,
treatment only should commence after consultation with the
patient's oncologist or appropriate medical specialist.
The
clinical trial used to support marketing did not evaluate the
safety or effectiveness of the device beyond two treatment
blocks (i.e., two cycles of treatment administered every 2 days
(three times a week) for three weeks. Increasing the amount of
treatment time or frequency of treatment will not necessarily
improve the results.
Ann Angel
Executive Director
7 Fleet St Richmond
South Australia SA 5033
p +61 8 8232 8822 f +61 8 8232 8833
We would like to
see a large study of many women, followed for years after its use,
with clinical guidelines.. Now that the laser is used in many
clinics, we would like to have data on the clinical experience that
has resulted from its use.
Here is a
link to what the
National Cancer
Institute
has to say about low level laser therapy:
Low-level
laser therapy
Studies
suggest that low-level laser therapy may be effective in
reducing lymphedema in a clinically meaningful way for some
women.[17] Two cycles of laser treatment were found to be
effective in reducing the volume of the affected arm,
extracellular fluid, and tissue hardness in approximately
one-third of patients with postmastectomy lymphedema at 3 months
post-treatment.[17] Suggested rationales for laser therapy
include a potential decrease in fibrosis, stimulation of
macrophages and the immune system, and a possible role in
encouraging lymphangiogenesis.[17]
As a
patient, you can report problems with any device or medication to
the FDA. If you have used the low level laser therapy and have had
adverse effects, please report these adverse effects to the
FDA at their
consumer website.
The fact that the FDA has "cleared" a
particular product, like the laser, does not mean the FDA has
"approved" it. FDA approval requires more substantial research
evidence that a product is safe and effective. Unfortunately,
the FDA may "clear" a product as a treatment method without
clear evidence that the product is effective or safe for the
intended use.
The 510 (K) process was never intended to
be utilized for the majority of medical devices that the FDA
clears, as it requires no study or proof of safety or
effectiveness, but due to multiple factors the 510 (K) process
is now utilized in 98% of medical devices that are cleared for
sale and use by the FDA.
This testimony offers an comprehensive
explanation of the 510 (K) process for medical devices.
"The small number of women studied and the
fact that the research was funded by the company that makes and
sells the laser raise questions about the reproducibility of the
results. The laser may be effective, but that can only be
proven when it has been tested in controlled trials on larger
numbers of patients, preferably with funding from an independent
source."
*Regarding FDA approval of medical devices
under 510(k) review,
we quote from the
New York Times, October 27, 2008:
* * *
"The nation's system for regulating
medical devices was set up more than three decades ago, when
devices played a much smaller role in medicine. A growing
chorus of doctors, consumer advocates and health
insurance executives say it is overdue for an overhaul.
The process has become "a barrier to evidence development,"
said Dr. Winifred S. Hayes, whose firm, Hayes Inc.,
evaluates new health care technologies.
Although federal drug regulation dates
back more than 100 years, medical devices did not come under
the government's purview until 1976, after Congress
responded to deaths linked to the Dalkon Shield, an
intrauterine contraceptive device.
Because the new law would not apply to
devices on the market before 1976, Congress did not want
makers of newer products to be at a competitive
disadvantage. So lawmakers provided the quick review process
for any new product deemed "substantially equivalent" to
something already on the market. That expedited process
became known as a 510(k) review under the relevant section
of the law.
But critics say that what Congress
intended as a way to let simple devices quickly enter the
market has expanded so much that even critical therapies are
cleared without enough research.
'It is supposed to be
for the Band-aids of the world," said Diana Zuckerman,
president of the National Research Center for Women and
Families, a Washington advocacy group. "The 510(k) process
should have been used less and less. It's being used more.'
* * *"
