There is no quick fix for lymphedema.
Unfortunately, there are, in our opinion, insufficiently researched
and tested medical devices out there, which can be purchased by the
patient directly from the internet,
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,
Lymphdrainage Gas Ionization, or endorse
or recommend the Low Level Laser as any type of long term effective treatment of lymphedema, we are including it here for those who have questions
about its use in lymphedema.
The
studies below included very small numbers of
patients, which we do not believe produced reliable
evidenced-based results.
Low level
laser therapy (LLLT) has been introduced into the US market for the
treatment of
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. The exact
mechanism of how the Low Level Laser Therapy works, or how long any
improvement lasts, is unknown.
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.
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
clearance. 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 directly through the internet by individuals to use in their home: please
note the precautions (at the end in small print) 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.
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 see 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]
* * *
The
National Lymphedema Network, in their recent October-December
2009 Newsletter, Lymphlink Vol.21, No.4, published two very
informative articles on use of the low level laser in the treatment
of lymphedema. They have graciously given us permission to
attach these articles to our website, and we suggest you read both
of them carefully to obtain more information and opinions on the use
of the low level laser in the treatment of lymphedema before
beginning low level laser treatment.
As Assessment of the Role of Low-Level Laser Therapy In the
Treatment of Lymphedema, by Jeffrey R. Basford, MD, PhD and
Andrea L. Chevelle, MD, MS.
Question Corner with Kathleen Francis, MD.
regarding use of the Low Level Laser Treatment in Lymphedema.
We quote from the last two paragraphs of
Dr.
Francis' article:
One last consideration: The LLLT devices currently being
used to treat LE were "cleared" by the FDA by a process called
510(K), which is not the same as "FDA approved." The 510(K)
process is much less rigorous than the FDA approval process for
drugs, and does not require any proof of safety or
effectiveness.
In summary, LLLT has shown some promise in relieving some
of the distressing symptoms of LE, but the evidence for its
effectiveness remains limited. Hopefully future studies and
wider experience with LLLT will confirm its usefulness as an
adjunct to our current approaches in treating LE. In the
meantime, it does not appear to be harmful, so you can make your
own decision to try it or not based on the available information
and your own comfort level with new treatments. Remember to
check with your insurance company regarding reimbursement, since
many of them do not cover LLLT for use in treating LE.
* * *
We again repeat our "Buyer Beware" and suggest
that ANY treatment modality you choose to treat your lymphedema
should be thoroughly discussed with your lymphedema therapist and
your oncologist, and only be used under their guidance and
supervision.
