Update regarding cold laser therapy

Thank you for this great info Trisha.  How long had you had lymphedema before your treatment?

How long did the treatment take...weeks or months?

Meggy, please know that the Rian laser was cleared by the FDA, not approved, as equivalent to other devices on the market.

The studies are considered small and inadequate, and currently there is one small study at Vanderbilt just to look at safety of the laser

Even Neil Piller's study (the creator and marketer of the Rian laser) that followed women for 2.5 years found little prolonged benefit.

The last time HappyTrisha posted, a year ago, she got very angry at our posts and swore never to come back here.

There was a National Lymphedema Network quarterly newsletter about the laser: with articles by noted lymphedema researchers--Andrea Cheville and Kathleen Francis, and all agreed that it showed some promise, but the studies were lacking. It's mechanism and risks are really unknown. It appears to work best on fibrosis. The newsletter is only available to subscribers to the NLN. 

The two researchers from Vancerbilt who are doing the study are convinced it works, but have little evidence to support their view. Their study is small and preliminary. There are three arms: laser alone, MLD alone and laser and MLD. The study is only 90 patients. There is no "double blinding"

http://clinicaltrials.gov/ct2/show/NCT00852930

Please read the entire thread and note HappyTrisha's responses to our previous dialogue.

I contacted Neil Piller, inventor of the laser, and asked if he intended to ever study it further, and he said no. Yet he writes in his studies that the mechanism is "a mystery".

Here is a link to the process by which is was CLEARED, not APPROVED (a mistake in Sheila Ridner's study information)

Here's their clearance letter--listed on their site as "approval letter"--it says that the laser is equvialent to a device on the market and they're cleared to market it, as long as they adhere to good marketing practices.

http://www.biohorizonmedical.com/resources/LTU904_FDA510K.pdf 

http://www.stepup-speakout.org/Lasers_for_lymphedema_treatment.htm 

The brochure to the public from Rian says the laser has no side effects: if that is really true, then it's biologically inactive. No biologically active treatment has no side effects.

I emailed a noted lymphedema therapist about her views, and she said that since the laser is not supposed to be used over metastatic cancer, and there is a 10% incidence of cancer in the nodes not found on sentinel node biopsy, she would never use it. This is a national instructior, at a national school.

I have written a patient editorial for the National Lymphedema Network: I want the laser to work, but I want adequate studies, understanding of the mechanism and no direct sales to the public of an experimental treatment. I've been in touch with the Vanderbilt researchers, and unfortunately, they are biased and their study is too small to be definitive.

HappyTrisha has accused Binney and myself of wanting women to have lymphedema due to our cautions about the laser. A low blow, and not true. We want effective, safe, well studied treatments.

Kira 

Oh Trisha,

  You just couldn't resist writing that response. I never attacked you: I explained why I chose not to get the laser treatment at the same center that treated you--my choice, my explaination--no personal attack.

This is a forum for respectful dialogue, and I find your post both insulting and deliberately hurtful.

Full disclosure: I work in medicine and treat oncology patients--my research is both for myself and the patients I treat who have lymphedema. I speak to researchers--not companies that sell medical appliances and make money off of them.

I don't hold myself out to be an expert in lymphedema or to be providing medical advice.

I shared my experience. You shared yours--and then felt the need to attack me. I wish you could respectfully support differing viewpoints.

This forum has never descended to this level--until now. 

Kira 

By the way: here is the conclusion of two true experts in lymphedema written for the National Lymphedema Network, about the laser:

the pool of evidence is limited and
further work by multiple investigators,
as well as more comparisons with
alternative treatments, is needed
before the benefits of LLLT for
lymphedema can be accepted
comfortably as established. Further,
how or whether LLLT should be
integrated in conventional complex
decongestive therapy (CDT) remains
uncertain. Until rigorous trials permit
therapeutic comparison of CDT and
LLLT, patients should be informed
that LLLT does not eliminate their
need for phase II CDT maintenance
treatments.

Hey All, 

Please, let us start this new year in a respectful tone.

Thanks !

Melissa

NLN:LymphLink Question Corner
October-December 2009
By Kathleen Francis, MD

Q: I recently developed lymphedema of my right arm as a result of treatment for breast cancer and have spoken to two therapists in my area about treatment. They both do Complete Decongestive Therapy (CDT), but one also offers treatment with low-level laser therapy (LLLT). Will the LLLT offer better results than CDT alone?

A: Your question brings up a multitude of issues which continue to be debated among lymphedema experts and others.

First of all, at this point lymphedema is a condition for which there is currently no curative treatment. Although the condition can nearly always be managed and controlled with a combination of treatments including CDT, use of compression garments and bandages, meticulous skin care, exercises, and weight management, all of us wish there were easier ways to treat it. As a result, there have been many attempts to find alternative treatments for LE.

Low-Level Laser Therapy (LLLT) is also referred to as cold laser. This modality generates light of a single wavelength that can penetrate skin and tissues without generating heat. Laser radiation may alter cell and tissue function, and "remarkable effects are reported for a surprisingly broad range of conditions from acne to myocardial infarction" (Carati et al., Cancer 2003). However, the mechanism of action by which laser affects cells and tissues continues to be explored and debated. Some theories include increase in cell energy production, stimulation of endorphins, reduction in inflammatory reactions, and improved blood circulation, among others. Many experts in evidence-based medicine feel that the accumulated evidence thus far has not substantially shown the effectiveness of LLLT, and nearly all third party payors (insurance companies) feel that LLLT remains "experimental and investigational" (Aetna Clinical Policy bulletin, 2004).

It is important to realize that research studies can vary greatly in their quality, and often treatments that showed great promise in early research later prove to be ineffective or sometimes even harmful. This is why "evidence-based medicine" has become the byword in evaluating medical treatments and interventions. Evidence-based medicine "grades" research studies on their design, giving the greatest weight of evidence to series of large randomized double-blinded controlled studies with good study design. Unfortunately, in the field of lymphedema there is very little research that meets the highest standards of evidence. All this simply means that we have to be careful in deciding what to believe when it comes to treating LE.

Several studies have examined the use of LLLT in treatment of arm lymphedema and indicated a benefit in reducing arm circumference, decreasing pain, and/or softening hard tissue. Some research suggests that LLLT increases lymphatic vessel pumping, stimulates lymph vessel regrowth, reduces pain, and softens firm tissue and scars. Again, the specific mechanism by which these effects may be achieved is unknown.

Research studies assessing LLLT for a variety of other conditions, including musculoskeletal pain, wound healing, nerve compression, and osteoarthritis to name just a few, have been small, apply a range of treatment parameters, and often are not compared to other treatments
or to placebo. Those who have examined efficacy in treating LE have similar limitations. Fortunately, to my knowledge there have been no published reports of significant adverse effects (harm) caused by LLLT devices used to treat lymphedema.

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.

Anne, it IS so interesting how we all make our treatment decisions. And it's so refreshing that we get to make them instead of being herded into protocols decided by someone who's an "authority"! 

But we do need all the information available. So, just to clarify, Dr. Cheville is not in any way implying she considers laser use a reasonable option at this time. She finds no harm in it exactly because those studies have not been done. What we DO know is that laser use is contraindicated in the presence of active cancer cells, so if we're 100% sure there are no stray cancer cells in the vicinity, that would be one reason to feel more comfortable with it. For myself, I'm not that sure, but I am at least 100% sure I don't want to do anything to stimulate any renegade cells.

Another concern is that there IS anecdotal evidence of serious damage in the form of triggering Radiation-Induced Brachial Plexopathy, a painful permanent paralysis of the affected arm. Again, if you have not had any radiation to the area that might be less concerning. 

Bottom line: no one has looked at long-term safety of laser use in post-bc women. There is no expert anywhere who can state with authority that it is safe, because that is simply unknown. 

As for home use, the few small studies that have been done of laser use were conducted with a very specific and limited protocol by specially trained fully-qualified lymphedema therapists, so venturing into self-treatment is an even more complex decision. 

Some of us are more comfortable with risk than others, and that's a good thing. But for myself, I draw a line between my own personal risk-taking and recommending or even pushing unproven treatments on other vulnerable women. We all want a cure. We are all desperate for one. We are all at serious risk of throwing caution to the wind for one "promise" or another.

I so hope that someone will conduct a truly objective study of laser use that specifically looks at both bc recurrence rates and RIBP over time, but there is no such study on the horizon. The one currently underway looks at such risks only incidentally -- if they pop out and whack the researchers in the face, presumably they'll notice. Communicating my concerns to the researchers involved has not moved them to be more pro-active about this, so I have little confidence in any declarations of safety from them. You don't always see what you're not looking for.

I'm disappointed. But I'm still hopeful. I'm as vulnerable as the rest of you to panting after something that will cure my lymphedema, but I don't want anyone to misunderstand this safety issue.

God bless us all!
Binney

I am one of the persons who owns the RianCorp Low Level Laser and have incorporated its use into my LE management routine for almost 2 years now.  I am well aware of all the issues and debate concerning current use of the laser for LE.  I think having the ability to discuss these issues openly, honestly and respectfully here on these forums is extremely valuable in furthering our knowledge base and aiding our personal decision process regarding new treatment modalities.

In that light, I would like to add my personal perspective on the laser.  As Kira has mentioned before, the NLN Lymphlink Oct-Dec 2009 issue was almost totally dedicated to the topic of the Low Level Laser.  In addition to a variety of research and clinical study articles provided by medical professionals, the Lymphlink often publishes a "Patient Perspective" which allows for input from the patient's themselves.  Kira and I were both honored by the NLN in their request that we provide our personal perspectives on the laser.  The NLN felt it would be helpful to have both opinions since we hold somewhat different viewpoints.

Here is my perspective on the laser as it appeared in the Lymphlink:

Given the current debate over the safety and effectiveness of the low level laser for Lymphedema (LE), how are we as patients to decide whether to incorporate this new modality into our treatment regimen?  We can always debate how much research is enough, but is it ever possible to conclusively prove that a treatment is safe before it is implemented?

As a retired RN who has been living with breast cancer since 2000 and lymphedema since 2006, I fully realize that the treatment decision process is one of the most difficult challenges we face. We quickly learn that medicine is not a perfect science and there are no guarantees of the outcomes of our choices.  The only thing we as patients can do is educate ourselves to the best of our ability and hopefully, find highly competent, experienced professionals to comprise our medical team.  I have been blessed with an excellent medical team including wonderful LE therapists who have played a pivotal role in the successful management of my LE.

I am a 2-time breast cancer survivor who developed LE following bilateral mastectomy and total axillary dissection.  My LE first presented during chemotherapy after an episode of Hand/Foot syndrome and then rapidly progressed to Stage 2 following 6 weeks of intensive 3-field radiation.  As a result, while I now have only moderate volume increase in my left arm compared to my right, I have persistent fibrosis in my hand and forearm.  The biggest functional issue I live with is decreased strength and dexterity of my left hand.

The gold standard of CDT has always been my primary treatment for LE and continues to be. In addition to wearing daytime and nighttime compression garments, I have regular professional MLD sessions twice a month. Through the creativity of my therapists, we have tried a variety of adjunctive therapies and found that elastic taping (Kinesio Tape) and using a pneumatic device (Flexitouch) designed to follow the principles of MLD were both effective to a degree on my fibrosis.  I have even used a rebounder (mini trampoline) on the theory that it helps to promote lymphatic flow and have supplemented my diet with Selenium for supposed anti-inflammatory properties.

My coping strategy has always been to stay informed of potential new treatments for both my cancer and my LE. As long as I feel a treatment is reasonably safe and the risk to reward ratio is favorable enough, I am willing to test it for effectiveness. Risk tolerance, however, is certainly unique to each individual’s personal perspective.  My interest was peaked when I first heard of the LTU-904 Low Level Laser at the NLN conference in Nashville in 2006. While I was concerned that no one could explain to my complete satisfaction how the laser actually worked, I was impressed with the number of positive anecdotal reports and the years of clinical use in Australia.

In the spring of 2008, my LE therapist obtained the laser on a 30-day trial and I underwent the treatment protocol as described in the Australian study.  At the completion of the 30 days, I decided to purchase the laser and continued its use under the supervision of my therapist for several months. Today I use the laser in the privacy of my home on a variable schedule, utilizing arm and hand treatment points in order to focus on my specific areas of fibrosis.

Since using the laser, I have found I no longer need to use elastic tape (Kinesio Tape). The skin across the top of my hand at the knuckles is much more mobile, resulting in better dexterity and stronger grip.  The large area of fibrosis down my inner forearm has become measurably smaller and softer.  The superficial blood vessels at my inner wrist are now visible and the skin shows normal wrinkling and mobility. These are all distinct changes not present prior to my use of the laser.  My arm size as determined by both tape measure and perometry has also consistently reduced. 

I strongly feel the laser has been a safe and effective adjunctive treatment for my LE.  While I would not characterize my personal results as overly dramatic, they are certainly significant and ongoing. In the absence of conclusive evidence that the laser causes harm, I feel its current use in the patient population provides valuable input to the question of its effectiveness. Anecdotal experience provided by professional therapists and their patients should be used to help guide the development of evidence based research.  While I agree additional research on the laser is needed, I feel fortunate to have benefited from its use now.

Additional Comment:

I have no expectations that my Stage 2 LE will somehow just go away with use of the laser.  I realize that ongoing maintenance will be my lifelong commitment until much greater understanding of the lymphatic system and development of new treatment modalities becomes a reality.  I will continue to practice CDT, wear my garments daily and nightly, get regular MLD sessions and practice risk prevention in addition to using the laser.  My hopes are that one day, convincing research evidence will support incorporating the low level laser into the standard of LE management.  I also recognize, however, that in spite of my personal positive experience with the laser and the improvements in my LE that I feel are directly related to my use of the laser, future clinical study and research data may not conclusively support my choice. As so many things in life, there are no guarantees.  We must make our own best decision based on the criteria and concerns that are important to us.

I welcome new research and clinical trialing of the laser, but will continue to use the laser until such time as new evidence based data warrants me rethinking my decision.

I own and use the LTU.  I see Dr. Kathleen Francis for my lymphedema.  When I saw her in October, she told me pretty much exactly what she said in the Q/A WRT the Rian LTU:  might work but the jury is out.  She was unaware of the 2009 paper (which I posted), and I gave her a copy.   She asked me where I used the laser and I said on my axilla as per the research papers.  She suggested that I also target the region of my forearm that is most affected.

 When I saw her last (in Dec) my measurements were down and my bioimped. scores were lower despite the fact that I had had a bad bout of cellulitis and was in a "bad phase" with respect to my axillary sores.  Francis was surprised by this and said to keep doing whatever I was doing. 

Frankly, given what my poor arm/axilla has been through, it is amazing to me that my LE is stable (and maybe even better).  Is it the laser?  I really don't know. During the Oct-Dec interval, I also finally got a sleeve that fit properly and I saw a new LE specialist who taught me new stretches and different method of doing massage.   KS1 

With respect to insurance coverage, I did not even try to get insurance to cover the laser.  I went through a company called BioHorizon.  THrough them,I  rented my laser for 3 months ($400/month).  After 3 months, I had to either by the machine (with the 1.2K rental going to the purchase price (of about 4K) or return it.  I opted to buy the machine.   

 Why did I decide to do it? Well,  as a scientist, I scrutinized the papers and decided, for me, I was willing to run the risk of being an early adopter.*  Are the studies perfect?  No, but they aren't bad. It would be fantastic if there were more and better studies, but there aren't .  That said, all of the published studies have basically shown that LLLT yields modest to moderate improvement for a subset of patients.  None have shown the LLLT group to do worse or the same as the contrast.  When multiple studies yield the same result, this is comforting.  One worry is that  maybe this is a case of  the "wastebasket" phenomenon where studies are done and no difference is found, and so the work never gets published.   (If results showed the LLLT group did significantly worse than the contrast group, this would be quite publishable.)

 When one reads the literature on the efficacy of any type of treatment modality for LE what quickly becomes apparent is the paucity of good studies, even for things that are considered absolutely mainstream like patient administered manual lymphatic drainage.    

- KS1 

* Full disclosure, although I have an MD and a PHD, I do not practice medicine and my research has nothing to do with LE.