Update regarding cold laser therapy

Sarah, slow down! I had nothing to do with your post being deleted. I only warned you about the rules of this board. I didn't even report it, because I hoped my comments would make you aware of the way you were coming across to your BC Sisters here, and that you'd want to curb that impression yourself.  I sure as heck don't make the rules here -- you and I are both guests on this board, with equal power (or actually, lack thereof!) to influence the moderators. Please do read the "Community Rules" that are available with a click in the upper right hand corner of this page. Whether I'm a "caring" person or not has nothing to do with what happens to your posts.

But I'm curious: are you saying that you make no profit from your affiliation with Ann's company? Nada? No salary, no compensation, no kick-backs, no percentage, no perks at all? Are you paying for your website out of your own pocket? That is indeed a moral high ground!

Ann, I'm glad to see your use of the word "cleared" for the FDA status of your laser. Until you were good enough to change it for the sake of honesty (perhaps due to pressure from the lymphedema community itself?) your earlier advertising used the word "approved," which as you're aware is a completely different category, one that the laser has not yet qualified for (at least in terms of use in lymphedema). FDA "approval" requires proof of both efficacy and safety, and the standards are considerably higher than those for mere "clearance" -- a classification that is considered by many in Congress to be a loophole in FDA procedures that needs closing in order to properly protect the public.

If you have abstracts of studies that show the safety of your laser in the hands of untrained patients -- to whom you market them without benefit of standard protocols, much less with the supervision of well-trained lymphedema therapists -- then do please post them. Anything short of that is sort of beside the point, isn't it?

As for correcting misinformation, be assured we have highly respected members here who use your laser as part of their self-care, who freely post their experiences here and update us on their results. There are studies we talk about that are currently being conducted looking at the use of the laser with post-bc lymphedema, and we'll all be excited to discuss them when they're published. No one is suppressing information here.

It's late and I'm going to bed. I'll just remind you, Ann, that in fact I gave you an anecdotal report of damage from a laser (which you affirmed had exactly the specifications of yours) two years ago, and you disregarded it entirely.

So, no, don't step over the "promotion" line -- that would not be nice.

Binney

Ann, I saw you at the NLN lecture by Andrea Cheville, which was a systematic review of the published literature on the laser--and the lack of good studies--she judged none of them to be of good quality.

And she concluded that the laser should not be used to treat lymphedema as there is no solid medical evidence to support its efficacy or safety, and she considers it a waste of valuable health care dollars for unproven technology.

You attempted to defend your laser directly to her, and she did not buy your arguements: I watched it.

Through the 510 (k) process, your laser was approved as equivalent to a heat lamp.

Since the FDA is notoriously lax in the 510 (K) process, I give them credit for taking 4 years to approve it.

You are not required to do post marketing survelliance, and you don't do it, and can't do it, as you sell direct to consumers.

There was an abstract presented at the SABC that showed that SNB are at least 10% false negatives--and the contraindication to your laser is active cancer--so if 10% of women harbor cancer cells in their axilla, that are not found on SNB, how can you consider the unsupervised use of it on the axilla safe.

http://www.abstracts2view.com/sabcs10/view.php?nu=SABCS10L_1394

Conclusions: The overall false negative rate with SNB greater than 10% and limited follow-up continue to raise concerns. While no increase in risk of recurrence or mortality in low risk patients managed primarily with SNB is evident to date, continued observation in these studies will be important in addition to more specific data on the accuracy and safety of SNB in higher risk patients. 

Anecdotal clinical reports from well trained therapists have reported that your laser may be helpful for softening fibrosis. So are foam chips--and a whole lot cheaper.

Your agenda is to market the laser. Period. So is Sara's. As such, you do violate the terms of this board, but I won't report your posts--if the moderators consider them inappropriate and violating the rules of the board, then they do.

Kira

Dear Kira,

I know from the postings you've gone into the laser treatment research and weighed up what you've found there.

Just specifically about lasers and active cancer, you may be aware that low level lasers (not the Riancorp ones) have been trialled in the treatment of the mouth ulcers cancer patients get from chemotherapy and stem cell treatment (e.g. http://www.ncbi.nlm.nih.gov/pubmed/17393191 but there were 13  randomised controlled studies on oral mucositis in December 2010 alone). May I recommend the Thor laser website which is an excellent source of research articles on laser therapy not limited to their own products.

 I'm sure Ann could inform you better than me but the attitude taken by clinics in the UK is that BC patients who have had their cancer treatments (after staging that showed no spread) are not started on either MLD or laser therapy for lymphoedema without an ultrasound scan for evidence of local cancer. Such caution may be overstated but better safe than sorry - we can only rely on live animal studies where cancer is concerned - as only oncologists experiment on human cancer patients (- there! that will annoy someone I'm sure).

Kind regards,

Sarah

I actually did not attempt to "defend" the laser at the NLN session as I believe that it is quite legitimate for clinicians to debate clinical research and it not appropriate for me to be part of that process.  However, I did point out inaccuracies, and continue to do so.

I wrote this following the session.

Those of you who attended the NLN may have attended the session on the pros and cons of laser for lymphedema with a presentation by Geoffrey Basford, PhD (pro) and Andrea Cheville, MD (con).  The concept of the session was great. However, I do have a few comments to make about the session since there was a lack of a clinician who uses laser as a treatment modality and it seems some of the recent trials were not included or at least addressed.

Omar et al, Journal of Surgical Research 2010, reported a randomised double blind study using laser for post mastectomy lymphedema on 50 patients (25 in each group). Patients were treated three times per week for 12 weeks with pulsed 904nm laser at a dose of 1.5jcm2. Patients were followed up at 16 weeks.  Omar showed statistically significant improvements in volume reduction, Shoulder mobility, grip strength in the laser group in comparison with the placebo group.

Kozanoglu et al reported in Clinical Rehabilitation 2009, a trial comparing low level laser and compression pumps on post mastectomy lymphedema patients.) Patients were assigned to receive 2 hours of compression pump over 4 weeks, or 20 minutes of laser over 4 weeks. Patients were followed over 12 months.  There were 47 patients.  Improvements to limb volume were significant in both groups, but still significant at 12 months in the laser group.  (The improvement was greater in the laser group). The authors concluded that the laser group had better long-term results than the pump group.

These controlled clinical trials both demonstrated efficacy of laser in treatment of patients with lymphedema and were not mentioned in the debate. They add to a continuing list of laser for lymphedema evidence including another 2  blinded studies by Lau et al (n=21) and Kaviani et al (n=11).

There was considerable criticism about the Carati et al RCT using laser for lymphedema.  As I pointed out during the comment period, it is quite reasonable and appropriate for clinicians and scientists to critically review published material, however, I was quite surprised at the level of criticism, given the well recognised view that clinical evidence for treatment of lymphedema is poor.  The Technology Assessment Diagnosis and Treatment of Secondary Lymphedema, May 28 2010, for the AHRQ Tech Assessment Program (US Dept of Health and Human Services) reported on the evidence to support the diagnosis and treatment of lymphedema.  The report was a systematic review of the literature to support the treatment and diagnosis of lymphedema. Interestingly, the Carati trial was the only RCT that received a "Jadad" score of 8. (information about the Jadad score is available in the report).  So, in the context of lymphedema trials, an independent review reported the Carati trial as the highest rated RCT for lymphedema studies.

Andrea did not review ALL of the literature.

At the session I corrected the inaccurate statement that the laser was cleared as a heat lamp. The Laser was NOT cleared as a heat lamp. I will follow up with FDA documentation regarding this as it to settle it once and for all.

Ann

I am anxious to trytheccold therapy. Can you tell where you went so I can peruse treatment.