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I do not want to get all angsty and omphaloskeptic, but I have been thinking more of late about the purpose of the blog and my role in it.  Blogs,and the people who write them,  are ephemeral.  It takes a unique personality and commitment to churn out these essays and commit them to the ether.  Especially since Michelson and Morley.

I have never given much thought as to who our readers are, at least as a composite.  I read most of the comments on every entry and have certainly developed a mental picture of some of our regular commenters, although I suspect I probably do not have even the gender correct most of the time.  The commenters represent a tiny fraction of the regular readers and an even smaller fraction of occasional readers.  It occurs to me I haven’t a clue who the real audience of this blog is.

I write  first for my own education and entertainment, then for the slightly bored and overwhelmed medicine resident, since that is who I spend most of my time educating at work.  Someone educated with an understanding of basic medicine but has more important things on their mind than a need for a detailed understanding of why homeopathy is complete nonsense.  I doubt the majority of my readers are health care workers and I suspect  continuing medical education is not a major part of the blog.

I never considered SBM to be a consumer protection group, but this week my wife showed me a half page advertisement in the local paper, and I realized that not only was the advertisement a good topic for blogging, but consumer protection is a fundamental result of this blog.  There really is no site on the interweb that looks at both SCAM and real medicine with quite the same skeptical eye.  Here is the headline:

A Special Wellness Report

New Medicine Based On An 88- Year Old Theory By Albert Einstein Can Help Almost Everyone Who Is Sick Or Injured!

New?  Well, on the Googles I find the same headline for an identical  ad and the same ill at ease looking dog  going back to 2008 and it was a topic by my second favorite computer in 2009*.

Einstein was one smart person, no doubt, but what does he have to do with medicine? Put your pinky in the corner of you mouth and say “sea bass.”  Sorry. Lasers. Fricken lasers.

Since Einstein came up with the first description of lasers  he is responsible for their medical application. It is a good thing Einstein is dead, as I am not certain if he would be happy to associated with this particular application of ideas.  He was not fond of E=mc2 being turned into an atomic bomb, and, while not as potentially awful as the a-bomb, he was not a fan of the misapplication of any of this ideas.

The advertisement is by Dr. Larry Lytle.  The Doctor is in dentistry (and when I think of universal disease treatments, I think dentist.  Got lung cancer?  See a dentist.  Rabies.  Dentist.  Cavities?  Acupuncturist. But that’s me)  and the PhD is from Donsbach University, an educational facility of suspect provenance.

The advertisement starts with

Registered with the FDA to be 100% Safe

In 2009 the FDA approved the use of “Healing Light” for Osteoarthritis of the Hand.

Evidently, the limited FDA approval was noted and then expanded upon, resulting in 2011 in a warning letter noting

 A review of our records reveals that you did not obtain marketing approval or clearance before you began offering the Q10 Laser and the 808 Enhancer Probe for sale, which is a violation of the law.

and although

A review of our records indicates that we cleared a premarket notification (510(k)) for the Q1000 Laser and 660 Enhancer Probe (QLaser System), K080513, with an intended use “for providing temporary relief of pain associated with osteoarthritis of the hand, which has been diagnosed by a physician or other licensed medical professional.

it was being marketed for other medical reasons.  As a result there is now an asterisk pointing to the bottom of the ad which was not present in 2008. The new warning states

“The QLaser system is indicated for providing temporary relief of pain associated with osteoarthritis of the hand, which has been diagnosed by a physician or other licensed medical professional. No other medical treatment claims are made or implied.”

No other medical treatment claims are made or implied?!?  Lets see.  Lasers can be used

To help almost every health problem ever experienced by a human being!

I guess since no specific disease is mentioned, it qualifies.

It least the description is true.

a somewhat un- scientific description of how this “Healing Light” can potentially reverse the damage done by human sickness and disease…It (low level lasers)  reenergizes the cells  in your body with the right kind and proper amount of healing energy…low level lasers have been clinically shown to reduce pain, reduce inflammation, increase cellular energy, increase cell permeability (so nutrients the cells needs to heal can get into the cell and even help correct faulty DNA*

The asterisk is where the aforementioned warning comes in.  But he summed it up nicely: un-scientific.

Dr. Lytle is understandably coy in his advertisement as to what can be treated with his laser; the FDA is watching after all.  His collected works are not.

…program your Q1000 with CANCELING FLU REQUENCIES and apply your laser preventively.

or

Low level lasers such as the Q1000 that produce soliton waves carry electrons back to the damaged atoms and cells, helping to restore normal DNA composition and normal, positive soliton wave communications between cells.

This process is how low level laser therapy can be effective for diabetes.  Remember that Type II diabetes results when cellular receptor sites have been altered and will not allow insulin to attach.

This reduces the cell’s ability to produce adequate ATP – the cells energy blocks.  When this damaged cell is reproduced millions of times, the result is Type II diabetes.

Low level laser therapy and particularly the patented Q1000 laser produces soliton waves that carry electrons to the damaged cells, restoring their capability to function normally.  Mode 3 of the Q1000 has 29 pre-programmed frequencies that have proven effective at restoring intercellular communication and helping to reduce blood sugar levels for Type II diabetics

Slightly un-scientific seems unnecessarily modest. Of course, his lasers treat pain of all types.

So what are low level lasers?  Lasers that are put on the skin that emit laser light that does not result in heating, usually somewhere in the infrared spectrum.  There is enormous variability in the various low level laser or cold lasers on the market with little (or lytle) in the way of standardization.

The first question is not does it work, but should it work?  Is there biologic plausibility?

Low level lasers are supposed to work by

The photochemical theory, which is not yet universally accepted,  (which) postulates that the absorbed light interacts with chromophores (organic molecules) which in turn modulate cellular activities.

A simple question is how much laser light actually penetrates the skin?  Hardly any.

The intensity of laser radiation reduced by 66% after being transmitted through a 0.784mm sample of human abdominal tissue. In this study most laser radiation was absorbed within the first 1mm of skin.”

and

The penetration of both He-Ne and infra-red lasers was observed for only a few millimeters. The most important absorption was observed at the depth level of 0.4 and 0.5 mm. These results suggested that the dermal vascular plexus barrier seemed to decrease the penetration at that level. This finding should mean that the laser therapy did not have really direct effects on the deep tissues.

It would seem unlikely that the gentleman quoted in one of Dr. Lytle’s testimonials who had relief from passing the laser over his prostate was having effect from the light. If you are a fan of prior plausibility, then low level lasers should only have effects on the most superficial of cutaneous problems.

However, a lack of plausibility is no barrier, since “ the effects can be mediated by many different pathways.”

Wandering the pubmeds and interwebs on low level lasers is a lot like wandering the acupuncture literature. Lasers are popular, has innumerable anecdotes, the validation of those are get paid to offer it and there are enough suggestive  lousy studies to keep the therapy alive.

It is difficult to compare results of the various studies into laser therapy as parameters, when fully recorded, often vary. Different conditions are treated, different dosages utilised and different outcome measures are recorded. Investigative findings are ambiguous. For practically every supportive trial, there is a contradictory counterpart. Laser appears a popular therapy lacking sufficient supportive research.

The is no good biologic reason to think that low level laser would have any effect.  Most of the purported mechanisms are unimpressive and often in cell cultures where that pesky skin is not in the way.  There is apparently no disease that low level laser can’t treat, including acupuncture or perhaps I misread the list. Acupuncture isn’t a disease is it? And it is quantum.

Like the various forms of acupuncture, there is no consensus on where to apply the lasers, what duration, what dose, what wavelength and whether or not to pulse the light.

Like acupuncture the most consistent effect is a decrease in pain, a subjective endpoint that is subject to bias, and like acupuncture, there is no reliable and consistent effect on any objective endpoint.

Like acupuncture, there is a huge literature (4000 on the Pubmeds) of mostly poorly done studies, some showing effect, some not. The Cochrane reviews were not supportive of laser therapy, but note the studies are uniformly lousy.

Like acupuncture, better studies demonstrate decreasing effects.

Like acupuncture, many of the studies are done by believers and published in journals who raison d’etre is the intervention being studied.   There is more than ample opportunity for the N-Ray effect.

Like acupuncture, reading the literature suggests there is no reason for lasers to have any real effects beyond placebo, which regular readers know I consider to be no more than the patient convincing themselves they are improved when, in fact, they are not.

The status of laser therapy is not unlike that of acupuncture a decade ago: a complete mess from which you can draw any conclusion you like, but, given prior plausibility and every helpful rules of Ioannidis, suggest that it is all sound and fury signifying nothing.

Unlike acupuncture I would not totally dismiss low level laser.  Superficial benefits, like minor wound healing,  are not without plausibility, but probably of little clinical relevance.

I suspect that time and careful studies on the efficacy of low level laser will have the same results as the last decade of acupuncture studies: there is no there there.

If I were a potential consumer of medical products advertised in my local paper, I think I would pass on laser therapy. Don’t go into the light.

* I did not read Orac’s column until after I had written mine. Really.  Great minds often think alike.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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Posted by Mark Crislip