This is a look at and cosmetic laser review of Zerona lasers, a medical laser procedure that is certainly getting more frequent with laser centers, cosmetic medical practices and skin clinics. This specific critique relates to a unique study named Low Level Laser Therapy Effectiveness For Reducing Pain After Breast Augmentation, American Journal Of Cosmetic Surgery Volume 26, November 3rd, 2009. This comprehensive study was initial available on Medical Spa MD.
1. The first thing they teach you throughout medical school on the way to evaluate scientific studies are who obtained the research. In this instance the patron for this research and review was Erchonia the business that makes Zerona lasers.
2. So , who authored this article? In this instance this article seems to have been written and published by Ryan Maloney. Who’s Ryan Maloney? He’s not just the medical director of Erchonia he literally is one of the owners of the patent of the Zerona laser. Other than you don’t identify his qualifications. We find out he’s certainly not a PhD or physician. Usually it would be right behind his name in the authorship of this article. He shows a direct fiscal gain to write this content in a positive light.
3. Eight subjects did not possess final measurements. The first dilemma is exactly why? Four were in the treated group and 4 had been in the placebo group. Initially that appears OK, but whenever you look further within it, these people retained all of those test subjects contained in the study. They took the last measurements for those subjects and carried them forward. Once again, it looks Ok initially but as soon as you begin to look at the trend of circumferential loss in the 2 weeks post treatment the dimensions are trending back again toward baseline. So if you incorporate these patient’s final measurement (which incidentally is the most desirable overall average circumferential loss through the treatments for the treated group) and carry them forward they are going to artificially decrease the true values two weeks post treatment. All 8 of these individuals should have already been removed from the analysis.
4. There isn’t any examination of aesthetic advantages. To have this be worth anything you would need before and after pictures which are reviewed by several people who are blinded to which procedure the individual participant received. So, to put it differently, is a 3 inch reduction aesthetically significant.
5. They just do not say if patients are male or female. Therefore the question is left, does it work as well on men as it may on women? This may be essential as males generally have thicker skin. Therefore, will the laser penetrate as deep in men?
6. the study was limited to patients with a BMI of 25 to 30. Now I think it is fine to have this limitation as you might have to start your research somewhere. But the limitation is that the article is implying that it will work for all BMI’s. What about the thinner female patient with a BMI of 20 but has a small lower abdominal pooch? Or what about the patient that has a BMI of 35? This should be stated in the conclusion but Mr. Maloney seems to forget this.
7. They also do not state if the patients received their procedures for free or if they were compensated for their time. This is only important for the portion of the study that talked about the patient satisfaction. We need to understand that patients will put a value on the treatment because if something is free their expectations are much lower. their expectations are much higher if they paid $2500 for the treatment. So if this was free to the patient and you could have 30% of the treated group that are dissatisfied or neutral what would that mean to a clinic if the patients are paying for it. I would guess you will have a much higher dissatisfied group that either wants their money back or free procedures. I do not want something in my clinic that has a 30% failure rate.
8. They do not discuss if either group was asked to change their diets. This should be stated up front in the methods portion of the article. They also do not mention if there were any dietary supplements required like niacin. Many clinics using Zerona are having the patients take niacin even Erchonia recommends it.
9. They set the standard for success to be an inch loss of 3 inches or greater. Only 62.86% of the treated group achieved success. So this translates in to a 37.14% failure rate. Again, not something that I would want to stake my reputation on.
10. Now what do the numbers mean? If you ever look at the numbers the patients baseline combined measurement average was 120.31 inches. At week 2 of treatment (the best measurements achieved) the average was 116.79 inches or an inch loss of 3.52 inches on average. This sounds pretty good until you look at the true numbers. Using the numbers from the study this equates to a 2.9% inch loss as measured over 4 areas. Is this clinically (visually) significant? I do not think that nearly all individuals will be able to view a 2.9% change or if they can it will be meaningful.
11. Lets take a look at the 2 weeks post procedure measurements. Remember, these are not true numbers as 4 patients had their best numbers included in these measurements pulled forward and included here. (I think all of their measurements should have been puled out). At 2 weeks post procedure, you see a .31 inch increase from the circumferential measurements at the 2 week treatments. What this equates to is an 8.8% increase in inches in only 2 weeks. So what takes place at 4 weeks? 6 Weeks? So if it were a perfectly linear increase it would only take about 20 weeks or so to be 100% back at baseline. That is if it were linear and I highly doubt it is really a linear response and if i had to guess almost all patients will be back at baseline measurements within 6 to 10 weeks and this is why there are no long term scientific studies. The business has had ample time to generate longer term casestudies they apparently do not want to.
So as you can see, there are a few issues with this article and how it was analyzed and written. The first and foremost problem is that the article was authored by an individual with direct financial interest in the product. The ASLMS journal never should have published this article on account of the authors conflict of interest or it should have a disclaimer prior to the abstract. I have no vested interest in any of these non-surgical technologies and would love to view something like this work and have long term benefits for the patients. I think this technology may have better long term benefits on cholesterol etc. I have heard that there are some interesting studies coming. I just hope they are not written by Mr. Maloney. And for others reading this I assume that Chad works for Erchonia or the advertising company that is selling this thing to anyone they can including chiropractors.
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