Zerona Laser Analysis & Review For Cosmetic Surgeons
This will be a synopsis and cosmetic laser review of Zerona lasers, a laser treatment that is certainly getting a lot more frequent with laser centers, medical spas and medical clinics. This critique relates to a certain report named Low Level Laser Therapy Effectiveness For Reducing Pain After Breast Augmentation, American Journal Of Cosmetic Surgery Volume 26, November 3rd, 2009. The complete guide was first available on Medical Spa MD.
1. The very first thing they educate you on through medical school regarding how to analyze scientific studies are what individuals obtained the actual research. In this instance the sponsor for this research and paper was Erchonia the business that produces Zerona lasers.
2. Exactly who submitted this article? In this instance this article seems to happen to have been authored by Ryan Maloney. Who’s Ryan Maloney? He is not only the medical director of Erchonia he actually is one of the owners of the patent on the Zerona laser. Aside from that you don’t know his experience. We know he’s not even a PhD or MD. Usually it might be right behind his name under the authorship of this article. He shows a special economic gain to publish this article in a beneficial light.
3. Eight individuals did not have finalized measurements. The 1st dilemma is why? Four had been from the treated group and four were in the placebo group. At first that seems to be OK, but if you examine further within it, they retained all of those test subjects within the study. They took the last measurements for those patients and brought them forward. Yet again, it looks Ok to start with but at the time you start to look at the pattern of circumferential reduction in the 14 days post treatment the sizes are trending back toward baseline. So if you ever include these patient’s final measurement (which by the way is the very best overall average circumferential reduction during the procedures for the treated group) and take them forward they’re going to artificially reduce the real values fourteen days post treatment. All eight of those subjects should’ve been removed from the study.
4. There isn’t any examination of aesthetic benefit. To have this be worth something you would have to have before and after pics which are assessed by several people that are blinded to which treatment the particular participant received. So, in other words, is a 3 inch reduction visually significant.
5. They just do not say if patients are male or female. So the question is left, can it work as well on males as it may on females? This is extremely important because men tend to have thicker skin. As a result, 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’ve 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 treatments 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 procedure because if something is free their expectations are much lower. their expectations are much higher if they paid $2500 for the procedure. So if this was free to the patient and you 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 such as niacin. Almost all 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? In the event you 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 many individuals will be able to see 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 treatment, 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 may be a linear response and if i had to guess many patients will be back at baseline measurements within 6 to 10 weeks and this is why there are no long term scientific studies. The organization has had ample time to produce longer term reviews 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-invasive technologies and would love to see 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 research 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 marketing and advertising company that is selling this thing to anyone they can including chiropractors.
Tags: laser clinic, medical spa, skin clinic, Zerona