This will be a comparison and cosmetic laser review of Zerona lasers, a medical laser treatment that’s starting to be a lot more frequent in laser centers, skin clinics and plastic surgeon clinics. This unique examination pertains to a unique study entitled Low Level Laser Therapy Effectiveness For Reducing Pain After Breast Augmentation, American Journal Of Cosmetic Surgery Volume 26, November 3rd, 2009. The full study was first shared on Medical Spa MD.
1. The very first thing they coach you on throughout medical school concerning how to appraise research is exactly who obtained the analysis. In this case the actual backer for this research and paper was Erchonia the business who makes Zerona lasers.
2. So , who authored this great article? In this case this article looks to have been written by Ryan Maloney. Who is Ryan Maloney? He is not only the medical director of Erchonia he literally has ownership in the patent of the Zerona laser. Aside from that you don’t know his experience. We discover he’s definitely not a PhD or doctor. Normally it will be behind his name beneath the authorship of this article. He has a direct economic gain to post this article in a positive light.
3. 8 individuals do not have final measurements. The first query is why? Four were in the treated group and four had been from the placebo group. At first that would seem OK, but at the time you look further into it, these people kept all of those test subjects included in the study. They took the last measurements for all those patients and carried them forward. Once more, it looks Ok to start with but while you start to look at the trend of circumferential loss in the fourteen days post treatment the sizes are trending back toward base line. So if you include these individual’s last measurement (which by the way is the most desirable total average circumferential reduction during the procedures for the treated group) and carry these forward they’re going to artificially decrease the real values two weeks post procedure. All eight of the individuals should’ve been eliminated from the study.
4. There isn’t any examination of aesthetic benefit. To have this be worth a thing you’d probably want before and after pictures which are examined by a group of those that are blinded to what procedure the individual participant received. So, put simply, is a three inch loss aesthetically appreciable.
5. They just do not assert if participants are male or female. Consequently the question is left, does it work as well on men as it will on women? This might be vitally important since men generally have thicker skin. As a result, can the laser penetrate as deep in guys?
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 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 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 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 might 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? As soon as 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 most 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 treatment, you view 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 usually a linear response and if i had to guess most patients will be back at baseline measurements within 6 to 10 weeks and this is why there are no long term medical studies. The organization has had ample time to create longer term reports they apparently do not want to.
So as you can view, 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 because 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 reports 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 and marketing organization that is selling this thing to anyone they can including chiropractors.