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« Is Botox & Restylane carrying your Medical Spa? | Main | Medical Spa MD: It's the Cook's Fault... Not the Stove! »
Thursday
Sep172009

The U.T. Zerona low level laser Study... A Pig is NOT Just a Pig!

I'd like to issue a rebuttal critique, if I may, regarding the University of Texas study on the ZERONA low level laser entitled the "Effect of Low-Level Laser Therapy on Abdominal Adipocytes before Lipoplasty Procedures".

I know there has been a tremendous amount of skepticism regarding this technology and I just want to share with you my thoughts, as fellow colleagues. If anything, it is continuing the valuable discussions we have here in our group that compels me to write this.

If you are not familiar with this study, it involved the use of a swine model. This is an area I am most proficient with. I was a veterinary technician before I became a nurse. I used to run the "pig labs" for clinical research and physician training for a major medical device company and have much experience in 510K clinical trials and was well regarded as a swine expert. I tell you my background only to hope you find validity in my critique.

My biggest problem is with the 300 lb.Yucatan pigs they used in the study. There are many categories of swine for use in experimental procedures and research with some being favored for one reason or another. The more proper Yucatan pig to use for any transdermal study is a Yucatan micro-pig (about 30 pounds) which has a skin thickness similar to that of human skin, and they are relatively hairless. This breed of pig was specifically bred in the swine labs at the Colorado State University in 1978.

I'm not certain as to why these researchers decided to use 300 pound Yucatan pigs with their incredibly thick skin and coarse hair. Perhaps they thought a pig was a pig. Perhaps they wanted to see if the Erchonia laser could penetrate steel... perhaps they know something about research pigs I don't My point is, there is more to this study than what seems to be "obvious" to some.

Here are two famous references I can direct you to to validate my statement that they used an inappropriate swine model:

1. Comparisons of in Vitro Nitroglycerine (TNG) Flux Across Yucatan Pig, Hairless Mouse, and Human Skins. Journal of Pharmaceutical Research. Springer Netherlands, publisher. ISSN: 0724-8741, Vol 7, Number 6. June 1990.

2. Fujii M, Yamanouchi S, Hori N, Iwanaga N, Kawaguchi N, Matsumoto M. Evaluation of Yucatan micropig skin for use as an in vitro model for skin permeation study. Biol Pharm Bull 1997 Mar; 20(3):249-54.

My other problems with the study include:

1. The pig underwent one ZERONA session, not the standard protocol of 6 (3 a week for 2 weeks).
2. No flushing niacin or any substantial vasodilator was used to facilitate fat transferral out of the interstitial space.
3. The Erchonia lasers were positioned 12 inches above the skin when they shouldn't be any further away than 6 inches.
4. The pig was immediately euthanized on the operating table after the single treatment. How are the adipocytes supposed to render any changes in morphology if the host is dead?
Clinical studies are always under scrutiny and this study is no exception. I'd bet a guess that you will start seeing more positive reviews of the ZERONA low level laser in the months to come. And, I base this on the sheer science of the technology. Only time and true trials of the device will tell.

Author: Paula D. Young RN runs internal operations and training at Young Medical Spa and is the author of the Advanced IPL & Laser Training course for medical estheticians and laser technicians.

Submit a guest post and be heard.

Reader Comments (34)

It would seem the author is right, One of the investigators at UTYSW coincidentally the incoming president of the ASPS just completed a human trial and saw excellent results and is now a paying customer.

There are still no long term studies to suppor tthe use of the Zerona LLL. There longest study is 2 weeks after the last treatment. Also, when you talk to users of Zerona they conitue to add to the protocol. I now hear that they are usinf niacin flushes, dietary restrictionsa and high volume costly nutritional supplements. I even know of one clinic that is using their VelaShape and compression garments to assist the Zerona.

So my question is that if Zerona is so great then why do you have to add all of the other things to make it work? I would like to see a study that lasts longer than 2 weeks after the last treatment and then looks at all of the additional things added on with and without the Zerona. At this time, I think the Zerona is nothing more than a placebo (a very ewxpensive one at that). They need to PROVE that the Zerona works and has long term benefits for the patient.

09.19 | Unregistered CommenterLH

Hi Paula,

Well we know that you think its a promissing technology. You also know that those of us who have survived so far are very skeptical of company claims even when they are backed up with white paper research.
My question to you is if you would be willing to post some of your before and after pictures so we may judge results from one of our own.
I have my actual Smartlipo clients before and after on my website. Perhaps you have the same on yours for the Zerona and you can direct us there.

I really want to believe a cold laser could reduce inches but I cant get there mentally yet. Help us.

Yours,
Mark

09.19 | Unregistered CommenterMark

Hi Mark,

Yes, I most certainly will post actual photos once our patients have completed our study. We had to send our first unit back that had an electrical problem. Also, we are trying to find the best protocol that will give our patients the best results.

We do start them on the Curva supplements and, as LH mentioned above, we are the facility that gives each of our patients a compression garment and the endermologie effect of the VelaShape to help facilitate the leaked fat out of the interstitial space. Let's face it, the cells aren't being lysed, they're being leaked. So we want to help get that fat out of there and off to the lymphatic system as fast as we can before the adipocyte reabsorbs it.

It's really hard to wrap your brain around this whole technology, isn't it? I just think it's exciting that there is, at least, an opportunity to do so and that technology is advancing!

Regards,
Paula

Paula: Perhaps you could try a "split body" study and do everything the same with each patient except that on the left side of the body she would receive the Zerona treatments and on the right side she would not.

Hopefully someone can come up with a better technique for measurement than the old tape measure as that is so easy to manipulate. Maybe you can get a copy of the writeup of the "human trial" mentioned by Peter Close in his post of Sept 18. I think a lot of us would like to see proof that this technology works -- it just seems hard to believe when you take into account basic laser physics. Using the low energy levels they are using I cannot imagine that ANY photons are penetrating into the subcutaneous fat. I would love to be proven wrong.

Here's what's hidden in the fine print. The promises you get of losing 8, 10, 12 inches ... that's collectively from every part of your body. As in an inch from your arm, an inch from your thigh, a half inch from your stomach. I an 5 treatments into the program, I asked when I'd see the six inches melt away from my waist. "Uh, a week to two weeks after you finish."

Somebody's gonna sue. It might be me!

11.12 | Unregistered CommenterHall

In the nearly 100 patients we've treated in the last 16 months, we've had inch-loss that is within 5% of the average inch loss reported in the initial studies. Each area of the body loses about 0.5 to 1.5 inches of circumference every two weeks of treatment. If you think it's 'no big deal' to lose an inch off your waist on your own in two weeks without changing your diet/activity, I urge you to try it yourself! Some of the most satisfied patients are those who are on the lower half of the inch-loss spectrum--this is because they are pretty 'lean' to begin with and are looking for more muscle definition, etc. One of my most unsatisfied patients lost over 12 inches of combined circumference because she didn't' lose the inches where SHE wanted to. At this point, there's no way to predict which areas respond better, although we usually get the most inch-loss in the lower abd. I urge skeptics to review Niera's extensive MRI/CT/SEM studies to learn what happens to adipocytes (fat cells) under the influence of this type of phototherapy. My wife was the biggest skeptic, until she lost six inches. Also we are very up front with patients that half of all patients keep off the inches over six months, and the other half do not.
Sincerely,
Dr. B.

50% recurrence rate in six months, Dr. Bauman? And shouldn't the fat be lost in the areas that were specifically targeted, rather than all over?

This sounds more like the effects of a temporary diet / exercise / metabolic change.

I have reviewed the studies, and the alleged physics of this device continue to mystify me, despite my undergraduate work as a physics major.... Show me a split body study, with blinded observers.

11.13 | Unregistered CommenterTF

I agree with TF. The longest study they have is 2 weeks after the final treatment. Until they have long term studies to support their claims I would not waste my money or a patients money on this. This is no more than VoDoo medicine.

11.15 | Unregistered CommenterLH

Actually, there seems to be some systemic effect--this was brought to our attention from patients. Then we started to measure it. Not sure if there is something akin to a paracrine release going on. A split-body study on LLLT? That surely goes against 90% of the published literature that I'm aware of. In the photomedicine literature (ASLMS), it's well known that photochemical treatments can have some systemic effects.
The inches are coming off in other areas, like the arms even though we are not lasing those areas. Also, you might want to remember that the double-blind, randomized, multi-center clinical trial was placebo-controlled using a sham-device. Those trial patients also didn't do any adjunctive lifestyle changes, massage, garments, etc. and they lost about an inch off of each area in the two weeks.

For physicians who are confused about the science of photochemisty, I urge you to speak directly with Dr. Ryan Maloney PhD, or just watch the video: Photochemistry of LLLT's effects on adipocytes It's only "voodoo" until you understand the mechanism.
Zerona is NOT a long-term fix. Patients that do any kind of body-slimming treatment, diet, surgery, exercise, etc. all understand that there is no such thing as a one-time cure or fix.

I watched the "scientific" video by Ryan Maloney, PhD.
I would consider that as "marketing material", not convincing science.

Still can't find any independent papers (not written by Neira et al) on LLLT effects on fat in any Medline- searchable medical journals.

Call me unconvinced.

11.17 | Unregistered CommenterTF

The fact that this is being touted on daytime TV tells you something right away. Remember how LASIX was marketed? With a huge number of studies and board-certified physicians backing it up. Until there are conclusive studies available, this is just another 'come-on' like organic ED pills hawked on late-night TV

11.21 | Unregistered Commentermitch

I am attending a Zerona seminar this week. What would be some good questions to ask? I guess one would be the existence of any long term studies. What has been your collective feedback on patient satisfaction after undergoing Zerona?

12.14 | Unregistered Commenterbarwest2

So would everything that's been said about Zerona apply to the Lapex 2000 also? Does anyone have the Lapex 2000 and would like to share some thoughts?

12.17 | Unregistered Commenterclh

Barwest,

If you are planning on meeting with the Zerona people, You should ask them how you could make your patients happy when they are paying me $2,000 to $3,000 and only noticing a difference of an inch or two all over. Also, you could ask you could demo a unit for a week or two to find out for myself if this machine is as good as the Zerona people claim it is. But mostly I would ask myself a few questions before attending a high pressure sales pitch. I would ask myself how I would handle patients demanding their money back because they did not see a result and what that might mean to my reputation. Further, I would do research on patient satisfaction so far with this machine. One way would be to go to www.realself.com and type in "Zerona" to read what patients are writing about their experiences. Also, I would call at least 10 businesses which already have this machine and ask the owners what they really think about it.

By going to a Zerona sales talk, you might not be able to perform an objective opinion of how well this machine actually works (or dosen't). If you have some time before you buy, try to research all the non-surgical fat melting machines and demo them in your office. The objective, of course, would be to find a machine with the least possible cost that will perform the best. Whether that machine is named Zarona, I am quite skeptical.

Wendy Hovorka

12.17 | Unregistered Commenterwendyh

Almost one month and no posts. Barwest, how did your seminar go?
Wendyh - reallife.com shows roughly a 20% satisfaction rate ... uh.. wonder
how many of those 'satisfied' posters are legit?

01.14 | Unregistered CommenterAMR

AMR,

I honestly have to tell you that we have a pretty decent satisfaction rate (70-80%) with the Zerona. The main point is that people are interested enough to call and schedule a consultation. Once we discuss their options, most are too large for the procedure or don't want to commit to the regimen. Any regimen, really, so they then choose to undergo Smartlipo, SlimLipo, Vaser or Body-Jet.

For those patients that are not candidates, medically, for a lipolysis procedure or choose not to have anything minimally invasive done to their body, the Zerona has been working just fine and they are pleased with their results. We are averaging a loss from 3 to 8 inches. For most, they're quite happy with being able to fit back into their pair of jeans again (see the profile of us on NBC 10 Philadelphia News: http://www.youtube.com/watch?v=iWI0DWl78HM). It gives them that little extra push that they needed.

We like the fact that we have a variety of procedures to fit everyone's needs and we are very up front with our patients as to their expectations, commitment and the cost of the procedure. To those patients who decide to move forward, it's worth it.

Some practitioners balk at the cost of the procedure for "what you get", but honestly... people can complain even after undergoing a more permanent procedure like laser lipolysis. You can't make everyone happy, but you can give them the best opportunity to try.

"We are averaging a loss from 3 to 8 inches"

Are you saying 3-8 inches from one site? ie one tape measure at one site on the waist or are you reporting a combined total of 3-8 inches from multiple sites? ie 0.25 + 0.25 + 0.1 + 0.3...................

They are, of course, two totally different things. Going from a 32 inch waist to a 24 inch waist is one thing (and one that I am going to have to see to believe), going from a 32 inch waist to a 31.75 inch waist is something else.

01.14 | Unregistered CommenterEC

EC,
Yes, it is a cumulative inch loss. Primarily what we have seen is that the majority of the inch loss is in the abdomen, waist and thighs and this is exactly what our patients were looking to achieve. For example, going from a size 10 jeans to a size 8 or 6 is awesome for most women and most of the time all it takes is an inch or two off the midsection of your body. Personally speaking, I don't like hanging over the sides of my jeans, so to lose that is awesome for me especially when my diet and exercise aren't doing the trick in that particular portion of my body (thanks to childbirth). I'd much rather add that type of treatment to my regimen than a minimally invasive procedure, if I could.

I am considering incorporating the Zerona into my practice, but unfortunatley it appears that most of the reviews are very negative. Why, if this technology is as good as advertised aren't more "satisfied customers" coming to sing its praises. Any feedback from those using The Zerona would be greatly appreciated. Dr. D

01.26 | Unregistered CommenterDr. D.

It seems like this treatment is somewhat systemic and not entirely localized to the abdomen. Have women noticed a loss of breast fat and a decreased cup size? This may not be a desirable place to lose fat.

01.29 | Unregistered CommenterDDK

DDK-- There is a study reporting the results of treatments done on a small number of subjects with the Zerona laser in the December issue of the ASLMS journal. You might want to try to obtain a copy so you can read it to see what the company is claiming is the mechanism of action, etc. I am still perplexed how the company has been allowed to continue selling the laser for a claim that is so far outside the cleared claim in their 510(k) (pain relief). They have never been cleared by FDA - to my knowledge -- to say ANYTHING about fat reduction or "slimming". They must have excellent legal counsel!

The results (or lack of I should say) reported in the study would be a concern to me if I was charging patients several thousand dollars for a series of these treatments. Pretty hard to "under promise" when your results are so under- whelming.

I participated in the Zerona treatment ($2,000 special offer) 6 treatments, supplements, exercise, injections and magic cream. What I found was the initial measurements were taken quite loosley - the follow up measurements quite snuggly. Even then no real loss of inches or body mass. No change in clothing size, no weight loss loss. Just $2000 lighter in the purse. A rip off entirely in my opinion. Trying to get some or all of my money back. So far no response from the VanDerVeer Clinic in Portland OR .

02.18 | Unregistered CommenterNJP

NJP,

I believe where Zerona is going wrong is by marketing on their website that you, as a patient, can expect at least a 3 to 9 inch loss. You should have signed something called an informed consent, which would have explained what to expect after your treatments, any possible complications, etc... If many patients are not noticing results, the consent you signed should have detailed the fact that some patients may not get a result. If I were a patient reading the Zerona website, I would assume that I would get a 3 to 9 inch loss from three areas of my body, unless I signed an informed consent reading otherwise. The following is taken from the Zerona website:

(www.myzerona.com)
"Is it effective?

Yes, with the Zerona® treatment and by following the recommended guidelines for success, you can expect to experience a loss of 3 – 9 inches from your waist, hips and thighs and a reduction in clothes size. Additionally, early patients have noticed an improvement in the appearance of cellulite."
_____________________________________________________________________________________________
Geez, no wonder why the reviews of Zerona on realself are 78% negative. The patients are not typically getting these results advertised on the Zerona website!

Even though Zerona is offering free additional sessions if patients are not seeing results, that still dosen't help a physician's office, who still had to pay for the down payment of the machine and the employee that has to run the treatment. The following is a review from a patient that didn't even want the free sessions. (taken from www.realself.com):

I had the treatment in Oct. I am in a healthy weight range, but would love to lose inches on my thighs. I was already working out 4 times a week and eating healthy. I added walking so that I was excercising every day. I took their vitamins too and drank the recommended fluid intake. We measured and recorded circumfrences at many places on my body. And there was NO result. I really, really wanted it to work. And had I recieved a good result...or any result for that matter...I would have considered doing it again. But I just feel ripped off. I am negotiating with the salon/dr to get other free services to compensate me for my cost. If a deal cannot be had, I will have to blitz all forums like this to spread the word. I am also considering logging a complaint with the FDA. I think that may be more influencial than sueing. Goto www.fda.gov. If they recieve enough complaints the FDA will investigate and fine the company and could ask for the product to be withdrawn from the market becuase of misleading labeling by the company as well as by the service providers.

View 4 repliesreply

cinmannon
11 posts
4 Dec 2009Im right there with you, let me know what happens and if i can help!

reply
Trikkegirl
52 posts
6 Jan 2010I feel the same way you do. I had no results and spent $2400. The way they have their calculations set up, it is tilted in their favor. You may not get any visible results, but may still "lose" at least 3 inches from all the areas they measure combined. I feel rippied-off too. My doctor is not even offering a "redo" to see if 6 more treatments may provide some result. I am greatly disappointed and feel that the FDA should reconsider this one.

reply
JOJO47
7 posts
8 Feb 2010I agree that the system is set up so they always show the required 3 inches. Take your measurements wiht a tape measure at the neck, bust,arms, knees, abdomen, hips and thighs and then do it again imediately afterward and you can easily come up with a three inch difference in either direction. The sad part is that almost all of my supposed "5" inch loss was from my knees and one thigh hmmmm. Luckily my thighs are still both the same size and I attribute the strange measurements to simple user error on the part of the girl doing the measuring. Unluckily for me and many others, is that all of me is still the same size dispite my supposed "success". I think Zerona should, at the very least, show where the weight is normally lost and maybe people would understand it's not necessarily from you desired area but more likely from the bust, knees, neck etc. I certainly wouldn't have signed up to pay $2000 to lose weight in my knees.

reply
Trikkegirl
52 posts
10 Feb 2010JOJO47, why don't you post your own review? Just so the numbers also include your negative experience in the percentage for overall satisfaction.
_______________________________________________________________________________________________

There are so many of us in the Cosmetic surgery/Medispa community these days that it seems to me like we need to form some sort of organization that independently tests the "latest and greatest" of what is coming out on the market. So many of us are just relying on fancy marketing ploys and believing fake promises of what paid researchers say these machines can do. This just isn't fair to our patients and to ourselves as medical professionals.

-Wendyh

02.18 | Unregistered Commenterwendyh

It is very funny that everyone on this website is arguing about the Zerona data, now I have posted several times on this blog and I remain indifferent.

But I dare anyone to produce a double-blind, placebo controlled trial for any other device besides Zerona! Produce a proper clinical trial. Provide the link or citation.

We talk about data, long-term data, and LH loves to bring up long-term data and he compares it to other trials, but LH, when you have long-term data from a non-randomized non-controlled trial, what do you have? Truly. I am not trying to judge or disrespect anyone, but if you examine 150 patients and do not compare to a control group, a placebo-controlled group of equal number you cannot statistically determine if the outcome is because of the treatment of normal course of dieting, exercise, etc. Moreover most trials you quote actually take that long to produce a result, that is not long-term data, that is a result that finally begins to become clinically meaningful

We talk about misrepresenting data; the Zerona is the only placebo-controlled trial, plain and simple. Now, I am not saying it works, nor will I comment on patient satisfaction, I just do not care. Of course patient satisfaction is important but that should not be under the same thread that discusses the clinical trial. The important thing is what type of trial was done if we are talking science, if we are talking outcome and money and satisfaction do not talk science.

Let's analyze their trial, and compare it to what is out there. Further, everyone stop quoting realself.com, do you not understand that sales reps. and other company members are most likely posting on that website and purposely putting negative comments.

So, please, show me another placebo-controlled, double blind randomized trial for the following companies and I will openly admit I am wrong and stop posting:

Zeltiq
Thermage
Ultrashape
Velashape
Liposonix

02.19 | Unregistered CommenterDr. H

I have taken the time to provide citations for all other clinical trials. Please review, and if you do not question these than you do not understand what a Level I study is? None of these trials are placebo-controlled, double-blind, randomized trials. What do we want for our industry, better trials, or not? We need to separate ourselves from non-peer reviewed sites and demand companies to produce these trials. We need higher study standards from our trials, the consumer is so overwhelmed with offers of fat loss and weight loss, we need to reestablish why they come to our clinics.
http://clinicaltrials.gov/ct2/results?term=Zeltiq
http://clinicaltrials.gov/ct2/results?term=ultrashape
Characterization of Non-thermal Focused Ultrasound for Non-invasive Selective fat Cell Disruption (lysis): Technical and Pre-clinical Assessment
Spencer A. Brown, Lior Greenbaum, Stella Shtukmaster, Yehuda Zadok,
Shmuel Ben-Ezra and Leonid Kushkuley
Body contouring by non-invasive transdermal focused ultrasound
J. Moreno-Moraga *, T. Valero-Altés, A. Martínez Riquelme, M.I. Isarria-Marcosy, J. Royo de la Torre
Instituto Médico Laser, Madrid, Spain

Non-Invasive Body Contouring By Focused Ultrasound:
Safety and Efficacy of the Contour 1 Device in a Multi-Center Controlled Clinical Study
Advances in Technology-Based Eyelid Skin Rejuvenation
Brian S. Biesman, MD
Cosmetic Dermatology, 2007
Results of a Survey of 5,700 Patient Monopolar Radiofrequency Facial Skin Tightening Treatments
Jeffrey S. Dover, MD, et.al
Dermatology Surgery, 2007
Clinical Parameters for Predicting Efficacy and Safety With Nonablative Monopolar Radiofrequency Treatments to the Forehead, Face, and Neck
Gordon Sasaki, MD et.al
Aesthetic Surgery Journal, 2007
A Randomized Trial to Determine the Influence of Laser Therapy, Monopolar Radiofrequency Treatment, and Intense Pulsed Light Therapy Administered Immediately after Hyaluronic Acid Gel Implantation
Mitchel P. Goldman, MD et.al
Dermatologic Surgery, 2007
Monopolar Radiofrequency Skin Tightening
Manoj T. Abraham, MD et.al
Facial Plastic Surgery Clinics of North America, 2007
Evaluation of the Multiple Pass, Low Fluence Algorithm for Radiofrequency Tightening of the Lower Face
Melissa A. Bogle, MD et.al
Lasers in Surgery and Medicine, 2007
Radiofrequency and 585-nm Pulsed Dye Laser Treatment of Striae Distensae: A report of 37 Asian Patients
Dong-Hye Suh, MD et.al.
Dermatologic Surgery, 2007
Monopolar Radiofrequency Treatment of Human Eyelids: A Prospective, Multicenter, Efficacy Trial
Brian S. Biesman, MD et.al
Lasers in Surgery and Medicine, 2006
The Role of Deep Heating for Noninvasive Skin Rejuvenation
Christine C. Dierickx, MD
Lasers in Surgery and Medicine, 2006
Monopolar Radiofrequency Facial Tightening: A Retrospective Analysis of Efficacy and Safety in Over 600 Treatments
Robert A. Weiss, MD et.al
Journal of Drugs in Dermatology, 2006
Effect of Monopolar Radiofrequency Treatment Over Soft-Tissue Fillers in an Animal Model: Part 2
Peter R. Shumaker, MD, et.al
Lasers in Surgery and Medicine, 2006
Effects of Monopolar Radiofrequency Treatment Over Soft-Tissue Fillers in an Animal Model: Part 1
Laura J. England, PhD et.al
Lasers in Surgery and Medicine, 2005
Current Concepts in Nonablative Radiofrequency Rejuvenation of the Lower Face and Neck
Manoj T. Abraham, MD and E. Vic Ross, MD
Facial Plastic Surgery, 2005
Lasers, Light and Radiofrequency for Treatment of Acne
Christine C. Dierickx, MD
Medical Laser Application, 2004

Trade Publications and White Papers
Clinical Advancements and Innovative Techniques in Non-Ablative Monopolar Radiofrequency Energy for Smoothing, Tightenin and Shaping the Thighs
Gregory Nikolaidis, MD
White Paper, 2007
Clinical Roundtable: Skin Tightening Pioneer Continues to Answer Consumer Demand
Lara G. Owens
Aesthetic Buyers Guide, 2008
Thermage ThermaTip CL: A Single Treatment, Non-Invasive Option for Improving Cellulite
Mitchell Chasin, MD
Aesthetic Trends & Technologies, 2008
Thermage Enters Body Shaping Arena with New ThermaTip DC
Lara G. Owens
Aesthetic Buyers Guide, 2007
Expanding Aesthetics: Is It Time to Include These Treatments in Your Practice? Aesthetics for the Ophthalmic Practice
Cataract & Refractive Surgery Today, 2007

02.19 | Unregistered CommenterDr. H

Hi - my name is Dave; I am writing on behalf of ZERONA and Erchonia.

I noticed this blog is actively engaged in discussion on ZERONA and hoped to provide a bit more information:

Erchonia tested ZERONA’s effectiveness in body contouring with a double-blind, placebo-controlled, randomized study. The study was submitted to the FDA pre-ide, the company followed the criteria set forth by the FDA, and an independent company monitored the trial. The ASLMS published this study which can be found at: http://www.sbmi.com/pdf/LowLevelLaserTherapy2009.pdf.

While the research was sponsored by Erchonia (manufacturers of ZERONA), no employed member of Erchonia was involved in the patient recruitment or clinical trial process.

RealSelf.com is one of many venues patients have to talk about their experiences with ZERONA. We can point to many great success stories reported from both doctors and patients, some of which are on our site: http://www.myzerona.com/patient-stories. We are also compiling these stories on our upcoming blog which will feature testimonials and additional before and after pictures.

There have been some concerns posted about the language on our site, that it is perhaps fueling unrealistic expectations from patients. We are looking at our messaging and are drafting revisions in order to better educate potential patients. Although Erchonia’s clinical trial proves an average of 3.65 inches lost from the waist, hips and thighs, ZERONA is not effective for everyone and we want to make sure patients understand that going in.

Another important aspect that sets ZERONA apart from competitors is that in over 30 years of research with low level laser technology, not one patient has experienced negative side effects.

If any of you has any further questions, either personal or on the technical side, we invite you to send us an email at feedback@sbmi.com and we will get back to you ASAP. You can also talk to us on Twitter @myzerona or Facebook, keyword Zerona.

02.22 | Unregistered CommenterDavid A.

Since I'm the one who started this who controversial post about the U.T. Study of the Zerona laser, I thought it was only appropriate to include this TV News coverage of Dr. Kenkel. As you may or may not know, Dr. Kenkel was involved in the original porcine study. The highlights of this news clip? 7 clinical trials, 90% of his patients saw dramatic results and he used a 3D measuring device to demonstrate the results.

http://www.nbcdfw.com/news/health/Some_Doctors_Using_Laser_to_Zap_Fat_Dallas-Fort_Worth.html

Dr. H,

First of all, you say to quit quoting realself because you believe sales reps from other companies are on there posting. I'm going to have to disagree on that issue. While is is possible that some fake people may get on there and quote how "great" their results were, I highly doubt the patients who are upset about the outcome of their Zerona treatments are from other competing companies. Years ago, when Mesotherapy first came out, I, myself had to be the first in line to try it out. I suffered an immediate infection, with a distended black and blue stomach for one month and I was in considerable pain. Needless to say, I was very angry that the medispa that performed the service refused to look at my result, or give me my money back for the remaining sessions. I had to complain to the state board, and anyone on the internet that would listen, so I know in a way what these patients are going through when they are stating they paid money for sessions and did not see a result. It makes you really mad. By the way, my above post was addressed to a patient who had posted on here above me not to you. Of course you are welcome to read it, but unless Jeff takes my post off, I have every right to post my opinions (even if you do not like them) at will do so at my will.

My husband is a Surgeon who specializes mainly in Vascular Surgery (venous insufficiency) but we do cosmetic surgery on the side. Our cosmetic side is probably one of the only few that specializes in nothing but melting fat and tightening skin both surgically and non-surgically. In fact, we were one of the first surgery centers who started using the Coollipo laser as we had been using the laser for our laser vein ablations for quite some time when CoolTouch gave us the attachment head to do laser-assisted lipolysis way back in 2006. With my Lipotron Radiofrequency machine, I have performed hundreds of procedures on patients over the last two years. The average amount they have lost has been 2-3 inches in ONE area. (some patients have lost as much as 7 inches in ONE area but results not typical). Even if I do not agree with others opinions on here, (such as yourself with a few points you mentioned) I fully respect what you have to say and look forward to debating topics such as these.

As for not caring what the patients think, that statement baffles me. I guess you were trying to emphasize that the research or "science" is more important than what patients think. My education and background is in marketing/business and from this perspective, I want our patents to leave after Liposuction or RF very happy, so what the patients think is very important to me. More specifically, what patients think is our livelihood and literally what feeds our family. I know I personally could never just take a patients money, not give them a result I had promised, then tell them to go away because there is a study out there that is "double-blind, placebo controlled" that states that 63% of patients with lose at least 3 inches from their neck to their knees, and hey I guess you were not in the 63%. Sorry. I believe you have to combine science and implement such science into your practice that not only you believe in based on research, but what would also be best for your patients needs.

And while I'm on my soapbox, lets go over this study again. Are we talking about the study that was published in Lasers in Surgery and Medicine 41:799, 2009? I guess I am having some issues with the fact that one is the authors is the CEO of Zerona and also holds the patent to the devise. And why, by the way, does the author on you tube state that he is a PHD, while on the study it is stated that he holds a BS (this does sound like a bunch of BS dosen't it?). Not to mention the fact, one of the authors does not have a degree at all, which is fine and all because you don't have to go to college to be a scientist, but does not lend credibility. So if this is the study that other medical professionals need to strive for in order to figure out what non-invasive fat melting devises would be good for their patients, I'm sure it won't be to difficult to match this. We just need to call the companies of Zerona's competitors and tell them that in order to create the same study, we need to have the CEO, who holds the patent to the machine, help conduct the study and make sure they get an assistant without a college education to even the playing field. I'm being idealistic here, but wouldn't it be nice to have studies where the CEO's or Physicians have no financial commitment to the machine they are studying?

Getting back to Zerona/Erchonia study, sponsored by Zerona, 37% of the respondents did not get the 3 inches all over loss. I guess this is why there are some unhappy people complaining on, do I dare I say it, realself. I am glad Dave from whatever his position at Zerona, has written in stating that Zerona will change the marketing on their website to include more realistic predictions on what they can expect from their treatments. Thank you Dave. Maybe some of the patients won't be as unhappy now if there is a clause in there that states they may be in the 37% that does not get a result. Although I am not sure if they will still feel they are getting their money's worth at the pricing point they are paying. The low level laser technology such as Zerona and Lapex probably does work and would probably work even better in combination with RadioFrequency, and I would love to try both modalities out together to increase patient satisfaction (wouldn't it be great to average 4-5 inches lost in one area instead of 2-3!) if only the price would go down for both physician to buy and patient to try. I just don't think my patients would pay between $1,800 to $3,000 for six sessions in addition to what RF costs when Liposuction produces a more dramatic result and cost less than the two combined.

Additionally, I am interested in hearing from physicians who have tried both low level laser with RF. Also, any patients out there reading these posts, PLEASE keep giving us feedback about these new devices positive or negative whether you feedback is on here or on realself. For every one physician who does not want to hear what you have to say, probably 100 more do. For a physician who makes honest, unbiased judgments, your feedback helps him/her to look into technologies that will best suit you.

Thank you for reading my long, rambling message.
-Wendy Hovorka

03.1 | Unregistered Commenterwendyh

Spring 2010 - Zerona doesn't work. Maybe it works for some, but not for me and a lot of other people on the internet. Save your money and time. I wonder if people providing this "service" have been reported to government agencies for fraud.

05.7 | Unregistered CommenterGinnie

I own a large chain of weight loss clinics in the UK. We have been in business for over 7 years and during this time we have used various technologies to assist with client demand for inch loss treatments.

We use LLL in all of our clinics.

I am not clinically/medically trained so my experience with LLL is based on a layman’s observation having managed a business that has completed over 450,000 treatments.

The first thing I will say is that the use of LLL results in an immediate inch loss (between 0.5 – 1 inch from the abdomen is a realistic average to quote).

However, if this is not followed up immediately with some form of exercise/lymphatic stimulation it will not stay off for long. Also whilst 0.5 – 1 inch sounds impressive it is not always physically noticeable. Although many clients do say that their clothes feel slightly looser and they feel more toned you would not see the difference with a before and after photo).

I am convinced that on its own LLL is not a satisfactory treatment for inch loss. But it is a good addition to other forms of inch loss/weight management techniques.
We have devised programs that over a four week period result in an average loss of between 8 and 12 cumulative inches.

We receive complaints from less than 0.5% clients and have many positive testimonials/ before and after photos from satisfied customers.

For LLL to be a success I believe manufactures need to become more realistic with the cost of their equipment.
You must also manage client’s expectations. Clients must be made aware before they start a course that their diet and lifestyle with have an effect on the short/long term results.

Finally you must charge a realistic price that matches the average results. If you charge too much you will have a lot of upset clients. (I believe the prices that Zerona and Meridian recommend are way too high).

08.27 | Unregistered CommenterBilly

So folks I have done a little research and if you do a search for Medsurge Advances on this site you will find a response from Travis Mahan. Travis Mahan is the director of sales at the Santa Barbara Medincal Innovations company( great name since they are based in Dallas) The medsurge reputation was not great which you can read a ton about on this site. Jeff can tell you all about Travis. Something smells in here.

Read all the post, confused what I should do. Do I do tickle lipo or zerona or lapex 2000? If I gain a little weight, I hear terrible stories with the lipo, and weight going other places including face. If I do zerona or lapex will it help my weight gain go all over verse right to my love handles? What is your thoughts

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