7

Zerona is a laser based non-invasive procedure that claims to reduce fat in targeted areas. They also appear to be FDA approved. However, I have seen claims that the FDA approval is not based on any efficacy testing, merely safety.

In addition, the commonly stated claim is that the treatment can remove up to "7 inches". However, this is a total reduction in at least four circumferential measurements around your body, which is a very vague and mutable standard, which is subject to a LOT of variables. Further more, the treatment requires you to stay on specific dietary standards, take a supplement, and drink 64 oz of water a day for it's duration.

There is enough here to be skeptical of it, but I have not heard much outcry against it, so I'm wondering if there IS any evidence it works, despite my reservations.

  • @xiaohouzi79 - That's because up until now none of the answers I've gotten to any of my questions have been complete or informative. Go check them out. I think the problem is that I'm used to looking things up and finding answers for myself, so I only have questions to put up here for which the information to answer them isn't readily available online or is unknown. – John Rhoades Jun 7 '11 at 13:20
  • 1
    The answer is yes, Zerona does have an effect on body fat. I am one of the 25,000 people who have been treated with Zerona. I noticed a great reduction of body fat after receiving 9 sessions (nine) of Zerona. I drank lots of water and was told to avoid fatty foods and to exercise daily. The lost fat stayed off for about 2 or 3 months. This was great but not worth the $3,000 which I paid. Barbara – user4002 Jul 12 '11 at 19:49
  • 2
    @barbara It's amazing how easy it is to spot a company crafted message, even when they go to the pain of including "the bad". In your case, the return of the weight. This is a good one, since most people reading will think "Oh, so it worked, but this one person didn't have what it takes to keep it off. Not Zerona's fault!" The rest reads like an informational pamplet though. It's transparent "social media marketing", and is unlikely to find any purchase here where people think about things critically. Still, I thought I should point it out for the visitors. – John Rhoades Jul 12 '11 at 20:53
5

TLDR - FDA granted market clearance based on the paper linked below. Which was a double-blind, randomized, placed-controlled study. With a success criteria of 3 inches and 35% individual success rate which was exceeded. There were no dietary or exercise requirements placed on patients.


I found this clinical trial paper published in Lasers in Surgery and Medicine 41:799–809 (2009) which details results of the double-blind, randomized, placebo-controlled, multi-center trial of non-invasive body slimming ZERONA.

Study Design/Patients and Methods:

Double-blind, randomized, placebo-controlled trial of a 2-week noninvasive laser treatment conducted from May 2007 to June 2008 across multiple-private practice sites in the United States of America. Sixty-seven volunteers between the ages of 18–65 with a body mass index (BMI) between 25 and 30 kg/m2 and who satisfied the set inclusion criteria participated.

Results:

Participants in the treatment group demonstrated an overall reduction in total circumference across all three sites of 3.51 in. (P<0.001) compared with control subjects who revealed a 0.684 reduction (P<0.071745).

Success criteria as defined by the FDA:

The overall study success criterion, established by Food and Drug Administration (FDA), was defined as at least a 35% difference between treatment groups, comparing the proportion of individual successes in each group. It was determined by the FDA that a reduction of at least 3.0 in. was clinically meaningful.

From the results (refer to the paper) 62.86% of the test group met the individual success criteria of 3 inches.

It's a long enough paper, so I've deliberately tried to display the most relevant information to the question.

Also of note is this passage here, and I'm not a doctor, but refer to the context yourself if you think I'm taking this out of context:

Discussing the basic principles of laser therapy as described above could help guide further investigations towards uncovering the exact mechanism employed by laser therapy that ultimately results in the formation of the adipocyte membrane aperture.

It would seem from the quote above the exact mechanism is not entirely know. That doesn't sound comforting to me.

Just found this:

The FDA granted market clearance following the completion of a placebo-controlled, randomized, double-blind, multi-site clinical investigation evaluating sixty-seven study participants. The results obtained from that study demonstrated an average inch loss reduction of 3.65 inches across patient's waist, hips, and thighs in as little as two weeks. The clinical trial, absent of diet restrictions, exercise requirements, or any other adjunctive components properly illustrated the clinical utility of the Zerona and set the precedent on how aesthetic devices should be evaluated.

It would appear from the above that the study I have mentioned in my answer was the one used by the FDA to allow market clearance. And further to your question (and as per quote above) the trial was done

absent of diet restrictions, exercise requirements, or any other adjunctive components

2

According to a paper in "Lasers in Surgery and Medicine", use of Zerona with or without supplement showed no statistically significant reduction 1 week or 1 month post-treatment. It was an extremely small study with only 5 subjects, but it does question Zerona's claims.

  • Five subjects? Seriously? With that small of a sample, why bother at all? – Borror0 Jun 5 '11 at 18:18
  • 2
    it is a "pre-clinical" study. it's the kind of thing you'll run to get funding for a larger study. My guess is that they included the data in some grant applications, didn't get money for a larger study, so they published this small set. – David Hall Jun 5 '11 at 19:30

You must log in to answer this question.

Not the answer you're looking for? Browse other questions tagged .