Bariatric Fusion Releases “Study”

On June 19, 2011, in Uncategorized, by Andrea

My first post from across the pond in Sweden, but I’m here.

The folks over at Bariatric Fusion released a “study” on their own patients regaling the efficacy of their product.

The reason I hesitate to call this a “study” is for a few reasons -

  • It is not peer-reviewed;
  • It only concerns the one year after surgery – most deficiencies hit further out;
  • It only contains 100 patients;
  • It does not compare patients using a different vitamin regimen.

Regardless, this “study” can be read, in full, here. It’s… short. Seriously, it will take you less than 3 minutes. You’ll see the need for the quotes.

Basically, 100 patients were limited to Fusion for 1 continuous year. Lab values were taken at the beginning and at the end to evaluate changes. Results, according to the folks at Fusion, is that of the 100 patients, there were no deficiencies in folate, B1, or calcium. Normal ranges for the “majority” were found for B12 (93%), iron (86%), and vitamin D (84%).

Fusion concludes:

Patients using the recommended daily regimen of Bariatric Fusion Chewable Vitamins had normal concentrations of the most important vitamins and minerals. Supplementation with iron and vitamin D is rarely needed, if pre-bypass levels are normalized.


Who’s got some questions here? Don’t all raise your hands at once, now..

My blog. I go first.

  1. What is the patient population in terms of surgery age? Surgery type (length of bypass)?
  2. When, exactly, does anyone ever become deficient in calcium? Seriously, how can this even be considered a win?
  3. Fusion had to be the vitamin for one year to be in the study – what about previous vitamins? Were patients who were on a previous supplementation regimen disqualified? (ie. would I be disqualified for possibly skewing the survey?)
  4. Which assays were evaluated? Was ferritin checked for iron, or just Hct and Hgb? Serum folate (which is very rarely deficient) or RBC folate which is the true measure of folate deficiency state? If it is serum that is checked, then we can count this just as good in terms of testing as the calcium draw.
  5. What happens at years 2? 3? 4? 5?

Gasteyger et al. found that standard multivitamin supplementation was not sufficient post RNYGP. This particular study did not release the actual specifics of the multivitamin in the study, but this peer-reviewed study showed a marked difference compared to the Fusion “study:”

From the original post I did way back in2009:

The study, in the end, included 137 morbidly obese patients (110 women and 27 men) — these were the ones who maintained the lab requirements, the supplementation requirements, the doctor visits, etc.  Initially, there were 348 patients in the study, but only about 33% complied with the postoperative care requirements, which, in of itself, is a sobering statistic.

Lab testing was done at 3, 6, 12, 18, and 24 months postoperatively.

This, folks, is where it gets really scary.

  • 3 months postop, 34% required at least one additional supplement to the multivite
  • 6 months postop, 59% required at least one additional supplement
  • 12 months postop, 86% required at least one additional supplement
  • 18 months postop, 93% required at least one additional supplement
  • 24 months postop, 98% required at least one additional supplement to the multivite
  • After 2 years, 2.2% took 0 additional supplements
  • 18.3% took 1 additional supplement
  • 19.7% took 2 additional supplements
  • 22.6% took 3 additional supplements
  • 27.7% took 4 additional supplements to the multivite
  • 6.6% took 5 additional supplements
  • 2.9% took 6 additional supplements
  • B12 was the most often supplemented — 10% were taking it at 3 months and 80% were taking it at 2 years
  • Iron was next — 15% at 3 months, and 60% at 2 years
  • Calcium +D — 17% at 3 months, 60% at 2 years
  • Folic Acid — 7% at 3 months, 45% at 2 years
  • B1 — 1% at 3 months, 4% at 2 years
  • B6 — 1% at 3 months, 13% at 2 years
  • Magnesium — 1% at 3 months, 13% at 2 years
  • Zinc — 1% at 3 months, 12% at 2 years

It seems odd to me to have such marked difference based simply on a single vitamin. I’d be interested in a more controlled study, with better controls, better questions, with better answers before alluding to Bariatric Fusion’s superiority.

Because as of right now, all I am wondering is “why is a 14% failure rate on an item that failed at 60% at the 2 year mark on the 2nd study, or an item that failed at a 16% failure rate that failed for Fusion at one year that failed at 60% at the 2 year mark on the original study” is considered a success..?

But that’s just me.



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6 Responses to “Bariatric Fusion Releases “Study””

  1. Anni says:

    Thank you again for blogging about this. I’ve tried to let others know about this vitamin regimen and others(ya’ll what I’m talking about). “Oh but my surgeon recommends them and my labs were fine. I know people that are 5 years out and their levels were fine too.” My answer is always the same. Everyone has natural stores pre-op and it make take time to become substantially deficient in some areas. And, then when I get the, whole thing about veteran post-op’s being on it and their labs were fine too, I always ask how long they’ve been on this or others vitamin regimens like this, because post-op’s on other supplementation previously, could take a little while to become deficient also.

    I am almost always hit with the “what do you know, you’re not far enough out to know.” ” Well, my Dr says it’s good and my levels are fine.” Blah, Blah, Blah…So, I have pretty much resigned to keep my mouth shut and let them reak havoc on their bodies and stop trying to help them save their, health, energy, bones, teeth, etc, because I don’t know anything anyway. Right? So thank you Andrea for blogging about this One More Time, so maybe some people will read this and be enlightened by someone that is seasoned and respected. I’m glad you are steadfast about spreading the word, because in all honesty I’ve all but given up. Maybe I’ll try again when I’m 10 years post-op and still have all my teeth, while all those others are glueing in their dentures….

  2. Dan says:

    Thank you for bringing this subject to my attention. I have been taking Fusion for 3 years without deficiencies. The daily regimen is very easy.There is always scientific data to support both sides of the fence. I have not seen any studies published or even attempted by Celebrate or Bariatric Advantage or anyone else for that matter. Please e-mail me if you have them. Maybe the deficiency rate is so high after WLS because they require us to take so many pills/tablets daily. There is something very wrong with 6-10 tablets/daily at different intervals. I mean who can “realistically” be compliant with that regimen. Spend $50 per month? I bet the compliance rate is less then 5% with the Celebrate and BA daily recommendations. I applaud the fact that Fusion is trying to make sense of this. Maybe it’s because the company is run by medical practitioners? I love your blog but being so narrow minded and negative doesn’t inspire.

  3. Andrea says:

    I disagree, Dan.

    Following ASMBS suggestions (which Fusion does not, by the way) is only a smart thing to do in the long run. And it’s something I can speak to from experience having had horrible ferritin levels, osteomalacia, etc due to inadequate supplementation advice from medical personnel.

    As for not having medical personnel on the boards, Dr. Jacqueline Jacques, the chief science officer and co-founder of Bariatric Advantage is a DOCTOR and knows more about nutrition than anyone alive. She is amazing to speak to and I could only wish to one day have a portion of her knowledge. She is an amazing woman willing to give out information that does not even go to help her own brand but to help our community and others high up in our community seek her out for this knowledge. In Orlando this past week, she was constantly being sought out by the top nutritionists in our field and I was in awe to be in her presence. Truly amazing mind she has. To say BA is not run by medical practitioners is wrong to say the least.

    As for not having deficiencies – I’m truly glad you don’t. However, I would hesitate to state that no one will. This “study” alone puts BF in a negative light and I worry about us all. It’s the mother in me as well as the compulsive fixer. I don’t want anyone to suffer some of the pain I have — bendy bones HURT. So I am glad you have not suffered, but I look at numbers to say that you may be in a minority years down the road.

    As for the regimen? It is all a small price to pay. If people are not willing to take their vitamins after surgery? Then they should not have surgery. End of story. This is not an option and one’s life and health are at stake.

    I am not here to inspire. There are countless other blogs that do that. Perhaps you know of them?

    I am here to present facts, and present my view (as narrow-minded as you find it to be).

    Here are the facts:

    Bariatric Fusion does not meet the suggestions put forth by the 2008 Aills document that has been adopted by the ASMBS as the Nutritional Guidelines for the post-bariatric surgical patient.
    Bariatric Fusion put out this “study” (which does not meet the requirements to actually be called a study by any sort of scientific literature) which does not really put them in a good light in my point of view given the deficiency rate at ONE YEAR.
    Bariatric Fusion, in this document, was somewhat coy in stating a lack of deficiency in calcium, an element that is one of the least likely items to be deficient in as it is absolutely critical for the body to maintain in homeostasis for cardiac function – the body will steal calcium from the bones to keep it from a deficient state in order to keep the heart going; Therefore stating a lack of deficiency is somewhat a misnomer.
    Bariatric Fusion, in this document, did not give any details, which would have been needed in a scientific document, which leaves more questions than answers.

    I applaud BF for trying to put out some data. I wish it had been done better. I wish their product had a bit more “umph” to it to hit more of the ASMBS recommendations. I really do as these are key things for our needs LONG TERM and it only helps us, as a community, if we have more than one or two companies worth turning to. Competition builds better products.

    Personally, all of this inspires me to be even more objective. But that’s just me.

  4. Dan says:

    I understand your loyalty considering the large BA banner on your website. I wonder if the “suggestions” would have been different if Tom Kinder (BA President) was not the chairman of the ASMBS Steering Committee when the “Suggestions” (not guidelines) were announced. Very few of the “suggestions” came from data based on Bariatric patients. I read them and was not impressed with the studies quoted from post menopausal non-operative woman. Not exactly apples to apples. I do believe Fusion meets or exceeds all of the criteria formulated by the Endocrine Society. Their suggestions were peer reviewed and all recommendations were based on Bariatric patients. Oh, and their publications were not biased and political in order to generate more sales and fool the naive. I was hoping you could e-mail me the studies BA has done on Bariatric patients. Call Jacqueline. I will be waiting.

  5. Andrea says:

    I am not LOYAL due to an ad. I call things as I see them and if you have actually read my blog (which I doubt at this point) you would know that I will call anyone out based on my beliefs — including BA if I feel it is necessary. I like Jacqueline a great deal, but have no personal obligation to Tom Kinder whatsoever. I also have no affiliation to Celebrate — and if you don’t believe that, just ask Vic and Nick.

    The reason why the ASMBS nutritional committee chose post-menopausal women was due to the achlorhydria present – something that is naturally present as people age. If one had read the studies, such as the achlorhydria rat study which leads to the citrate/carbonate study, one would understand this reasoning. There are others they did not include — such as a gastric probe study used for beta carotene testing, but alas not everything is perfect.

    There are no true studies on post-operative people — something I really wish would be rectified. I wish it to be true – very much so. Again – if you’ve read this blog (another point which proves you have not) I’ve wished for hard science on our absorption rates. As of now, we have nothing but achlorhydriac rat studies, Crohn’s disease, resected folks, and gastrectomy-due-to-illness folks.. but none of us. I still refuse to call this a “study” because it does not meet the requirements set forth by any scientific literature.

  6. Sandra says:

    I could really care less if people have to tweak their original supplement regimen somewhere down the road after WLS. My partner and I are 2 and 3 years out respectively and used BA the entire time. Within the past year I needed more iron (temporarily) and he needed more B12. Even if we have to supplement BF with additional calcium – something I will absolutely do as I think their claims that their delivery system does not put calcium and iron in opposition are a lot of hooey – we still come out way ahead of all the stuff BA and Celebrate require for their regimen. Time will tell if we need to change again, but we will never let things go so long as to damage ourselves. On a related note: I do not think delivery methods have anything to do with compliance. Having participated in a WLS support group for more than 4 years I have heard every reason under the sun why people get off track. Only occasionally is it b/c they can’t find anything that works for them. While observation is not science, it is still valuable in informing trends.

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