This is a “debunking” article. Some ostomy group newsletters have recently carried an updated version of an old article titled “Vitamin B12, Folic Acid and Potassium.” The original version of that article, which ran previously in numerous support group newsletters (including our newsletter in our March 2003 issue), asserted that if a person cannot absorb vitamin B12 the normal way (via terminal ileum), they need B12 shots. The updated version adds the sentence: “Now vitamin B12 is available in a “sublingual” tablet (under the tongue) or through a patch.” Here, I examine both of these delivery methods critically. I’ll start with some conclusions:
“Sublingual” B12 tablets have been around since the 1980s. They “work” in the sense of delivering useful amounts of vitamin B12, but they probably don’t deliver it sublingually (through membranes under the tongue), and they’re a waste of money because you can obtain the same benefits at lower cost by taking regular (non-sublingual) B12 tablets.
The B12 Skin Patch is a much newer product, introduced around 2006, and marketed by one company (“Vita Sciences” of Airmont, NY). Nothing has been published so far about this technique in the scientific literature. It may deliver a useful amount of vitamin B12, but doesn’t do so predictably, as the amount actually delivered varies greatly from one person to the next.
Before discussing these methods in greater detail, I’ll refer to an article I wrote in the Sept 2008 issue of this newsletter titled “Vitamin B-12 Replacement Therapy” which you can also read online at www.ostomyok.org/newsletter/news0809a.shtml That article described three scientifically accepted methods of vitamin B12 supplementation for people who can’t absorb it the usual way (via terminal ileum):
Regarding the two methods in the title of this article, it’s important to understand that delivering vitamin B12 by either the sublingual route (through membranes under the tongue) or transdermally (through skin on the surface of the body) is very difficult because vitamin B12 is a very large, complex molecule, with molecular weight of about 1357. Many medications are delivered successfully using either the sublingual or transdermal method, but they tend to be much smaller molecules. For example, nitroglycerin is often administered sublingually, but its molecular weight is only 227. Nicotine is often applied with a skin patch, but its molecular weight is only 162. The large size of the vitamin B12 molecule makes it very difficult to pass through these body tissues.
“Sublingual” B12 was mentioned in my “Vitamin B-12 Replacement Therapy” article, where I described it as “just a gimmick to sell B-12 at a higher price.” Nobody has ever shown that a such a product is actually absorbed sublingually. Clinical trials comparing “sublingual” B12 with regular (non-sublingual) oral B12 have been published in the scientific literature, but found both to be equally effective if used in the same dosage. The instructions for the “sublingual” products tell you to hold them under your tongue before swallowing. In all likelihood, they just dissolve, but don’t get absorbed to any significant extent, while holding them under your tongue. Then you swallow, and they get absorbed in the same way as any other oral B12 preparation. The most telling evidence is that these “sublingual” B12 products are sold in the same high dosages (usually 1000 micrograms or more) that are known to be necessary for any oral B12 preparations to be effective in people with impaired B12 absorption. If they were really absorbed sublingually, they could be sold in smaller dosages.
Oral B12 works, if taken in adequate dosages, but you’re wasting your money if you buy the more expensive “sublingual” versions.
The B12 Patch is a new product (available since 2006) promoted through the website b12patch.com and sold by the company “Vita Sciences” of Airmont, NY. I’ve done several MEDLINE searches, but couldn’t find anything in the scientific literature about this kind of product. A search of the US Patent and Trademark website did reveal two recent patent applications (not actual granted patents) for the B12 Patch, namely, US Patent Applications 20080160070 and 20080233180. These patent applications include various possible product formulations and explain how the product is supposed to work.
Transdermal skin patches include chemicals referred to as “permeation enhancers” or “penetration enhancers” intended to increase the permeability of skin to allow a desired substance to pass through. As indicated earlier, the large size of the vitamin B12 molecule makes it very difficult to deliver transdermally. Companies that make transdermal patches have been working to develop improved penetration enhancers to enable delivery of larger molecules. Even so, vitamin B12 is at just about the upper limit of the molecules deliverable with current transdermal technology.
One of the patent applications cited above (number 20080160070) described a tiny clinical trial of the B12 Patch on only 4 people, two of whom did repeated tests so they could obtain 6 data sets. This is probably the only clinical test of the B12 Patch that has ever been published (considering that a page of the website selling the product at b12patch.com/research.html seems to refer to that same tiny clinical trial). In that experiment, average B12 blood levels roughly doubled during an 8 hour period. However, the patent application also stated, “The rate of vitamin B12 delivery varied between subjects by as much as five-fold.” The inventor attributed this variation as “likely due to differences in the skin of test subjects.” In any case, given this huge person-to-person variability, the B12 Patch can hardly be said to deliver the vitamin predictably or reliably.
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