FAQ: HAVE THERE BEEN RECENT CLINICAL TRIALS USING BENFOTIAMINE?

Yes, in the past couple of years interest in this compound has grown significantly.  You may link to some of the recent clinical trial abstracts here: 

 

Articles and Abstracts Regarding Benfotiamine Research

 

FAQ: HOW ABOUT INTERACTIONS WITH OTHER MEDICATIONS?

Benfotiamine has no known negative interactions with any medications.  In fact, the use of some medications may cause a thiamine deficiency which benfotiamine would likely correct:  

 

Vitamin B1

 

Also indexed as: Thiamin, Thiamine

Drug Interactions Safety Check

Certain medications interact with vitamin B1: Some interactions may increase the need for vitamin B1, other interactions may be negative and indicate vitamin B1 should not be taken without first speaking with your physician or pharmacist, others may require further explanation. Refer to the individual drug article for specific details about an interaction.

Note: the following list only includes the generic or class name of a medication.

FAQ: WHAT TYPE OF CONDITIONS MAY RESPOND WELL TO BENFOTIAMINE?

While the recent clinical trials have concentrated on conditions such as neuropathy, retinopathy and nephropathy, there is an expectation among those studying this compound that its beneficial effects may be far more wide-ranging, to include:  sciatica, vascular health, general nerve health, improved blood pressure, general cellular protection, anti-aging, fibromyalgia, prevention of lactic acidosis, and treatment for Alzheimer’s disease.  

Benfotiamine is not just for diabetics.  Any condition that is the result of a thiamine deficiency will likely respond quite well to benfotiamine.  Of course, any bodily function that is improved by a therapeutic level of thiamine would most likely be enhanced by benfotiamine, since benfotiamine is perhaps the most effective form of thiamine.  

VITAMIN B1 (Thiamine)

 

What does it do? Vitamin B1 is needed to process carbohydrates, fat, and protein. Every cell of the body requires vitamin B1 to form the fuel the body runs on—ATP. Nerve cells require vitamin B1 in order to function normally.

Where is it found? Wheat germ, whole wheatpeasbeans, enriched flourfish,peanuts, and meat are all good sources of vitamin B1.

Vitamin B1 has been used in connection with the following conditions(refer to the individual health concern for complete information):

Rating

Health Concerns

Three Stars

Anemia (for genetic thiamine-responsive anemia)

Two Stars

Alzheimer’s disease

Canker sores

Childhood intelligence (for deficiency)

Diabetes

Dialysis (for encephalopathy and neurologic damage; take only under medical supervision)

Hepatitis

Low back pain (in combination with vitamin B6 and vitamin B12)

One Star

Cardiomyopathy (only for wet beri beri)

Dysmenorrhea (painful menstruation)

Fibromyalgia

HIV support

Multiple sclerosis

Pre- and post-surgery health

 

 

Three Stars: Reliable and relatively consistent scientific data showing a substantial health benefit.
Two Stars: Contradictory, insufficient, or preliminary studies suggesting a health benefit or minimal health benefit.
One Star: An herb is primarily supported by traditional use, or the herb or supplement has little scientific support and/or minimal health benefit.

Who is likely to be deficient? A decline in vitamin B1 levels occurs with age, irrespective of medical condition.1 Deficiency is most commonly found in alcoholics, people with malabsorption conditions, and those eating a very poor diet. It is also common in children with congenital heart disease.2 People with chronic fatigue syndrome may also be deficient in vitamin B1.3 4 Individuals undergoing regular kidney dialysis may develop severe vitamin B1 deficiency, which can result in potentially fatal complications.5 Persons receiving dialysis should discuss the need for vitamin B1 supplementation with their physician.

Can I take too much? Vitamin B1 is nontoxic, even in very high amounts.

Are there any interactions with other nutrients? Vitamin B1 works hand in hand with vitamin B2 and vitamin B3. Therefore, nutritionists usually suggest that vitamin B1 be taken as part of a B-complex vitamin or other multivitamin supplement.

Are there any drug interactions? Certain medications may interact with vitamin B1. Refer to the drug interactions safety check for a list of those medications.

References:

  1. Wilkinson TJ, Hanger HC, George PM, Sainsbury R. Is thiamine deficiency in elderly people related to age or co-morbidity? Age Ageing 2000;29:111–6.
  2. Shamir R, Dagan O, Abramovitch D, et al. Thiamine deficiency in children with congenital heart disease before and after corrective surgery. JPEN J Parenter Enteral Nutr 2000;24:154–8.
  3. Heap LC, Peters TJ, Wessely S. Vitamin B status in patients with chronic fatigue syndrome. J R Soc Med 1999;92:183–5.
  4. Grant JE, Veldee MS, Buchwald D. Analysis of dietary intake and selected nutrient concentrations in patients with chronic fatigue syndrome. J Am Diet Assoc1996;96:383–6.
  5. Hung SC, Hung SH, Tarng DC, et al. Thiamine deficiency and unexplained encephalopathy in hemodialysis and peritoneal dialysis patients. Am J Kidney Dis2001;38:941–7.
  6. Cheraskin E, Ringsdorf WM, Medford FH, Hicks BS. The “ideal” daily vitamin B1 intake. J Oral Med 1978; 33:77–9.

 

 FAQ: HOW MUCH BENFOTIAMINE SHOULD I USE DAILY?

Though the body cannot use more than about 10mg. of common, water-soluble vitamin B-1 per day, benfotiamine is lipid-soluble and can safely be used at much higher levels than common vitamin B-1.

Most people get excellent results in 14-21 days time using two 150mg. capsules twice per day (two in the morning and two in the evening - 600mg/day). Benfotiamine need not be taken with meals. Some people get better results increasing the dosage to 900mg. or 1200mg. per day after the first two weeks. The point here is that benfotiamine appears safe at any reasonable daily usage level. An individual should merely find the level that produces the maximum beneficial effect without reaching a point of diminishing return beyond which the excess amount is wasted.

Dr. Brownlee participated in a clinical trial using 600mg./day:   Lou, Founder of BenfoComplete, noted dramatic results after increasing his daily usage to more than 600mg.  His neuropathy symptoms ceased progression and began to reverse and he experienced a complete cessation of sciatica episodes.  Also, his average blood pressure dropped from a persistent 145/90 to 120/80, without the use of other blood pressure medications.  Lou found maximum relief taking four capsules in the morning and four in the evening and found the higher dose further reduced his neuropathy symptoms without negative side effects. I would refer you to FAQ #2, above, for information on safety and upper daily limits.

FAQ: WHAT IS THE FDA POSITION ON BENFOTIAMINE?

At first I was curious as to whether benfotiamine is considered a drug or a supplement.  I have established to my satisfaction (and based on the expert opinion of others in the industry) that benfotiamine, a synthetic derivative of vitamin B-1, is a dietary supplement under the Dietary Supplement Health and Education Act (DSHEA) of 1994.  During 2003 I have successfully imported to the U.S. both bottled tablets as well as bulk benfotiamine, with full disclosure and full FDA and U.S. Customs review and approval at the respective U.S. ports of entry.  Let me emphasize that.  The FDA did a hands-on review and inspection of my imported benfotiamine, with full disclosure as to contents by both name and chemical formula, and approved all items for import.  Benfotiamine may be imported under Tariff Number:  2936.22.00.00, (thiamine and its derivatives).   

For those curious as to the current FDA stance on dietary supplements, I offer the following quote from their website:

“Under DSHEA, a firm is responsible for determining that the dietary supplements it manufactures or distributes are safe and that any representations or claims made about them are substantiated by adequate evidence to show that they are not false or misleading. This means that dietary supplements do not need approval from FDA before they are marketed.”  See:  http://www.cfsan.fda.gov/~dms/ds-oview.html.   As to the safety of benfotiamine, please see the data provided above in this document. 

FAQ: WHY HAVEN’T I HEARD OF BENFOTIAMINE BEFORE?

Though attempts were made by the Japanese pharmaceutical manufacturer Sankyo to market benfotiamine in the U.S. decades ago, there was little interest until the recent article published in the U.S. by Dr. Brownlee.  Since that time, interest in benfotiamine has increased dramatically.  I have heard some speculation that since the patent on benfotiamine expired years ago, no large company is interested in investing in its promotion.  I personally remain mystified as to why this very beneficial compound has languished in obscurity in this country until now.

FAQ: WHAT DOES “PHARMACEUTICAL GRADE” MEAN?

“Pharmaceutical grade” means that the product has been manufactured under GMP conditions and is safe, pure and effective.  Under GMP (Good Manufacturing Practices) every step of the process is documented by using established SOPs (Standard Operating Procedures).  This includes training, equipment, raw materials, facilities, and final release criteria.  Everything can be traced back to the date, time, person, lot number, and piece of equipment used.