Benfotiamine and Treating Diabetic Complications

Girl holding a syringe with insulin
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Benfotiamine is a man-made form of thiamine or B1. Thiamine is a water-soluble vitamin and therefore not as easily used by the body. Benfotiamine is a fat-soluble composition and is better absorbed and utilized. There has been some evidence that benfotiamine may help relieve the severity of diabetic complications such as retinopathy, nephropathy, and neuropathy.

Benfotiamine for Diabetic Neuropathy

Benfotiamine has undergone several studies in recent years. The main focus of the studies involves using benfotiamine as a treatment for complications of diabetes.

Most diabetes complications are caused by prolonged hyperglycemia (high blood sugar) due to poorly controlled blood glucose or to disease progression over time. The excess glucose in the blood is deposited in nerve cells and small blood vessels of the extremities, causing damage in these areas which result in signs and symptoms of complications.

The Four Pathways to Cellular Damage

There are four separate pathways that occur in the body that can lead to small blood vessel damage due to hyperglycemia in diabetes.

  • Advanced glycation endproducts (AGE)
  • Protein kinase C (PKC)
  • Hexosamine pathway activation
  • Polyol pathway activation

Benfotiamine appears to block three of these pathways in clinical studies. An article, which appeared in the journal Nature Medicine in February 2003, titled "Benfotiamine Blocks Three Major Pathways of Hyperglycemic Damage and Prevents Experimental Diabetic Retinopathy" showed that benfotiamine did prevent diabetic retinopathy in laboratory animals.

Advanced Glycation End Products

Hyperglycemia causes damage in the blood vessels and nerves of the body, which in turn develop into the major complications of diabetes. Damage happens when excess glucose in the blood settles into the cells and forms a substance known as advanced glycation endproducts (AGE) These accumulate over time. AGE's are found in vessels of the eyes, kidneys, and extremities. They also are found in other major blood vessels and lead to plaque formation and atherosclerosis, contributing to heart disease.

What Benfotiamine Does

Studies have shown that benfotiamine seems to help prevent complications of neuropathy, retinopathy, and nephropathy by inhibiting the build-up of glucose in the vessels. This means that the occurrence of diabetic complications might be slowed or prevented. A clinical study that appeared in the ADA journal Diabetes in 2003 showed that high-dose thiamine and benfotiamine seemed to prevent microalbuminuria and proteinuria (protein in the urine) in diabetic rats. Studies done on people have shown that benfotiamine appears to also relieve neuropathic pain.

The Current Status of Benfotiamine

Benfotiamine is still in the clinical trial phase. The studies have mostly been done on rats who have been induced to have diabetes. More intensive trials are needed to determine if benfotiamine works the same way in people with diabetes. Effective dosages have yet to be established, and long-term side effects are not known.

Although benfotiamine is not officially recommended by American healthcare professionals at this time, it does look like it may be a promising treatment for diabetes complications down the road.

Approval Still Pending by the FDA

The Food and Drug Administration (FDA) has not yet approved benfotiamine for public use. There are conflicts about how the substance should be labeled, whether as a dietary supplement or a vitamin. There are concerns about the overall safety of long-term use of benfotiamine and what constitutes a safe dosage. The FDA requires more proof that benfotiamine produces the results seen in the trials.

Last year, benfotiamine was submitted to the FDA as a dietary supplement, but approval is pending at this time.

  • FDA Response Letter to Submission of Benfotiamine as a Dietary Supplement
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