Pamlab L.L.C., announced today the results of a study measuring epidermal nerve fiber density (ENFD) in patients with Diabetic Neuropathy (DN). This study was published in the second quarter 2011 issue of Review in Neurological Diseases.
Patients with diabetes tend to have both small and large peripheral nerve fiber dysfunction. Small fiber neuropathy is typically the source of the earliest sign of diabetic neuropathy and is marked by deterioration in epidermal nerve fiber density (ENFD). Damage to or loss of small nerve fibers often results in burning pain, tingling or numbness that typically affects the limbs. The most reliable method for diagnosing small fiber neuropathy involves skin punch biopsy. Skin biopsy is a minimally invasive procedure in which 3mm diameter punch biopsy specimens are taken from the lower extremity. Small nerve fibers in the epidermis are counted under a microscope, and epidermal nerve fiber densities are calculated and compared with established normative values.
Allen M. Jacobs, DPM, of the Allen M. Jacobs & Associates, LTD., P.C. of St. Louis, Missouri, acted as lead study investigator. "Diabetes patients often have a disruption in the metabolic processes that regulate vascular and nerve repair. By providing nutritional management with Metanx® to correct this imbalance, patients in this trial experienced an increase in nerve fiber density which correlated with improvement in numbness, tingling and burning pain".
"This study reinforces that there is great need for a therapy like Metanx®, which addresses the distinct nutritional needs of patients with diabetes and in effect, has been shown to create a nutritional environment which supports increased nerve fiber density," said Harold O. Koch, Jr., Senior Vice President of Business & Scientific Affairs, and Chief Scientific Officer of Pamlab.
At the end of 6 month therapy, compared to baseline measurements 8 of the 11 (73%) patients demonstrated an increase in ENFD. Mean ENFD of the 11 patients at end of treatment was 3.07/mm, as compared to a mean of 1.56/mm at baseline, representing an overall 97% increase in ENFD (p=0.004). Eighty-two percent of patients experienced both reduced frequency and intensity of numbness, tingling and burning pain. There were no adverse patient outcomes due to biopsy and no reported adverse effects from the oral administration of Metanx®.
About Medical Foods and Metanx®
As regulated by the FDA, medical foods are specially formulated to manage a specific disease or condition for which medical evaluation, based on recognized scientific principles, has established distinct nutritional requirements. All components of a medical food must have GRAS status (Generally Recognized as Safe) as designated by the FDA or independent review.
Metanx® is a medical food dispensed by prescription and indicated for the distinct nutritional requirements of patients with endothelial dysfunction who present with loss of protective sensation and neuropathic pain associated with diabetic neuropathy. Each oral tablet contains the active forms of folate, vitamin B12 and B6 (L-methylfolate, methylcobalamin, and pyridoxal 5'-phosphate, respectively). Metanx® offers a nutritional benefit by improving endothelial function and maintaining blood flow in the vessels that carry important nutrients and oxygen to the peripheral nerves.
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