Restoration of Cutaneous Sensorum in Patients with Diabetic Peripheral Neuropathy (DPN) Via Oral L-methylfolate, Methylcobalamin and Pyridoxal 5'-phosphate

Evaluation of quantitative and qualitative neural response to the combination of a single oral tablet containing 2.8mg L-methylfolate, 25mg Pyridoxal 5'-phosphate, and 2mg methylcobalamin in patients with sensorimotor neuropathy. This was utilized to address the endothelial dysfunction, nitric oxide depletion and hyperhomocysteinemia that are theorized to contribute to the development of diabetic neuropathy.

Sixteen subjects were enrolled in the study. Each patient was measured/quantified utilizing the Pressure Specified Sensory Device ™, along with documentation of subjective complaints. In this study there are eight outcome measurements: medial plantar nerve and calcaneal branch of lateral plantar nerve of both feet, one-point and two-point static measured in Gm/mm˛. The study outcomes were measured at baseline, 6 months,and one year, comparing baseline vs. after half a year of treatment as well as baseline vs. one year treatment for all eight measurements. Statistical analysis was performed by Baylor Health Systems.

The study compares baseline versus after six months of treatment, baseline versus after one year, and six months versus one year for all four measurements.

All of the comparisons between baseline vs. 6 months and baseline vs. 1 year generated significant results. This combination of L-methylfolate, Pyridoxial 5'-phosphate, and methylcobalamin demonstrated a significant improvement in restoring damaged nerve fibers, particularly after six months of therapy with even greater improvement after one year of therapy. This evidence seems to confirm the restoration of the endothelial complex, renewing distal perfusion and particularly flow to the peripheral nerve, essentially reversing the steps of the pathophysiology of DPN.