Efficacy Information for Healthcare Professionals
Restoration of Cutaneous Sensorum in Diabetic Peripheral Neuropathy Utilizing a Novel Pharmacological Approach12
Objective
- The purpose of this study was to evaluate quantitative neural response in diabetes patients with sensorimotor neuropathy to a combination oral tablet consisting of 2.8mg L-methylfolate, 25mg Pyridoxal 5'-phosphate and 2mg Methylcobalamin.
Methods
- Thirty-one patients with subjective neuropathic symptoms and established sensory loss were consectutively enrolled and measured / qualified utilizing the Pressure Specified Sensory Device (PSSD) along with documentation of subjective complaints for 6 months and 1 year.
- Patients were given 2 tablets daily for 2 weeks then 1 tablet per day for 6 months and 12 months, respectively.
Results
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6 Month Follow-Up
Compared to baseline, after 6 months of nutritional management with Metanx®, diabetes patients with sensorimotor neuropathy experienced significant restoration of sensation.
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1 Year Follow-Up
Compared to baseline, after 1 year months of nutritional management with Metanx®, diabetes patients with sensorimotor neuropathy experienced significant restoration of sensation.
No adverse events reported with the addition of Metanx® up to 1 year.
Conclusion
This novel combination of 2.8mg L-methylfolate, 25mg Pyridoxal 5'-phosphate, and 2mg Methylcobalamin demonstrated an increase in nerve density resulting in a significant change in sensation in patients with diabetic peripheral neuropathy (DPN).12
Flow Mediated Dilation after Immediate and Long Term Oral L-Methylfolate in Homocysteinemia5
Background
Flow Mediated Dilation (FMD) measures the ability of the vessel to respond to certain changes within its environment. Nitric Oxide, a potent vasodilator, is compromised in endothelial dysfunction and is a sensitive indicator of blood vessel disease.
Objective
The aim of the study was to compare FMD during immediate and long term oral supplementation with L-methylfolate with and without vitamins B6 and B12.
Methods
Ninety-two patients above age 45 were studied. They were put into three groups: (1) L-methylfolate, (2) Metanx®, and (3) Placebo. FMD measurement and serum analysis was performed at baseline, 90 minutes after oral administration, and after 8 weeks of daily administration. Patients were further categorized into normal or abnormal FMD responders.
Normal FMD responders: > 8%
Abnormal FMD responders: < 8%
Results
Conclusion
In patients with endothelial dysfunction, Metanx® increased blood flow by 136% (P-0.02).