TITLE:
Post-Marketing Surveillance of Fixed Dose Combination of Methylcobalamin, Alpha Lipoic Acid, Folic Acid, Biotin, Benfotiamine & Vitamin B6-Nutripathy for the Management of Peripheral Neuropathy
AUTHORS:
Manish Maladkar, Chitra Tekchandani, Urja Dave
KEYWORDS:
Peripheral Neuropathy, Methylcobalamin, Alpha Lipoic Acid, Folic Acid, Biotin, Benfotiamine, Vitamin B6
JOURNAL NAME:
Journal of Diabetes Mellitus,
Vol.4 No.2,
May
21,
2014
ABSTRACT: Background: Peripheral neuropathy is a commonly
encountered troublesome condition which is often disabling & worsens when
left untreated. Traditional neuropathic pain medications primarily provide
symptomatic relief; however, the pathogenesis of nerve damage remains
unresolved. Extensive literature survey reveals that patients with peripheral
neuropathy experience significant benefits with the use of B-vitamins like
methylcobalamin (B12), folic acid (B9), biotin (B7), benfotiamine (B1) and
pyridoxine (B6). The other well documented antineuropathic agents include alpha
lipoic acid, glutathione, omega fatty acids, myoinositol, certain trace
elements, etc. Materials and
Methods: A multicentre, prospective, open-label, non-comparative clinical
study was carried out in 497 patients with peripheral neuropathy. A fixed dose
combination of methylcobalamin, alpha lipoic acid (ALA), folic acid, biotin,
benfotiamine & vitamin B6 capsule was orally administered once daily for 12
weeks. Results: Treatment
led to significant reduction from baseline score in various neuropathy symptoms
from the 4th week itself. After 12 weeks of treatment, the mean pain score
declined by 78.0%, numbness by 92.1% and muscle weakness by 96.9%. Also, there
was 96.0% & 99.2% reduction in tingling & burning sensation
respectively. No serious adverse events were reported.Conclusion: The
current study confirms that fixed dose combination of methylcobalamin, ALA,
folic acid, biotin, benfotiamine & vitamin B6 is effective & well
tolerated in the management of peripheral neuropathy.