Product Information
2007 ADA Scientific Session – Oral Presentation
Soft Gels
Effect of 4-Year Antioxidant Treatment with Alpha-Lipoic Acid in Diabetic
What is in NutriNerve® 2.2?
A patented formulation that supports the body against neuropathy* Results:
The aim of this study was to evaluate the efficacy and safety of [alpha]- lipoic acid over 4 years in diabetic patients with mild to moderate distal symmetric polyneuropathy (DSP). In this multicenter, randomized, double-masked, paral el-group clinical trial 460 diabetic patients with *GLA is the active ingredient derived from Borage Oil stage 1 or stage 2a DSP were randomly assigned to oral treatment with [alpha]-lipoic acid 600 mg qd (ALA; n=233) or placebo (n=227) for 4
Physician Support and Involvement
years fol owing a 6-week placebo run-in phase. Outcome measures Please tel your doctor as soon as you start taking NutriNerve® as
included: Primary outcome measure was a composite score of including he/she may be aware of unpublished information regarding the use the Neuropathy Impairment (NIS) Score of the lower limbs and 7 nerve of these ingredients in treating neuropathy. function tests (NIS[LL]+7 tests; a ). Secondary outcome measures included the Total Symptom Score (TSS); nerve symptom change),
Prescription information:
Neuropathy Symptoms and Change (NSC), NIS, NIS[LL], individual NIS Take 4 capsules per day with meals (2 BID). 4-6 months of components, motor and sensory nerve conduction attributes, and uninterrupted use is necessary to see the ful benefit. quantitative sensory testing (QST). Data analysis was based on the intention to treat. The demographic variables and the outcome Precautions
measures at baseline were comparable between the groups as were Some patients may experience an upset stomach and serious the HbA1c levels during fol ow-up. The NIS[LL]+7 tests composite score diarrhea in doses that equal or exceed 6 capsules in a 24-hour improved after 4 years vs. baseline by 0.45 ± [plusmn]0.37 period. There are no known issues with renal insufficiency. (mean±[plusmn]SEM) in the ALA group and worsened by 0.34 ± [plusmn]0.35 points in the placebo group (p=0.105). The NIS and Statement of Use and Treatment Program
NIS[LL] improved by 0.68 ± [plusmn]0.44 and 0.34 ± [plusmn]0.30 The ingredients in NutriNerve® have been shown to improve
points on ALA and worsened by 0.61 ± [plusmn]0.46 and 0.43 ± neuropathy symptoms by improving underlying physiology*. This [plusmn]0.31 points on placebo, respectively (p=0.028 and p=0.051). goes beyond simply relieving symptoms, such as pain. Please visit The NIS[LL] muscular weakness subscore improved by for a more peer reviewed references. 0.21[[±]plusmn]0.11 on ALA and deteriorated by 0.17 ± [plusmn]0.15
NutriNerve® is maintained by our scientific advisory board and is
on placebo (p=0.045). The NSC score for weakness severity improved
by 0.05 ± [plusmn]0.03 points on ALA and worsened by 0.04 ± [plusmn]0.03 points on placebo (p=0.008). No significant differences Medical Advisors:
between both groups after 4 years were noted for the nerve conduction Dr. Aaron Vinik, MD, PhD, FCP, FACP
parameters and QST. The rates of adverse events were comparable Strelitz Diabetes and Neuroendocrine Center, Eastern Virginia between the groups during the study. In conclusion, 4-year treatment
with [alpha]-lipoic acid in mild to moderate DSP is well tolerated
Prof. Dr. Med. Dan Ziegler, MD, FRCP
and improves some neuropathic deficits and symptoms, but not
German Diabetes Center, Heinrich Heine University nerve conduction. Future long-term trials should not anticipate significant progression of DSP in diabetic patients.
Ingredient Summary
Alpha Lipoic Acid (ALA) has been shown in placebo control ed
i Oral treatment with alpha-lipoic acid improves symptomatic randomized studies to improve diabetic neuropathy symptoms. In diabetic polyneuropathy: the SYDNEY 2 trial.Diabetes Care. the SYDNEY 2 trial, there was demonstrated to be a 52% decrease in Total Symptom Score (including stabbing pain, burning pain, Irbesartan and lipoic acid improve endothelial function and reduce markers of inflammation in the metabolic syndrome: paresthesia, and asleep numbness of the feet) after five weeks of results of the Irbesartan and Lipoic Acid in Endothelial 600 mg ALAi. ALA is also attributed with a 44% increase in Dysfunction (ISLAND) study. Circulation. 2005 Jan Gamma Linolenic Acid (GLA) has been shown to restore nerve
iii Beneficial effects of gamma linolenic acid supplementation conduction velocity in animals that that have had a 25% decrease in on nerve conduction velocity, Na+, K+ ATPase activity, and membrane fatty acid composition in sciatic nerve of diabetic nerve conduction velocity due to diabetesiii. rats.J Nutr Biochem. 1999 Jul;10(7):411-20. Benfotiamine A statistical y significant (p = 0.0287) improvement in
iv Benfotiamine in the treatment of diabetic polyneuropathy--a the neuropathy score was observed in a group given benfotiamineiv. three-week randomized, controlled pilot study (BEDIP study). Vitamin C is a powerful antioxidant and has been shown to improve
Int J Clin Pharmacol Ther. 2005 Feb;43(2):71-7. endothelial function and nerve perfusion v Lipid independent effects of statins on endothelial function and bioavailability of nitric oxide in hypercholesterolemic patients Am Heart Journal 2005; 149, 471 *This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.


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