2007 ADA Scientific Session – Oral Presentation
Effect of 4-Year Antioxidant Treatment with Alpha-Lipoic Acid
What is in NutriNerve® 2.2?
A patented formulation that supports the body against neuropathy*
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®
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he/she may be aware of unpublished information regarding the use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)
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
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
www.neuroeffex.com for a more peer reviewed references.
plusmn]0.11 on ALA and deteriorated by 0.17 ±
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
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.
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.
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).
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.
E. Comments from Survey Respondents In this appendix, we provide selected comments that we received from surveyrespondents. The comments have been organized according to the topicsdiscussed in Chapter 5 and are divided into three sections—general commentsfrom direct-care system prescribers; comments from direct-care prescribersspecifically in response to a question on changes they would make
Study on Racial Encounters and Discrimination Experienced by South Asians Executive Summary Background 1. A survey on “Study on Racial Encounters and Discrimination Experienced by South Asians” was commissioned by the Equal Opportunities Commission (EOC) to the Centre for Civil Society and Governance, The University of Hong Kong, and the Policy 21 Limited. Interviews