While the treatment of diabetic neuropathy has improved with the use of antiepileptic drugs and antidepressants, it still remains frustrating. Most of the commonly used medications have anticholinergic side effects or cause sedation. At best, they are only partially effective because they do not treat the underlying cause of the neuropathy but only the symptoms. The goal of this study was to determine if we could improve patients’ reports of pain and numbness with the utilization of nutritional supplements that may partially address the causes of diabetic complications.
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Selection of Supplemental Nutrients
In designing which nutrients to replenish, the authors assumed multiple factors are missing from the average American diet that which may be adversely impacting patients with diabetic neuropathy. Five nutritional supplements, dubbed NeuropathyRX, were chosen on the basis of their activity and application to the theories of diabetic complications enumerated above. NeuropathyRX contains N-acetyl-cysteine (NAC), alpha-lipoic-acid (ALA), L-carnitine (LCA), vitamin C, and selenium.
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Study Population
This was an open label study. Patients enrolled were selected from a practice of podiatrists specializing in surgical and nonsurgicalcare of the feet and ankles. The nature of their practice results in a large population of patients suffering from complications of the diabetic foot including ulcers, infections, calluses and neuropathy. Patients complaining of symptoms of neuropathy, despite maximal medical therapy, were entered in the study investigating the use of nutritional supplements for control of pain. Thirty patients were enrolled and 28 completed the study over a six month period extending from November of 2006 through May of 2007, with twelve men and sixteen women participating. The average age was 68 with a range from 48 to 94. Most patients had comorbid conditions including hypertension, obesity and hyperlipidemia.
Methods
After informed consent, patients were asked to rate eight parameters using a modification of the Wong-Baker FACES Pain
Rating Scale. ...
Results
Burning
Initiation - 6.59
four weeks - 4.71
eight weeks - 3.06
twelve weeks - 2.44
% change - -29%
% change - - 54%
% change - -63%
Numbness
Initiation - 7.41
four weeks - 6.21
eight weeks - 5.16
twelve weeks - 4.37
% change - -16%
% change - -30%
% change - -41%
Overall Pain
initiation - 6.54
four weeks - 4.98
eight weeks - 3.67
twelve weeks - 2.85
% change - -24%
% change - -44%
% change - 56%
Impairment Of Function
Initiation - 4.3
four weeks - 3.93
eight weeks - 2.96
twelve weeks - 2.76
% change - -9%
% change - -31%
% change - 36%
Impairment Concentration
Initiation - 3.11%
four weeks - 2.91%
eight weeks - 2.33%
twelve weeks - 2.26%
% change - -6%
% change - 25%
% change - 27%
Impairment Clarity
Initiation - 2.18
four weeks - 2
eight weeks - 1.78
twelve weeks - 1.74
% change - -8%
% change - -18%
% change - -20%
Impairment Alertness
Initiation - 2.39
four weeks - 2.2
eight weeks - 1.69
twelve weeks - 1.52
% change - -8%
% change - 30%
% change - 36%
Impairment Energy
Initiation - 4.89
four weeks - 4.29
eight weeks - 3.61
twelve weeks - 3.33
% change - -12%
% change - - 26%
% change - -32%
... it is apparent there were significant reductions in the primary endpoints of burning, numbness, and overall pain. There were also significant reductions in impairment of mental function, although not to the same degree. Interestingly, every parameter improved at every assessment, suggesting that had the patients been studied for a longer period of time, the study may have recorded further improvement. The most dramatic improvement was in burning pain. Many patients requested to remain on the supplement after the study ended
due significant reductions in their pain.
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Conclusion
While over-consumption of the macronutrients carbohydrates and fats can lead to obesity and diabetes, it is less obvious that under-consumption of key micronutrients can lead to diabetic complications, including neuropathy. This investigation indicates that a combination of certain nutrients can alleviate the complaints of burning and pain that accompany diabetic neuropathy. It would also suggest that other critical nutrients may be lacking from diets of diabetics and their absence could also contribute to diabetic complications. In the future, it would appear from our findings that it would be beneficial to counsel diabetics to include key nutrients in their diet as well as watch their calories.
