Over the past six years, Vital Studies have endeavored to study the effects of nutritional supplements in the treatment of various symptoms of the peripheral nervous system brought on by environmental and/or genetic dispositions. Two open label studies into the effects of a combination of Vitamin C, Selenium, L-Carnitine, Alpha Lipoic Acid and N-Acetyl Cysteine, hereafter known as NeuropathyRx®, in diabetic and chemo-induced neuropathies showed great promise, with a 63% decrease in overall burning pain and 41% decrease in numbness.

In the summer of 2008, a Neurofibromatosis 1 patient with visible tumors along his brachial nerves (resulting in serve pain, numbness and function loss) reported shrinkage after a six week regimen of NeuropathyRx®. He also reported a decrease in pain and numbness while his hand function returned to normal.  He has remained on the supplement for a year and continues to report tumor shrinkage along with a report of no new tumor growth.

After another search into the published research, Dr. Mark Gostine offers this explanation as to why NeuropathyRx® could be used in the treatment of the symptoms of Neurofibromatosis:   

The fundamental defect in NF is a mutant variety of the protein neurofibromin (NM) which normally inhibits Ras, a potent activator of cell growth and proliferation.  Left unchecked Ras leads to overgrowth in Schwann cells causing the tumors characteristic of NF.

Glutathione S-transferase (GST) is an enzyme that works with glutathione (GTH).  This activity is useful in the detoxification of endogenous compounds such as oxidized lipids, as well as the metabolism of xenobiotics. As well as their enzymatic activities, GST may also bind toxins and function as a transport protein.  One critical activity of GST is the inhibition of Ras. 
Our product increases GTH which is a cofactor for GST activity.  Increasing GST activity may help suppress the over expression of Ras present in patients with NF and the mutant NM.

With this additional research, Terraceuticals launched an open label study in November, 2008. Patients with a diagnosis of NF1 and NF2 with various stages of tumor growth were followed for a period of one year with monthly interviews as they take a daily doses of Neuropathy Rx® (two capsules of NRX in the morning and two at lunch,) asking questions concerning physical and mental well-being as well as their observations on tumor size and growth.

After three months, twenty-three patients reported the following:

• 39% decrease in overall pain
• 87% decrease in burning pain
• 85% increase in ability to function
• 11% decrease in numbness
• 30% improvement in concentration and energy levels.

Of the twenty-three patients, eleven (44%) have reported a decrease in tumor size, three confirmed by their personal physicians.

 In January, 2010, a double-blind, placebo-based study was launched to compare the use of NeuropathyRx® in patients with Neurofibromatosis 1 against those using a placebo. Each patient was required to be at least twelve years of age, with a diagnosis of Neurofibromatosis 1, and measureable tumors. After meeting all eligibility requirements, participants were asked to sign a consent form and give a brief medical history, answer questions on the SF-36 and Universal Pain Scale.  They received either placebo or NeuropathyRx® with instructions, a monthly diary, calipers for measuring tumors and appointment for follow up. Over the next six months, patients were asked about any concerns or questions in regard to the study, turned in monthly dairies, answered questions on the Universal Pain Scale and reported tumor measurements.

A total of thirty patients were enrolled, fifteen patients were assigned study supplement while fifteen were given placebo. Of the fifteen on study supplement, eleven patients(73%) completed three or more months with nine patients (60%) completing the entire six month period, two (15%) completing three to five months,  and  four patients(25%)  never starting the study once paperwork was signed. Of the fifteen on placebo, only four (27%) completed the study. Of the eleven who washed out, six(55%) quit between the second and third month.

Of the eleven who were on study supplement for more than three months, eight (72%) reported a change in tumor color and density, six (55%) reported no new tumor growth and three (27%) reported a decrease in tumor size by two to three millimeters between months two and three.  Tumor color and density was reported as transparent and softening throughout study. Of the three patients who reported pain at the start of the study, all reported a decrease in overall pain.

In the four patients on placebo who finished the study, three (66%) reported increased tumor growth with pain remaining unchanged.