Small fiber neuropathy (SFN) is triggered by damage of small diameter somatic nerve fibers, which carry pain and temperature information, and small autonomic fibers involved in regulating sympathetic and parasympathetic nervous system functions (e.g., cardiovascular and sweat functions). SFN is associated with many different types of neuropathy including metabolic, autoimmune, inflammatory, infectious and toxic etiologies, as well as with fibromyalgia. One of the most common causes of metabolic peripheral neuropathy associated with SFN is diabetes mellitus. SFN is a complex condition, resistant to treatment with conventional medications. Currently, the first line treatment for neuropathic pain consists of anticonvulsants (such as Lyrica and Neurontin) and antidepressant drugs. However only about 50% pain relief is achieved in less than half of the patients treated with these agents, and many discontinue treatment due to serious side effects. But a team of clinical scientists from JFK Neuroscience Institute, JFK Medical Center in New Jersey, led by Michael L. Rosenberg in collaboration with Research, Gilad&Gilad LLC, Henderson, Nevada, have now found that supplementation with dietary agmatine has a significant effect in reducing neuropathic pain intensity associated with painful SFN resistant to treatment with conventional neuropathic pain medications.
Based on previous clinical studies, which strongly support the use of high dietary agmatine supplementation as a safe and effective treatment for neuropathic pain, the scientists conducted an open-label consecutive case series study to evaluate the effectiveness of agmatine in neuropathies associated with painful SFN (Study Registry: ClinicalTrials.gov, System Identifier: NCT01524666). Participants diagnosed with painful SFN and autonomic dysfunctions were treated with 2.67 g/day agmatine sulfate (AgmaSet® capsules containing G-Agmatine® brand of agmatine sulfate) for a period of 2 months. Before the beginning (baseline) and at the end of the treatment period, participants answered an established neuropathic pain questionnaire specifically developed to distinguish symptoms associated with neuropathy and to quantify their severity. Twelve patients resistant to conventional treatment were recruited, and 11 patients—8 diagnosed with diabetic neuropathy, two with idiopathic neuropathy and one with inflammatory neuropathy—completed the study. None of the patients showed any serious side effects. All patients showed improvement in neuropathic pain to a varied extent. The average decrease in pain intensity was highly significant at 46.4% reduction in overall pain. The results substantiate reports from hundreds of people who use long-term agmatine sulfate treatment effectively to mitigate symptoms in several types of neuropathy known to involve small fiber pathology. Larger controlled studies are expected to establish agmatine sulfate as a preferred treatment for neuropathies.