Evidence for Dietary Agmatine Sulfate Effectiveness in Neuropathies Associated with Painful Small Fiber Neuropathy. A Pilot Open-Label Consecutive Case Series Study

• Main Authors: Michael L. Rosenberg, Vahid Tohidi, Karna Sherwood, Sujoy Gayen, Rosina Medel, Gad M. Gilad
• Format: Article
• Language: English
• Published: MDPI AG 2020-02-01
• Series: Nutrients
• Subjects: agmatine; neuropathic pain; neuropathies; peripheral neuropathy; small fiber neuropathy
• Online Access: https://www.mdpi.com/2072-6643/12/2/576

Peripheral neuropathies associated with painful small fiber neuropathy (SFN) are complex conditions, resistant to treatment with conventional medications. Previous clinical studies strongly support the use of dietary agmatine as a safe and effective treatment for neuropathic pain. Based on this evidence, we 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^&#174; capsules containing G-Agmatine^&#174; brand of agmatine sulfate) for a period of 2 months. Before the beginning (baseline) and at the end of the treatment period, participants answered the established 12-item neuropathic pain questionnaire specifically developed to distinguish symptoms associated with neuropathy and to quantify their severity. Secondary outcomes included other treatment options and a safety assessment. Twelve patients were recruited, and 11 patients&#8212;8 diagnosed with diabetic neuropathy, two with idiopathic neuropathy and one with inflammatory neuropathy&#8212;completed the study. All patients showed improvement in neuropathic pain to a varied extent. The average decrease in pain intensity was 26.0 rating points, corresponding to a 46.4% reduction in overall pain (<i>p</i> &lt; 0.00001). The results suggest that dietary agmatine sulfate has a significant effect in reducing neuropathic pain intensity associated with painful SFN resistant to treatment with conventional neuropathic pain medications. Larger randomized placebo-controlled studies are expected to establish agmatine sulfate as a preferred treatment.