Therapeutic efficacy of benfotiamine in patients with painful diabetic neuropathy.

Simeonov S, Pavlova M, Mitkov M, Mincheva L, Troev D.

Endocrinology and Metabolic Disorders Clinic
Higher Medical Institute
Plovdiv, Bulgaria.
Folia Med (Plovdiv). 1997;39(4):5-10.

Abstract

Forty-five diabetes patients with painful peripheral polyneuropathy were enrolled in a 3-month observational study comparing the therapeutic efficacy of 50 mg benfothiamine with parallel randomized treatment assignment with the conventional vitamin B complex treatment regimen Neurobex (B1 10mg, B2 10mg, B6 2mg, B12 5mg, Niacinamide 50mg, Zinc sulfate 61.8mg). Thirty patients in group one were randomized to receive two benfothiamine tablets qid for three weeks followed by 1 benfothiamine tablet tid for 9 weeks. In group two 15 patients received two Neurobex tablets tid for the entire 3-month study period. Therapeutic efficacy was assessed on the basis of within-patient differences in pain severity between benfothiamine and Neurobex-treated patients and in vibration perception thresholds using the Rydel-Seiffer biothesiometer at baseline and at the end of the study. Statistically significant relief of both background and peak neuropathic pain was achieved in all of the benfothiamine-treated patients and vibration perception thresholds dramatically improved with a median of 1.56 measured on the biothesiometer scale (t = 3.24, P < 0.01). The sensory symptoms improvement was insignificant in the Neurobex-treated patient group and the changes in the vibration perception thresholds failed to reach statistical significance. The therapeutic efficacy of benfothiamine was greater in patients with early-stage diabetes as compared with those with advanced diabetic neuropathy. No adverse reactions were observed following the administration of the medication. Our results underscore the importance of benfothiamine tablets as an indispensable element in the therapeutic regimen of patients with painful diabetic polyneuropathy.