Forty-five diabetes patients with painful peripheral
polyneuropathy were enrolled in a 3-month observational study comparing the therapeutic efficacy of
Milgamma tablets (50 mg
benfothiamine and 0.25 mg cyancobalamine) with parallel randomized treatment assignment with the conventional
vitamin B complex treatment regimen Neurobex. Thirty patients in group one were randomized to receive two
Milgamma tablets qid for three weeks followed by 1
Milgamma 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
Milgamma 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
Milgamma-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
Milgamma 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
Milgamma tablets as an indispensable
element in the therapeutic regimen of patients with painful
diabetic polyneuropathy.