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Therapeutic efficacy of "Milgamma" in patients with painful diabetic neuropathy.

Abstract
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.
AuthorsS Simeonov, M Pavlova, M Mitkov, L Mincheva, D Troev
JournalFolia medica (Folia Med (Plovdiv)) Vol. 39 Issue 4 Pg. 5-10 ( 1997) ISSN: 0204-8043 [Print] Bulgaria
PMID9575643 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial)
Chemical References
  • Vitamin B Complex
  • Vitamin B 12
  • Thiamine
  • benphothiamine
Topics
  • Adult
  • Aged
  • Diabetic Neuropathies (drug therapy, physiopathology)
  • Female
  • Humans
  • Male
  • Middle Aged
  • Pain (drug therapy, physiopathology)
  • Thiamine (administration & dosage, analogs & derivatives, therapeutic use)
  • Vitamin B 12 (administration & dosage, therapeutic use)
  • Vitamin B Complex (therapeutic use)

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