Exp Clin Endocrinol Diabetes 2008; 116(10): 600-605
DOI: 10.1055/s-2008-1065351
Article

© Georg Thieme Verlag KG Stuttgart · New York

Benfotiamine in Diabetic Polyneuropathy (BENDIP): Results of a Randomised, Double Blind, Placebo-controlled Clinical Study

H. Stracke 1 , W. Gaus 2 , U. Achenbach 3 , K. Federlin 1 , R.G. Bretzel 1
  • 1Medical Clinic und Policlinic III, University Hospital Giessen and Marburg, Location Giessen, Germany
  • 2Institute for Biometrics, University Ulm, Germany
  • 3Wörwag Pharma GmbH & Co. KG, Böblingen, Germany
Further Information

Publication History

received 28.11.2007 first decision 08.01.2008

accepted 11.03.2008

Publication Date:
13 May 2008 (online)

Abstract

Aim: Efficacy and safety of benfotiamine in treatment of diabetic polyneuropathy.

Methods: Double blind, placebo-controlled, phase-III-study. 181 patients were screened. 165 patients with symmetrical, distal diabetic polyneuropathy were randomised to one of three treatment groups entering the wash-out phase and 133/124 patients were analysed in the ITT/PP analysis: Benfotiamine 600 mg per day (n=47/43), benfotiamine 300 mg per day (n=45/42) or placebo (n=41/39).

Results: After 6 weeks of treatment, the primary outcome parameter NSS (Neuropathy Symptom Score) differed significantly between the treatment groups (p=0.033) in the PP (per protocol) population. In the ITT (intention to treat) population, the improvement of NSS was slightly above significance (p=0.055). The TSS (Total Symptom Score) showed no significant differences after 6 weeks of treatment. The improvement was more pronounced at the higher benfotiamine dose and increased with treatment duration. In the TSS, best results were obtained for the symptom “pain”. Treatment was well tolerated in all groups.

Conclusion: Benfotiamine may extend the treatment option for patients with diabetic polyneuropathy based on causal influence on impaired glucose metabolism. Further studies should confirm the positive experiences.

References

Correspondence

Prof. Dr. H. Stracke

University Hospital Giessen and Marburg GmbH

Medical Clinic and Policlinic III

Rodthohl 6

35392 Giessen

Germany

Phone: +49/641/994 27 54

Fax: +49/641/994 27 69

Email: Hilmar.Stracke@innere.med.uni-giessen.de

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