H Stracke1, W Gaus, U Achenbach, K Federlin, R G Bretzel. 1. Medical Clinic und Policlinic III, University Hospital Giessen and Marburg, Location Giessen, Germany. Hilmar.Stracke@innere.med.uni-giessen.de
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.
RCT Entities:
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.
Authors: Gary E Gibson; José A Luchsinger; Rosanna Cirio; Huanlian Chen; Jessica Franchino-Elder; Joseph A Hirsch; Lucien Bettendorff; Zhengming Chen; Sarah A Flowers; Linda M Gerber; Thomas Grandville; Nicole Schupf; Hui Xu; Yaakov Stern; Christian Habeck; Barry Jordan; Pasquale Fonzetti Journal: J Alzheimers Dis Date: 2020 Impact factor: 4.472
Authors: Gary E Gibson; Joseph A Hirsch; Rosanna T Cirio; Barry D Jordan; Pasquale Fonzetti; Jessica Elder Journal: Mol Cell Neurosci Date: 2012-09-13 Impact factor: 4.314