Benfotiamine in diabetic polyneuropathy (BENDIP): results of a randomised, double blind, placebo-controlled clinical study.
OBJECTIVE
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.


CONCLUSIONS
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.
Stracke
H
H
Medical Clinic und Policlinic III, University Hospital Giessen and Marburg, Location Giessen, Germany. Hilmar.Stracke@innere.med.uni-giessen.de
Gaus
W
W
Achenbach
U
U
Federlin
K
K
Bretzel
R G
RG
D000276:Adjuvants, Immunologic / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D003922:Diabetes Mellitus, Type 1 / Q000150:complications; D003924:Diabetes Mellitus, Type 2 / Q000150:complications; D003929:Diabetic Neuropathies / Q000188:drug therapy* / Q000503:physiopathology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010919:Placebos; D012449:Safety; D012684:Sensory Thresholds / Q000187:drug effects; D013831:Thiamine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use
D000276:Adjuvants, Immunologic; D010919:Placebos; D013831:Thiamine; C013835:benphothiamine