Efficacy and safety of benfotiamine in treatment of diabetic polyneuropathy.
Double blind, placebo controlled, phase-III-study.
181 patients were screened.
Main outcome measures
As primary endpoint of this study the NSS (Neuropathy Symptom Score) after 6 weeks was defined. A minimum of 180 patients (60 in each treatment group) was calculated to detect significant differences. A difference in the main outcome parameter of at least 20 % was expected. Secondary outcome parameters were the improvement of NDS (Neuropathy Disability Score), TSS (Total Symptom Score according to Ziegler et al., 1995) and the vibration perception threshold (tuning fork test).
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.
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.
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