Efficacy of intravenous administration of trometamol salt of thioctic (alpha-lipoic) acid in diabetic neuropathy

A two-central randomised single-blind placebo-controlled study was conducte d to assess efficacy of intravenous administration of trometamol salt of th ioctic (alpha-lipoic) acid (thiotacid 600, <<ASTA Medica>>, Germany) in 200 ml of physiological solution in 40 non-insulin dependent diabetic patients with symptomatic diabetic neuropathy. 10 patients of the control group rec eived a physiological solution stained with 1% solution of riboflavin monon ucleate (B-2 vitamine) as placebo. Intravenous infusion was administered on ce daily during a period of 3 weeks. Diabetic neuropathy score was assessed at the entry as well as on days 7, 14 and 21 of therapy. Indicators of lip id peroxidation (oxidative stress) - malonic dialdehyde levels in plasma an d membranes of erythrocytes. Electroneuromyography were performed. Most of the patients (29) noted symptomatic improvement after 7-10 infusions and on day 14 a significant reduction of the diabetic neuropathy score was noted in comparison to a baseline (p<0,05). The further improvement of clinical p icture had been pronounced by day 21 (p<0,001). Improvement of symptom scor e was obtained in 39 patients (97,5%). The response rate in the control gro up was 40%. Parameters of oxidative stress and electroneuromyography improv ed significantly in the main group of patients, while these in placebo grou p remained without changes.