[The efficacy of the intravenous administration of the trometamol salt of thioctic (alpha-lipoic) acid in diabetic neuropathy]

Abstract

A two-central randomised single-blind placebo-controlled study was conducted to assess efficacy of intravenous administration of trometamol salt of thioctic (alpha-lipoic) acid (Thioctacid 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 received a physiological solution stained with 1% solution of riboflavin mononucleate (B2 vitamin) as placebo. Intravenous infusion was administered once 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 lipid peroxidation (oxidative stress)--malonic dialdehyde levels in plasma and 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 picture had been pronounced by day 21 (p < 0.001). Improvement of symptom score was obtained in 39 patients (97.5%). The response rate in the control group was 40%. Parameters of oxidative stress and electroneuromyography improved significantly in the main group of patients, while these in placebo group remained without changes.