The sensory symptoms of diabetic polyneuropathy are improved with alpha-lipoic acid: the SYDNEY trial.

OBJECTIVE: Because alpha-lipoic acid (ALA), a potent antioxidant, prevents or improves nerve conduction attributes, endoneurial blood flow, and nerve (Na(+) K(+) ATPase activity in experimental diabetes and in humans and may improve positive neuropathic sensory symptoms, in this report we further assess the safety and efficacy of ALA on the Total Symptom Score (TSS), a measure of positive neuropathic sensory symptoms. RESEARCH DESIGN AND METHODS: Metabolically stable diabetic patients with symptomatic (stage 2) diabetic sensorimotor polyneuropathy (DSPN) were randomized to a parallel, double-blind study of ALA (600 mg) (n = 60) or placebo (n = 60) infused daily intravenously for 5 days/week for 14 treatments. The primary end point was change of the sum score of daily assessments of severity and duration of TSS. Secondary end points were sum scores of neuropathy signs (NIS), symptoms (NSC), attributes of nerve conduction, quantitative sensation tests (QSTs), and an autonomic test. RESULTS: At randomization, the groups were not significantly different by the criteria of metabolic control or neuropathic end points. After 14 treatments, the TSS of the ALA group had improved from baseline by an average of 5.7 points and the placebo group by an average of 1.8 points (P < 0.001). Statistically significant improvement from baseline of the ALA, as compared with the placebo group, was also found for each item of the TSS (lancinating and burning pain, asleep numbness and prickling), NIS, one attribute of nerve conduction, and global assessment of efficacy. CONCLUSIONS: Intravenous racemic ALA, a potent antioxidant, rapidly and to a significant and meaningful degree, improved such positive neuropathic sensory symptoms as pain and several other neuropathic end points. This improvement of symptoms was attributed to improved nerve pathophysiology, not to increased nerve fiber degeneration. Because of its safety profile and its effect on positive neuropathic sensory symptoms and other neuropathic end points, this drug appears to be a useful ancillary treatment for the symptoms of diabetic polyneuropathy.

[Cardiovascular neuropathy in pregnant women with type 1 diabetes]. / Kardiovaskularna neuropatija u trudnica s dijabetesom tipa 1.

OBJECTIVE: Autonomic neuropathy has recently been recognized as a potential risk factor in pregnancy of type 1 diabetics. The aim of the study was to highlight this poorly recognized problem in the obstetric management of diabetic mothers. STUDY DESIGN: 94 pregnant type 1 diabetics aged 20-35 with a minimum five--year duration of diabetes. A normal population, i.e. 46 age-matched pregnant women without diabetes were evaluated, because there are no normal values for this population. Cardiovascular tests and structured clinical examination were performed on 3 occasions 3 times during pregnancy (once in each trimester). Cardiovascular tests were performed using the ProSciCard system. A full test battery were performed and six basic tests were evaluated. HbA1c was used to assess diabetes control. Diabetic polyneuropathy was clinically assessed by Dyck's staging system. RESULTS: The incidence of moderate and severe autonomic neuropathy in type-1 diabetic pregnant women was 8.5%. There was no increase in the perinatal morbidity and mortality associated with moderate and severe autonomic neuropathy. CONCLUSION: The presence of moderate to severe symptomatic autonomic neuropathy in patients with type-1 diabetes is not a contraindication for pregnancy. If pregnancy is achieved, the patients should be monitored for the occurrence of pernicious vomiting.