Effects of Treatment With the Antioxidant α-Lipoic Acid on Cardiac Autonomic Neuropathy in NIDDM Patients: A 4-month randomized controlled multicenter trial (DEKAN Study)

OBJECTIVE To evaluate the efficacy and safety of oral treatment with the antioxidant alpha-lipoic acid (ALA) in NIDDM patients with cardiac autonomic neuropathy (CAN), assessed by heart rate variability (HRV). RESEARCH DESIGN AND METHODS In a randomized, double-blind placebo-controlled multicenter trial (Deutsche Kardiale Autonome Neuropathie [DEKAN] Study), NIDDM patients with reduced HRV were randomly assigned to treatment with daily oral dose of 800 mg ALA ( n = 39) or placebo ( n = 34) for 4 months. Parameters of HRV at rest included the coefficient of variation (CV), root mean square successive difference (RMSSD), and spectral power in the low-frequency (LF; 0.05–0.15 Hz) and high-frequency (HF; 0.15–0.5 Hz) bands. In addition, cardiovascular autonomic symptoms were assessed. RESULTS Seventeen patients dropped out of the study (ALA n = 10; placebo n = 7). Mean blood pressure and HbA 1 levels did not differ between the groups at baseline and during the study, but heart rate at baseline was higher in the group treated with ALA ( P P 2 (−0.09 to 0.62) in ALA, whereas it declined by −0.01 bpm 2 (−0.48 to 1.86) in placebo ( P P = 0.097 and P = 0.094 for ALA vs. placebo). The changes in cardiovascular autonomic symptoms did not differ significantly between the groups during the period studied. No differences between the groups were noted regarding the rates of adverse events. CONCLUSIONS These findings suggest that treatment with ALA using a well-tolerated oral dose of 800 mg/day for 4 months may slightly improve CAN in NIDDM patients.