Ziegler D, Schatz H, Conrad F, Gries F A, Ulrich H, Reichel G
Diabetes-Forschungsinstitut an der Heinrich-Heine-Universität, Düsseldorf, Germany.
Diabetes Care. 1997 Mar;20(3):369-73. doi: 10.2337/diacare.20.3.369.
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).
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.
Seventeen patients dropped out of the study (ALA n = 10; placebo n = 7). Mean blood pressure and HbA1 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 < 0.05). RMSSD increased from baseline to 4 months by 1.5 ms (-37.6 to 77.1) [median (minimum-maximum)] in the group given ALA and decreased by -0.1 ms (-19.2 to 32.8) in the placebo group (P < 0.05 for ALA vs. placebo). Power spectrum in the LF band increased by 0.06 bpm2 (-0. 09 to 0.62) in ALA, whereas it declined by -0.01 bpm2 (-0.48 to 1.86) in placebo (P < 0.05 for ALA vs. placebo). Furthermore, there was a trend toward a favorable effect of ALA versus placebo for the CV and HF band power spectrum (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.
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.
通过心率变异性（HRV）评估口服抗氧化剂α-硫辛酸（ALA）治疗非胰岛素依赖型糖尿病（NIDDM）合并心脏自主神经病变（CAN）患者的疗效和安全性。
在一项随机、双盲、安慰剂对照的多中心试验（德国心脏自主神经病变[DEKAN]研究）中，HRV降低的NIDDM患者被随机分配接受每日口服800mg ALA治疗（n = 39）或安慰剂治疗（n = 34），为期4个月。静息时HRV参数包括变异系数（CV）、逐次差值均方根（RMSSD）以及低频（LF；0.05 - 0.15Hz）和高频（HF；0.15 - 0.5Hz）频段的频谱功率。此外，对心血管自主神经症状进行了评估。
17名患者退出研究（ALA组10名；安慰剂组7名）。两组在基线期和研究期间的平均血压和糖化血红蛋白水平无差异，但ALA治疗组的基线心率较高（P < 0.05）。接受ALA治疗的组中，RMSSD从基线到4个月增加了1.5ms（-37.6至77.1）[中位数（最小值 - 最大值）]，而安慰剂组降低了-0.1ms（-19.2至32.8）（ALA组与安慰剂组比较，P < 0.05）。ALA组LF频段的功率谱增加了0.06bpm²（-0.09至0.62），而安慰剂组下降了-0.01bpm²（-0.48至1.86）（ALA组与安慰剂组比较，P < 0.05）。此外，ALA组与安慰剂组相比，在CV和HF频段功率谱方面有产生有利效应的趋势（ALA组与安慰剂组比较，P = 0.097和P = 0.094）。在研究期间，两组心血管自主神经症状的变化无显著差异。两组不良事件发生率无差异。
这些发现表明，使用每日800mg耐受性良好的口服剂量ALA治疗4个月可能会使NIDDM患者的CAN略有改善。
