Internal Medicine Department, Port-Said University, Port-Said, Egypt.
Internal Medicine Department, Mansoura University, Mansoura, Egypt.
Endocr Metab Immune Disord Drug Targets. 2020;20(9):1531-1534. doi: 10.2174/1871530320666200506081407.
Alpha-lipoic acid (ALA) was used in the treatment of diabetic peripheral neuropathy (DPN) using different routes, doses and treatment durations. The aim of this work is to assess the efficacy of oral 600mg ALA twice daily over 6 months in the treatment of patients with DPN.
This is a prospective, single-center, double-blinded, placebo-controlled study conducted at the outpatient clinic of Mansoura Specialized Hospital, Mansoura University. A total of 200 patients with DPN were randomly assigned to add on treatment with either oral 600mg twice daily ALA (n=100) or placebo (n=100) for 6 months. Treatment outcome was assessed using vibration perception threshold (VPT), neurological symptom score (NSS), neurological disability score (NDS), and visual analog scale (VAS) for pain at baseline and at each visit (1, 3 and 6 months) after the start of treatment.
Comparison between the study groups regarding the baseline data revealed no statistically significant differences. with respect to the outcome parameters, no significant differences were found between the studied groups at baseline. However, in subsequent visits, ALA-treated patients had significantly better results regarding almost all the outcome parameters (NSS, NDS, VAS, VPT). Mild nausea was reported in 6 patients. None of the studied patients discontinued treatment.
Oral 600mg ALA twice-daily treatment for DPN over 6 months is effective, safe and tolerable.
α-硫辛酸（ALA）已被用于治疗糖尿病周围神经病变（DPN），采用不同的途径、剂量和治疗持续时间。本研究旨在评估每日两次口服 600mg ALA 治疗 DPN 患者 6 个月的疗效。
这是一项在曼苏拉大学曼苏拉专科医院门诊进行的前瞻性、单中心、双盲、安慰剂对照研究。共有 200 例 DPN 患者被随机分配接受每日两次口服 600mg ALA（n=100）或安慰剂（n=100）治疗 6 个月。在基线和治疗开始后每个访视（1、3 和 6 个月）时，使用振动感觉阈值（VPT）、神经症状评分（NSS）、神经功能缺损评分（NDS）和疼痛视觉模拟量表（VAS）评估治疗效果。
两组患者基线数据比较，无统计学差异。在观察终点时，两组患者的 NSS、NDS、VAS 和 VPT 评分均显著改善，但 ALA 组患者的改善更明显。6 例患者出现轻度恶心，但无患者因不良反应而停药。
每日两次口服 600mg ALA 治疗 DPN 6 个月是有效、安全且耐受良好的。
