Division of Endocrinology and Metabolism, Department of Internal Medicine, Cardiovascular and Metabolic Disease Center, Inje University Sanggye Paik Hospital, Inje University College of Medicine, Seoul, Korea.
Division of Endocrinology and Metabolism, Department of Internal Medicine, Yeouido St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
Diabetes Metab J. 2020 Aug;44(4):542-554. doi: 10.4093/dmj.2019.0099. Epub 2019 Nov 4.
This study was a multicenter, parallel-group, double-blind, double-dummy, randomized, noninferiority trial to evaluate the efficacy and safety of γ-linolenic acid (GLA) relative to α-lipoic acid (ALA) over a 12-week treatment period in type 2 diabetes mellitus (T2DM) patients with painful diabetic peripheral neuropathy (DPN).
This study included 100 T2DM patients between 20 and 75 years of age who had painful DPN and received either GLA (320 mg/day) and placebo or ALA (600 mg/day) and placebo for 12 weeks. The primary outcome measures were mean changes in pain intensities as measured by the visual analogue scale (VAS) and the total symptom scores (TSS).
Of the 100 subjects who initially participated in the study, 73 completed the 12-week treatment period. Per-protocol analyses revealed significant decreases in the mean VAS and TSS scores compared to baseline in both groups, but there were no significant differences between the groups. The treatment difference for the VAS (95% confidence interval [CI]) between the two groups was -0.65 (-1.526 to 0.213) and the upper bound of the 95% CI did not exceed the predefined noninferiority margin (δ₁=0.51). For the TSS, the treatment difference was -0.05 (-1.211 to 1.101) but the upper bound of the 95% CI crossed the noninferiority margin (δ₂=0.054). There were no serious adverse events associated with the treatments.
GLA treatment in patients with painful DPN was noninferior to ALA in terms of reducing pain intensity measured by the VAS over 12 weeks.
本研究是一项多中心、平行组、双盲、双模拟、随机、非劣效性试验，旨在评估γ-亚麻酸（GLA）相对于α-硫辛酸（ALA）在 12 周治疗期间在 2 型糖尿病（T2DM）伴痛性糖尿病周围神经病变（DPN）患者中的疗效和安全性。
本研究纳入了 100 名年龄在 20 至 75 岁之间的 T2DM 患者，这些患者患有痛性 DPN，接受 GLA（320mg/天）和安慰剂或 ALA（600mg/天）和安慰剂治疗，为期 12 周。主要结局指标为视觉模拟评分（VAS）和总症状评分（TSS）测量的疼痛强度的平均变化。
在最初参加研究的 100 名受试者中，有 73 名完成了 12 周的治疗期。基于方案分析显示，两组的 VAS 和 TSS 评分均较基线显著下降，但两组间无显著差异。两组间 VAS 的治疗差异（95%置信区间[CI]）为-0.65（-1.526 至 0.213），95%CI 的上限未超过预设的非劣效性边界（δ₁=0.51）。对于 TSS，治疗差异为-0.05（-1.211 至 1.101），但 95%CI 的上限越过了非劣效性边界（δ₂=0.054）。治疗过程中没有与治疗相关的严重不良事件。
在 12 周内，与 ALA 相比，GLA 治疗痛性 DPN 患者的 VAS 测量疼痛强度无差异。
