Diabetes Center, 1st Propaedeutic Department of Internal Medicine, Aristotle University of Thessaloniki, AHEPA Hospital, 54636 Thessaloniki, Greece.
Department of Clinical Nutrition and Dietetics, AHEPA Hospital, 54636 Thessaloniki, Greece.
Nutrients. 2024 Sep 10;16(18):3045. doi: 10.3390/nu16183045.
To investigate the efficacy of Palmitoylethanolamide (PEA, 300 mg), Superoxide Dismutase (SOD, 70 UI), Alpha Lipoic Acid (ALA, 300 mg), vitamins B6 (1.5 mg), B1 (1.1 mg), B12 (2.5 mcg), E (7.5 mg), nicotinamide (9 mg), and minerals (Mg 30 mg, Zn 2.5 mg) in one tablet in people with Diabetic Neuropathy (DN).
PATIENTS-METHODS: In the present pilot study, 73 people (age 63.0 ± 9.9 years, 37 women) with type 2 Diabetes Mellitus (DMT2) (duration 17.5 ± 7.3 years) and DN were randomly assigned to receive either the combination of ten elements (2 tablets/24 h) in the active group ( = 36) or the placebo ( = 37) for 6 months. We used the Michigan Neuropathy Screening Instrument Questionnaire and Examination (MNSIQ and MNSIE), measured vibration perception threshold (VPT) with biothesiometer, and Cardiovascular Autonomic Reflex Tests (CARTs). Nerve function was assessed by DPN Check [sural nerve conduction velocity (SNCV) and amplitude (SNAP)]. Sudomotor function was assessed with SUDOSCAN, which measures electrochemical skin conductance in hands and feet (ESCH and ESCF). Pain score (PS) was assessed with Pain DETECT questionnaire. Quality of life was assessed by questionnaire.
In the active group, there was a large improvement of pain (PS from 20.9 to 13.9, < 0.001). There was also a significant improvement of vitamin B12 (B12) levels, MNSIQ, SNCV, VPT, and ESCF (222.1 vs. 576.3 pg/ mL, < 0.001; 6.1 vs. 5.9, = 0.017; 28.8 vs. 30.4, = 0.001; 32.1 vs. 26.7, = 0.001; and 72.2 vs. 74.8, < 0.001 respectively). In the placebo group, neither pain (21.6 vs. 21.7, = 0.870) or any other aforementioned parameters changed significantly, and MNSIE worsened (2.9 vs. 3.4, < 0.001). As a result, changes from baseline to follow-up in pain, B12 levels, VPT, and MNSIQ differed significantly between the two groups ( < 0.001, 0.025, 0.009, and <0.001, respectively). CARTs, SNAP, ESCH did not significantly change in either of the two groups.
The combination of the ten elements in one tablet for 6 months at a daily dose of two tablets in people with DN significantly improves pain, vibration perception threshold, and B12 levels.
研究棕榈酸乙醇酰胺（PEA，300mg）、超氧化物歧化酶（SOD，70UI）、α-硫辛酸（ALA，300mg）、维生素 B6（1.5mg）、B1（1.1mg）、B12（2.5mcg）、E（7.5mg）、烟酰胺（9mg）和矿物质（Mg 30mg，Zn 2.5mg）在糖尿神经病变（DN）患者中的疗效。
患者-方法：在本初步研究中，73 名（年龄 63.0±9.9 岁，37 名女性）2 型糖尿病（DMT2）（病程 17.5±7.3 年）和 DN 患者被随机分配接受联合十种元素（每日 2 片/24 小时）的活性组（n=36）或安慰剂（n=37）治疗 6 个月。我们使用密歇根州周围神经病变筛查工具问卷和检查（MNSIQ 和 MNSIE），使用生物测振仪测量振动感觉阈值（VPT），并进行心血管自主反射测试（CART）。神经功能通过 DPN Check [腓肠神经传导速度（SNCV）和幅度（SNAP）]进行评估。自主神经功能通过 SUDOSCAN 评估，该检查测量手和脚的电化学皮肤电导率（ESCH 和 ESCF）。使用疼痛 DETECT 问卷评估疼痛评分（PS）。使用问卷评估生活质量。
在活性组中，疼痛显著改善（PS 从 20.9 降至 13.9，<0.001）。维生素 B12（B12）水平、MNSIQ、SNCV、VPT 和 ESCF 也显著改善（222.1 与 576.3pg/mL，<0.001；6.1 与 5.9，=0.017；28.8 与 30.4，=0.001；32.1 与 26.7，=0.001；72.2 与 74.8，<0.001）。在安慰剂组中，疼痛（21.6 与 21.7，=0.870）或任何其他上述参数均无明显变化，且 MNSIE 恶化（2.9 与 3.4，<0.001）。因此，两组间疼痛、B12 水平、VPT 和 MNSIQ 的基线至随访的变化差异具有统计学意义（<0.001、0.025、0.009 和 <0.001，分别）。CART、SNAP、ESCH 在两组中均无明显变化。
DN 患者每日服用两片，连续服用 6 个月，联合使用这十种元素可显著改善疼痛、振动感觉阈值和 B12 水平。
