Pinzon Rizaldy Taslim, Wijaya Vincent Ongko, Veronica Vanessa
Faculty of Medicine, Duta Wacana Christian University, Yogyakarta, Indonesia.
Department of Neurology, Bethesda Hospital, Yogyakarta, Indonesia.
J Pain Res. 2021 Dec 19;14:3865-3875. doi: 10.2147/JPR.S341862. eCollection 2021.
Previous studies have demonstrated a significant relationship between vitamin D deficiency and the development of diabetic peripheral neuropathy (DPN). However, current studies are limited regarding the potential therapeutic benefits of vitamin D therapy in these patients.
This study aimed to assess the effect of oral vitamin D supplementation in patients with diabetic peripheral neuropathy in addition to standard treatment.
This study was a controlled, open-label, randomized clinical trial with an active comparator randomly allocated with a 1:1 ratio. The experimental group received an add-on oral vitamin D 5000 IU once daily and standard treatment (pregabalin, gabapentin, or amitriptyline) over eight weeks. The control group received standard treatment alone. The measured outcomes were the change in the score of the visual analog scale (VAS), numerical rating scale (NRS), and brief pain inventory (BPI). Vitamin D levels were also measured before and after the trial.
Data from 68 subjects with DPN was collected and analyzed. Most of them (60.3%) were female, aged 64.96 ± 8.3 years. After eight weeks of treatment, the experimental group showed a more significant reduction of mean VAS (-3.34 ± 2.03 vs -2.37 ± 2.2, p=0.044) and burning pain (1.76 ± 7.16 vs 6.18 ± 13.93, p=0.046) scores compared to controls. Mood also improves better in the experimental group (88.2% vs 70.6%, p=0.031). At the end of the study, vitamin D levels were also improved more significantly in the experimental group (40.02 ± 15.33 ng/mL vs 18.73 ± 6.88 ng/mL; p<0.001) with greater changes from the baseline to week 8 (+24.14±13.68 ng/mL vs +3.10±4.20 ng/mL; p<0.001) compared to control group. The intervention group showed a negative correlation between vitamin D level and VAS score (r = -0.403, P = 0.018). There were no adverse events recorded in this study.
The addition of oral vitamin D 5000 IU to standard treatment significantly improves pain, mood, and vitamin D levels more effectively than standard treatment alone in patients with diabetic neuropathy.
ClinicalTrials.gov.no NCT04689958.
先前的研究已证明维生素D缺乏与糖尿病周围神经病变（DPN）的发生之间存在显著关联。然而，目前关于维生素D治疗对这些患者潜在治疗益处的研究有限。
本研究旨在评估除标准治疗外，口服补充维生素D对糖尿病周围神经病变患者的影响。
本研究为一项对照、开放标签、随机临床试验，采用活性对照，随机分配比例为1:1。实验组在八周内每日额外口服5000国际单位维生素D并接受标准治疗（普瑞巴林、加巴喷丁或阿米替林）。对照组仅接受标准治疗。测量的结果为视觉模拟量表（VAS）、数字评定量表（NRS）和简明疼痛问卷（BPI）得分的变化。试验前后还测量了维生素D水平。
收集并分析了68例DPN患者的数据。其中大多数（60.3%）为女性，年龄64.96±8.3岁。治疗八周后，与对照组相比，实验组的平均VAS得分（-3.34±2.03对-2.37±2.2，p = 0.044）和灼痛得分（1.76±7.16对6.18±13.93，p = 0.046）降低更为显著。实验组的情绪改善也更好（88.2%对70.6%，p = 0.031）。在研究结束时，实验组的维生素D水平改善也更为显著（40.02±15.33纳克/毫升对18.73±6.88纳克/毫升；p<0.001），从基线到第8周的变化更大（+24.14±13.68纳克/毫升对+3.10±4.20纳克/毫升；p<0.001）。干预组的维生素D水平与VAS得分之间呈负相关（r = -0.403，P = 0.018）。本研究未记录到不良事件。
在糖尿病神经病变患者中，在标准治疗基础上加用口服5000国际单位维生素D比单纯标准治疗更有效地改善疼痛、情绪和维生素D水平。
ClinicalTrials.gov.no NCT04689958。
