Add-on Vitamin E in Improving Treatment Outcomes in Diabetic Peripheral Neuropathy: A Prospective Interventional Study

Rudra Paul, Shatavisa Mukherjee, Sharmistha Basu, Nilanjan Sengupta
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Abstract

Background: Neuropathy is one of the most common long-standing complications of diabetes, affecting over 50% of the diabetic individuals. Managing DPN and its complications involves comprehensive care and a multidisciplinary approach. Besides pharmacological treatments, botanicals and dietary supplements that have also been found to improve symptoms of DPN without affecting glucose control. The possible role of vitamin E in the management of DPN have been postulated in various studies. The present study thus aimed to prospectively assess whether add-on treatment with vitamin E can improve treatment outcomes in diabetic peripheral neuropathy.Methods: The study included newly diagnosed patients with diabetic peripheral neuropathy for a period of initial two months. Patients were randomly allocated to either standard treatment Group (Group A) or the interventionGroup (Group B). As a part of intervention, patients received vitamin E 400mg once daily in addition to thestandard of care. Efficacy Parameters measured at baseline, 6 months and 12 months included changes in visual analog scoring, mean pain score, brief pain inventory and patient’s global impression of change. Treatment safety, quality of life and treatment adherence was assessed. Data was statistically analysed.Result: The study included a total of 100 patients, 50 patients in each Group. Significantly higher decrease of glycaemic measures was noted for Group B compared to Group A in terms of PPPG and serum creatinine, however, there was comparable change in HbA1c and FPG for both Groups. There was comparable significant reduction in mean VAS scoring at 6 and 12 months for Group B. Considering all the efficacy measures, there was highest reduction for the pain interference in the intervention arm (Group B), in comparison to Group A. (p<0.001). Quality of life measures and mean adherence scoring significantly increased for treatment group B as compared to A at both 6 months and 12 months of study assessments. No major safety concerns were reported during the study period.Conclusion: Our study noted that addition of vitamin E as an added supplementation to the standard of careshowed benefits in terms of patient reported reduced pain interference and pain perception, which also significantly improved overall quality of life in these patients.
添加维生素 E 改善糖尿病周围神经病变的治疗效果:前瞻性干预研究
背景:神经病变是糖尿病最常见的长期并发症之一,影响 50%以上的糖尿病患者。治疗 DPN 及其并发症需要综合护理和多学科方法。除药物治疗外,植物药和膳食补充剂也能在不影响血糖控制的情况下改善 DPN 的症状。多项研究都推测维生素 E 在治疗 DPN 中可能发挥的作用。因此,本研究旨在前瞻性地评估加用维生素 E 是否能改善糖尿病周围神经病变的治疗效果:研究对象包括新确诊的糖尿病周围神经病变患者,为期两个月。患者被随机分配到标准治疗组(A 组)或干预组(B 组)。作为干预措施的一部分,患者除了接受标准治疗外,还接受维生素 E 400 毫克,每天一次。在基线、6 个月和 12 个月时测量的疗效参数包括视觉模拟评分、平均疼痛评分、简短疼痛清单和患者对变化的总体印象的变化。对治疗安全性、生活质量和治疗依从性进行了评估。对数据进行了统计分析:研究共包括 100 名患者,每组 50 人。就 PPPG 和血清肌酐而言,与 A 组相比,B 组的血糖指标下降幅度明显更高,但两组的 HbA1c 和 FPG 变化相当。考虑到所有疗效指标,与 A 组相比,干预组(B 组)的疼痛干扰降低幅度最大(P<0.001)。在 6 个月和 12 个月的研究评估中,与 A 组相比,B 组的生活质量指标和平均依从性评分均有显著提高。研究期间没有出现重大安全问题:我们的研究结果表明,在标准治疗的基础上增加维生素 E 作为补充剂,在患者报告的疼痛干扰和疼痛感觉减轻方面显示出益处,这也明显改善了这些患者的整体生活质量。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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