Diabetes Research Center, Sahid Sadoughi University of Medical Sciences, Yazd, Iran.
Community and Preventive Medicine, Yazd Diabetes Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
Inflammopharmacology. 2024 Feb;32(1):551-559. doi: 10.1007/s10787-023-01338-2. Epub 2023 Nov 13.
Diabetic neuropathy is one of the most common complications of diabetes. The synthetic drugs available in the market have side effects and limitations for diabetic patients, the vast majority of whom are in the upper age group. In this regard, based on Persian medicinal sources, Nigella sativa (N. sativa) has proved to have beneficial effects on neuropathic pain and neurological disorders. In this study, the effect of N. sativa is investigated topically in patients with diabetic neuropathy.
This study was performed as a double-blind clinical trial on 120 neuropathic patients. The patients were divided into three groups. The first group received a topical N. sativa product as an ointment, the second group was given a topical placebo, and the third received 300 mg gabapentin capsules. The blindness was done in first and second groups. Diabetic neuropathy was assessed before the study using the Michigan Neuropathy Screening Instrument (MNSI). In addition, neuropathy symptoms were evaluated after the trial using the MNSI questionnaire.
The data were elicited from the patients' answers to a number of questions in the Michigan questionnaire. There were statistically significant differences between the group that received the topical N. sativa product and the other two groups in terms of legs and feet numbness (p value = 0.001), burning pain in feet or legs (p value = 0.001), muscle cramps in feet or legs (p value = 0.001), prickling fleeing in feet or legs (p value = 0.001), hurting of the skin when the bed covers touch it (p value = 0.005), aggravated symptoms at night (p value = 0.001) and hurting feelings in the legs when walking (p value = 0.032). However, the three studied groups were not statistically different in distinguishing hot water from cold water.
According to the results of this study, the topical use of N. sativa, compared to the current drugs, has acceptable improving effects on diabetic neuropathic patients.
糖尿病性神经病是糖尿病最常见的并发症之一。市场上的合成药物对糖尿病患者有副作用和局限性，而绝大多数糖尿病患者都在年龄较大的群体中。在这方面，基于波斯医学文献，黑种草（N. sativa）已被证明对神经病理性疼痛和神经紊乱具有有益的作用。在这项研究中，研究了黑种草局部治疗糖尿病性神经病患者的效果。
这项研究是一项针对 120 名神经病患者的双盲临床试验。患者被分为三组。第一组接受黑种草产品作为软膏的局部治疗，第二组接受局部安慰剂治疗，第三组接受 300mg 加巴喷丁胶囊治疗。第一组和第二组采用盲法。在研究之前，使用密歇根神经病变筛查工具（MNSI）评估糖尿病性神经病。此外，在试验后使用 MNSI 问卷评估神经病症状。
从密歇根问卷中患者的答案中获得了数据。在腿部和脚部麻木（p 值=0.001）、脚部或腿部烧灼感（p 值=0.001）、脚部或腿部肌肉痉挛（p 值=0.001）、脚部或腿部刺痛感（p 值=0.001）、当床罩碰到它时皮肤疼痛（p 值=0.005）、夜间症状加重（p 值=0.001）和行走时腿部刺痛感（p 值=0.032）方面，接受局部黑种草产品治疗的组与其他两组之间存在统计学显著差异。然而，三组在区分热水和冷水方面没有统计学差异。
根据这项研究的结果，与目前的药物相比，黑种草的局部使用对糖尿病性神经病患者具有可接受的改善作用。
