Amiri Mohammad, Imani Mohammad Hossein, Imani Amir Hossein, Bazrafshan Hanieh, Bazrafshan Mehdi, Vardanjani Hossein Molavi, Zohalinezhad Mohammad Ebrahim
Research Center for Traditional Medicine and History of Medicine, Department of Persian Medicine, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran; Student research committee, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.
Student research committee, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.
Explore (NY). 2025 Jul-Aug;21(4):103189. doi: 10.1016/j.explore.2025.103189. Epub 2025 May 16.
Diabetic neuropathy, a prevalent complication of diabetes mellitus, significantly impairs quality of life due to chronic pain and sensory deficits. Conventional pharmacotherapies, while effective, are often limited by systemic adverse effects. Chamomile (Matricaria chamomilla L.) oil, renowned for its anti-inflammatory, antioxidant, and analgesic properties, presents a promising topical alternative for mitigating neuropathic symptoms.
This study aimed to evaluate the efficacy of topical chamomile oil in improving neuropathy indices among patients with controlled diabetes, as measured by validated clinical tools.
A randomized, double-blind, placebo-controlled trial was conducted involving 72 participants with diabetic neuropathy. Participants were allocated to either the intervention group (chamomile oil) or the control group (placebo), with both groups continuing standard gabapentin therapy. Neuropathy outcomes were assessed using Neurothesiometer scores, the Michigan Neuropathy Screening Instrument (MNSI), and the DN4 questionnaire at baseline and post-intervention. ANCOVA was employed to analyze intergroup differences, adjusting for baseline covariates.
The chamomile oil group exhibited statistically significant improvements in neuropathy indices compared to the placebo group (p < 0.05). Post-intervention, reductions in Neurothesiometer scores (mean difference: -1.14 ± 0.42), MNSI (-1.89 ± 0.31), and DN4 (-1.97 ± 0.28) were observed in the intervention group, with no comparable changes in controls. ANCOVA confirmed the robustness of these findings (F = 6.72, p = 0.012).
Topical chamomile oil significantly alleviates neuropathic symptoms in diabetic patients, offering a safe and adjunctive therapeutic option. Its mechanism may involve modulation of oxidative stress and inflammatory pathways, warranting further investigation into long-term benefits and molecular targets.
This trial was registered at the Iranian Registry of Clinical Trials (IRCT), registration number IRCT20240611062090N1. The full protocol is available at www.irct.ir.
糖尿病神经病变是糖尿病常见的并发症，因慢性疼痛和感觉障碍严重影响生活质量。传统药物疗法虽有效，但常受全身不良反应限制。洋甘菊（母菊）油以其抗炎、抗氧化和镇痛特性而闻名，是缓解神经病变症状的一种有前景的局部用药选择。
本研究旨在通过经过验证的临床工具评估局部使用洋甘菊油对改善血糖控制良好的糖尿病患者神经病变指标的疗效。
进行了一项随机、双盲、安慰剂对照试验，纳入72例糖尿病神经病变患者。参与者被分配到干预组（洋甘菊油）或对照组（安慰剂），两组均继续标准加巴喷丁治疗。在基线和干预后，使用神经感觉测量仪评分、密歇根神经病变筛查工具（MNSI）和DN4问卷评估神经病变结局。采用协方差分析（ANCOVA）分析组间差异，并对基线协变量进行校正。
与安慰剂组相比，洋甘菊油组神经病变指标有统计学显著改善（p < 0.05）。干预后，干预组神经感觉测量仪评分（平均差值：-1.14 ± 0.42）、MNSI（-1.89 ± 0.31）和DN4（-1.97 ± 0.28）降低，而对照组无类似变化。协方差分析证实了这些结果的稳健性（F = 6.72，p = 0.012）。
局部使用洋甘菊油可显著减轻糖尿病患者的神经病变症状，提供了一种安全的辅助治疗选择。其机制可能涉及氧化应激和炎症途径的调节，有必要进一步研究其长期益处和分子靶点。
本试验在伊朗临床试验注册中心（IRCT）注册，注册号为IRCT20240611062090N1。完整方案可在www.irct.ir获取。
