局部洋甘菊油作为糖尿病神经病变的一种新的治疗干预：一项随机双盲对照临床试验

IF 1.9 4区医学 Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE

Explore-The Journal of Science and Healing Pub Date : 2025-05-16 DOI:10.1016/j.explore.2025.103189

Mohammad Amiri , Mohammad Hossein Imani , Amir Hossein Imani , Hanieh Bazrafshan , Mehdi Bazrafshan , Hossein Molavi Vardanjani , Mohammad Ebrahim Zohalinezhad

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引用次数: 0

摘要

糖尿病神经病变是糖尿病的一种常见并发症，由于慢性疼痛和感觉缺陷而严重影响生活质量。传统的药物治疗虽然有效，但往往受到全身不良反应的限制。洋甘菊油以其抗炎、抗氧化和镇痛特性而闻名，是缓解神经病变症状的一种有希望的局部替代方案。目的：本研究旨在评估洋甘菊油局部应用对控制糖尿病患者神经病变指标的改善作用，并通过验证的临床工具进行测量。方法对72例糖尿病性神经病变患者进行随机、双盲、安慰剂对照试验。参与者被分配到干预组（洋甘菊油）或对照组（安慰剂），两组都继续标准的加巴喷丁治疗。在基线和干预后，使用Neurothesiometer评分、密歇根神经病变筛查仪器（MNSI）和DN4问卷评估神经病变结果。采用ANCOVA分析组间差异，调整基线协变量。结果与安慰剂组相比，洋甘菊油组在神经病变指标方面有统计学意义的改善(p <；0.05)。干预后，干预组Neurothesiometer评分（平均差值：- 1.14±0.42）、MNSI（- 1.89±0.31）和DN4（- 1.97±0.28）下降，对照组无可比较的变化。ANCOVA证实了这些发现的稳健性（F = 6.72, p = 0.012）。结论洋甘菊油可显著缓解糖尿病患者的神经病变症状，是一种安全的辅助治疗方法。其机制可能涉及氧化应激和炎症途径的调节，需要进一步研究其长期益处和分子靶点。试验注册本试验在伊朗临床试验注册中心（IRCT）注册，注册号为IRCT20240611062090N1。完整的协议可在www.irct.ir上获得。

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Topical chamomile oil as a novel therapeutic intervention for diabetic neuropathy: A randomized double-blind controlled clinical trial

Background

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.

Objective

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.

Methods

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.

Results

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).

Conclusion

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.

Trial registration

This trial was registered at the Iranian Registry of Clinical Trials (IRCT), registration number IRCT20240611062090N1. The full protocol is available at www.irct.ir.

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来源期刊

Explore-The Journal of Science and Healing 医学-全科医学与补充医学

CiteScore

3.00

自引率

8.30%

发文量

179

审稿时长

25 days

期刊介绍： EXPLORE: The Journal of Science & Healing addresses the scientific principles behind, and applications of, evidence-based healing practices from a wide variety of sources, including conventional, alternative, and cross-cultural medicine. It is an interdisciplinary journal that explores the healing arts, consciousness, spirituality, eco-environmental issues, and basic science as all these fields relate to health.