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.