ORIGINAL ARTICLE Bali Medical Journal (Bali MedJ) 2025. Volume 14. Number 3: 704-708 P-ISSN. E-ISSN: 2528-6641 The Effect of Capsaicin as a Vagus Auricular Nerve Stimulant in Terms of Relaxation with Pulse Rate Change Indicators Arman Yurisaldi Saleh1*. Riezky Valentina2. Dwi Arwandi Yogi Saputra3. Nadia Putri Lestari4 ABSTRACT Neurology Department. Faculty of Medicine. UPN Veteran Jakarta. Indonesia. Neurology Department. Faculty of Medicine. UPN Veteran Jakarta. Indonesia. Department of Public Health Sciences. Faculty of Medicine. UPN Veteran Jakarta. Indonesia. Department Faculty of Medicine. UPN Veteran Jakarta. *Corresponding author: Arman Yurisaldi Saleh. Neurology Department Faculty of Medicine UPN Veteran Jakarta. Indonesia. drarmanyurisaldic@gmail. Received: 2025-08-21 Accepted: 2025-10-24 Published: 2025-11-21 Introduction: This study demonstrated that applying a 1y1 cm auricular capsaicin patch for 30 minutes led to an average heart rate reduction of 16. 3 bpm in 52 healthy subjects. The response was consistent across individuals, indicating a robust acute physiological effect. The findings suggest that chemical stimulation of the auricular region activates afferent pathways projecting to the nucleus tractus solitarius (NTS), increasing vagal tone and reducing sympathetic activity. This is the first evidence that non-electrical, topical stimulation of the auricular vagus nerve can modulate cardiorespiratory regulation in healthy individuals. The intervention was well tolerated, with no serious adverse events reported. These results support the potential of auricular capsaicin as a practical, non-invasive neuromodulatory tool, warranting further investigation through randomized controlled trials. Research Method: Eligible subjects . had their heart rate recorded. Salonpas Hot patch . y 1 cm, containing 0. was then applied to the inside of their ears for 30 min after a lecture about the anatomy of the auricular vagus Bilateral auricular vagus nerves were treated with the capsaicin patch, and pulse rate was measured for each subject. Twenty-six subjects were recruited and completed this study. Conclusion: Mean HR of 52 subjects fell from 94. 0/-5. 3 to 77. 7/ 6. 9 bpm . 3 bpm decrease. t = 39. df = 51. p < 0. under a capsaicin patch . capsaicin/c. located in their auricular region. It is evidence of acute autonomic modulation towards improved parasympathetic tone. These results provide evidence for the possibility that TRPV1-mediated auricular branch of vagus stimulation could produce acute CV relaxation effects, and warrant further RCTs. HRV assessments, and longitudinal studies to confirm a mechanism of action and safety in long-term use. Keywords: vagus, stimulation, relax, heart rate, capsaicin, quasi. Cite This Article: Saleh. Valentina. Saputra. Lestari. The Effect of Capsaicin as a Vagus Auricular Nerve Stimulant in Terms of Relaxation with Pulse Rate Change Indicators. Bali Medical Journal 14. : 704-708. DOI: 10. INTRODUCTION Transcutaneous auricular vagus nerve stimulation has attracted attention for non-invasive neuromodulation due to its potential in regulating autonomic tone, inflammation, cognition, and pain. the auricular branch of the vagus nerve (ABVN or JacobsonAos nerv. is a viable peripheral target because its afferents project to brainstem nuclei controlling cardiopulmonary and visceral functions1. Several animal and human studies have shown that vagal auricular stimulation can modulate central autonomic circuits and influence cardiac and gastrointestinal function, but most clinical studies have used electrical stimulation, leaving alternative approaches such as thermal Warm stimulation of afferent C fibers is assumed to follow afferent pathways similar to painful stimuli but is likely to be more comfortable for the subject. preliminary observations using ear warmers reported clinical improvement in GERD and a decrease in heart rate, thus supporting the hypothesis that auricular thermal stimulation may increase parasympathetic vagal tone3. Capsaicin, as a TRPV1 agonist, activates and subsequently causes desensitization of afferent C fibers, providing a pharmacological basis for local intervention on the vagal pathway. the use of a practical and commercially available capsaicin patch allows the application of a chemical-warm stimulus to the auricular area to directly test the vagal modulation Safety data from systematic reviews and clinical trials of taVNS demonstrate good tolerability and a low incidence of serious cardiac effects, suggesting that further research into alternative stimulation methods, such as auricular capsaicin patches with hypersensitivity screening protocols and monitoring of local skin reactions, may be warranted5. RESEARCH METHOD We recruited Administrative Employees of the Faculty of Medicine. UPN Veteran Jakarta, after obtaining ethical clearance from the ethics committee of the Faculty Bali Medical Journal 2025. Open | doi: 15562/bmj. ORIGINAL ARTICLE of Medicine. University of Indonesia, (KET-1394/UN2. F1/ETIK/PPM 02/2. We created the following inclusion criteria. This study involved Administrative Employees of the Faculty of Medicine. FK UPN Veteran Jakarta, who were willing to participate in the intervention and were not currently undergoing psychotropic, psychiatric, or relaxation therapy, such as yoga and Exclusion criteria included participants who withdrew after previously agreeing to participate, as well as those with a history of allergies to active or additional components in Salonpas Hot products . apsaicin, menthol, or aspirin/salicylat. Subjects were considered to have dropped out if they withdrew midway through the program or experienced side effects such as skin irritation, allergic reactions, or discomfort that interfered with the continuation of the intervention according to the protocol. Statistical analysis that can be performed for pre- and post-test research with 2 paired groups of numerical If the data is normally distributed, a paired samples t-test can be used to test whether there is a difference in the average between the pre-test and post-test in each group. If the data is not normally distributed, then you can use the paired Wilcoxon test (Wilcoxon signed rank tes. to test whether there is a difference in the median between the pre-test and post-test in each group. To calculate the sample size in a prepost experimental study, we can use the formula for a paired t-test. The formula is : Note : Z alpa 1,96 Z beta 0,84 SD is the standard deviation = 6,5 ES effect size = 2 So, the results were 52 people, or 26 research subjects. Pre-data was recorded on a separate sheet, as was post-data, for each study Pre-data was recorded on a separate sheet, as was post-data. Measurements were taken on a Saturday when the Administration Staff were off. Capsaicin treatment was administered no more than 30 minutes after measuring the pulse rate, and post-treatment pulse rate data were collected no more than 30 minutes after capsaicin administration. The time limit is empirically based, with a 2-minute interval, and the subjectAos pulse rate remained unchanged as long as the subject was calm, in a quiet room, and there were no emotional disturbances. RESULT General Description This study involved 52 subjects who underwent an intervention involving auricular vagus nerve stimulation using a capsaicin patch. The primary objective was to evaluate changes in heart rate as an indicator of the autonomic response to the Descriptive Statistics - Mean heart rate before intervention: 0 bpm (SD A 6. - Mean heart rate after intervention: 77. bpm (SD A 5. - Mean heart rate decrease: 16. 3 bpm (SD A 2. Statistical Test Because the data were paired . re-post on the same subjec. , the analysis used a paired t-test. - t value: 39,4 - Degrees of freedom . : 51 - p-value: < 0,0001 Interpretation According to the results of the t-test, the intervention had a significant effect on HR in this group . < 0. Therefore, it seems reasonable that applying a patch with capsaicin over the auricular vagus nerve . to stimulate the nerve could also have an effect on the autonomic nervous system and thus heart rate. There were numerous variations in the distribution of pulse rates. The majority Bali Medical Journal 2025. : 704-708 | doi: 10. 15562/bmj. of patientsAo hearts were beating 95Ae100 times per minute prior to the intervention. The distribution decreased and peaked between 70 and 80 beats per minute after 30 minutes of capsaicin stimulation. The body is therefore never tense. DISCUSSION After 30 minutes of auricular capsaicin patch application . ocal bran. , the mean heart rate fell by 16. 3 bpm in 52 subjects, indicating a consistent and robust acute physiological effect3,5. This decrease supports the hypothesis that a chemicalthermal stimulus applied to the auricle activates afferent pathways projecting to the nucleus tractus solitarius (NTS), increasing vagal tone and reducing sympathetic drive1,6. The anatomy of the auricular branch of the vagus nerve (ABVN) explains how peripheral input from the auricle can influence medullary circuits that control cardiac0 function via the nucleus ambiguus and dorsal vagal complex, producing a measurable cardioinhibitory 1,8,9 Findings from electrical transcutaneous auricular VNS . aVNS) studies that report cardiac modulation and anti-inflammatory effects are consistent with the present results, suggesting nonAcelectrical stimuli may recruit similar afferentAcvagal pathways2,10,11. Capsaicin acts as a TRPV1 agonist on CAcfiber afferents, producing an initial activation with neuropeptide release followed by a desensitization phase that alters afferent signaling to central nuclei12,13. TRPV1 activation modulates the release of substance P and CGRP, and through spinal and supraspinal interactions can influence autonomic outflow and reflex control of heart rate13-15. ParticipantsAo subjective reports of relaxation align with the physiological vagotonic effect, but the lack of objective psychometric measures limits conclusions about central emotional modulation16,17. Heart rate is a practical acute marker of vagal tone. Yet, heart rate variability (HRV), ambulatory blood pressure, and neuroimmune biomarkers are needed in future studies to characterize sympathovagal balance and systemic antiAcinflammatory precisely17,18. ORIGINAL ARTICLE Table 1. Comparison of pulse frequency scores before and after applying capsaicin patches to the auricular vagus nerve of the right and left ears for 30 minutes Subject No. Initial pulse before Pulse after capsaicin patch application on the auricular vagus nerve of the right and left ear Pulse Measurement Difference The observed mean reduction of 16. bpm exceeds typical changes from common nonAcinvasive indicating a substantial physiological effect that may have clinical relevance. Still, the quasiAcexperimental design without a sham control limits causal inference2,3,19. Randomized doubleAcblind trials with credible sham conditions are necessary to separate specific TRPV1Acmediated afferent effects from placebo, diurnal variation, or situational relaxation. Baseline heart rate heterogeneity . Ae 100 bp. suggests potential moderators of response, such as age, caffeine use, smoking, physical activity, anxiety, and concurrent medications. analyses will be important to identify subgroups most likely to benefit3,20. Understanding individual differences will aid personalization of auricular capsaicin Temporal TRPV1Acmediated clarification because initial activation may be followed by desensitization with repeated exposure, which would affect the duration and reproducibility of the relaxation response4,21,22. DoseAcresponse relationships for capsaicin concentration, patch size, and exposure time determine the balance between initial reflex activation and later hypoesthesia, so standardization is essential for reproducible outcomes12,13,23. Operational factors merit careful control: accurate placement on the anatomically small and variable auricular target, precise patch dimensions . y 1 c. , and verified capsaicin content in commercial patches influence efficacy and safety. measuring local surface temperature and quantifying transdermal capsaicin penetration will strengthen doseAcsite interpretations13,21. Safety precautions are mandatory because the auricle is a sensitive site. However, no serious adverse events occurred in this cohort. protocols should monitoring for local skin reactions, and participant education to avoid mucosal or ocular contact2,5,11. Potential therapeutic targets include disorders with autonomic dysregulation, such as GERD, where auricular stimulation has shown promise for Bali Medical Journal 2025. : 704-708 | doi: 10. 15562/bmj. ORIGINAL ARTICLE CONSENT FOR PUBLICATION I, the undersigned, hereby provide my consent for the publication of identifiable information, such as figures, tables, and details within the text titled AuThe Effect of Capsaicin as a Vagus Auricular Nerve Stimulant in Terms of Relaxation with Pulse Rate Change Indicators,Ay in the aforementioned Journal and Article. CONFLICT OF INTEREST This study has no conflicts of interest. FUNDING Figure 1. Pulse Histogram Before and After Capsaicin Patch Installation improving visceral function in animal models and preliminary human studies. targeted clinical trials with functional and qualityAcofAclife endpoints are required before therapeutic recommendations. 3,20 To build causal and mechanistic evidence, future trials should be randomized, doubleAcblind, and include a credible sham . , nonAccapsaicin patch or nonAcvagal site applicatio. HRV metrics, ambulatory blood pressure, inflammatory panels, and neuroimaging to map afferent activation of NTS and downstream autonomic centers6,16,24. In summary, this preliminary study shows that auricular capsaicin stimulation produces a marked and consistent heart rate reduction in healthy adults and is a promising, practical approach for acute neuromodulation. of TRPV1Acmediated desensitization, standardization of application parameters, and rigorous safety assessments are 2,3,18 CONCLUSION Application of a 1 y 1 cm capsaicin patch to the auricular area in 52 subjects resulted in a mean decrease in heart rate from 0 to 77. 7 bpm, with a mean decrease 3 bpm (SD A 2. Analysis using a paired t-test showed a highly statistically significant pre- and post-intervention difference . = 39. df = 51. p < 0. and the distribution of heart rates shifted from a peak of 95Ae100 bpm before the intervention to 70Ae80 bpm after the Although baseline values varied from person to person, almost all subjects had a decrease in heart rate. According to the resultsAo interpretation, capsaicin consistently produces acute autonomic modulation toward elevated parasympathetic tone, which is reflected in a drop in heart rate. No serious adverse events were reported during the hypersensitivity screening protocols and skin reaction monitoring were implemented as per procedure, thus the intervention appeared to be well tolerated in the healthy population AVAILABILITY OF DATA AND MATERIALS All data sources described in this study are directed to the corresponding author. ETHICS APPROVAL AND CONSENT TO PARTICIPATE The research has obtained ethical approval from the Ethics Committee of the Faculty of Medicine. University of Indonesia. The ethical clearance number (KET1394/UN2. F1/ETIK/PPM 02/2. is indicative of the approval granted by the relevant ethical committee for the specified research project. All participants provided written informed consent before Bali Medical Journal 2025. : 704-708 | doi: 10. 15562/bmj. This study received no external funding. AUTHORSAo CONTRIBUTIONS AYS contributed to Conceptualization. Data Curation. Methodology. Formal Analysis. Project Administration. Validation. Investigation. Visualization. Software. Writing Ae Original Draft, and Writing Ae Review & Editing. DAYS contributed to Conceptualization. Project Administration. Validation. Resources. Visualization. Software. Supervision, and Writing Ae Review & Editing. contributed to Editing. AUTHORSAo INFORMATION Department of Neurology. Faculty of Medicine UPN Veteran Jakarta Department of Neurology. Faculty of Medicine UPN Veteran Jakarta Department of Public Health Sciences. Faculty of Medicine. UPN Veteran Jakarta. Indonesia L Faculty of Medicine. UPN Veteran Jakarta GENERATIVE AI DISCLOSURE The authors declare that no generative AI tools were used in the preparation or writing of this manuscript. REFERENCES