This randomized controlled trial assessed the efficacy and safety of acute-phase transcutaneous auricular vagus nerve stimulation (taVNS) in middle-aged and elderly patients with acute herpes zoster (HZ) who also had comorbid depressive and anxiety symptoms. The investigators aimed to determine whether a short course of taVNS administered during the acute rash phase could reduce the incidence of subacute pain and improve emotional and sleep outcomes.
The study enrolled 40 middle-aged and elderly patients with acute-phase HZ who presented to the Department of Dermatology at Xuanwu Hospital, Capital Medical University, and one additional dermatology department between June 2024 and June 2025. Participants were randomized in a 1:1 ratio using a random number table to either the active taVNS group (n = 20) or a sham stimulation group (n = 20).
Baseline characteristics reported in the source included sex and age: the taVNS group comprised 7 women (35%) with mean age 64.1 ± 9.7 years, while the sham group comprised 10 women (50%) with mean age 61.5 ± 8.5 years. Baseline scores for pain, mood, and sleep (measured by VAS, PHQ-4, and ISI) did not differ significantly between groups (all P > 0.05).
Participants in the active group received taVNS for 5 consecutive days. The control arm received sham stimulation over the same 5-day period. Both groups received standard antiviral therapy and had access to on-demand rescue analgesia. The specific taVNS device parameters and sham procedures were not detailed in the PubMed abstract.
Primary outcome:
Secondary outcomes included:
Pain, anxiety/depression, and sleep quality were assessed using the Visual Analog Scale (VAS), the 4-item Patient Health Questionnaire (PHQ-4), and the Insomnia Severity Index (ISI) respectively.
Primary outcome:
Mood and sleep:
Analgesic consumption:
Longer-term pain (PHN):
No serious adverse events occurred in either the taVNS or sham groups during the study period as reported in the abstract. The authors declared no conflicts of interest. Detailed adverse event profiles or device-related tolerability data were not provided in the abstract.
In this randomized trial of 40 middle-aged and elderly patients with acute HZ and comorbid depressive and anxiety symptoms, a 5-day course of acute-phase taVNS appeared feasible and safe and was associated with a significantly lower incidence of subacute pain at 30 days compared with sham stimulation. taVNS also produced greater short-term improvements in mood (PHQ-4) and sleep (ISI) scores and reduced cumulative lofentadine consumption at 1 and 2 weeks. There was no statistically significant difference in PHN incidence at 90 days in this study.
Clinical interpretation should note the sample size (n = 40) and that device parameters and many procedural details were not reported in the abstract. The findings support further investigation of taVNS as an adjunctive, noninvasive neuromodulation strategy for acute HZ pain in older patients with coexisting mood disturbance, with larger trials and longer follow-up needed to clarify effects on PHN prevention and to better characterize safety and tolerability.