Efficacy of Electroacupuncture for Acute Herpes Zoster-Associated Pain and Biomarker Evaluation

Condition(s) studied

Investigational drug(s) / intervention(s)

Acupuncture: EA will be applied at Ashi points (sites of severe pain in herpetic lesions) and Jiaji points (EX-B2) on the affected side.All participants will undergo a 2-week treatment. Acupuncture will be performed thrice a week.A dense-disperse wave (2/100 Hz) will be used

Sham: non-penetrating placebo acupuncture

Valacyclovir, pregabalin and mecobalamin: Antiviral therapy: The main treatment is with valacyclovir (oral, 1000 mg, three times daily, for 7 days). In patients with non-severe hepatic or renal impairment, or other conditions that require dose adjustment, the antiviral regimen (dose or drug choice) should be modified according to the Chinese Consensus on the Diagnosis and Management of Herpes Zoster (2022). Antineuralgic therapy: Pregabalin (oral, 75 mg, two times daily throughout the trial). Neurotrophic therapy: Mecobalamin (oral, 0.5 mg, three times daily throughout the trial)

Study summary

Background: Herpes zoster (HZ) is an acute dermatological condition caused by the varicella-zoster virus. Its onset is characterized by severe pain, imposing significant physical and psychological burdens on patients. Acupuncture offers distinct advantages in treating acute herpes zoster and associated pain. However, the therapeutic efficacy of electroacupuncture for acute herpes zoster, its potential to reduce PHN incidence, and the role of biomarkers in predicting PHN incidence require further clinical validation.

Methods: A total of 228 patients with acute herpes zoster will be recruited from 3 hospitals and randomly assigned to EA group or medication-alone group or sham acupuncture group in a 1:1:1 ratio, utilizing multicenter stratified block randomization. The trial will involve a 2 week treatment period, and a 3-month follow-up period. All variables will be evaluated at week 0, week 1, week 2, and on the 90th day after rash onset. All participants will continue antiviral medication treatment. Primary outcome is Numerical Rating Scale; secondary outcomes include herpes lesion crusting time, pain episodes within a 24-hour period, Hamilton Anxiety Scale, Hamilton Depression Scale, 36-Item Short Form Health Survey, changes of biomarkers (Erythrocyte sedimentation rate, C-reactive protein, Tumor Necrosis Factor-α, Interleukin-10, Substance P and neuropeptide Y) and PHN incidence rate. All adverse effects will be assessed during the trial.

Conclusion: This study will elucidate the efficacy of electroacupuncture in treating acute herpes zoster, whether electroacupuncture can reduce the incidence of PHN, and the role of biomarkers in predicting the incidence of PHN.

Eligibility

Primary outcome measure(s)

• Numerical Rating Scale — week 0, 1, 2, 13
  an 11-point continuum ranging from 0 ('no pain') to 10 ('intolerable pain')

Trial sites (1)

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