Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2026 Jan 14:19:561192.
doi: 10.2147/JMDH.S561192. eCollection 2026.

Developing a Core Outcome Set for Herpes Zoster-Associated Neuralgia in Clinical Trials of Traditional Chinese Medicine: A Study Protocol

Junyi Wang  1 , Tanundorn Jutaputthi  1 , Yuanyuan Cheng  1 , Ziqi Ye  1 , Moran Xu  1 , Yuanyuan Wu  1   2 , Zongda Jin  1   2
Affiliations

Developing a Core Outcome Set for Herpes Zoster-Associated Neuralgia in Clinical Trials of Traditional Chinese Medicine: A Study Protocol

Junyi Wang et al. J Multidiscip Healthc. .

Abstract

Context: Herpes zoster-associated neuralgia (ZAN), the most common symptom across all stages of herpes zoster, significantly impacts patients' quality of life and emotional well-being. Traditional Chinese Medicine (TCM) treatments have demonstrated unique efficacy in treating ZAN. However, non-standardized outcome reporting remains a significant challenge. Therefore, establishing a core outcome set (COS) is essential for standardizing TCM clinical research on ZAN.

Objective: This study aims to develop a COS for future clinical trials of TCM for ZAN (COS-TCM-ZAN).

Methods: This study determined the list of outcomes measures by systematically searching databases and clinical trial registeres. Subsequently, multiple stakeholder groups from various fields were selected to conduct two rounds of Delphi surveys to assess the importance of each outcome measure. Finally, we will hold a face-to-face consensus conference to approve the final COS-TCM-ZAN.

Timeline: The study will start in April 2025, aiming to finalize the outcomes list by June 2025. Then having stakeholder screening, a Delphi survey (July-Dec 2025), and a consensus conference in early 2026. In line with the COS-STAR (Core Outcome Set-STAndards for Reporting) guidelines, the COS findings will be reported and exchanged at national and international conference.

Conclusion: The standardized COS will enhance the identification of effective evaluation indicators for TCM treatment of ZAN, thereby enhancing the comparability and reproducibility in research and clinical practice for TCM in the field of ZAN treatment.

Trial registration: This COS has been prospectively registered in the COMET database (registration #3370, available at https://www.comet-initiative.org/studies/details/3370). Clinical trial number: not applicable.

Keywords: core outcome set; herpes zoster-associated neuralgia; traditional Chinese medicine.

PubMed Disclaimer

Conflict of interest statement

The authors report no conflicts of interest in this work.

Figures

Figure 1
Figure 1
Flowchart of developing core outcome set of the clinical trials of TCM for ZAN.
See this image and copyright information in PMC

References

    1. Gregg RK, Kapil A, Isoba LG, et al. Herpes zoster in older adults: diagnosis, treatment, and care strategies. Geriatric Dermatol. 2024;13:1–12.
    1. Anant P, Mohamad G, Uwe W. Herpes zoster: a review of clinical manifestations and management. Viruses. 2022;14(2):192. doi: 10.3390/v14020192 - DOI - PMC - PubMed
    1. Catherina XP, Michelle SL, Vinod EN. Global herpes zoster incidence, burden of disease, and vaccine availability: a narrative review. Therape Adv Vaccines Immunotherapy. 2022;10:1–19. - PMC - PubMed
    1. Yang C, Guo Z, Deng X, et al. Global, regional, and national burden of varicella-zoster infections in adults aged 70 years and older from 1997 to 2021: findings from the global burden of disease study. J Infect Public Health. 2025;18(10):102868. doi: 10.1016/j.jiph.2025.102868 - DOI - PubMed
    1. Devor M. Neural basis of pain in herpes zoster and postherpetic neuralgia: the ectopic pacemaker hypothesis. Herpes Zoster. 2017;06:157–187. - PMC - PubMed