Efficacy and Mechanism of Acupoint Catgut Embedding in the Treatment of Chronic Spontaneous Urticaria: Protocol for a Randomized Double-Blind Placebo-Controlled Trial
Background
Chronic spontaneous urticaria (CSU) is a common skin disease causing itching and wheals, significantly impacting quality of life. Acupuncture has shown promise in treating CSU, but its short duration of action and frequent treatments are limitations. Acupoint catgut embedding (ACE) offers longer-lasting effects and higher compliance, making it a potential solution for CSU.
Objective
This trial aims to provide definitive evidence for the treatment of CSU with ACE and explore its mechanism of action.
Methods
A randomized, double-blind, placebo-controlled trial will be conducted with 108 participants. The treatment group will receive ACE, while the control group will receive sham ACE. Both groups will undergo acupuncture, but only the treatment group will receive catgut sutures. Treatment will be performed twice weekly for 8 weeks, with a 1-week run-in period and a 16-week follow-up. Functional magnetic resonance imaging will be conducted on a subset of participants. The primary outcome will be the urticaria activity score over 7 days (UAS7).
Results
Recruitment began on March 1, 2023, and is expected to be completed by March 1, 2025. The results are planned to be published by the winter of 2025. As of November 1, 2023, 25 participants with CSU have been enrolled.
Conclusions
This trial aims to provide definitive evidence for the treatment of CSU with ACE and explore its mechanism of action. The study hypothesizes that participants receiving active therapy will show greater improvement in wheals and itching compared to those receiving sham treatment.
Trial Registration
Chinese Clinical Trial Registry ChiCTR2200066274
International Registered Report Identifier (IRRID)
DERR1-10.2196/54376
