JMIR Publications

ABSTRACT

Background:

Chronic spontaneous urticaria (CSU) is a common chronic inflammatory skin disease that manifests as itching and wheals, seriously affecting quality of life. Clinical observations and previous research trials have shown that acupuncture is safe and effective for the treatment of CSU. However, there are problems, such as a short duration of action and frequent treatment. Compared with traditional acupuncture, acupoint catgut embedding (ACE) has the advantages of a longer effect and higher compliance. Clinical trials are needed to prove its efficacy and mechanism of action.

Objective:

This trial aims to provide definitive evidence for the treatment of CSU with ACE and explore the mechanism of ACE.

Methods:

This was a randomized, double-blind, placebo-controlled trial. In this trial, eligible 108 participants aged 18-60 years, who have been diagnosed with CSU and have no prior history of ACE, will be randomly assigned to two groups in a 1:1 ratio by using the Statistical Analysis System (SAS): treatment (ACE) and control (sham ACE). Neither the participants nor the efficacy evaluators knew the grouping results. Both the ACE and sham ACE groups will undergo acupuncture, the control group will not receive catgut sutures. Treatments will be performed twice weekly for 8 weeks, with a 1-week run-in period and a 16-week follow-up period will also include. Twenty patients will be randomly selected from each group to undergo functional magnetic resonance imaging (fMRI) before and after the treatment period. The primary outcome will be urticaria activity scores over 7 days (UAS7), and the secondary outcomes will include the urticaria control test (UCT), Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL), Dermatology Life Quality Index (DLQI), Self-Rating Anxiety Scale (SAS), Self-Rating Depression Scale (SDS), and Insomnia Severity Index (ISI). We will use R (version 4.0.1) to perform ANOVA and independent sample t test to compare the differences within and between groups before and after treatment by judging the rejection range based on a significance level of 0.05.

Results:

The study protocol has been approved by the Ethics Committee of Guang' anmen Hospital on 7 September 2022, and has been registered on 30 November 2022. The date of recruitment began on 1 March 2023, 4-6 participants were expected to be received per month, the planning completed recruitment date is approximately 1 March 2025 and we expect to publish our results by the winter of 2025. As of 1 November 2023, we enrolled 25 CSU participants.

Conclusions:

This randomized, double-blind, placebo-controlled trial aims to provide definitive evidence for the treatment of CSU with ACE and explore the mechanism of ACE. We hypothesize that wheals and itching of patients on active therapy will improve significantly compared to patients on sham treatment. However, the limitations of this study include the single-center trial design, small sample size, and short treatment duration, which may have a certain impact on the research results. Clinical Trial: The Ethics Committee of Guang' anmen Hospital approved the study protocol (approval number:2022-114-KY), which has been registered in the Chinese Clinical Trial Registry (trial registration number: ChiCTR2200066274). Registered on 30 November, 2022).