Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jul 3, 2024
Date Accepted: Mar 15, 2025
Efficacy and safety of acupoint catgut embedding for perennial allergic rhinitis:study protocol for a randomized clinical trial
ABSTRACT
Background:
Allergic rhinitis (AR) is a non-infectious chronic inflammatory disease of the nasal mucosa characterized mainly by itching, sneezing, nasal congestion, and rhinorrhea, mediated by immunoglobulin E (IgE). Allergic rhinitis is one of the most common allergic diseases globally, affecting 10-20% of the population worldwide, with some regions even reaching rates as high as 50%, posing a global health issue. The prevalence of allergic rhinitis has been increasing since the 1960s, with a significant increase in recent years. At present, modern medicine with desensitization therapy, the use of anti-allergic drugs, antihistamines, hormones, and other improved symptoms or immune regulation, but clinical near and long-term efficacy is general after stopping the symptoms are easy to repeat, and long-term drug toxicity side effects are obvious.
Objective:
Acupoint catgut embedding(ACE) therapy is widely used to treat allergic rhinitis (AR) in China. Acupoint catgut embedding has been reported to be effective in managing the symptoms of allergic rhinitis, but the evidence suffers from methodological limitations. Therefore, we designed a parallel-arm, randomized controlled, multicentre,placebo-controlled, and single-blinded trial to evaluate the efficacy and safety of acupoint catgut embedding therapy for allergic rhinitis.
Methods:
This study will be a parallel-group, patient-blind,placebo-controlled randomized controlled trial conducted in the Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.Ningxia Hui Autonomous Region Hospital and Academy of Traditional Chinese Medicine,Yinchuan,China in the future.Affiliated Hospital of Shanxi University of Traditional Chinese Medicine,Taiyuan,China. The trial consists of 4-week treatment conducted along with a three-month follow-up. After providing written informed consent, eligible participants will be randomized at a ratio of 1: 1 into one of two groups: an acupoint catgut embedding group receiving acupoint catgut embedding treatment; a sham acupoint catgut embedding group receiving sham acupoint catgut embedding treatments; And both groups receiving conventional loratadine treatment.
Results:
The funding was started in January, 2022, and is expected to start on February 1, 2025 and end in February, 2026, and the results will be released in March, 2026.
Conclusions:
We consider that this research will provide important insights into the efficacy of ACE treatment for AR and generate robust data for the foundation of future research in the field. Clinical Trial: Trial Registry (ChiCTR2500095634)
Citation
Request queued. Please wait while the file is being generated. It may take some time.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.