Journal of Clinical Trials
Open Access

Abstract

Effectiveness of Moxibustion Combined with Conventional Treatment for Moderate-Severe Persistent Allergic Rhinitis: Protocol for a Randomized, Controlled Trial

Sheng Chen, Sheng-Nan Guo, Xue-Si Hou, Zhi-Hong Wen, Yi-Fan Jia, Shu-Han Qu, Wei-Mei Zeng, Yi Xiao, Federico Marmori, Dong-Mei Li and Ji- Ping Zhao

Introduction: The incidence of allergic rhinitis (AR) has risen dramatically in recent years, and presents with higher symptom frequency, affecting quality of life. Clinical research shows that conventional medical treatment can rapidly relieve AR symptoms; however, there is a high incidence of relapse. Moxibustion treatment reportedly has a good effect in reducing the relapse rate. However, trial-based evidence for the effectiveness of these combined treatments is necessary.

Methods and analysis: This is a protocol for a randomized, controlled trial comparing the effects of combined moxibustion and conventional treatment with conventional treatment alone for patients with moderate-severe persistent AR. After intervention, both groups will be followed-up for 3 months. The primary outcome is frequency of AR symptoms, which will be obtained via a self-recorded AR diary. The secondary outcomes include the Rhinoconjunctivitis Quality of Life Questionnaire score and use of daily medication.

Ethics and dissemination: Ethical approval for the study has been granted by the Institutional Review Board of Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine (ECPJ-BDY-2016-16). Written informed consent will be obtained from all participants. The study findings will be published in open access peer-reviewed journals.

Strengths and limitations of this study

� The trial is designed to address the gap in evidence regarding the effects of combined moxibustion and conventional treatment for patients with moderate-severe persistent AR.

� Experiences with moxibustion treatment in reducing the relapse rate of AR patients will be examined.

� The findings may provide the inter-complementary programme for patients with moderate-severe persistent AR.

� Although numerous of outcomes are assessed, even including some original parts, there may exist different perspectives on what the most suitable outcomes are.

� This RCT is an exploratory study with limited experience. Therefore, there are significant improvements still to be made in the sample size and follow-up pattern.

Trial registration number: ChiCTR-IOR-16008855