Effect of acupuncture at the sphenopalatine ganglion for the treatment of moderate to severe seasonal allergic rhinitis: Study protocol for a three-armed randomized controlled trial

Weiming Wang; Hui Chen; Ning Gao; Shudan Yu; Jiahua Liao; Shijie Wang; Ziqi Gao; Zhishun Liu

doi:10.3389/fmed.2022.904864

Effect of acupuncture at the sphenopalatine ganglion for the treatment of moderate to severe seasonal allergic rhinitis: Study protocol for a three-armed randomized controlled trial

Front Med (Lausanne). 2022 Sep 6:9:904864. doi: 10.3389/fmed.2022.904864. eCollection 2022.

Authors

Weiming Wang¹, Hui Chen², Ning Gao¹, Shudan Yu¹, Jiahua Liao², Shijie Wang³, Ziqi Gao³, Zhishun Liu¹

Affiliations

¹ Department of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences Guang'anmen Hospital, Beijing, China.
² Department of Traditional Chinese Medicine, China Aerospace Science & Industry Corporation 731 Hospital, Beijing, China.
³ Department of Otolaryngology, China Aerospace Science & Industry Corporation 731 Hospital, Beijing, China.

Abstract

Introduction: Seasonal allergic rhinitis (SAR) is a major health problem with a relatively high worldwide prevalence that severely limits the quality of life for sufferers. Acupuncture is widely used for SAR treatment in China; however, the evidence on the efficacy of acupuncture at the sphenopalatine ganglion (SPG) for SAR is inconclusive. Therefore, this study aims to investigate the efficacy and safety of acupuncture at the SPG acupoint for the treatment of SAR.

Methods and analysis: A total of 120 participants with SAR will be recruited and randomly assigned to the acupuncture group, placebo acupuncture (PA) group, or rescue medication (RM) group with a 1:1:1 allocation ratio. Participants in the acupuncture group and PA group will receive 8 sessions of acupuncture stimulus at the SPG plus RM or 8 sessions of shallow needling at the SPG acupoint plus RM for 4 weeks with a 4-week follow-up in the first year and a 1-week follow-up in the second year. Participants in the RM group will only receive RM throughout the study. The primary outcome is the change from baseline in the average daily combined symptoms and medication score (CSMS) over weeks 1-4. All analysis will be based on an intention-to-treat principle. All statistical tests will be two-sided and a p-value < 0.05 will be considered to be statistically significant.

Keywords: acupuncture; protocol; randomized controlled trial; seasonal allergic rhinitis; sphenopalatine ganglion.