Wang Weiming, Chen Hui, Gao Ning, Yu Shudan, Liao Jiahua, Wang Shijie, Gao Ziqi, Liu Zhishun
Department of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences Guang'anmen Hospital, Beijing, China.
Department of Traditional Chinese Medicine, China Aerospace Science & Industry Corporation 731 Hospital, Beijing, China.
Front Med (Lausanne). 2022 Sep 6;9:904864. doi: 10.3389/fmed.2022.904864. eCollection 2022.
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.
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 -value < 0.05 will be considered to be statistically significant.
季节性变应性鼻炎（SAR）是一个主要的健康问题，在全球范围内患病率相对较高，严重限制了患者的生活质量。针灸在中国被广泛用于治疗SAR；然而，关于针刺蝶腭神经节（SPG）治疗SAR疗效的证据尚无定论。因此，本研究旨在探讨针刺SPG穴位治疗SAR的疗效和安全性。
共招募120名SAR患者，按1:1:1的分配比例随机分为针刺组、假针刺（PA）组或急救药物（RM）组。针刺组和PA组的参与者将接受8次SPG针刺刺激加RM，或8次SPG穴位浅刺加RM，为期4周，第一年随访4周，第二年随访1周。RM组的参与者在整个研究过程中仅接受RM治疗。主要结局是第1 - 4周平均每日综合症状和药物评分（CSMS）相对于基线的变化。所有分析将基于意向性分析原则。所有统计检验将采用双侧检验，P值<0.05将被认为具有统计学意义。
