Zhang Lu, Li Lei, Shi Da-Zhuo, Chen Lu-Quan, Zheng Kai-Min, Cheng Kai, Tao Ye, Guo Hai-Yan, Li Shu-Liang, Liu Jing, Xu Feng, Shen Jian-Wu
Xiyuan Hospital, China Academy of Chinese Medical Sciences, No. 1 Xiyuan Caochang Road, Haidian District, Beijing, 100091, China.
Beijing Tongren Hospital, Capital Medical University, No. 2, Chongwenmennei Street, Dongcheng District, Beijing, 100730, China.
Trials. 2015 Apr 23;16:183. doi: 10.1186/s13063-015-0707-0.
Allergic rhinitis is a symptomatic allergic disease of the nose that affects 10 to 20% of the global population. Chinese otolaryngologists use one acupuncture needle to stimulate the sphenopalatine ganglion because of its potential advantages for treating moderate-severe persistent allergic rhinitis compared with traditional Chinese acupuncture (verum acupuncture); however, little evidence is available to support the wide clinical use thus far. Therefore, we propose a protocol for a parallel, multicenter, assessor-blinded, randomized controlled trial to evaluate sphenopalatine ganglion stimulation with one acupuncture needle compared to verum acupuncture for treatment of moderate-severe persistent allergic rhinitis.
In the trial, 96 patients previously diagnosed with moderate-severe persistent allergic rhinitis and meeting all inclusion criteria will be allocated to one of two equal therapeutic groups by using a computer-generated randomization list. The interventional group will receive sphenopalatine ganglion stimulation with one acupuncture needle for 4 weeks (once or twice weekly, total four to eight sessions); attending physicians will decide whether the second session is required in a week by examining signs and symptoms. The control group will receive individualized verum acupuncture for 4 weeks (twice weekly, total eight sessions). Follow-up evaluations will be performed 1 month later. The primary outcome measure is the change in the total nasal symptom score from the baseline to week 4. The secondary outcome measures include onset time and duration of effectiveness in every session, change in number of days with moderate-severe persistent allergic rhinitis from the baseline to week 8, change in total immunoglobulin E level and eosinophil count in venous blood from the baseline to week 4, change in Rhinoconjunctivitis Quality of Life Questionnaire score from the baseline to week 4, and clinical waiting time.
The trial should provide evidence for the benefits of sphenopalatine ganglion stimulation with one acupuncture needle for treating moderate-severe persistent allergic rhinitis, including better change in total nasal symptom score, faster onset time, longer duration of effectiveness, and shorter treatment time.
Current Controlled Trials: ISRCTN21980724 (registered on 27 March 2014).
变应性鼻炎是一种鼻部症状性变应性疾病，影响全球10%至20%的人口。中国耳鼻喉科医生使用一根针灸针刺激蝶腭神经节，因为与传统中医针灸（真针灸）相比，其在治疗中重度持续性变应性鼻炎方面具有潜在优势；然而，迄今为止几乎没有证据支持其广泛的临床应用。因此，我们提出一项平行、多中心、评估者盲法、随机对照试验方案，以评估用一根针灸针刺激蝶腭神经节与真针灸相比治疗中重度持续性变应性鼻炎的效果。
在该试验中，96名先前被诊断为中重度持续性变应性鼻炎且符合所有纳入标准的患者将通过计算机生成的随机列表被分配到两个相等的治疗组之一。干预组将接受用一根针灸针刺激蝶腭神经节治疗4周（每周一次或两次，共四至八次）；主治医生将通过检查体征和症状来决定是否需要在一周内进行第二次治疗。对照组将接受个体化真针灸治疗4周（每周两次，共八次）。1个月后进行随访评估。主要结局指标是从基线到第4周总鼻症状评分的变化。次要结局指标包括每次治疗的起效时间和疗效持续时间、从基线到第8周中重度持续性变应性鼻炎天数的变化、从基线到第4周静脉血中总免疫球蛋白E水平和嗜酸性粒细胞计数的变化、从基线到第4周鼻结膜炎生活质量问卷评分的变化以及临床等待时间。
该试验应为用一根针灸针刺激蝶腭神经节治疗中重度持续性变应性鼻炎的益处提供证据，包括总鼻症状评分的更好变化、更快的起效时间、更长的疗效持续时间和更短的治疗时间。
当前对照试验：ISRCTN21980724（于2014年3月27日注册）。
