Efficacy, Safety and Underlying Mechanisms of Sphenopalatine Ganglion Acupuncture for Seasonal Allergic Rhinitis: a Randomized, Double-blind, Placebo Controlled Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change from baseline symptom scores at visit 4
研究概览
简要总结
In recent years, a number of randomized controlled trials have confirmed the efficacy and safety of acupuncture in the treatment of allergic rhinitis (AR). Indeed, the latest American clinical guidelines recommended acupuncture treatment for AR patients who are interested in non-pharmacological treatment.
In conventional acupuncture treatment for AR, needles are inserted at specific acupoints in the body; with several studies demonstrating acupuncture of sphenopalatine ganglion (SPG) to improve nasal symptoms and quality of life in nasal inflammatory diseases.
The investigators hypothesize that, compared with sham acupuncture and rescue medication (RM), active SPG acupuncture combined with RM would lead to greater improvements in symptoms score and reduction in overall need for antihistamines. To test this hypothesis the investigators design a randomized, double blind, controlled trial to evaluate the efficacy of SPG acupuncture in pollen-induced seasonal AR patients and to explore the potential underlying mechanisms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •history of physician-diagnosed SAR with at least 2 years of typical symptoms, and TNSS>=6 at v
- •positive skin prick test (SPT) and/or positive serum antigen specific IgE to local seasonal pollens (Giant Ragweed, Mugwort, Goosefoot, etc)
排除标准
- •oral steroids within 4 weeks prior to recruitment
- •nasal steroids and/or antihistamine 2 weeks prior to recruitment
- •perennial AR
- •any respiratory infection within the previous 4 weeks prior to recruitment
- •history of nasal polyps, asthma or autoimmune disorders
- •previously received acupuncture therapy for AR within 1 month prior to recruitment
研究组 & 干预措施
SPA acupuncture
active SPG acupuncture plus rescue medication (AA group)
干预措施: SPA acupuncture (Procedure)
sham acupuncture
sham-SPG acupuncture plus rescue medication (SA group)
干预措施: sham acupuncture (Procedure)
结局指标
主要结局
Change from baseline symptom scores at visit 4
时间窗: Symptom scores will be assessed at baseline (V0), visit 4( V4). V4 is within 15 minutes after the fourth acupuncture.
Patients recorded nasal and ocular symptom severity during the trial. Four nasal symptoms (itching, sneezing, rhinorrhoea and nasal obstruction) and two ocular symptoms (ocular itch and watery eyes) were individually graded on a ten-point scale (0, no symptoms; 1-3, mild symptoms; 4-7, moderate symptoms; 8-10, severe symptoms). Our primary outcome is TNSS change from baseline at the end of four-acupuncture treatment at Visit 4 (15 minutes after the fourth acupuncture ). The investigator will compare the symptom scores between the active acupuncture group and the sham acupuncture group.
次要结局
- SNOT-22(SNOT-22 will be assessed at baseline (V0), and each visit. V1 to V4 is within two weeks. V5 is one week after the fourth acupuncture, and V6 is two weeks later. There is no acupuncture during both V5 and V6.)
- Rescue medication score(RMS will be assessed at baseline (V0), and each visit. V1 to V4 is within two weeks. V5 is one week after the fourth acupuncture, and V6 is two weeks after the fourth acupuncture. There is no acupuncture during both V5 and V6)
- neuropeptides in nasal secretions(Nasal secretions can be obtained at each visit. V1 to V4 is within two weeks. V5 is one week later and V6 is two weeks later. There is no acupuncture during both V5 and V6.)
- inflammatory cytokines in nasal secretions(Nasal secretions can be obtained at each visit. V1 to V4 is within two weeks. V5 is one week later and V6 is two weeks later. There is no acupuncture during both V5 and V6.)
- nasal patency(NCV, NAR and MCA will be assessed at baseline (V0), and each visit. V1 to V4 is within two weeks. V5 is one week after the fourth acupuncture, and V6 is two weeks after the fourth acupuncture.)
- adverse events(adverse events will be recorded at V1 to V4. V1, V2, V3, and V4 is within two weeks. V5 is one week after fourth treatment and V6 is two weeks later. There is no acupuncture during both V5 and V6.)
研究者
Luo Zhang
Vice president
Beijing Tongren Hospital