Acupuncture in Seasonal Allergic Rhinitis- Effects on the Autonomic Nervous System (AUTO-ACUSAR)- an Explorative Substudy of ACUSAR
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Heart Rate Variability
研究概览
简要总结
There is inconclusive evidence whether acupuncture treatment is effective in the treatment of seasonal allergic rhinitis (SAR). Furthermore, the underlying mechanisms of acupuncture in SAR are only poorly understood. It was hypothesised that the therapeutic mechanism of acupuncture is related to changes in autonomic function. AUTO-ACUSAR is a sub-study of the DFG-funded three-arm randomized controlled trial ACUSAR trial investigating the efficacy of acupuncture vs. sham acupuncture vs. rescue medication in SAR. The aim of AUTO-ACUSAR was to investigate short and long-term effects of acupuncture vs. sham acupuncture on autonomic function in a sub-group of ACUSAR patients. Baseline values were compared to data from matched healthy controls.
详细描述
In AUTO-ACUSAR a subsample of ACUSAR patients from acupuncture or sham acupuncture groups were included. Tests of autonomic functions included measurement of heart rate variability during paced breathing, blood pressure, heart rate and salivary alpha amylase response to a cold pressure test (CPT) and cortisol awakening response before the first and the last of twelve treatment sessions. Healthy matched controls underwent the same measurement once only
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 16 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or male patients (aged 16-45 years) with seasonal allergic rhinitis, clinically positive and test positive (skin-prick test and/or RAST) to grass and birch pollen
- •Patients with >2 years of moderate to severe SAR
- •Positive skin-prick test and/or RAST (at least class 2) results
- •Visual analogue scale >40mm and <80 mm for SAR symptoms during the past year
- •Patients must be able to complete a diary for self-evaluation of symptoms and recording use of anti-symptomatic medication
- •Use of, or indication for, oral antihistamines as anti-allergic medication
- •Written informed consent
排除标准
- •Perennial SAR or other types of chronic rhinitis
- •Allergic asthma and/or moderate to severe atopic dermatitis
- •Active tuberculosis
- •Auto-immune disorders
- •Severe chronic inflammatory diseases
- •History of anaphylactic reactions
- •Hypersensitivity to Rescue medication or related drugs used in study related drugs
- •Specific immunotherapy >3 years
- •Simultaneous participation in other clinical trials
- •Serious acute or chronic organic disease or mental disorder
- •Pregnancy or breast feeding
- •Allergy desensitisation therapy (current, during the past two years, or planned in the next two years)
- •Blood coagulation disorder and/or current use of anticoagulants
- •Previous acupuncture treatment for SAR
- •Any Complementary and alternative medicine treatment at the moment, in the last three months or planned in the next two years
- •intake of Beta-Blocker Medication
- •use of pacemaker
研究组 & 干预措施
acupuncture
12 sessions of acupuncture according to TCM
干预措施: sham acupuncture (Other)
sham acupuncture
superficial acupuncture at non acupuncture sites
干预措施: sham acupuncture (Other)
结局指标
主要结局
Heart Rate Variability
时间窗: 8 weeks
RMSSD, LF, HF, HR, blood pressure
次要结局
- Salivary Amylase and Cortisol, Cortisol Awakening Response (CAR)(8 weeks)
研究者
Benno Brinkhaus
Prof. Dr. Benno Brinkhaus
Charite University, Berlin, Germany