Acupuncture in Seasonal Allergic Rhinitis (ACUSAR) - Design and Protocol of a Randomised Controlled Multi-Centre Trial
Acupuncture in Seasonal Allergic Rhinitis (ACUSAR) - Design and Protocol of a Randomised Controlled Multi-Centre Trial
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DOI：
10.1159/000303012
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发表时间：
2010-01-01
影响因子：
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通讯作者：
Willich, Stefan N.
中科院分区：
文献类型：
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作者：
Brinkhaus, Benno;Witt, Claudia M.;Willich, Stefan N.
背景：我们报道了一项随机对照试验(针灸治疗季节性变应性鼻炎，ACUSAR)的研究设计和方案，该试验旨在调查针灸治疗季节性变应性鼻炎(SAR)的疗效。目的：探讨针刺治疗急性呼吸窘迫综合征的疗效是否优于(A)透刺假针刺和(B)抢救药物。设计：3组随机对照多中心试验，第1年总随访时间为16周，第2年为8周。单位：德国37个门诊部的41名内科医生专门从事针灸治疗。患者：400名季节性变应性鼻炎患者，有临床症状，对桦树和草花粉均呈阳性(皮肤点刺试验和/或特异性IgE)。干预措施：患者将按2：1：1的比例随机分为三组：(A)半标准化针灸加救援药物(西替利嗪)；(B)非穴位透刺假针加救援药物；或(C)单独救援药物治疗8周(标准治疗组)。针灸和假针灸将在8周内为每位患者提供12次治疗。主要观察指标：第1年6~8周鼻炎生活质量问卷(RQLQ)总分和抢救药物评分(RMS)的平均数，调整基线值。展望：2011年公布的这项试验结果将对是否应考虑将针灸作为治疗SAR的一种治疗方案的决定产生重大影响。
Background: We report on the study design and protocol of a randomised controlled trial (Acupuncture in Seasonal Allergic Rhinitis, ACUSAR) that investigates the efficacy of acupuncture in the treatment of seasonal allergic rhinitis (SAR). Objective: To investigate whether acupuncture is non-inferior or superior to (a) penetrating sham acupuncture and (b) rescue medication in the treatment of SAR. Design: 3-armed, randomised controlled multi-centre trial with a total follow-up time of 16 weeks in the 1st year and 8 weeks in the 2nd year. Setting: 41 physicians in 37 out-patient units in Germany specialised in acupuncture treatment. Patients: 400 seasonal allergic rhinitis patients with clinical symptoms and test-positive (skin-prick test and/or specific IgE) to both birch and grass pollen. Interventions: Patients will be randomised in a 2:1:1 ratio to one of three groups: (a) semi-standardised acupuncture plus rescue medication (cetirizine); (b) penetrating sham acupuncture at non-acupuncture points plus rescue medication; or (c) rescue medication alone for 8 weeks (standard treatment group). Acupuncture and sham acupuncture will consist of 12 treatments per patient over 8 weeks. Main Outcome Measures: Average means of the Rhinitis Quality of Life Questionnaire (RQLQ) overall score and the Rescue Medication Score (RMS) between weeks 6 and 8 in the first year, adjusted for baseline values. Outlook: The results of this trial available in 2011 will have a major impact on the decision of whether acupuncture should be considered as a therapeutic option in the treatment of SAR.