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. Copyright 2010 S. Karger AG, Basel.
RCT Entities:
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 rhinitispatients 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. Copyright 2010 S. Karger AG, Basel.
Authors: Heather Greenlee; Katherine D Crew; Jillian Capodice; Danielle Awad; Anne Jeffres; Joseph M Unger; Danika L Lew; Lisa K Hansen; Frank L Meyskens; James L Wade; Dawn L Hershman Journal: J Acupunct Meridian Stud Date: 2015-04-23
Authors: Miriam Ortiz; Claudia M Witt; Sylvia Binting; Cornelia Helmreich; Josef Hummelsberger; Florian Pfab; Michael Wullinger; Dominik Irnich; Klaus Linde; Bodo Niggemann; Stefan N Willich; Benno Brinkhaus Journal: BMC Complement Altern Med Date: 2014-04-06 Impact factor: 3.659