Acupuncture in Seasonal Allergic Rhinitis (ACUSAR) – Design and Protocol of a Randomised Controlled Multi-Centre TrialBrinkhaus B. · Witt C.M. · Ortiz M. · Roll S. · Reinhold T. · Linde K. · Pfab F. · Niggemann B. · Hummelsberger J. · Irnich D. · Wegscheider K. · Willich S.N.
a Institute for Social Medicine, Epidemiology, and Health Economics, Charité – University Medical Center, Berlin, b Institute of General Practice, Klinikum rechts der Isar, Technische Universität München, Munich, c Department of Dermatology and Allergy, Technische Universität München, Munich, d Division of Environmental Dermatology and Allergy, Helmholtz Zentrum München/TUM, ZAUM-Center for Allergy and Environment, Munich, e Pediatric Allergology and Pneumology, German Red Cross Hospital Westend, Berlin, f International Society for Chinese Medicine (Societas Medicinae Sinensis, SMS), Munich, g Department of Anaesthesiology, Ludwig-Maximilians-University, Munich, h Department of Medical Biometry and Epidemiology, University Medical Center Eppendorf, Hamburg, Germany
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.