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.
Prof. Dr. Benno Brinkhaus, Institute for Social Medicine, Epidemiology, and Health Economics, Charité – University Medical Center, Berlin, 10098 Berlin, Germany, Tel. +49 30 450 529–002, Fax -902, firstname.lastname@example.org
Published online: April 20, 2010
Number of Print Pages : 8
Forschende Komplementärmedizin / Research in Complementary Medicine (Research Practice Perspectives - Wissenschaft Praxis Perspektiven)
Vol. 17, No. 2, Year 2010 (Cover Date: April 2010)
Journal Editor: Walach H. (Frankfurt/O.)
ISSN: 1661-4119 (Print), eISSN: 1661-4127 (Online)
For additional information: http://www.karger.com/FOK
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