Acupuncture in Seasonal Allergic Rhinitis (ACUSAR) – Design and Protocol of a Randomised Controlled Multi-Centre Trial

Institute for Social Medicine, Epidemiology, and Health Economics, Charité - University Medical Center, Berlin, Germany.
Forschende Komplementärmedizin / Research in Complementary Medicine (Impact Factor: 1.65). 04/2010; 17(2):95-102. DOI: 10.1159/000303012
Source: PubMed


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).
To investigate whether acupuncture is non-inferior or superior to (a) penetrating sham acupuncture and (b) rescue medication in the treatment of SAR.
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.
41 physicians in 37 out-patient units in Germany specialised in acupuncture treatment.
400 seasonal allergic rhinitis patients with clinical symptoms and test-positive (skin-prick test and/or specific IgE) to both birch and grass pollen.
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.
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.
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.

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Available from: Claudia M Witt, Mar 10, 2014
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    • "The participating physicians were recruited in a manner designed to ensure that their qualifications were adequate to perform a treatment procedure which included a CM diagnosis before acupuncture. According to the trial protocol [3], trial physicians had to fulfil the following criteria: (1) acupuncture training of at least 140 hours (equals an ‘A-diploma’ from the major German acupuncture associations); (2) at least 3 years of practical experience with acupuncture; (3) 50% of participating physicians had to have at least 350 h of acupuncture training (equals ‘B-diploma’); (4) 50% of trial physicians had to have experience working in clinical studies; and (5) required participation in trial training sessions on trial methods, applied trial interventions, and standards for performing clinical trials (ICH-GCP). At the trial beginning of the trial we sent a questionnaire to all 46 trial physicians. "
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