title: Acupuncture in seasonal allergic rhinitis (ACUSAR)--design and protocol of a randomised controlled multi-centre trial.
abstract: 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.
  
  
  METHODS
  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.
  
  
  METHODS
  41 physicians in 37 out-patient units in Germany specialised in acupuncture treatment.
  
  
  METHODS
  400 seasonal allergic rhinitis patients with clinical symptoms and test-positive (skin-prick test and/or specific IgE) to both birch and grass pollen.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Institute for Social Medicine, Epidemiology, and Health Economics, Charité - University Medical Center, Berlin, Germany. benno.brinkhaus@charite.de
authors.forename: Benno
authors.initials: B
authors.lastname: Brinkhaus
authors.forename: Claudia M
authors.initials: CM
authors.lastname: Witt
authors.forename: Miriam
authors.initials: M
authors.lastname: Ortiz
authors.forename: Stephanie
authors.initials: S
authors.lastname: Roll
authors.forename: Thomas
authors.initials: T
authors.lastname: Reinhold
authors.forename: Klaus
authors.initials: K
authors.lastname: Linde
authors.forename: Florian
authors.initials: F
authors.lastname: Pfab
authors.forename: Bodo
authors.initials: B
authors.lastname: Niggemann
authors.forename: Josef
authors.initials: J
authors.lastname: Hummelsberger
authors.forename: Dominik
authors.initials: D
authors.lastname: Irnich
authors.forename: Karl
authors.initials: K
authors.lastname: Wegscheider
authors.forename: Stefan N
authors.initials: SN
authors.lastname: Willich
mesh_terms: D015670:Acupuncture Therapy / Q000379:methods*; D000293:Adolescent; D000328:Adult; D018926:Anti-Allergic Agents / Q000627:therapeutic use; D003131:Combined Modality Therapy; D005260:Female; D006633:Histamine Antagonists / Q000627:therapeutic use; D006801:Humans; D007073:Immunoglobulin E / Q000097:blood; D007428:Intradermal Tests; D008297:Male; D011852:Radioallergosorbent Test; D006255:Rhinitis, Allergic, Seasonal / Q000175:diagnosis / Q000628:therapy*; D055815:Young Adult
chemical_list: D018926:Anti-Allergic Agents; D006633:Histamine Antagonists; D007073:Immunoglobulin E