Acupuncture for Seasonal Allergic Rhinitis
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional

Summary: 
      Acupuncture is widely use by patients with seasonal allergic rhinitis (SAR), although there
      is only limited evidence of its effectiveness. The aim of this three armed randomised
      controlled multicentre trial is to investigate the efficacy of acupuncture plus rescue
      medication vs. minimal (sham) acupuncture plus rescue medication vs. (b) rescue medication
      alone in the treatment of seasonal allergic rhinitis.
    

Detailed description: 
      Acupuncture is widely use by patients with seasonal allergic rhinitis (SAR), although there
      is only limited evidence of its effectiveness. The aims of this 3-armed, randomised
      controlled trial are to investigate whether acupuncture plus rescue medication is
      non-inferior (closed testing procedure: in case of success in non-inferiority: test of
      superiority) to minimal acupuncture plus rescue medication in the treatment of SAR (closed
      testing procedure: closed testing procedure: in case of success in non-inferiority: test of
      superiority), and whether acupuncture plus rescue medication is non-inferior to rescue
      medication alone consisting only of oral antihistamines for this indication. The trial
      interventions will be performed in approximately 40 outpatient centres in Germany. In total,
      400 patients with SAR will be randomised to one of three groups: acupuncture plus rescue
      medication, minimal acupuncture (i.e. superficial needling at non-acupuncture points) plus
      rescue medication, or rescue medication only. Rescue medication will consist of oral
      antihistamines. Acupuncture and minimal acupuncture will be administered by physicians
      specialised in acupuncture and will consist of 12 sessions per patient in the first 8 weeks.
      Patients in the rescue medication group will receive 12 sessions of acupuncture after 8
      weeks. The primary outcome measures will be the mean of Rhinitis Quality of Life
      Questionnaire score (RQLQ scores between weeks 6 and 8 of the first year (adjusted for
      baseline values) and the Rescue Medication Score (RMS) between weeks 6 and 8 of the first
      year (adjusted for baseline values).
    

Intervention name(s): acupuncture; minimal (sham)acupuncture; cetirizine dihydrochloride (rescue medication)
Intervention type(s): Procedure; Procedure; Drug
Intervention description(s): arm 1: verum acupuncture group: 12 interventions (semi-standardised): 8 in the first 4 weeks and 4 in the next 4 weeks + rescue medication (up to 2 doses of second-generation oral antihistamines daily (e.g. 2 x 1 cetirizine dihydrochloride/daily)); arm 2: minimal (sham) acupuncture group: 12 interventions (standardised): 8 in the first 4 weeks and 4 in the next 4 weeks + rescue medication (up to 2 doses of second-generation oral antihistamines daily (e.g. 2 x 1 cetirizine dihydrochloride/daily)); arm 3: rescue medication (up to 2 doses of second-generation oral antihistamines daily (e.g. 2 x 1 cetirizine dihydrochloride/daily)) alone
Intervention MeSH terms: Cetirizine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: seasonal allergic rhinitis; acupuncture; RCT; CAM