Acupuncture for seasonal allergic rhinitis - a randomized controlled trial (ACUSAR)

• Applicant: Professor Dr. Stefan N. Willich
• Subject Area: Epidemiology and Medical Biometry/Statistics
• Term: from 2008 to 2011
• Project identifier: Deutsche Forschungsgemeinschaft (DFG) - Project number 54104120

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 is non-inferior (closed testing procedure: in case of success in non-inferiority: test of superiority) to minimal acupuncture in the treatment of SAR (closed testing procedure: closed testing procedure: in case of success in non-inferiority: test of superiority), and whether acupuncture is noninferior to rescue medication 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). Further outcome measures will include the SF-12 score, symptoms of SAR rated on a visual analogue scale, immunologic parameters, cost analyses, and treatment safety. The results of this trial will have a major impact on the decision of whether acupuncture should be considered as a therapeutic option in the treatment of SAR.

• DFG Programme: Clinical Trials