Acupuncture in seasonal allergic rhinitis (ACUSAR)--design and protocol of a randomised controlled multi-centre trial.
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.
Brinkhaus
Benno
B
Institute for Social Medicine, Epidemiology, and Health Economics, Charité - University Medical Center, Berlin, Germany. benno.brinkhaus@charite.de
Witt
Claudia M
CM
Ortiz
Miriam
M
Roll
Stephanie
S
Reinhold
Thomas
T
Linde
Klaus
K
Pfab
Florian
F
Niggemann
Bodo
B
Hummelsberger
Josef
J
Irnich
Dominik
D
Wegscheider
Karl
K
Willich
Stefan N
SN
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
D018926:Anti-Allergic Agents; D006633:Histamine Antagonists; D007073:Immunoglobulin E