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

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


Background: Acupuncture is frequently used to treat seasonal allergic rhinitis (SAR) despite limited scientific evidence.

Objective: To evaluate the effects of acupuncture in patients with SAR.
Design: Randomized, controlled multicenter trial. (ClinicalTrials.gov: NCT00610584)

Setting: 46 specialized physicians in 6 hospital clinics and 32 private outpatient clinics.

Patients: 422 persons with SAR and IgE sensitization to birch and grass pollen.
Intervention: Acupuncture plus rescue medication (RM) (cetirizine) (n = 212), sham acupuncture plus RM (n = 102), or RM alone (n = 108). Twelve treatments were provided over 8 weeks in the first year.

Measurements: Changes in the Rhinitis Quality of Life Questionnaire (RQLQ) overall score and the RM score (RMS) from baseline to weeks 7 and 8 and week 16 in the first year and week 8 in the second year after randomization, with predefined noninferiority margins of -0.5 point (RQLQ) and -1.5 points (RMS).

Results: Compared with sham acupuncture and with RM, acupuncture was associated with improvement in RQLQ score (sham vs. acupuncture mean difference, 0.5 point [97.5% CI, 0.2 to 0.8 point]; P < 0.001; RM vs. acupuncture mean difference, 0.7 point [97.5% CI, 0.4 to 1.0 point]; P < 0.001) and RMS (sham vs. acupuncture mean difference, 1.1 points [97.5% CI, 0.4 to 1.9 points]; P < 0.001; RM vs. acupuncture mean difference, 1.5 points [97.5% CI, 0.8 to 2.2 points]; P < 0.001). There were no differences after 16 weeks in the first year. After the 8-week follow-up phase in the second year, small improvements favoring real acupuncture over the sham procedure were noted (RQLQ mean difference, 0.3 point [95% CI, 0.03 to 0.6 point]; P = 0.032; RMS mean difference, 1.0 point [95% CI, 0.2 to 1.9 points]; P = 0.018).
Limitation: The study was not powered to detect rare adverse events, and the RQLQ and RM scores were low at baseline.

Conclusion: Acupuncture led to statistically significant improvements in disease-specific quality of life and antihistamine use measures after 8 weeks of treatment compared with sham acupuncture and with RM alone, but the improvements may not be clinically significant.

Publications:

Brinkhaus B, Ortiz M, Witt CM, Roll S, Linde K, Pfab F, Niggemann B, Hummelsberger J, Treszl A, Ring J, Zuberbier T, Wegscheider K, Willich SN. Ann Intern Med. 2013 Feb 19;158(4):225-34.

Brinkhaus B, Witt CM, Ortiz M, Roll S, Reinhold T, Linde K, Pfab F, Niggemann B, Hummelsberger J, Irnich D, Wegscheider K, Willich SN. Acupuncture in Seasonal Allergic Rhinitis (ACUSAR) - Design and Protocol of a Randomised Controlled Multicenter Trial. Forsch Komplement 2010; 17 (2):95-102.

 

Principle investigator:
Willich, MD, MPH
Brinkhaus, MD

Research associate:
Ortiz, MD
Witt, MD, MBA

Statistics:
Wegscheider, PhD
Roll, PhD

Coorperation:
Dept. of Dermatology and Allergology, TU Munich (Ring, MD)
Dept. of Dermatology and Allergology, Charit√© (Zuberbier, MD)
Institute for Biometrics, UKE Hamburg (Wegscheider, PhD)
Allgemeinmedizin TU M√ľnchen (Linde, MD)

Data management:
Binting

Study nurse:
Cree

Project duration:
2008-2012

Project status:
completed

Funding:
Deutsche Forschungsgemeinschaft (DFG)