Benno Brinkhaus, MD; Miriam Ortiz, MD; Claudia M. Witt, MD, MBA; Stephanie Roll, PhD; Klaus Linde, MD; Florian Pfab, MD; Bodo Niggemann, MD; Josef Hummelsberger, MD; András Treszl, PhD; Johannes Ring, MD, PhD; Torsten Zuberbier, MD; Karl Wegscheider, PhD; Stefan N. Willich, MD, MPH
Acknowledgment: The authors thank the participating patients, study randomization center and monitoring trial centers, and the physicians and staff who assisted with the study (see Appendix 2).
Disclaimer: Drs. Brinkhaus and Willich had full access to all of the data in the study and take full responsibility for the integrity of the data and the accuracy of the data analysis.
Grant Support: By grant WI 957/16-1 from the German Research Foundation.
Potential Conflicts of Interest: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M11-3084.
Reproducible Research Statement: Study protocol: Available at http://epidemiologie.charite.de. The protocol and the predefined data analysis plan of this trial are available on request. Details of the protocol were published in reference 10. Statistical code: Available from Dr. Roll (e-mail, firstname.lastname@example.org). Data set: Certain portions of the analytic data set are available to approved individuals through written agreements with the author or research sponsor.
Requests for Single Reprints: Prof. Dr. Benno Brinkhaus, Institute for Social Medicine, Epidemiology and Health Economics, Charité University Medical Center, 10098 Berlin, Germany.
Current Author Addresses: Drs. Brinkhaus, Ortiz, Witt, Roll, Zuberbier, and Willich: Charité University Medical Center, Luisenstrasse 57 and Charitéplatz 1, 10098 Berlin, Germany.
Dr. Linde: Institute of General Practice, Klinikum rechts der Isar, Technical University of Munich, Orleansstrasse 47, 81667 Munich, Germany.
Drs. Pfab and Ring: Christine Kühne Center for Allergy Research and Education, Biedersteinerstrasse 29, 80797 Munich, Germany.
Dr. Niggemann: German Red Cross Hospital Westend, Spandauer Damm 130, 14050 Berlin, Germany.
Dr. Hummelsberger: Hackenstrasse 7, 80331 Munich, Germany.
Drs. Treszl and Wegscheider: Department of Medical Biometry and Epidemiology, University Medical Center Eppendorf, Martinistrasse 52, 20246 Hamburg, Germany.
Author Contributions: Conception and design: B. Brinkhaus, M. Ortiz, C.M. Witt, S. Roll, K. Linde, F. Pfab, B. Niggemann, J. Hummelsberger, J. Ring, K. Wegscheider, S.N. Willich.
Analysis and interpretation of the data: B. Brinkhaus, M. Ortiz, C.M. Witt, S. Roll, K. Linde, F. Pfab, A. Treszl, J. Ring, K. Wegscheider, S.N. Willich.
Drafting of the article: B. Brinkhaus, F. Pfab, B. Niggemann.
Critical revision of the article for important intellectual content: M. Ortiz, C.M. Witt, S. Roll, K. Linde, F. Pfab, J. Ring, T. Zuberbier, K. Wegscheider, S.N. Willich.
Final approval of the article: B. Brinkhaus, C.M. Witt, S. Roll, K. Linde, F. Pfab, B. Niggemann, J. Hummelsberger, K. Wegscheider, S.N. Willich.
Provision of study materials or patients: B. Brinkhaus, M. Ortiz, F. Pfab, J. Ring.
Statistical expertise: S. Roll, A. Treszl, K. Wegscheider.
Obtaining of funding: B. Brinkhaus, S.N. Willich.
Administrative, technical, or logistic support: B. Brinkhaus, M. Ortiz, F. Pfab, S.N. Willich.
Collection and assembly of data: B. Brinkhaus, F. Pfab.
Brinkhaus B, Ortiz M, Witt CM, Roll S, Linde K, Pfab F, et al. Acupuncture in Patients With Seasonal Allergic Rhinitis: A Randomized Trial. Ann Intern Med. 2013;158:225-234. doi: 10.7326/0003-4819-158-4-201302190-00002
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Published: Ann Intern Med. 2013;158(4):225-234.
Acupuncture is frequently used to treat seasonal allergic rhinitis (SAR) despite limited scientific evidence.
To evaluate the effects of acupuncture in patients with SAR.
Randomized, controlled multicenter trial. (ClinicalTrials.gov: NCT00610584)
46 specialized physicians in 6 hospital clinics and 32 private outpatient clinics.
422 persons with SAR and IgE sensitization to birch and grass pollen.
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.
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).
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]).
The study was not powered to detect rare adverse events, and the RQLQ and RMS values were low at baseline.
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.
German Research Foundation.
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