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Original Research |

Acupuncture in Patients With Seasonal Allergic Rhinitis: A Randomized Trial

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; and Stefan N. Willich, MD, MPH
[+] Article and Author Information

From Charité University Medical Center and German Red Cross Hospital Westend, Berlin, Germany; University of Maryland School of Medicine, Baltimore, Maryland; Technical University of Munich, Helmholtz Center Munich, and International Society for Chinese Medicine, Munich, Germany; Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts; and University Medical Center Eppendorf, Hamburg, Germany.

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, stephanie.roll@charite.de). 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.


Ann Intern Med. 2013;158(4):225-234. doi:10.7326/0003-4819-158-4-201302190-00002
Text Size: A A A

Chinese translation

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 RMS values 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.

Primary Funding Source: German Research Foundation.

Figures

Grahic Jump Location
Figure 1.

Study design.

Baseline in the second-year follow-up started at birch pollen flow onset. RMS = rescue medication score; RQLQ = Rhinitis Quality of Life Questionnaire; SF-36 = Short Form-36 Health Survey; VAS = visual analog scale.

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Grahic Jump Location
Figure 2.

Study flow diagram.

All patients with available baseline data were included in the analyses. RMS = rescue medication score; RQLQ = Rhinitis Quality of Life Questionnaire; SAR = seasonal allergic rhinitis.

* Missing outcome values were imputed on the basis of baseline values. No patient is excluded because of missing outcome values.

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Grahic Jump Location
Figure 3.

RQLQ and RMS values at baseline, in weeks 7 and 8 of the first year, in weeks 15 and 16 of the first year, and in weeks 7 and 8 of the second year.

Means and 95% CIs are adjusted for baseline value, study center, region, and year of randomization. Baseline means are not adjusted for baseline values. RMS = rescue medication score; RQLQ = Rhinitis Quality of Life Questionnaire.

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concerns regarding internal validity
Posted on April 18, 2013
Charles Kirkpatrick, MD, FACP, Matthew Germinaro, MD
University of Colorado School of Medicine
Conflict of Interest: none

We read with great interest the Brinkhaus et al. article “Acupuncture in Patients With Seasonal Allergic Rhinitis” recently published in the Annals (1), but have several concerns regarding internal validity. By recruiting 80% of participants through “newspaper articles about the use of acupuncture or CAM for AR,” the authors introduced an element of recruitment bias as these subjects were more likely to harbor positive beliefs regarding the effects of acupuncture and CAM. The baseline characteristics are suggestive of selection bias despite apparent randomization.  A larger percentage of patients in the acupuncture group received prior acupuncture treatment (23.6%) compared to the sham acupuncture (16.7%) and rescue medication (20.4%) groups, respectively.  The acupuncture group also had higher expectations for acupuncture efficacy (84.8%) compared to the sham acupuncture group (72.5%).  Moreover, the mean RQLQ overall score was highest in the acupuncture group, which could have impacted the primary outcome measure, mean change from baseline RQLQ.  Perhaps most importantly, 27 patients (16 in the acupuncture group, 4 in the sham acupuncture group, and 7 in the RM group) used "anti-allergic medications” (mostly topical steroids and cromoglicic acid).  “Anti-allergic medications” were not permitted according to the study protocol.  Of note, these patients were not excluded from statistical analysis and therefore, potentially skewed the results in favor of acupuncture.  The statement, “study nurses contacted patients directly to obtain missing data from questionnaires and diaries” also raises concern about data acquisition.  Collectively, the aforementioned issues may have had an impact on the demonstrated statistical significance and consequent study conclusions.

Providers must be aware of the problems with internal validity in this study before altering their management of seasonal allergic rhinitis.  As-needed use of cetirizine, as designated in the control group, is not the most effective medication for controlling symptoms of allergic rhinitis (2). If acupuncture was compared directly with a daily intranasal corticosteroid using RQLQ scoring as the primary outcome measure, we suspect acupuncture would be found inferior.  Additional, more rigorous study is needed before acupuncture can be recommended as a viable treatment option for seasonal allergic rhinitis.

Matthew Germinaro, MD

Charles Kirkpatrick, MD, FACP

 University of Colorado School of Medicine

Division of Allergy &Clinical Immunology

Aurora, Colorado

1.            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. 19 February 2013;158(4):225-234.

2.            Wallace DV, Dykewicz MS, Bernstein DI, Blessing-Moore J, Cox L, Khan DA, Lang DM, Nicklas RA, Oppenheimer J, Portnoy JM, et al. The diagnosis and management of rhinitis: an updated practice parameter. J Allergy Clin Immunol. 2008 Aug; 122(2 Suppl):S1-84.

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Summary for Patients

The Effects of Acupuncture on Seasonal Allergic Rhinitis

The full report is titled “Acupuncture in Patients With Seasonal Allergic Rhinitis. A Randomized Trial.” It is in the 19 February 2013 issue of Annals of Internal Medicine (volume 158, pages 225-234). The authors are B. Brinkhaus, M. Ortiz, C.M. Witt, S. Roll, K. Linde, F. Pfab, B. Niggemann, J. Hummelsberger, A. Treszl, J. Ring, T. Zuberbier, K. Wegscheider, and S.N. Willich.

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