Acupuncture in Patients With Seasonal Allergic Rhinitis: A Randomized Trial
Publication: Annals of Internal Medicine
Volume 158, Number 4
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Abstract
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.
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Published In
Annals of Internal Medicine
Volume 158 • Number 4 • 19 February 2013
Pages: 225 - 234
History
Published online: 19 February 2013
Published in issue: 19 February 2013
Keywords
Copyright
© 2013 American College of Physicians.
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Acupuncture in Patients With Seasonal Allergic Rhinitis: A Randomized Trial. Ann Intern Med.2013;158:225-234. [Epub 19 February 2013]. doi:10.7326/0003-4819-158-4-201302190-00002
Acupuncture in Patients With Seasonal Allergic Rhinitis: A Randomized Trial. Ann Intern Med.2013;158:225-234. [Epub 19 February 2013]. doi:10.7326/0003-4819-158-4-201302190-00002
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concerns regarding internal validity
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.
Disclosures: none