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Acupuncture in patients with seasonal allergic rhinitis: a randomized trial [with consumer summary] |
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 |
Annals of Internal Medicine 2013 Feb 19;158(4):225-234 |
clinical trial |
8/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: Yes; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
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 versus acupuncture mean difference 0.5 point (97.5% CI 0.2 to 0.8 point; p < 0.001); RM versus acupuncture mean difference 0.7 point (97.5% CI 0.4 to 1.0 point; p < 0.001)) and RMS (sham versus acupuncture mean difference 1.1 points (97.5% CI 0.4 to 1.9 points; p < 0.001); RM versus 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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