Neue Trends Bei Alten Themen - Alte Themen in Neuen Trends

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.