Brinkhaus, Benno; Ortiz, Miriam; Witt, Claudia M; Roll, Stephanie; Linde, Klaus; Pfab, Florian; Niggemann, Bodo; Hummelsberger, Josef; Treszl, András; Ring, Johannes; Zuberbier, Torsten; Wegscheider, Karl; Willich, Stefan N
Acupuncture in patients with seasonal allergic rhinitis: a randomized trial.
Chinese translationAcupuncture 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.