Efficacy of warm needling in patients with persistent allergic rhinitis: A multicenter randomized controlled trial

Objective: Although there is evidence to support the therapeutic effect of acupuncture on allergic rhinitis (AR), it is not clear whether acupuncture can achieve an efficacy comparable to that of pharmacological therapy. This multicenter, non-inferiority, single-blinded randomized controlled trial aimed to compare the differences in efficacy between warm needling (WN) therapy and loratadine (LO) in improving AR symptoms and quality of life. Methods: A total of 98 patients with persistent AR (PAR) were randomly divided into two groups in a 1:1 ratio: treatment group receiving WN therapy at Dazhui (GV14) and normal acupuncture at other acupoints for 12 sessions in 4 weeks and control group receiving LO at a dosage of 10 mg/day for oral administration. The study duration was 28 weeks (4-week treatment period with a 24-week follow-up). The primary outcome was the mean change in the Total Nasal Symptom Score (TNSS) from baseline to week 28, and the secondary outcomes included the Total Non-Nasal Symptom Score (TNNSS) and the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score. Statistical analyses were conducted using SPSS22.0. Both intention-to-treat and treatment compliance analyses were performed to analyze all outcomes. Results: After intervention, TNSS scores improved from baseline to week 28 by 5.18 (95 % confidence interval [CI]: 3.91, 6.45; P < 0.001) in the WN group and 4.59 (95 % CI 3.28, 5.89; P < 0.001) in the LO group, but the changes did not differ between the groups (P = 0.515). The margin by 95 % CI (−1.20, 2.38) was not reached, indicating non-inferiority. WN therapy resulted in clinical improvements in TNNSS, with a significant difference compared with LO treatment (f = 5.466, P = 0.021). WN therapy also resulted in clinical improvements in RQLQ scores, with a significant difference compared with LO (f = 9.222, P = 0.003). Conclusions: WN therapy demonstrated comparable efficacy to oral LO in improving nasal symptoms of PAR. However, it showed superior effects in alleviating concomitant nasal symptoms and enhancing patients’ quality of life.Clinical Trial Registration: ClinicalTrials.gov Identifier NCT02339714.