Efficacy of Bimin Decoction on patients with perennial allergic rhinitis: an open-label non-inferiority randomized controlled trial

Abstract

Background: Allergic rhinitis (AR) is a common allergic disease which affects people worldwide and traditional Chinese medicine is getting popular among AR patients for definite clinical effect and less adverse reactions. Lung qi deficiency and cold syndrome (LQDCS) is a frequent type of AR, and Chinese herbal medicine Bimin Decoction (BMD) was generated for AR patients with LQDCS. This study aimed to compare the clinical efficacy of BMD for AR patients with LQDCS to conventional medicine loratadine and fluticasone nasal spray. Methods/Design: The study was designed as an open-label, non-inferiority, randomized controlled trial. A total of 108 AR patients with LQDCS aged 19 to 60 were 1:1 randomly allocated to BMD group and control group by central computer system in Beijing Hospital of Traditional Chinese Medicine from January 2017 to April 2018. 98 completed the study (n=51; n=47). Patients in BMD group received Bimin Decoction while the control group received fluticasone nasal spray and loratadine tablets for a 4-week treatment. The primary outcome was change of the Total Nasal Symptom Score (TNSS) at baseline and the end of treatment. Alterations in Rhinoconjunctivitis Quality Life quality Questionnaire (RQLQ), nasal resistance (NR) and acoustic rhinometry parameters were second outcomes. Any side effect of treatment was observed and recorded. Results: After the 4-week treatment the TNSS total score was significantly reduced in both groups from baseline ( P < 0.05), no significant between-groups differences were observed for the changes of TNSS scores [-0.298 (95% CI -0.640 to 0.140)], which was within the defined non-inferiority margin. RQLQ in both groups decreased significantly ( P < 0.001) from baseline and more obvious reduction in BMD group was observed ( P < 0.001). There was no significant difference in the nasal resistance, the nasal volume and the nasal minimum cross-sectional area after treatment between groups ( P > 0.05). Conclusions: These findings indicated that BMD helps relieve PAR symptoms and improve rhinitis-related life quality. Our study indicated that BMD is non-inferior to loratadine tablets and fluticasone nasal spray for AR patients with LQDCS. Trial registration: Chinese Clinical Trial Registry, ChiCTR-INR-16010063. Registered on 2 December, 2016 Keywords: Perennial allergic rhinitis, Chinese traditional medicine, Randomized controlled trial, Clinical efficacy