Objective To evaluate the efficacy of Chinese medicine acupoint application(CMAA)combined with Western medicine for perennial allergic rhinitis(PAR)in children.Methods In this prospective,parallel,randomized,placebo-c...Objective To evaluate the efficacy of Chinese medicine acupoint application(CMAA)combined with Western medicine for perennial allergic rhinitis(PAR)in children.Methods In this prospective,parallel,randomized,placebo-controlled and single-blind trial from August to September,2017,180 children with PAR were randomly assigned to an integrative group(CMAA and Montelukast),CMAA group(CMAA and placebo tablet),or Montelukast group(placebo CMAA and Montelukast).Participants were applied with CMAA for 6 sessions over 2 weeks,and/or Montelukast Chewable Tablet orally once daily for 12 weeks.The changes in severity of symptoms were measured by Visual Analog Scale(VAS)and rhinitis control assessment test(RCAT)at 0,2,4 and 12 weeks of treatment.Blood samples were collected for serum interleukin-4,interferon gammaγand T helper type 1(Th1)/Th2 flow cytometric analysis at the time points of 0,4 and 12 weeks.Results Eight cases dropped out from the trial,3 in the integrative group,2 in the CMAA group and 3 in the Montelukast group.The VAS scores decreased significantly while the RCAT scores increased significantly in all three groups at 4 and 12 weeks compared with baseline(P<0.01 or P<0.05).The VAS scores were significantly lower while the RCAT scores were significantly higher in the integrative and CMAA groups than the Montelukast group at 2 and 4 weeks(P<0.01 or P<0.05).At 2,4 and 12 weeks,the scores of nasal congestion,sneezing,sleep problem,and rhinitis symptom control in the integrative and CMAA groups increased significantly compared with baseline(P<0.01 or P<0.05).The least percentages of Th2 and the most alleviated Th2 shift(highest Th1/Th2)were observed in the integrative group at 12 weeks compared with the other two groups(P<0.05).Conclusion The combination of CMAA with Montelukast might be more effective and appropriate than either option alone for children with PAR.(Registered at Chinese Clinical Trial Register,registration No.ChiCTR-IOR-17012434).展开更多
基金Supported by the Medicine Leading Science and Technology Project of Shanghai Municipal Science and Technology Commission(No.15401933800)。
文摘Objective To evaluate the efficacy of Chinese medicine acupoint application(CMAA)combined with Western medicine for perennial allergic rhinitis(PAR)in children.Methods In this prospective,parallel,randomized,placebo-controlled and single-blind trial from August to September,2017,180 children with PAR were randomly assigned to an integrative group(CMAA and Montelukast),CMAA group(CMAA and placebo tablet),or Montelukast group(placebo CMAA and Montelukast).Participants were applied with CMAA for 6 sessions over 2 weeks,and/or Montelukast Chewable Tablet orally once daily for 12 weeks.The changes in severity of symptoms were measured by Visual Analog Scale(VAS)and rhinitis control assessment test(RCAT)at 0,2,4 and 12 weeks of treatment.Blood samples were collected for serum interleukin-4,interferon gammaγand T helper type 1(Th1)/Th2 flow cytometric analysis at the time points of 0,4 and 12 weeks.Results Eight cases dropped out from the trial,3 in the integrative group,2 in the CMAA group and 3 in the Montelukast group.The VAS scores decreased significantly while the RCAT scores increased significantly in all three groups at 4 and 12 weeks compared with baseline(P<0.01 or P<0.05).The VAS scores were significantly lower while the RCAT scores were significantly higher in the integrative and CMAA groups than the Montelukast group at 2 and 4 weeks(P<0.01 or P<0.05).At 2,4 and 12 weeks,the scores of nasal congestion,sneezing,sleep problem,and rhinitis symptom control in the integrative and CMAA groups increased significantly compared with baseline(P<0.01 or P<0.05).The least percentages of Th2 and the most alleviated Th2 shift(highest Th1/Th2)were observed in the integrative group at 12 weeks compared with the other two groups(P<0.05).Conclusion The combination of CMAA with Montelukast might be more effective and appropriate than either option alone for children with PAR.(Registered at Chinese Clinical Trial Register,registration No.ChiCTR-IOR-17012434).
