| BackgroundAllergic rhinitis is an inflammatory disease of nasal mucosa mediated by immunoglobulin E(IgE)and driven by Th2 helper cells after exposure to inhaled allergens.It is characterized by sneezing,runny nose,nasal itching and nasal obstruction.According to the duration of allergic rhinitis in clinical symptoms,it is divided into intermittent allergic rhinitis and persistent allergic rhinitis.Persistent allergic rhinitis lasts longer than 4 days a week and lasts longer than 4 weeks a year.It is a chronic,inflammatory and non-infectious disease.It is estimated that about 400 million people suffer from allergic rhinitis in the world,and the prevalence rate is from 5%to 50%.The prevalence of allergic rhinitis is increasing year by year,which has a very important impact on people' s life.In Chinese Medicine,allergic rhinitis is called Biqiu”.The main pathogenesis is deficiency of lung-qi and cold,weakness of spleen-qi,insufficiency of kidney-yang and heat in lung meridians.Lung is the nasal orifices,If lung is weak,the muscles are loose,and the pathogens of wind and cold are easy to enter by virtue of deficiency,leading to nasal orifices feeling cold evil;Spleen is the acquired basis,the source of Qi and blood biochemistry,and the spleen is weak,which easily leads to the loss of nasal orifices incubation,while the external evil enters the nasal orifices;The kidney is the congenital basis.If the kidney yang is insufficient,it is difficult to absorb,which leads to-arm neglect of duty and the nasal orifices not being nourished.The evil of water and dampness also offends nasal orifices and induces snoring.The etiology is attributed to external and internal injuries.Internal injury is due to the deficiency of vital energy,deficiency of viscera,insufficiency of lung,spleen and kidney.The pathogenesis of allergic rhinitis focus on the mechanism of symptomatic cytokines,hygiene hypothesis and genetic factors.The treatments include environmental control,drug treatment,immunotherapy and surgery.Environmental control advises allergic rhinitis patients to avoid exposure to known allergens,which is beneficial to the improvement and relief of these symptoms.Drugs include intranasal glucocorticoids,oral antihi.stamines,leukotriene receptor antagonists.Drug therapy has a short-term efficacy,but if we use them for a long-term,drug may have side effects for patients due to the cumulative effect of doses.Immunotherapy is the basic treatment methods.Based on the pathogenesis of the disease,the main intention is to reduce sensitivity.But the treatment needs a long time and the cost is a little bit high.Surgery is sufficient for the patients with poor drug efficacy or abnormal nasal anatomy.It can relieve symptoms and improve the quality of peope's life.In modern society,more and more people are willing to accept traditional Chinese medicine treatment,including acupuncture,Chinese medicine,massage and other methods.But how to choose an appropriate treatment for patients,is a little bit difficult for us.So it is of great practical significance and clinical needs to find a more effective and safe treatment.Allergic rhinitis is characterized by repeated attacks and protracted course of disease.At present,the treatment of Western medicine has certain advantages in time]y curative effect.In the long-term curative effect,there are many problems,like side effects and high costs.Therefore,it is of great practical significance to find a long-lasting,safe and reliable treatment methodFrom ancient times,acupuncture and moxibustion have been used for allergic rhinitis.Now,there are many ways of intervention for clinical studies about acupuncture and moxibustion for allergic rhinitis.Although most clinical studies have achieved good results,there are still some problems,like low quality of studies,small samples and more subjective evaluation indicators.It is difficult to reflect the effectiveness and safety of interventions.In this study,we have compared acupuncture therapy with loratadine to evaluate the short term and long term efficacy.ObjectiveTo evaluate the short-term and long-term efficacy of acupuncture and moxibustion for the treatment of persistent allergic rhinitis,and to clarify the characteristics and advantages of this therapy in the long-term efficacy,and the safety.MethodsA randomized,control led,single-blind clinical trial design.The subjects who met the inclusion criteria and voluntarily signed the informed consent were randomly divided into 49 cases in the acupuncture group and 49 cases in the western medicine group.Acupuncture group,Dazhui,Yintang,Sibai,Yingxiang,Shangyingxiang,Chize and Hegu points were selected.After the acupoints were punctured,Dazhui acupoint was placed with moxa and ignited.The distance from the skin was 1 cm to 1.5 cm.The needles were retained for 20 minutes.The course of treatment was 4 weeks.Western medicine group took loratadine orally for 4 weeks,once a day.This study was conducted for 58 weeks,including baseline evaluation of 0 week,a treatment of 4 weeks and follow-up of 54 weeks.The primary outcome was total score of nasal symptoms(treatment of 2,4 weeks,follow-up of 16 weeks,28 weeks,54 weeks).Secondary outcome measures were Total Non Nasal Symptom Score(treatment of 2,4 weeks,follow-up of 16 weeks,28 weeks,54 weeks)and Rhinoconjunctivitis Quality of Life Questionnaire(treatment of 4 week,follow-up of 16 weeks,28 weeks,54 weeks),as well as safety.We use SPSS 24.0 for statistical analysis.The data were described by mean and standard deviation or 95%confidence interval(Cl).The changes of each group before and after treatment were compared by paired test,and independent sample test was used for comparison between groups.Frequency was used for counting data,and X2 test or non-parametric test was used for comparing two groups.Multiple time points were compared by repeated measurement variance analysis.P less than 0.05 is considered to be statistically significant.Result1.The primary outcome was the change from baseline in the average nasal symptoms scores(TNSS).It was respectively in the Acupuncuture group 4.15(2.96,5.34),5.33(4.14,6.53),5.61(4.42,6.80),5.57(4.38,7.27),6.08(4.89,7.27).It was respectively in the Western medicine group 3.44(2.02,4.87),5.21(3.78,6.74),4.84(3.41,6.26),4.90(3.47,6.32),5.09(3.66,6.51).The two groups both showed reductions in TNSS scores compared with baseline at these evaluation points.The results showed no signif'icant differences in the change from baseline in nasal symptoms scores(P>0.05).2.The secondary outcome was the change from baseline in the Total Non Nasal Symptom Score(TNNSS).The change from baseline in TNNSS was respectively in the Acupuncuture group 2.23(1.42,3.04),2.57(1.76,3.38),2.89(2.08,3.70),3.02(1.74,3.36),2.95(2.14,3.76).It was respectively in the Western medicine group 1.22(0.31,2.13),1.69(0.78,2.61),1.52(0.61,2.43),1.61(0.70,2.5),1.73(0.81,2.64).The two groups both showed reductions in TNNSS scores compared with baseline.Acupuncture group showed a more significant improvement in the Total Non Nasal Symptom Score at all evaluation points compared with Western medicine group(P<0.05).3.The secondary outcome was the change from baseline in Rhinoconjunctivitis Quality of Life Questionnaire(RQLQ)at week 4,follow-up 3 month,6 month,1 year.It was respectively in Acupuncture group 43.94(34.55,53.32),49.96(40.57,59.34),50.47(41.09,59.86),53.60(44.21,62.98).It was respectively in Western medicine group 27.29(16.56,38.01),28.09(17.37,38.82),29.51(18.79,40.24)30.84(20.12,41.57).The results estimated reductions in RQLQ scores compared with baseline at these evaluation points.Acupuncture treatment is better than western medicine in RQLQ(P<0.05).Acupuncture can improve the quality of life for allergic rhinitis.4.Safety analysis.No serious adverse events occurred during the experiment.The incidence of adverse events related to moxibustion was 10.2%.The adverse events were disappeared after taking corresponding measures.No adverse events occurred in the western medicine group and no participants withdrew the study because of these events.ConclusionAcupuncture and moxibustion and Loratadine can effectively relieve nasal symptoms and non nasal symptom.Acupuncture and moxibustion not only have short-term effect in improving non nasal symptom,but also have long-term sustained effect.After treatment,the long-term effect can last for one year. |
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