| 1.BackgroundAllergic rhinitis is an allergic disease of nasal mucosa in which allergic individuals are exposed to allergens,which is released by IgE mediated mediators.The typical clinical symptoms are nasal itching,nasal congestion,paroxysmal sneezing and runny nose.It is reported that the global prevalence of allergic rhinitis is about 10%-20%,and that in China is about 8.7%-37.9%.AR was previously classified as seasonal or perennial allergic rhinitis,while the new edition of "allergic rhinitis and its impact on asthma"(ARIA)diagnosis and treatment guide defines the classification of allergic rhinitis as intermittent or persistent allergic rhinitis,and also puts forward a new severity classification:mild,moderate and severe.Current strategies for the treatment of AR include avoiding exposure to allergens,drug therapy,immunotherapy and patient education.International guidelines suggest that the first-line drugs for the treatment of Ar are oral or nasal second-generation or new H1 antihistamines,nasal glucocorticoids,leukotriene receptor antagonists,etc.The above recommended drugs are effective and take effect quickly,but they may not completely alleviate all symptoms and maintain long-term efficacy.In addition,adverse reactions such as epistaxis,dry nose,intranasal drug stimulation and drowsiness caused by antihistamines will limit the effect of these drugs.The biggest problem of allergic rhinitis is recurrent.Therefore,the clinical treatment of AR urgently needs to study a long-lasting,safe and effective method to reduce the frequency and degree of disease attack and prevent the further development of AR on the basis of alleviating the symptoms of rhinitis.Allergic rhinitis belongs to the category of "rhinorrhea" in traditional Chinese medicine.Doctors of past dynasties have different explanations on the etiology and pathogenesis.It is basically characterized by the lack of solid guard,,and the wind cold taking advantage of the deficiency.Acupuncture and moxibustion therapy is widely used in the clinical treatment of AR.Some studies have pointed out that acupuncture and moxibustion can improve ar symptoms by reducing the content of serum immunoglobulin E(IGE),regulating cytokine secretion,inhibiting the release of inflammatory neuropeptides and reducing inflammatory cell infiltration.This topic is a part of the "evidence-based capacity building project of traditional Chinese medicine"(2019xzzx-zj)of the State Administration of traditional Chinese medicine.The first part summarizes the current clinical evidence of acupuncture and moxibustion in the treatment of AR through the method of systematic evaluation,focuses on exploring the advantages of acupuncture and moxibustion compared with conventional therapy through comparison with western medicine,and explores the curative effect difference of different acupuncture and moxibustion therapies in acupuncture and moxibustion therapy through subgroup analysis.The second part is a randomized controlled clinical trial of acupuncture combined with Fluticasone Propionate Nasal Spray to improve the nasal symptoms of persistent allergic rhinitis.2.ObjectiveTo systematically evaluate the efficacy and safety of acupuncture therapy in the treatment of allergic rhinitis;To evaluate the clinical efficacy of acupuncture combined with fluticasone propionate nasal spray in improving nasal symptoms of moderate and severe persistent allergic rhinitis.3.Methods(1)The literatures of seven databases were searched by computer.After the quality evaluation of the included literature,revman 5 The software makes quantitative analysis on the data extracted from the included literature.The TNSS,TNNSS,the questionnaire of quality of life of rhinoconjunctivitis,the total effective rate of treatment,total serum IgE,peripheral blood eosinophils(EOS)and the incidence(or number)of adverse events were used to evaluate the effectiveness and safety of acupuncture and moxibustion.(Ⅱ)relative risk(RR)and its 95%confidence interval(CI)were used for classified data;The continuity data were standardized mean difference(SMD)and its 95%CI.(2)This study adopts prospective,parallel control,central randomized,single blind(evaluator blind)clinical research design method.The participants were from nine(or nine)research institutes,including the Institute of Acupuncture and Moxibustion,Chinese Academy of Sciences.Subjects who met the inclusion and exclusion criteria and signed the informed consent were randomly divided into the treatment group and the control group through central distribution.Treatment group and control group 130 cases.The treatment group was treated with acupuncture combined with fluticasone propionate nasal spray.Acupuncture Dazhui,Yintang,Sibai,Yingxiang,Shangyingxiang,Shangxing,Jize(bilateral),Hegu(bilateral)points.After acupuncture,the 1cm long Ai segment ignite Ai segment,placed on the needle handle,so that the igniting end toward Dazhui point,the igniting end from the skin surface of the vertical distance of 1cm-1.5cm.Remove the ashes after Ai Duan burnt out,and place an Ai Duan lit until extinguished.The control group was treated with Fluticasone Propionate Nasal Spray,once a day morning,both sides,50 ug each time.Both groups were treated for six weeks,three times a week four weeks before acupuncture treatment;five to six weeks twice a week.The main curative effect index is the change of the total score of nasal symptoms after 6 weeks of treatment compared with the baseline.The secondary efficacy indicators were the change value of the total score of nasal symptoms compared with the baseline,the total score of accompanying symptoms,eye symptom score,quality of life scale,medication change and rhinitis control assessment scale.Efficacy was assessed at baseline,weekly after treatment,at the end of treatment(6th week)and during follow-up(10th,18th and 30th weeks from the beginning of treatment).4.Result4.1 Part Ⅰ72 literatures were included in this study,including 62 Chinese literatures and 10 English literatures.After extracting the data for analysis,the results are as follows.4.1.1 Total Nasal Symptom Score(TNSS):TNSS outcome index data of 33 literatures were analyzed(SMD-0.59,95%CI-0.82 to-0.37;I2=87%,P<0.00001).Analysis results of different control groups:at the end of treatment,acupuncture and moxibustion therapy was statistically significant compared with blank group(MD=-2.37,95%CI-4.07 to-0.68;I2=66%,P=0.006),sham acupuncture group SMD=-0.29(95%CI0.45 to-0.14;I2=0%,P=0.0002)and conventional western medicine group(SMD=-0.50,95%CI-0.79 to-0.21;I2=89%,P=0.0006).There was significant difference between acupuncture combined with conventional western medicine and conventional western medicine alone(SMD=-1.38,95%CI-1.79 to-0.97;I2=65%,P<0.00001).During the follow-up period within one year,there was significant difference between acupuncture group and sham acupuncture group(SMD=-0.33,95%CI-0.48 to-0.17;I2=0%,P<0.0001)and conventional western medicine group(SMD=-1.37,95%CI-2.04 to-0.71;I2=94%,P<0.0001).Subgroup analysis based on different acupuncture methods in the literature of acupuncture group compared with conventional western medicine group:hand acupuncture SMD=-0.39(95%CI-0.84 to 0.07;I2=84%,P=0.09,7 studies),electroacupuncture SMD=0.05(95%CI-0.25 to 0.34;I2=0%,P=0.76,3 studies),sphenopalatine meridian SMD=-0.51(95%CI-0.87 to-0.16;I2=0%,P=0.005,2 studies),Acupoint catgut embedding SMD=-0.15(95%CI-0.67 to 0.36;I2=64%,P=0.56,2 studies),moxibustion SMD=-0.41(95%CI-0.82 to-0.01;I2=84%,P=0.05,6 Studies).4.1.2 Total Non Nasal Symptom Score(TNNSS):the outcome indexes of tnnss in 17 literatures were analyzed.There was significant difference between the acupuncture group and the control group(SMD=-0.51,95%CI-0.81 to-0.21;I2=84%,P<0.00001).Analysis results with different control groups:at the end of treatment,there was significant difference between the acupuncture group and the blank group(MD=0.84,95%CI-1.20 to-0.48;I2=0%,P<0.00001).There was no significant difference between acupuncture group and sham acupuncture group(MD=0.08,95%CI-0.30 to 0.46;P=0.68)and conventional western medicine group(SMD=-0.37,95%CI-0.76 to 0.03;I2=87%,P=0.07).There was significant difference between acupuncture combined with conventional western medicine and conventional western medicine alone(SMD=-0.91,95%CI-1.36 to-0.46;I2=66%,P<0.0001).And there was no significant difference between the acupuncture group and the conventional western medicine group(SMD=-0.39,95%CI-0.97 to 0.19;I2=86%,P=0.18)during the oneyear follow-up period,.4.1.3 Rhinoconjunctivitis Quality of Life Questionnaire(RQLQ):25 literatures provided the data of the outcome index RQLQ.The results showed that there was significant difference between the acupuncture group and the control group at the end of treatment(SMD-0.58,95%CI-0.83 to-0.34;I2=88%,P<0.00001).Analysis results of different control groups:at the end of treatment,acupuncture group and blank group(SMD=-0.87,95%CI-1.10 to-0.64;I2=37%,P<0.00001),sham acupuncture group(SMD=-0.42,95%CI-0.69 to-0.16;I2=60%,P=0.002),conventional western medicine group(SMD=-0.67,95%CI-1.12 to-0.22;I2=93%,P<0.003),There was significant difference between acupuncture combined with conventional western medicine and conventional western medicine alone(SMD=-1.60,95%CI-2.84 to0.36;I2=93%,P=0.01).Subgroup analysis based on different acupuncture methods in the literature of acupuncture group compared with conventional western medicine group:hand acupuncture SMD=-0.30(95%CI-0.80 to 0.20;I2=82%,P=0.24,6 Studies),electroacupuncture MD=0.55(95%CI 0.01 to 1.09;P=0.04,1 study),sphenopalatine ganglion SMD=-0.05(95%CI-0.53 to 0.43;I2=61%,P=0.84,3 studies),Acupoint catgut embedding MD=0.18(95%CI-0.187 to 0.55;P=0.33,1 study),moxibustion SMD=-2.18(95%CI-3.52 to-0.84;I2=97%,P=0.001,5 studies).4.1.4 Visual analogue scale(VAS):the meta-analysis results of VAS scores of 12 acupuncture groups compared with the conventional western medicine group showed that SMD=-0.27(95%CI-0.67 to 0.12;I2=81%,P=0.17).There was no significant difference between the two groups.4.1.5 Total effective rate:at the end of treatment,there was significant difference in the total effective rate between acupuncture group and conventional western medicine group(RR=0.55,95%CI 0.45 to 0.68;I2=25%,P<0.00001),acupuncture combined with conventional western medicine group and conventional western medicine group(RR=1.14,95%CI 1.05 to 1.24;I2=72%,P=0.001).And there was significant difference in the total effective rate between acupuncture group and conventional western medicine group(RR=1.42,95%CI 1.21 to 1.68;I2=68%,P<0.0001),acupuncture combined with conventional western medicine group and conventional western medicine group(RR=1.26,95%CI 1.02 to 1.55;P=0.003)during the followup period within one year,.4.1.6 Laboratory indicators4.1.6.1 Total serum IgE:at the end of treatment,the difference between acupuncture group and conventional western medicine group(SMD=-0.61,95%CI-0.97 to-0.26;I2=89%,P=0.0008),acupuncture combined with conventional western medicine group and conventional western medicine group(SMD=-2.26,95%CI-3.21 to-1.31;I2=94%,P<0.00001)was statistically significant.4.1.6.2 EOS:at the end of treatment,there was significant difference between acupuncture group and conventional western medicine group(SMD=-0.62,95%CI1.56 to 0.31:I2=92%,P=0.19).4.1.7 Adverse eventsA total of 16 studies reported adverse events.There was no difference in adverse events between the acupuncture group and the control group(RR=0.79,95%CI 0.47 to 1.30;I2=18%,P=0.35).4.2 Part Ⅱ4.2.1 Baseline dataThere was no significant difference between the treatment group and the control group in age,course of disease,TNSS,TNNSS,eye symptom score,quality of life scale and assessment scale of rhinitis control.4.2.2 Main efficacy evaluation indexes:Total Nasal Symptom Score(TNSS)TNSS score of the treatment group decreased from 8.85 ± 1.79 to 5,13±2.55 after 1 week of treatment.After 6 weeks of treatment,the score decreased to 2.26±1.60,with statistically significant differences(P<0.01).TNSS score of the control group decreased from 8.57±1.72 to 6.05±2.46 after 1 week of treatment.After 6 weeks of treatment,the score decreased to 4.14±2.44,with statistically significant differences(P<0.01).After 4 weeks of treatment,there was significant statistical difference between the two groups(P<0.01).4.2.3 Secondary outcome indicators4.2.3.1 Total Nasal Symptom Score during the follow-up period(TNSS)TNSS scores of the treatment group were 3.15±1.65,2.85±1.49 and 3.23±1.80 at the 10th,18th and 30th week of follow-up,respectively,with statistically significant differences(P<0.01).The differences before and after treatment were 5.70±2.29,6.00±2.16 and 5.62±2.41,respectively,with statistically significant differences(P<0.01).TNSS scores of the control group at week 10,18 and 30 were 5.00±1.97,5.70±1.97 and 5.52±2.02,respectively,with statistically significant differences(P<0.01).The differences before and after treatment were 3.59±2.33,2.86±2.42 and 3.05±2.70,respectively,with statistically significant differences(P<0.01).There were significant statistical differences between the two groups at each follow-up time point(P<0.01)4.2.3.2 Total Non Nasal Symptom Score(TNNSS)Comparing TNNSS results before and after treatment,the results of the treatment group after 1 week of treatment and control group for 2 weeks were 3.02±1.96,3.48±2.15 respectively and had a considerable statistical difference(P<0.01),and the difference between the two groups was noticeably significant in 2 weeks after treatment and at the end of treatment(P<0.01).It was statistically important to compare the differences between the two groups in weeks 18 and 30(P<0.05).It suggests that in terms of the Outcome of TNNSS,the long-term effectiveness of the treatment group was better than that of the control group.Comparing the difference in TNNSS between the two groups before and after treatment,the difference between the two groups was 2.94±2.63,2.32±2.47 respectively,starting 4 weeks after treatment,which showed important importance(P<0.01).4.2.3.3 Total Ocular Symptom Score(TOSS)Comparing toss results before and after treatment between the two groups,treatment group results at 1 week treatment and control group in 2 weeks of treatment were 2.26±2.16,2.25±1.81 respectively and there was a significant statistical difference(P<0.01).At each time point in the following period,points changes in both groups were statistically important(P<0.01).It was statistically important to compare the differences between the two groups at each point of the following time(P<0.05).The difference between the two groups before and after treatment was compared between the two groups and the difference between the two groups was statistically significant from one week after treatment(P<0.05).4.2.3.4 Rhinoconjunctivitis Quality of Life Questionnaire(RQLQ)The RQLQ scores of the two groups after treatment and nursing were compared.The scores of the closure group and the management group were 29.21±18.45;39.41±30.66,continuous,with statistical difference(P<0.01).At the end of treatment,the two groups were compared with the two groups,and the statistical data were very different(P<0.05).4.2.3.5 Use of Antiallergic DrugsThe medication scores of the treatment group and the control group were 1.40±4.20 and 5.07±6.66 respectively,and no statistical difference between the two groups(P>0.05).And no difference compared with the statistical difference between treatment(P>0.05)and follow-up for 10 to 30 weeks(P<0.05).There was significant difference between the two groups at all time points except the 18th week of follow-up(P<0.05).The difference between the two pre-and post-treatment groups was statistics observed at week 30 of follow-up(P<0.05),suggesting that the curative effects of the two groups were different.4.2.3.6 Rhinitis Control Assessment Test(RCAT)There was significant difference in RCAT score between the two groups after 1 week of treatment(P<0.01).The difference between the two groups was statistically significant after 6 weeks of treatment(P<0.05).During the follow-up period,the score changes of the two groups at 10 weeks,18 weeks and 30 weeks were statistically significant(P<0.01).Compared between the two groups at each time point,the difference between the two groups showed statistical importance(P<0.05)starting from 6 weeks after treatment.During the following period,the difference between the two groups was statistically different at each point of follow-up(P<0.05),suggesting that the treatment group had a certain long-term effect on rhinitis control compared to the control group.5.Conclusion(1)At the end of allergic rhinitis treatment,nasal symptoms,nasal symptoms and quality of life improved better in the acupuncture group than in the control group.During the follow-up within one year,acupuncture also showed a good sustained effect in improving nasal symptoms compared with sham acupuncture or conventional western medicine.Subgroup analysis showed that acupuncture combined with western medicine in the treatment of allergic rhinitis was significantly better than western medicine alone in symptom severity and quality of life,suggesting that acupuncture combined with western medicine may be a more effective treatment.Subgroup analysis of different acupuncture and moxibustion treatments showed that there were significant differences in the effects of sphenopalatine ganglion stimulation and moxibustion compared with western medicine in the severity of nasal symptoms,suggesting that the clinical effects of sphenopalatine ganglion stimulation and moxibustion may be better than other treatments.(2)Acupuncture combined with fluticasone propionate nasal spray and fluticasone propionate nasal spray alone were effective.The effect of acupuncture combined with fluticasone propionate nasal spray is better than that of nasal spray alone,which is reflected in alleviating nasal symptoms,accompanying symptoms,quality of life and rhinitis control,and the curative effect can be sustained until half a year after the end of treatment. |
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