Clinical Observation On Reinforcing Earth To Generate Metal-based Acupoint Application In The Treatment Of Allergic Rhinitis With Spleen Deficiency

ObjectiveTo observe the effect of reinforcing earth to generate metal-based acupoint application on the quality of life,clinical symptoms and laboratory indicators of allergic rhinitis(AR)with spleen deficiency,and to evaluate the effectiveness and safety of reinforcing earth to generate metal-based acupoint application on AR with spleen deficiency.MethodsIn this study,patients who met the inclusion criteria from July 2018 to September 2019 were randomly allocated to acupoint application group or loratadine group according to the proportion of 1:1.In acupoint application group,subjects accepted reinforcing earth to generate metal-based acupoint application once a week for 4 weeks continuously,and in loratadine group,subjects accepted oral loratadine once a day for 4 weeks continuously.The primary outcome was rhino-conjunctivitis quality of life questionnaire(RQLQ),which was assessed before treatment,after treatment and follow-up period.The secondary outcomes were visual analogue scale(VAS)of nasal symptoms,VAS of non-nasal symptoms,total nasal symptoms score(TNSS),total non-nasal symptoms score(TNNSS),total Immunoglobulin E(IgE)and eosinophils(EOS),which were assessed before and after treatment.The safety outcome was the incidence of adverse events,which was recorded in detail from baseline to the end of this study.Results1.In this study,70 eligible subjects were randomly allocated to acupoint application group and loratadine group according to the proportion of 1:1.All subjects accepted at least one treatment.Finally,64 subjects completed the trial,including 32 subjects in acupoint application group and 32 subjects in loratadine group,and 6 subjects dropped or removed.2.Baseline data:There was no significant difference between the two groups in various baseline data(gender,age,course of disease and outcomes before treatment),which was comparable(P>0.05).3.Quality of life(RQLQ):After treatment,RQLQ of both groups decreased significantly(P<0.05),and there was no significant difference in RQLQ between the two groups(P>0.05).At follow-up period,RQLQ of both groups decreased significantly(P<0.05),and RQLQ of acupoint application group was lower than that of loratadine group(P<0.05).4.Clinical symptoms:(DVAS of nasal symptoms:After treatment,VAS of nasal symptoms of both groups decreased significantly(P<0.05),and there was no significant difference in VAS of nasal symptoms between the two groups(P>0.05).②VAS of non-nasal symptoms:After treatment,VAS of non-nasal symptoms of both groups decreased significantly(P<0.05),and there was no significant difference in VAS of non-nasal symptoms between the two groups(P>0.05).③TNSS:After treatment,TNSS of both groups decreased significantly(P<0.05),and there was no significant difference in TNSS between the two groups(P>0.05).④TNNSS:After treatment,TNNSS of both groups decreased significantly(P<0.05),and there was no significant difference in TNNSS between the two groups(P>0.05).5.Laboratory indicators:①Total IgE:In the two group,there was no significant difference in total IgE between before treatment and after treatment(P>0.05);and there was no significant difference in total IgE between the two groups after treatment(P>0.05).②Total EOS:In the two group,there was no significant difference in total EOS between before treatment and after treatment(P>0.05);and there was no significant difference in total EOS between the two groups after treatment(P>0.05).6.Safety outcome:The incidence of adverse events in acupoint application group was 11.43%,and the incidence of adverse events in loratadine group was 5.71%.There was no significant difference in the incidence of adverse events between the two groups(P>0.05).Conclusion1.Reinforcing earth to generate metal-based acupoint application could improve the quality of life of AR with spleen deficiency,which was equivalent to the effect of oral loratadine.During the follow-up period of 3 months after treatment,reinforcing earth to generate metal-based acupoint application improved better than oral loratadine on quality of life.2.Reinforcing earth to generate metal-based acupoint application could relieve the nasal symptoms and non-nasal symptoms of AR with spleen deficiency,which was equivalent to the effect of oral loratadine.3.Reinforcing earth to generate metal-based acupoint application and oral loratadine did not have significant effect on the total IgE and EOS in AR with spleen deficiency.4.There was no significant difference in the incidence of adverse events between reinforcing earth to generate metal-based acupoint application and oral loratadine.