Clinical Study On The Prevention And Treatment Of Moderate To Severe Seasonal Allergic Rhinitis By Acupuncture Interventio

BackgroundWith the increasing prevalence of allergic rhinitis,the prevention and treatment of allergic rhinitis has been highly valued by health departments at home and abroad.For patients with seasonal allergic rhinitis caused by seasonal inhaled allergens such as pollen and fungi,considering that they cannot completely get rid of allergens in real life,how to carry out effective preventive treatment before the onset of the disease(before the spread of allergenic pollen)needs to be solved urgently.Study have found that in the early stage of plant pollen dissemination,although low concentrations of pollen cannot stimulate clinical symptoms,they can cause mild and persistent inflammation response in the nasal mucosa of patients with seasonal allergic rhinitis.If we can intervene before the onset of symptoms and control the inflammatory response of the nasal mucosa,we can effectively reduce the onset of the disease,alleviate the onset symptoms,and reduce the occurrence of complications.It is of great significance to improve the quality of life of patients,reduce the economic burden of patients and save medical resources.Standards of Chinese Acupuncture and Moxibustion Association The Evidence-Based Clinical Practice Guideline ofAcupuncture and Moxibustion:Allergic Rhinitis points out that acupuncture and moxibustion intervention during the remission period of allergic rhinitis can reduce the frequency of recurrence and relieve recurrent symptoms.However,insufficient attention has been paid to the prevention and treatment of seasonal allergic rhinitis with acupuncture and moxibustion in the past,and there is a lack of high-quality evidence to support the clinical efficacy.Therefore,it is necessary to explore an effective scheme of early intervention of acupuncture in the prevention and treatment of seasonal allergic rhinitis.ObjectiveThe method of combining quantitative research and qualitative research was used to explore the feasibility of early intervention of acupuncture in the prevention and treatment of moderate to severe seasonal allergic rhinitis.A randomized controlled trial was conducted to observe the clinical efficacy of early intervention of acupuncture in the treatment of moderate to severe seasonal allergic rhinitis,semi-structured interviews were also conducted to explore the subjective and objective factors that affect the willingness of seasonal allergic rhinitis patients to receive early acupuncture intervention in advance of the onset of the disease,with a view to provide data support for clinical research of acupuncture in the treatment of seasonal allergic rhinitis and put forward suggestions for optimizing the regimen for acupuncture in the prevention and treatment of seasonal allergic rhinitis.MethodsStudy 1 A Randomized Controlled Trial of Early Intervention of Acupuncture in the Prevention and Treatment of Moderate to Severe Seasonal Allergic RhinitisA randomized,controlled,blinded clinical trial design was adopted.Using the random number table method,a total of 102 patients with moderate to severe seasonal allergic rhinitis who met the inclusion criteria were randomly divided into experimental group(intervene before onset period+intervene during onset period)and control group(intervene during onset period only)at a ratio of 1:1,with 51 patients in each group.During the study period,there were 4 people in experimental group and 3 people in control group dropped out.Finally,95 patients were enrolled,including 47 cases in experimental group and 48 cases in control group.1 Treatment plan(1)Acupoint selection:LI20,GV29,LI4,ST36,GB20,GV14,BL13,BL20,BL23(2)Operation method:First,take the prone position,Fengchi(GB20),obliquely needling 0.8-1.2 cun toward the tip of the nose and was given uniform reinforcing-reducing method for 30 seconds after reaching deqi sensations(a composite of sensations including soreness,distention,heaviness,and other sensations).Dazhui(GV14),upward obliquely needling 0.51.0 cun;Feishu(BL13)and Pishu(BL20),obliquely needling 0.5-0.8 cun toward the spine;Shenshu(BL23),perpendicularly needling 0.5-1.0 cun;all the above acupoints were given twirling supplementation method for 30 seconds after reaching deqi sensation,and the needles were retained for 20 minutes.Then take the supine position,Yintang(GV29),horizontally needling 0.3-0.5 cun from top to bottom toward the root of the nose;Yingxiang(LI20),obliquely or horizontally needling 0.3-0.5 cun along the nasolabial groove from bottom to top;Hegu(LI4),perpendicularly needling 0.5-1.0 cun,all these acupoints were given uniform reinforcing-reducing method for 30 seconds after reaching deqi sensations.Zusanli(ST36),perpendicularly needling 0.5-1.0 cun and was given twirling supplementation method for 30 seconds after reaching deqi sensations.Infrared light irradiation was given during the retention of the needles.(3)Treatment time,frequency and course of treatment:①Experimental group:Acupuncture intervention was given to patients 4 weeks before the attack period,and continued with 4-week acupuncture treatment after the attack.Acupuncture was given once every other day,3 times a week,continued for 8 weeks to the 4th week of the attack period.②Control group:The patients did not take any intervention before the attack period,and were given acupuncture treatment for 4 weeks after the attack.Acupuncture was given once every other day,3 times a week,continued for 4 weeks to the 4th week of the attack period.During the attack period,patients in both groups can use rescue medication if necessary,and the researchers are responsible for instructing patients to accurately record the medicines used every day in the rescue medication diary card.2 Observation index and evaluation time pointThe primary outcomes:the incidence,total nasal symptom scale(TNSS).The secondary outcomes:the total non-nasal symptom score(TNNSS)and the Rhinitis Quality of Life Questionnaire(RQLQ)score,rescue medication score(RMS),patient satisfaction and acceptance.Evaluation time:TNSS,TNNSS and RQLQ scores during the onset of seasonal allergic rhinitis one year ago recalled by patients were used as baseline data.The seizure information of the patients was collected at the end of the pollen season,and the incidence of the two groups were calculated.TNSS,TNNSS and RQLQ score were collected at the 1st week,the 2nd week,the 4th week and the 6th week of the attack.The RMS score was collected weekly from the 1 st week to the 6th week of the attack period.The patients’ satisfaction and acceptance were evaluated at the end of the attack period.3 Statistical AnalysisAll the data were statistically analyzed by SPSS 25.0 software,and P<0.05 was considered as statistically significant.Study 2 A Qualitative Study on the Acceptability of Early Acupuncture Intervention in Patients with Seasonal Allergic RhinitisThe semi-structured interview method was adopted.Based on the principles of purposeful sampling and dynamic sampling,interviewees were selected from seasonal allergic rhinitis patients who received early intervention of acupuncture.Try to ensure the difference and representativeness of gender,age,education,illness and course of disease,in order to collect data as much as possible.The sample size was determined according to the principle of information saturation.The interview mainly focused on the patients’ cognition of the disease,prevention concept,acupuncture benefits,acupuncture feelings and other aspects,to explore the relevant factors that affect the patients’ willingness to receive acupuncture intervention in advance for prevention and treatment of seasonal allergic rhinitis.The interview time was limited to 20-35 minutes.The interview audio-recordings were transcribed verbatim into text,and NVivo12 Plus software was used to assist in organizing the data.The three-level decoding was strictly conducted in accordance with the standard procedure and the thematic analysis method was applied to analyze the interview data.Results:Study 1 A Randomized Controlled Trial of Early Intervention of Acupuncture in the Prevention and Treatment of Moderate to Severe Seasonal Allergic Rhinitis1 Primary outcomes(1)Incidence:The incidence of the experimental group was 80.85%(38/47),which was lower than 100.0%(48/48)of control group(P<0.05).(2)TNSS:Intra-group comparison:The TNSS total scores and all the sub-item scores of patients in two groups at each time point in this year’s attack period were all significantly lower than those in the previous year’s attack period(P<0.05).Comparison between groups:The TNSS total scores at each time point of this attack period in the experimental group were significantly lower than those in the control group(P<0.05).Also,the change in TNSS total scores and three sub-items scores of nasal congestion,nasal itching and sneezing at each time point of this attack period from the previous year’s attack period in the experimental group were all obviously greater than those in the control group(P<0.05).2 Secondary outcomes(1)TNNSS:Intra-group comparison:The TNNSS scores of patients in two groups at each time point in this year’s attack period were both significantly lower than those in the previous year’s attack period(P<0.05),Comparison between groups:There were significant differences in TNNSS scores and the change in TNNSS scores from the previous year’s onset period between the experimental group and the control group at the 1st,2nd,4th week of attack(P<0.05).But no significant difference was found in TNNSS scores and the change in TNNSS scores from the previous year’s attack period between two groups in 6th week of attack(P>0.05).(2)RQLQ:Intra-group comparison:The RQLQ total scores and scores of each dimension of patients in two groups at each time point in this year’s attack period were all significantly lower than those in the previous year’s attack period(P<0.05).Comparison between groups:The RQLQ total scores and the scores of the four dimensions of activity,sleep,nasal symptoms,and non-nasal/eye symptoms in the experimental group were significantly lower than those in the control group(P<0.05).Also,the change in RQLQ total scores and scores of dimensions of activity,sleep,nasal symptoms,and non-nasal/eye symptoms at each time point of this attack period from the previous year’s attack period in the experimental group were all obviously greater than those in the control group(P<0.05).(3)RMS:The weekly RMS scores of the experimental group from the 1st week to the 6th week of the attack period were all significantly lower than those of the control group(P<0.05).(4)Patient satisfaction and acceptance:there was no significant difference in patient satisfaction and acceptance between the two groups(P>0.05).Study 2 A Qualitative Study on the Acceptability of Early Acupuncture Intervention in Patients with Seasonal Allergic RhinitisFinally,a total of 25 SAR patients who received acupuncture early intervention were interviewed.After sorting out and analyzing the content of the interview,five themes of"patient’s own factors","acupuncture-related factors","treatment effect","medical service factors" and "cost factors" were extracted.1 The trouble of symptoms,the poor effect of other treatments in the past,and the concern about the side effects of drugs were the internal factors that promote patients to receive acupuncture intervention in advance to prevent and treat seasonal allergic rhinitis,while the recommendations from doctors,relatives,friends and wardmates were the external factors.2 Patients’ awareness of disease hazards,concept of prevention and treatment,understanding of acupuncture therapy,therapeutic effect,acupuncture tolerance,acupuncture safety,doctors’ service attitude,expense costs and time-distance costs were frequently mentioned in the interview,which can be summarized as follows:(1)The higher the awareness of the hazards of allergic rhinitis hazards,the stronger the concept of prevention and treatment,the deeper the understanding of acupuncture therapy,patients are often more willing to receive acupuncture treatment in advance before the attack of seasonal allergic rhinitis.(2)Patients’ expectation of the curative effect during the attack period and the improvement of their physical condition during the remission period are the key reasons prompting them to receive acupuncture intervention in advance of the attack period.(3)Acupuncture therapy has no exogenous drug intake and few side effects,which makes patients more inclined to choose acupuncture therapy to prevent and treat seasonal allergic rhinitis when they are asymptomatic.(4)A good service attitude of doctors helps to bring in the doctor-patient relationship and enhance patients’ willingness to receive treatment.(5)Both patients’ tolerance to acupuncture and affordability of acupuncture expenses will affect their willingness to accept acupuncture intervention when seasonal allergic rhinitis does not attack.(6)Acupuncture therapy requires more time-distance cost,which will reduce patients’willingness to receive acupuncture intervention in advance to a certain extent,so flexible time and appropriate distance for medical treatment will help to improve seasonal allergic rhinitis patients’ acceptance of acupuncture intervention in the remission.Conclusions(1)Acupuncture intervention of moderate and severe seasonal allergic rhinitis 4 weeks in advance can effectively prevent seasonal allergic rhinitis and reduce the incidence of seasonal allergic rhinitis.(2)For moderate to severe seasonal allergic rhinitis,the curative effect of early intervention of acupuncture is better than acupuncture intervention at the attack period,which can significantly reduce the onset symptoms,improve the quality of life,reduce the use of rescue medication.In particular,it plays a better role in reducing the degree of disturbance to activities,improving sleep quality,relieving nasal symptoms and non-nasal/eye symptoms.(3)Early intervention of acupuncture for moderate to severe seasonal allergic rhinitis has high patient satisfaction and acceptance,strong feasibility,and is worthy of clinical promotion and application.(4)Strengthen patient education,improve doctor’s acupuncture techniques,pay attention to humanistic care,give full play to the advantages of the overall conditioning effect of acupuncture and moxibustion,increase the convenience of medical treatment and the economy of the treatment,construct a practical and effective therapeutic regimen will help to further improve the patients’ acceptance of treatment.