| ObjectiveTo evaluate effectiveness and safety of combination acupuncture with medication for treatment of rhinallergonsis, the randomized-controlled trial was undertaken.MethodsThe objects were patients with rhinallergonsis (AR). Cases resource:120 patients with AR were recruited clinically. Diagnosis criteria:according to the standards diagnosis of Bichou (allergic rhinitis) from Standards of Diagnosis and Effectiveness of Traditional Chinese Medicine Diseases and Syndrome, promulgated by state administration of traditional Chinese medicine, and referred to diagnosis standards of rhinallergonsis (AR) drawn up by otorhinolaryngology branch of Chinese Medical Association(CMS). Western medicine diagnosis criteria:①paroxysm rhinocnesmus, continuous sneezing, nasal obstruction, nasal mucus of clear-thin and much quantity were main symptoms, accompanying with symptoms of hyposmia, itching of eyes and itching of throat.②fast onset, symptoms generally continue several minutes to dozens of minutes and no sneezing and nasal obstruction at the interval..③usually induced by touching allergic material or change of temperature.④by nasal cavity test, nose mucosa was swelling, pale or hyperemia, turbinate bones were turgescent, and many clear-thin secretion were found when breaking out. Diagnosis standard of Chinese medicine syndrome referred to standard of Chinese medicine syndrome score for rhinallergonsis (AR) with syndrome of deficiency qi and superficies. Case including criteria:met diagnosis standards of Chinese medicine syndrome differentiation and western medicine. Age was ten years above and no limitation of gender. Exact diagnosis, and exclude patients with other relative diseases that could interfere to judgment of treatment results, or with danger, emergent and serious diseases that could not receive the trial. Pretreatment, there had at lest 2 or more than 2 symptoms that were above the moderate severity (score of AR symptoms or signs was over 2 points). Doctors should explain the character, objective and procedure of the trial to the patients and gain the informed consents, which were printed anticipation by research center, signed by patients with their agreement. Excluding criteria:Patients who cannot meet the diagnosis standards of Chinese syndrome differentiation and western medicine were excluded; patients with accessory nasal cavity inflammation or upper, lower respiratory infection, nasal polyp, serious deflection of nasal septum and asthmatic attacking can not be included; patients who take cortical hormone within recent week, take Astemizole recent month or take other antihistaminic drugs within 3 days, or take Sodium Cromoglicate recent 2 weeks (all including application all over the body or locally)were excluded; patients who are pregnancy or lactation women, have serious adverse function of liver or kidney, or had other serious diseases that could not receive the treatment, were all excluded; patients who disagree to join or have not sign the informed consents were excluded. Clinical research design use randomi zed-control led trial methods. Randomized qualified cases by 1:1:1 into three groups:needling yingxiang acupoint plus traditional Chinese drugs group (called acupuncture plus medication group for short), traditional Chinese drugs controlled group (called medication group for short) and needling yingxiang acupoint controlled group (called acupuncture group for short). There were 40 cases in each group. objects came either from admission department or outpatient department, and cases from outpatient should be strictly controlled for the mobile elements. Cases grouping used simple random method. Allocation of specific random was designated to the researchers, by operating SAS (Statistical Analysis System) software to get the random number, and making random distribution cards, then adding sealed envelopes, whose serial number were the same with cards serial number. When qualified cases entered in the trial, according to their entry order, researcher opened the same number of envelopes to give patients treatment stated grouping by cards in envelopes. Random number tables were preserved according to requirements.Therapeutic and selecting acupoints methods: acupuncture group:select the points of both sides, after arrival of qi, remain needle for fifteen minutes. The operation is once per three days. Medication group:use yanghe decoction plus minus:xixin (Herba Asari) 1-3g, honey-fried huangqi (Radix Astragali seu Hedysari) 10～15g, honey-fried mahuang(Herba Ephedrae)3g, guizhi(Ramulus Cinnamomi)6g, gangjiang(Rhizoma Zingiberis)5g, baijiezi(Semen Brassicae)6g, gancao(Radix Glycyrrhizae)3g, wuweizi(Fructus Schisandrae Chinensis) 10g, baishao(Radix Paeoniae Alba) 10g, lujiaojiao(Colla Corni Cervi)10g, baishu(Rhizoma Atractylodis Macrocephalae)10g, fangfeng (Radix Saposhnikoviae) 10g, one decoction per day, decoting with water, take medicine two times morning and eveing respectively. Acupuncture plus medication group:on the basis of needling yingxiang acupoint, take traditional Chinese drugs (yanghe decoction plus minus as medication group) everyday. The course in all groups was 7days and total 3 courses were made.Observation items:safety observation:before treatment, that means on the first day, electrocardiogram, urine routine, blood routine, liver function and kidney function of patients were tested and after treatment, on the 21st day, all the items were tested again. Pay attention to ask whether patients have any discomforts, especially lethargy, dry mouth, fatigue, headache, thought slowness, depression and disgestive canal symptoms, etc. effects observation:before treatment, record nasal cavity's symptoms and signs first time and after treatment, record the symptoms and signs after the first week, second week and third week respectively, totally for four times. The work was in charge of professional doctors.Observation methods:when patients visited, their clinical signs and symptoms were record in detail and after treatment, the changes were recorded. Laboratory test items were tested before and after treatment respectively, and if any specific situation happened, such as suspect adverse reaction, the items should be tested in time. During treatment procedure, any other drugs were not allowed to take except drugs regulated by the proposal. If some specific situation happened and must take other drugs or receive other treatment measure, detailed information should be recorded in the clinical observation tables (including drug name, dosage, and usage, etc.)Effectiveness evaluation standard:to judge the therapeutic effects exactly and objectively, symptoms ranking and signs ranking were used.①symptoms ranking:sneezing(continuous number each time) was≥15 times (3 points), 10～14 times(2 points),3-9 times(1 point); nose running(times of blowing on the nose everyday)≥10times(3 points),5～9 times(2 points),≤4 times(lpoint); stuffy nose almost breathed through mouth(3 points), occasionally(1 point), and between the two condition(2 points); rhinocnesmus was unbearable(3 points), had formication but was still bearable(2 points), occasionally(1 point).②signs ranking:if inferior turbinate was close tightly to floor of nose, nasal septum and middle turbinate could not be seen, or mucosa of middle turbinate turned to polypoid change, polyi, then calculated as 3 points; if inferior turbinate was close tightly to floor of nose(or nasal septum), yet nasal septum, middle turbinate still could be seen, calculated as 2 points; inferior turbinate was slightly turgescent, nasal septum, middle turbinate still could be seen, calculated as 1 points. Efficacy judgment standard referred to Diagnosis Standard of Rhinallergonsis, published by otorhinolaryngology branch of Chinese Medical Association (CMS) 1997.According to the score sum of symptoms and signs, percentage of improvement before and after treatment, the followed formula was used to evaluate the effectiveness of perennial allergic rhinitis. All information such as symptoms severity, symptoms frequency and continuous time, must be recorded objectively, and be analyzed to find out the reasons. If drugs should be stopped due to serious symptoms, some relative measure should be adapted.Adverse evens, adverse reactions happened during research period, should be recorded in the case report table in accordance with their kinds, degree, happen time, continuous time, treatment measure and treatment process, etc, and on the basis of considering the complication, accompanying drugs, evaluated their relationship with trial drugs, in additional recorded in detail.In addition, if adverse evens, adverse reactions were found, observation doctors could decide whether to stop observation according to the disease condition and the cases that were stopped treatment due to adverse evens, adverse reactions should be followed up and the results should be recorded in detail. Safety test indices (blood routine, urine routine, stool routine, electrocardiogram, liver function and kidney function) appeared abnormal after treatment, they must be rechecked on the appropriated time, and the results should be analyzed with patients'other information to determine whether those phenomenon were relative to the trial. In serious adverse evens happened during the clinical research, researchers should adapt suitable protective measure for the patients immediately, and report to the ethics committee and drug clinical research base, and signature in the report and indicate the exact date. When the trial was over, clinical information was gather in time, input into computer, set up database and carried out data management, and then used Epi Data software to make statistic analysis. Compared with the total clinical efficacy, efficacy of clinical symptoms and signs between three groups, by statistic analysis, and at last evaluated objectively their clinical effects and safety.Statistic methods:classification data used X2 test, rank data used two-samples comparison Wilcoxon rank sum test (corrected), two samples mean comparisons used t test or Wilcoxon rank sum test, before and after self-comparison matching t test or Wilcoxon matching rank sum test. Three groups measurement data comparison used analysis of variance. Three groups ranking data comparison used K-WH rank sum test (corrected), statistic analysis used SPSS17.0 software to finish.ResultsClinical research design use randomized-controlled trial methods. Randomized qualified cases by 1:1:1 into three groups:needling yingxiang acupoint plus traditional Chinese drugs group (called acupuncture plus medication group for short), traditional Chinese drugs controlled group (called medication group for short) and needling yingxiang acupoint controlled group (called acupuncture group for short). There were 40 cases in each group and 120 qualified patients. Objects all came from outpatient department. Comparability test in three groups:there were no significant difference of age, gender and disease course among three groups. Degree of sneezing, nose running, stuffy nose, rhinocnesmus, fear of cold, stethocatharsis clear-thin, hyposmia, itching of eyes, itching of throat, and clinical signs of allergic rhinitis, had no significant difference. Comparison of tongue manifestation and pulse manifestation among three groups had no significant difference. Pathogenetic condition accumulated score among three groups had no significant difference. Those results showed the age, gender, disease course, clinical symptoms, tongue manifestation, pulse manifestation and other relative biochemical indicators had no significant difference, indicating the main factors that could influence the prognosis among three groups, was comparable. Effectiveness comparison:recent clinical curative rate was 25.0%, excellent rate was 47.5%, effective rate was 20.0%, and recent clinical rate of curative and excellent was 72.5% and total effective rate was 92.5% in the acupuncture plus medication group; recent clinical curative rate was 15.0%, excellent rate was 25.0%, effective rate was 45.0%, and recent clinical rate of curative and excellent was 40.0% and total effective rate was 90.0% in the acupuncture group; recent clinical curative rate was 15.0%, excellent rate was 22.5%%, effective rate was 47.5%, and recent clinical rate of curative and excellent was 37.5% and total effective rate was 87.5% in the medication group. Comparison with effectiveness of Chinese medicine syndrome among three groups had no significant difference. Neither the symptoms of allergic rhinitis, sneezing, nose running, stuffy nose, rhinocnesmus, fear of cold, coughing up clear and thick phlegm, hyposmia, itching of eyes, itching of throat before treatment, nor improvement of those symptoms and signs after treatment among three groups, had no significant difference. After treatment, the disappearance rate of main clinical symptoms and signs such as sneezing, nose running, stuffy nose, rhinocnesmus, fear of cold, coughing up clear and thick phlegm, hyposmia, itching of eyes, itching of throat among three groups, had no significant difference. Before treatment, patients'disease condition accumulated points among three groups, was no statistic significance (one factor analysis of variacne, P>0.05). Those results indicated the information among three groups was comparable. Intra-group comparisons:there was significant difference of disease condition accumulated points after treatment compared with that before treatment in all groups (matching t test, P<0.05), which indicated disease condition accumulated points had improved in all groups after treatment. After treatment, comparison of disease condition accumulated points among three groups, had significant difference (one factor analysis of variacne, P<0.05). Differences between groups were compared with LSD-t test, the result showed the points in acupuncture plus medication group was lower than that in either acupuncture group or medication group (P<0.05). Comparison of different value of disease condition accumulated points (post-treatment period of 3 weeks) among three groups showed statistically significantly different (one factor analysis of variacne, P<0.05). Three samples'mean were compared with LSD-t test and showed decreasing value of disease condition accumulated points in acupuncture group was higher either than acupuncture group nor medication group (P<0.05), which indicating that all groups could effectively reduce the patients'disease condition accumulated points, and the acupuncture plus medication group had the best effect.Safety test:all patients'blood routine, stool routine, urine routine, liver function (GPT), kidney function (BUN), electrocardiogram, showed no abnormality before and after treatment.Adverse evens observation:there was no any adverse reaction in the treatment group and the control groups before and after treatment.ConclusionsEffectiveness in three groups all showed excellent effects. Chinese medicine syndrome efficacy showed better after treatment intra-group comparison, however, by the group comparison, there was no significant difference. recent clinical curative rate was 25.0%, excellent rate was 47.5%, effective rate was 20.0%, and recent clinical rate of curative and excellent was 72.5% and total effective rate was 92.5% in the acupuncture plus medication group; recent clinical curative rate was15.0%, excellent rate was 25.0%, effective rate was 45.0%, and recent clinical rate of curative and excellent was 40.0% and total effective rate was 90.0% in the acupuncture group; recent clinical curative rate was 15.0%, excellent rate was22.5%%, effective rate was 47.5%, and recent clinical rate of curative and excellent was 65.0% and total effective rate was 87.5% in the medication group.Safety test results showed, patients with normal result of blood routine, urine routine, stool routine, liver function, kidney function and electrocardiogram before treatment, were safe as their indices mentioned above were rechecked and showed no abnormality again. Using the therapy method of needling yingxiang acupoint plus Chinese drugs for treatment of rhinallergonsis was safe and effective.
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