A Double Blinded,Double Dummy,Randomized Controlled Trial Of Chinese Herbal Medicine Formula With "Enrich Earth To Engender Metal" Method For Allergic Rhinitis

Objective:This clinical trial aims to observe the efficacy and safety of Chinese herbal medicine formula(CHMF)with “enrich earth to engender metal” method in the treatment of allergic rhinitis(Allergic Rhinitis,AR)in a double blinded,double dummy,randomized,controlled clinical study.The outcome we get from this trial will provide theoretical and clinical basis for the application of CHMF in AR treatment,while promoting the application of Chinese medicine in Otolaryngology diseases.Methods:After two weeks of baseline observation,38 allergic rhinitis patients with Lung qi and Spleen qi deficiency syndrome(LSDS)was recruited and randomly allocated to CHMF group and 38 to the control group.The patients in CHMF group took CHMF(30mg bid)and placebo Levocetirizine Hydrochloride orally(10ml:5mg qn),while the participants in control group took Levocetirizine Hydrochloride(10ml/5mg qn)and placebo CHMF(30mg bid)orally.All participants will receive four weeks treatment.Both groups were followed every 2 weeks for the whole four-week treatment,and every one month after treatment for 3 months to record their total nasal symptoms score(TNSS),the standardized version of the Rhinoconjunctivitis Quality of Life Questionnaire(RQLQ(S)),days of attack and Visual Analogue Scale(VAS)which reflected the severity of Rhinitis symptoms.Part of them in both groups were asked to complete nasal resistance(NR)and nasal volumn(NV)in order to evaluate nasal ventilation function.Statistical methods ued in this study: single factor repeated measures analysis variance were used for statistics of the intragroup multiple time measured data.Multi factor analysis of variance were used for multiple time measured data between two groups.Paired sample t-test was used for intragroup comparison and independent sample t-test was used for comparison between paired sample groups.Results:The scores of “Sneeze”,“nasal congestion”,TNSS,RQLQ(s),“days of rhinitis attack”,VAS,NR and NV in the treatment group were compared with the control group,difference of which was not statistically significant(P > 0.05)suggesting that CHMF with“enrich earth to engender metal” method was effective in reliving Sneeze,nasal congestion and total nasal symptoms,improving quality of life,reducing the number and degree of attacks as well as reducing Nasal resistance and increasing nasal cavity volume.Further more,the effect of CHMF with“enrich earth to engender metal” method was equivalent to levocetirizine hydrochloride oral solution.The scores of “flowing” and “nice itch” symptoms in the treatment group were significantly different from those in the control group(P < 0.05),whose symptom scores at each time point were higher than those in the control group.The outcome suggesting that CHMF with“enrich earth to engender metal” method is inferior to levocetirizine hydrochloride oral solution “inflowing” and “nose itch” relieving.Conclusion:CHMF has the equivalent efficacy of Levocetirizine Hydrochloride in relieving clinical symptoms,improving quality of life,increasing nasal ventilation in allergic rhinitis patients with LSDS.CHMF act excellently in its safety as well as its efficacy,which is a kind of curative,safe and reliable treatment of AR.