Clinical Observation Of Saffron Active Ingredient Nasal Spray In The Treatment Of Moderate To Severe Allergic Rhinitis

BACKGROUNDAs a traditional Chinese and Tibetan medicine,the dried stigma of saffron has been identified by modern pharmacology as having four main active components:crocin,crocetin,picrorocin,and safranal.Other components include carotenoids,carbohydrates,proteins,anthocyanins,vitamins,and minerals.According to domestic and foreign literature,the active ingredient of saffron exhibits good anti-inflammatory,antioxidant,and immune regulatory functions in immunology and pathophysiology.Currently,it has been successfully applied to the respiratory system in the treatment of bronchial asthma.Based on the argument of "the same airway,the same disease",it has good pharmaceutical development potential in the treatment of allergic rhinitis,but there is no clinical efficacy study on the application of the active ingredient of saffron in allergic rhinitis at home and abroad.OBJECTIVETo observe the improvement of symptoms,signs,and quality of life of patients with persistent moderate to severe allergic rhinitis treated with saffron active ingredient nasal spray,and preliminarily explore the clinical efficacy of saffron active ingredient in allergic rhinitis.METHODThe sample size was estimated to be 90 cases through pre experiments.According to the inclusion and exclusion criteria,90 patients with persistent moderate to severe allergic rhinitis diagnosed in the Otolaryngology Department of the People’s Hospital of the Tibet Autonomous Region from May 2022 to July 2022 were collected and randomly divided into saffron treatment group and control group.Finally,40 patients in the treatment group and 38 patients in the control group were completed.The control group was given standardized treatment recommended by the guidelines in accordance with the Chinese Guidelines for the Diagnosis and Treatment of Allergic Rhinitis(Revised 2022)(hereinafter referred to as the guidelines),while the saffron treatment group was given standardized treatment recommended by the guidelines+saffron active ingredient nasal spray treatment.The course of treatment was 4 weeks.A total of 3 time nodes were selected before treatment,2 weeks after treatment,and 4 weeks after treatment.The rhinoconjunctivitis quality of life questionnaire score(RQLQ)was used as the primary outcome indicator,and the total nasal symptom score(TNSS)and nasal endoscopy score were used as secondary outcome indicators.Statistical analysis was conducted on the changes in the scores of the above three scales,the total treatment efficiency,and the occurrence of adverse events in the two groups.RESULT1.In this study,12 cases were lost and 78 cases of allergic rhinitis were treated,including 40 cases in the saffron treatment group and 38 cases in the control group.2.There is no statistical difference between the saffron treatment group and the control group in baseline indicators such as age,gender,course of disease,past history,pre treatment RQLQ score,pre treatment TNSS score,and pre treatment nasal endoscopy score,which is comparable.3.The main outcome measure was the nasal conjunctivitis quality of life questionnaire score(RQLQ).In the saffron treatment group,the score before treatment was(104.38 ± 17.99,n=40),which decreased to(72.47 ± 25.61,n=40)after2 weeks of treatment,and decreased to(46.58 ± 11.13,n=40)after 4 weeks of treatment.There were significant differences before and after treatment,P<0.05.In the control group,the score before treatment was(107.92 ± 17.97,n=38),decreased to(76.05 ± 21.57,n=38)after 2 weeks of treatment,and decreased to(57.13 ± 11.50,n=38)after 4 weeks of treatment.There were significant differences before and after treatment,P<0.05.In comparison between groups at the same time,there was a statistically significant difference in RQLQ scores between the saffron treatment group and the control group after 2 weeks of treatment,P<0.05;After 4 weeks of treatment,there was a statistically significant difference in RQLQ scores between the saffron treatment group and the control group,P<0.05;Among the seven dimensions included in the RQLQ scale,there were statistical differences between the saffron treatment group and the control group in four dimensions: daily activity,sleep,non nasal eye symptoms,and nasal symptoms(P<0.01).4.One of the secondary outcome indicators,the total score of nasal symptoms(TNSS),was 12.00(10.25,14.00)before treatment in the saffron treatment group,decreased to 9.00(8.00,10.75)after 2 weeks of treatment,and decreased to 4.50(1.25,6.00)after 4 weeks of treatment.There were significant differences before and after treatment,P<0.05.In the control group,it was 12.00(9.00,14.00)before treatment,decreased to 9.00(8.00,11.00)after 2 weeks of treatment,and decreased to5.50(3.75,7.00)after 4 weeks of treatment.There were significant differences before and after treatment,P<0.05.In comparison between groups at the same time,there was no significant difference in TNSS scores between the saffron treatment group and the control group after 2 weeks of treatment(P>0.05);After 4 weeks of treatment,there was a statistically significant difference in TNSS scores between the saffron treatment group and the control group,P<0.05;Among the four dimensions included in the TNSS scale,there were statistical differences between the saffron treatment group and the control group in terms of nasal congestion and runny nose(P<0.01).5.The second secondary outcome measure,nasal endoscopy score,was 10.00(9.00,11.00)before treatment in the saffron treatment group,decreased to 7.00(5.00,8.00)after 2 weeks of treatment,and decreased to 3.00(2.00,4.00)after 4 weeks of treatment.There were significant differences before and after treatment,P<0.05.In the control group,it was 10.00(8.00,12.00)before treatment,7.50(6.00,9.00)after 2weeks of treatment,and 4.00(2.75,5.00)after 4 weeks of treatment.There were significant differences before and after treatment,P<0.05.In comparison between groups at the same time,there was a statistically significant difference between the saffron treatment group and the control group on nasal endoscopy after 4 weeks of treatment,P<0.05;Among the four dimensions included in the nasal endoscopy scoring scale,there were also two dimensions,namely,the degree of turbinate mucosa swelling and the amount of nasal watery secretion.There were significant differences between the saffron treatment group and the control group,P<0.01.6.After 4 weeks of treatment,the total effective rate in the saffron treatment group was 95.0%(38/40),higher than that in the control group 76.3%(29/38),with a statistically significant difference(P<0.05).7.During and after treatment,there were no adverse reactions in the saffron treatment group and the control group.CONCLUSION1.Using saffron active ingredient nasal spray in combination with the standard treatment recommended by the guidelines can significantly improve symptoms,signs,and quality of life indicators related to allergic rhinitis compared to simply giving the standard treatment recommended by the guidelines.".2.For patients with allergic rhinitis,whose main symptoms are nasal congestion and runny nose,whose main physical signs are swelling of the nasal concha mucosa,and the amount of watery secretion in the nasal cavity,as well as those with limited activity,sleep,and non nasal eye symptoms,the efficacy of using saffron active ingredient nasal spray in combination is more significant than simply giving standard treatment recommended by the guidelines.3.Combined use of saffron active ingredient nasal spray based on the standard treatment recommended by the guidelines is safe and has no adverse reactions.