| BackgroundChronic rhinosinusitis(CRS)is a prevalent chronic disease in China,affecting around 8%of the population.This condition can significantly impact a person’s quality of life and lead to increased healthcare consumption and decreased productivity,resulting in a substantial societal burden.Currently,the primary treatments for chronic sinusitis include glucocorticoids,antibiotics,biologics,and surgery as the last resort for complete eradication.ObjectiveTo clarify the clinical efficacy of precise electro-acupuncture stimulation technique in the pterygoid fossa in the treatment of chronic sinusitis;to evaluate the clinical safety of this technique.MethodsThis was a prospective randomized controlled study that enrolled subjects who met the diagnostic,inclusion,and exclusion criteria after signing an informed consent form.The subjects were randomly divided into four groups using SAS 9.1 software,and opaque randomized envelopes were used to conceal the random sequential allocation.The study aimed to include 128 patients,but only 66 were treated:13 in the PEA&WM group,20 in the PEA group,15 in the WM group,and 18 in the GA group.All patients received treatment for three months,and the outcome indicators included the Lund-Mackay score from sinus CT scans,visual analog scale(VAS),sinonasal outcome test-20(SNOT-20),and primary and secondary symptom-sign score(PSSSS).Adverse events were evaluated using a 3-level statistical analysis for safety.Results1.Baseline information:The study found no significant statistical differences in age,disease duration,Lund-Mackay score,SNOT-20 score,VAS score,and PSSSS score among the patients who were enrolled.2.Lund-Mackay score:Comparing within groups:The mean value of the difference in the Lund-Mackay score before and after treatment in the PEA&WM group was 1 1.15±6.61 and 10.23±5.33,respectively,with statistical significance observed at P<0.05.In the PEA group,there was a statistically significant difference(P<0.05),with mean values of 14.40±6.06 before treatment and 13.30 ± 5.40 after treatment.However,there was no significant difference in the WM group,with mean values of 10.80±5.16 before treatment and 10.67±4.89 after treatment.The difference in the GA group before and after treatment was not statistically significant,with mean values of 10.56±7.10 and 10.44±7.17,respectively.Comparing between groups,there was no significant difference between the PEA&WM and the PEA,WM,and GA before and after treatment.However,there was a significant difference between the PEA and the WM and GA before and after treatment(P<0.05).There was no significant difference observed between the WM and the GA before and after treatment.3.VAS:Comparing within groups:The initial values for the PEA&WM group were 40.08±20.97,which decreased to 28.62± 17.75 at week four,21.69± 11.12 at week eight,and 12.77±9.78 at week twelfth.Statistical analysis showed significant differences(P<0.05)between the pre-treatment period and the fourth,eighth,and twelfth weeks of treatment.The PEA values before treatment were 35.00±18.62,which decreased to 21.40± 13.68,15.95±9.62,and 9.95±9.01 at the fourth,eighth,and twelfth week of treatment,respectively.Significant differences(P<0.05)were observed when comparing the PEA values during the treatment period with the pre-treatment value.The study found statistically significant differences(P<0.05)in the WM before treatment(36.47± 14.58)and during treatment at the eighth and twelfth weeks(30.53± 14.29 and 28.47± 15.80,respectively)compared to pre-treatment.However,no statistical significance was found in the fourth week of treatment when compared to pre-treatment.In the GA,there was a statistically significant difference(P<0.05)observed in the eighth week of treatment(22.39± 8.94)when compared to pre-treatment(29.22±16.57),but no significant difference was observed in the fourth and twelfth week of treatment compared to pre-treatment.Comparing between groups:At the fourth week of treatment,no statistically significant differences were found between PEA&WM and PEA,WM,or GA groups.However,significant differences were found between PEA&WM and GA groups before and after treatment(P<0.05).There were no statistically significant differences between WM and GA groups before and after treatment.At the eighth week of treatment,there were significant differences between PEA&WM and WM,GA groups before and after treatment(P<0.05).No significant differences were observed between PEA&WM and PEA groups before and after treatment,and between WM and GA groups before and after treatment.At the twelfth week of treatment,significant differences were observed between PEA&WM and WM,GA groups before and after treatment(P<0.05).No significant differences were observed between PEA&WM and PEA groups before and after treatment,and between WM and GA groups before and after treatment.4.SNOT-20:Comparing within groups:Before treatment,the PEA&WM value was 23.00± 10.32,which decreased to 19.92±8.75 in the fourth week of treatment,16.46±8.79 in the eighth week of treatment,and 10.46±6.48 in the twelfth week of treatment.The differences were statistically significant(P<0.05)in the eighth and twelfth weeks of treatment compared to pre-treatment,and there was no statistically significant difference in the fourth week of treatment compared to pre-treatment.The PEA value was 23.75± 16.00 before treatment,15.55±11.13 in the fourth week of treatment,10.05±6.66 in the eighth week of treatment,and 7.75±5.05 in the twelfth week of treatment,with statistically significant differences(P<0.05)in all weeks of treatment compared to pre-treatment.In the WM,the value was 26.13±11.83 before treatment,which changed to 25.80±11.63 in the fourth week of treatment,24.93±11.14 in the eighth week of treatment,and 23.40±11.29 in the twelfth week of treatment,with statistically significant differences(P<0.05)only in the eighth week of treatment compared to pre-treatment.In the GA,the value was 27.94±15.64 before treatment,which changed to 27.56±14.41 in the fourth week of treatment,27.11±14.49 in the eighth week of treatment,and 21.89±13.11 in the twelfth week of treatment,with a statistically significant difference(P<0.05)only in the twelfth week of treatment compared to pre-treatment.There was no statistically significant difference in the eighth and twelfth weeks of treatment compared to pre-treatment in GA.Comparing between groups:In the fourth week of treatment,there was no significant difference between the PEA&WM and the other treatments(PEA,WM,and GA)before and after treatment.However,the comparison between the PEA and the WM and GA was significant(P<0.05)before and after treatment.There was no significant difference between the WM and GA before and after treatment.At the eighth week of treatment,there was no significant difference between the PEA&WM and the other treatments(PEA,WM,and GA)before and after treatment.However,the comparison between the PEA and the WM and GA was significant(P<0.05)before and after treatment.There was no significant difference between the WM and GA before and after treatment.At twelve weeks of treatment,there was a significant difference(P<0.05)between the PEA&WM and the WM before and after treatment.There was no significant difference between the PEA&WM and the PEA or GA before and after treatment.The comparison between the PEA and the WM and GA was significant(P<0.05)before and after treatment,but there was no significant difference between the WM and GA.5.PSSSS:Comparing within groups:In the PEA&WM group,the mean score was 18.15±8.38 before treatment,which decreased to 17.85±8.18 in the fourth week,17.69±7.91 in the eighth week,and 17.23±7.51 in the twelfth week.The difference was statistically significant(P<0.05)when compared with the pre-treatment period.However,there was no statistically significant difference between the fourth and eighth weeks of treatment compared with the pre-treatment period.In the PEA group,the mean score was 20.00±7.28 before treatment,which decreased to 18.20±5.80 in the fourth week,18.50±5.65 in the eighth week,and 18.40±5.60 in the twelfth week.The difference was statistically significant(P<0.05)in the fourth,eighth,and twelfth weeks of treatment compared with the pre-treatment period.In the WM group,the mean score was 17.60±7.53 before treatment,which decreased to 17.07±7.21 in the fourth week and then remained relatively stable at 17.20±7.32 in the eighth week and 17.20±7.63 in the twelfth week.The difference was statistically significant(P<0.05)in the fourth week of treatment compared with the pre-treatment period,but there was no statistically significant difference in the eighth and twelfth weeks of treatment compared with the pre-treatment period.In the GA group,the mean score was 15.78±8.48 before treatment,which decreased slightly to 15.44±8.25 in the fourth week and then remained relatively stable at 15.56±8.33 in the eighth week and 15.56±8.13 in the twelfth week.There was no statistically significant difference in the fourth,eighth,and twelfth weeks of treatment compared with the pre-treatment period.Comparing between groups:During the fourth week of treatment,there were no significant differences between the PEA&WM and the PEA,WM,and GA groups before and after treatment.However,there were significant differences between the PEA group and the WM and GA groups before and after treatment(P<0.05).At the eighth week of treatment,there were no significant differences between the PEA&WM and the PEA,WM,and GA groups before and after treatment.However,there were significant differences between the PEA group and the WM and GA groups before and after treatment(P<0.05).There were no significant differences between the WM and GA groups before and after treatment.At the twelfth week of treatment,there were no significant differences between the PEA&WM and the PEA,WM,and GA groups before and after treatment.However,there were significant differences between the PEA group and the GA group before and after treatment(P<0.05).There were no significant differences between the WM and PEA,and the GA groups before and after treatment.ConclusionCombining the four outcome outcomes,the PEA&WM and PEA showed good results in the treatment of CRS.By comparing between groups,it was found that the PEA was significantly better than the WM and GA,and did not show significant differences when compared with the PEA&WM. |
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