A Multicenter Randomized Controlled Study of Auricular Pressure Pellet Combined with Auricular Acupressure Therapy on Myopia in Children and Adolescents
OBJECTIVE To observe the clinical effectiveness and safety of auricular pellet compression combined with auricular press needle therapy in treating myopia in children and adolescents.METHODS A total of 156 cases(156 eyes)of mild myopia and pre-myopia children treated in six hospitals,including the Eye Hospital,China Academy of Chinese Medical Sciences,from July 2021 to October 2022 were randomly divided into experimental and control groups,each comprising 78 cases(78 eyes).The control group received health education and orthokeratology lenses(health education only for pre-myopia children);The experimental group received combined treatment of auricular pellet compression and auricular press needle therapy based on the control group.Uncorrected distance visual acuity(UCDVA),spherical equivalent(SE),axial length(AL),and systemic symptom scores were measured before treatment,at six weeks(6 w),12 weeks(12 w),and 24 weeks(24 w)post-treatment,followed by statistical analysis.RESULTS There were no statistically significant differences in UCDVA,SE,AL,and systemic symptom scores between the two groups before treatment(P>0.05).(1)UCDVA:There were no statistically significant differences in UCDVA compared to pre-treatment at each time point in the experimental group(P>0.05).The UCDVA of the control group decreased significantly at 12 weeks and 24 weeks post-treatment compared to pre-treatment(Z12 w=3.495,Z24 w=3.950,all P=0.000).Comparing between the two groups,the UCDVA at 6,12 and 24 weeks post-treatment were higher in the experimental group than in the control group,showing statistical significance(Z6 w=2.655,P=0.08;Z12 w=3.441,P=0.001;Z24 w=2.933,P=0.003).(2)SE:Post-treatment comparisons showed that SE significantly increased at 12 and 24 weeks in the experimental group compared to pre-treatment(t12 w=2.349,P=0.020;t24 w= 3.643,P=0.000).The control group also had a significant increase in SE at each time point post-treatment compared to pre-treatment(t6 w=5.861,t12 w=7.640,t24 w=9.845,all P=0.000).Comparing between the two groups,the SE at 6,12 and 24 weeks post-treatment were lower in the experimental group than in the control group,showing statistical significance(t6 w=3.392,P=0.001;t12 w=3.468,P=0.001;t24 w=3.968,P=0.000).The SE difference between the two groups at 24 weeks post-treatment showed statistical significance(t=4.529,P=0.000).(3)AL:There were no statistically significant differences in AL between the two groups compared to pre-treatment or between the groups at each time point(P>0.05).Compared with the difference between the groups,the AL difference at 24 weeks post-treatment were lower in the experimental group than in the control group,showing statistical significance(t=2.035,P=0.044).(4)Systemic symptom scores:Post-treatment comparisons showed that systemic symptom scores at 6,12,and 24 weeks were significantly reduced in the experimental group compared to pre-treatment(Z6 w=5.358,Z12 w= 5.690,Z24 w=5.886,all P=0.000).In the control group,the systemic symptom scores at 6 and 12 weeks post-treatment were significantly lower than before treatment(Z6 w=4.411,P=0.000;Z12 w=3.259,P=0.001).Comparison between the two groups showed that the systemic symptom scores at 12 and 24 weeks post-treatment in the experimental group were lower than in the control group,showing statistical significance(Z12 w=1.999,P=0.046;Z24 w=3.093,P=0.002).(5)Adverse reactions and compliance:No adverse reactions occurred in both groups.There was no statistically significant difference in compliance between the two groups(P>0.05).CONCLUSIONS Auricular pellet compression combined with auricular press needle therapy plays a role in controlling the progression of myopia in children and adolescents,controlling refractive power increase,delaying axial length increase,stabilizing vision,and improving systemic symptoms.It is safe,well-tolerated,and worth promoting.
myopiaauricular therapypress needlemulticenter randomized controlled studychildren and adolescents
NETL
NSTL
万方数据
维普
