| ObjectiveIdiopathic blepharospasm incidence has increased in recent years.The disease can develop persistent eye closure and even functional blindness in the late stage,which not only severely affect work and life,but also easily affects personal emotions.Treatment is based on the symptomatic measures include oral medications,surgery,local injection of type A botulinum toxin,etc.All of the above treatments cannot remove the cause,have large side effects and are difficult to relieve the patient’s eyes,face,and tongue symptons.Traditional Chinese medicine focuses on holistic syndrome differentiation,seeking the roots of disease treatment,and can coordinate and solve the diseases of different lesions,which has unique advantages.Therefore,this study aims to systematically observe the efficacy of traditional Chinese medicine in the treatment of idiopathic blepharospasm,and scientifically evaluate the therapeutic effect of Wumeiwan Jiawei Decoction on idiopathic blepharospasm,aiming to provide a referene for the treatment of idiopathic blepharospasm(including Meige syndrome).MethodsA prospective randomized controlled trial was used to enroll patients with idiopathic blepharospasm(including patients with Meige syndrome)who met the inclusion criteria established in this study.The current mainstream treatment method,namely type A botulinum toxin injection,was used as the control group,and Wumei Wan Jiawei Decoction was used as the test group.Patients were randomly assigned to the test group or the control group.Observe the general condition of the included patients,the distribution of the five movements and six dlimates,whether they have been misdiagnosed,the triggering factors,aggravating factors,and protective factors.To observe the effectiveness and safety of classical preions Wumei Wan Jiawei Decoction in the treatment of idiopathic blepharospasm.The efficacy evaluation indicators are mainly the TCM syndrome scale for liver-yang deficiency,Jankovic Rating Scale(JRS),and blepharospasm disability index(Blepharospasm DisabilityIndex,BSDI).The safety evaluation index is mainly the incidence of adverse reactions.The main outcome indicator was the Jankovic rating scale,and the secondary outcome indicators were the liver-yang deficiency TCM syndrome scale and the blepharospasm disability index.Results1.A total of 41 cases were included in the study.The descriptive part included 31 cases in the test group and 10 cases in the control group.During the experiment,the test group and the control group each had 2 cases shedding.The efficacy and safety observation research part included 29 cases in the test group and 8 cases in the control group.The test group and the control group were comparable in age,gender,course of disease,severityof illness,Jankovic score before treatment,TCM syndrome score for liver-yang deficiency,and blepharospasm disability index score before treatment,and other general data were comparable with baseline levels,and there was no statistical significance(P>0.05).2.Among 41 patients,there was no statistically significant difference between the host climatic qi(p=0.344,P>0.05).There was no statistically significant difference between the celestial manager qi and qi in the earth at birth(P=0.258,P>0.05).The distribution of the host climatic qi at birth was based on the Jue Yin Feng Mu,the Yang Ming Zao Jin and the Tai Yang Han Shui,and the distribution of host climatic qi is statistically significant(P=0.004,P<0.05).3.Among 41 patients,16 cases were caused by emotional changes.16 cases got worse when mood change.17 cases got worse when rest inadequately.13 ca-ses got worse when sunlight exposure.7 cases got better when attention wasfocused.4.After the test,the JRS scores of the two groups of patients were low-er than preclinical stage,and the JRS scores of each follow-up time node in the test group were lower than the previous follow-up node.Compared to the baseline,the difference within the group was statistically significant(P=0.000,P<0.001),the JRS score of the control group reached the lowest at 42 day-s after treatment,and the difference was statistically significant compared to the baseline within the group(P=0.042,P<0.05).By 3 and 6 months after treatment,the JRS score was higher than that at 42 days after treatment.The difference from baseline was not statistically significant(P=0.180,P=0.317,P>0.05).At 14 days and 42 days of treatment,the difference between the groups was not statistically significant(P=0.940,P=0.679,P>0.05).At 3 months and 6 months of treatment,the JRS score of the test group was lower than that of the control group,and the difference between the groups was statistically significant(P=0.004,P=0.001,P<0.05).5.After the test,the TCM syndrome scale scores for liver-yang deficiency of the patients in the test group were lower than preclinical stage,and the TCM syndrome scale scores for liver-yang deficiency of each follow-up time node in the test group were lower than the previous follow-up node.Compared to the baseline,Compared to the baseline,the difference within the group was statistically significant(P=0.000,P<0.001).The score of the control group decreased at 14 days and 42 days after treatment,and the lowest score was at 42 days.There was no significant difference compared to the baseline level(P=0.088,P>0.05).The scores were lower than the baseline level at 3 months and 6 months after treatment,the difference was not statistically significant(P=0.914,P=0.056,P>0.05).At 14 days and 42 days of treatment,there was no significant difference between the two groups(P=0.592,P=0.267,P>0.05).At 3 months and 6 months of treatment,the scores of TCM syndrome for liver-yang deficiency in the test group were lower than those in the control group.Difference between the groups was statistically significant(P=0.004,P=0.001,P<0.05).6.After the test,the BSDI score of the test group was lower than that before the test,and the BSDI score of each follow-up time node was lower t ban that of the previous follow-up node.Compared with the baseline,the di fference within the group was statistically significant(P=0.015,P=0.006,P=0.001,P=0.000,P<0.05).The BSDI score of the control group decreased at 14 days,42 days and 3 months after treatment,and the lowest score was at 42 days.There was no statistically significant difference compared to the bas eline level(P=0.116,P>0.05).The score was higher at 6 months after treatm ent.The baseline level increased,and there was no statistically significa nt difference compared to the baseline(P=0.408,P>0.05).At 14 days,42 day s and 3 months after treatment,the difference between the two groups was n ot statistically significant(P=0.656,P=0.529,P=0.008,P>0.05).At 6 months of treatment,the BSDI score of the test group was lower than that of the c ontrol group,and the difference between the groups was statistically signi ficant(P=0.002,P<0.05).7.The clinical efficacy of the test group was significantly different from that of the control group(79.3%vs 12.5%,0.001,P<0.05).8.At present,the adverse reactions of Wumei Wan Decotion in the treatment of idiopathic blepharospasm have not been observed.ConclusionsAccording to the analysis of the current research results,mood changes and fatigue may be the induceing and aggravating factors of idiopathic blepharospasm,and concentration is the protective factor of this disease.Individuals who were born into Jue Yin Feng Mu,Yang Ming Zao Jin and Tai Yang Han Shui as the host climatic qi may be prone to idiopathic blepharospasm.Idiopathic blepharospasm is often accompanied by dry eyes,photophobia,sleep disorders and mood disorders.The initial symptom and ocular surface symptoms of this cause are different,and it is easy to be misdiagnosed as other eye diseases.Wumei Wan Decotion can effectively improve the ocular and systemic symptoms of patients with idiopathic blepharospasm,reduce the impact on daily life,have good short-term and long-term curative effects,and have good safety. |
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