| Objectives:The incidence of Meniere’s disease(MD)s high.and it is difficult to cure MD.The typical symptoms of MD are vertigo,tinnitus,hearing loss and aural fullness,some patients cannot stand stability,which brings big psychological burden to patients.At present,the etiology and pathogenesis of MD is not clear,and there is no specific drug treatment for this disease at home and abroad.The main treatment methods include dilation of blood vessels,improvement of microcirculation,diuresis,sedation,etc.However,the clinical efficacy of these treatments is poor.Betahistine is the most common drug for MD,studies have reported that betahistine has effect on relieving dizziness.However,it is not effective for tinnitus,hearing loss and aural fullness.Recurrence is the main characteristic of MD,and it is important to control the illness in the early stage of the disease It is necessary to explore safe and effective treatment.MD belongs to vertigo disease category in Chinese medicine.The pathological basis of the disease is"endolymphatic hydrops",which is similar to pathogenesis of "retention"in traditional Chinese medicine.According to the clinical analysis of 11868 patients(outpatients of the Department of Neurology and ENT,during the period from 2010.1.1 to 2014.10.28,alisma decoction accounted for 30%in all drug treatments.Alisma decoction comes from《Jingui Yaolue》,which is written by Zhang Zhongjing,the original prescription is composed of alisma and atractylodes,which has effect of tonifying spleen and eliminating phlegm.Each generation of physicians treat vertigo by alisma decoction.It is worthy of clinical study and application.This study is to observe the clinical effects of alisma decoction combined with betahistine on MD in acute stage.This study will probably provide a safe and effective treatment for MD.Methods:This was a single-blind randomized controlled trial.The patients who were at acute stage of MD were the subjects of this study,these patients were found in Neurology and Otolaryngology department in Dongzhimen hospital during June 2015 to December 2016,the subjects were randomly divided into observation group and control group.The observation group was treated by alisma decoction and betahistine,the control group only treated by betahistine,1 course of treatment lasted for 7 days.Both groups received one course of treatment.Before the study and after 7 days of treatment,dizziness handicap inventory(DHI),tinnitus handicap inventory(THI),visual analogue scale(VAS)and TCM syndrome score of the two groups were collected.The clinical efficacy of the two groups was statistically analyzed after one course of treatment.Results:1.General situation analysis:60 subjects(26 male and 34 female)had been obversed,with 30 cases in each group,falling out of 0 cases.Their age ranged from 21 to 70 years old,mean age was 54.60±30.19(years old);Their duration ranged from 6 months to 10 years,the average duration was 50.63±32.00(month).There was no significant difference between the two groups in gender,age and course of disease(p>0.05).2.Curative effect analysis:2.1 Comprehensive effects:After treatment,the TCM syndrome scores of the two groups were statistically significant compared with that before treatment(p<0.05),the total efficiency of the observation group was 90.0%,that of the control group was 63.3%,the difference between the two groups was statistically significant(p<0.05);2.2 DHI score:After treatment,the DHI scores of the two groups were statistically significant compared with that before treatment(p<0.05),the efficiency of the treatment group was better than that of the control group,the difference between the two groups was statistically significant(p<0.05);2.3 THI score:After treatment,the THI score of the treatment group was statistically significant compared with that before treatment(p<0.05),the THI score of the control group was no statistical difference compared with that before treatment(p>0.05).The difference between the two groups was statistically significant(p<0.05);2.4 VAS score of aural fullness symptom:After treatment,the VAS scores of aural fullness of the two groups were statistically significant compared with that before treatment(p<0.05),the efficiency of the treatment group was better than that of the control group,the difference between the two groups was statistically significant(p<0.05);3.Security analysis:In the treatment of patients with 60 cases in the process,no drug related adverse events occurred,before and after treatment the patient’s safety indicators,including the three conventional,livers and kidney function and ECG all found no obvious abnormalities.Conclusion:The therapy of alisma decoction combined with betahistine was safe and effective in acute stage of MD,the clinical effects of alisma decoction combined with betahistine on dizziness,tinnitus and aural fullness were better than betahistine. |
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