Researches Of Correlation Between Subjective Evaluation And Objective Evaluation Of Meniere’s Disease

Background and purposeMeniere’s disease (MD) is one of the most common diseases of peripheral vertigo. Due to recurrent episodic vertigo, it has a great impact on patient’s quality of life. According to the American Academy Otolaryngology-Head Neck Surgery (AAO-HNS) and the Chinese Medical Association diagnostic criteria, the diagnosis of MD mainly depends on clinical symptoms and pure tone audiometry. The clinical symptoms are characterized with recurrent spontaneous episodic vertigo, fluctuating hearing loss,, tinnitus and aural fullness. Hearing tests often begin with showing a fluctuating low-frequency sensorineural hearing loss. Over years, this gradually progresses to a "peaked" pattern with both low- and high-tone reduction, and finally a "flat" pattern,In addition to pure tone audiometry, A variety of other methods can be used to assess the MD In clinic. Endolymphatic hydrops(ELH) can be evaluated by the glycerol test and electrocochleogram, the vestibular function examination can be used to evaluate peripheral vestibularfunction. In recently years, some new technologies such as vestibular myogenic evoked potential(VEMP), can evaluate the utricle and saccule function; some other advances in imaging by three-dimensional fluid-attenuated inversion recovery(3D-FLAIR) of magnetic resonance imaging(MRI), in association with enhancement by gadolinium-based contrast agents, enables visualization of ELH in patients with MD.However, we found that in clinic, the objective evaluation of patients do not match sufficiently with the subjective symptoms.We attribute it to two reasons:One is the objective evaluation can only reflect a specific point in time, but MD has fluctuant characteristic, so the detection of a certain time can not reflect the whole progression. The other reason is that because of the existence of central compensation, the patient does not necessarily show obvious vertigo even ipsilateral vestibular function was obviously reduced,.In order to better assess the overall of MD, we need to establish a comprehensive subjective evaluation system, and analyze the correlation between objective evaluation and subjective evaluation which can provide the basis for establishing better clinical evaluation system.This study is divided into two parts. In the first part,we will use the principle component analysis method to establish comprehensive evaluation function in patients with MD, In the second part, we will analyze the correlation between subjective evaluation and objective evaluation on the basis of first part.Methods1. PatientsAccording to the guidelines for the diagnosis and treatment of Meniere’s diease (2006,Guiyang) established by the Chinese Medical Association in Otolaryngology Head Neck Surgery branch,95 cases unilateral MD patients from September 2012 to September 2014 were enrolled,, patients with diabetes, hypertension, migraine, hematopathy, hyperlipemia, systemic autoimmune disease,acoustic neuroma,cochlear window rupture,etc were excluded. All selected patients completed the questionnaire survey and the function tests within 24 hours after acute vertigo.2. Subjective evaluationAccording to the typical symptoms of MD, including recurrent episodic vertigo, fluctuating sensorineural hearing loss, tinnitus, and aural pressure, we set up the subjective assessment content and standard.2.1 General information including gender, age, suffering from ear, and how many years of hearing loss, fluctuation or not with hearing loss,and vertigo attact frequency nearly 1 month, duration of vertigo. Tinnitus nature and duration;if there is aural pressure, and it’s frequency and duration.2.2 Dizziness Handicap Inventory(DHI)and Tinnitus Handicap Inventory(THI):Both DHI and THI include 25 items, each question has 3 answers, "no, sometimes, always" scores for"0,2,4",0 represents no effect on patients,2 represents sometimes effect on patients,4 represents always effect on patients. The total score is 100, the higher the score, the more severe is the influence degree of the patients.2.3 Visual Analog Scale (VAS):We use VAS score for hearing loss and aural pressure.The VAS score is used a ruler with 100mm scale, the left end is labeled as 0,the right end is 100.When we assess of the severity of subjective symptoms, ask the patients to read the symptom scores in the scale according to the extent of their feelings.The higher the score, the more serious is the degree.3. Objective evaluationAll patients with MD were test by pure tone audiometry, EcochG, glycerol test and caloric test. Record the test results.4. Statistical analysisAll statistical tests and graphics were made using SPSS 17.0, and P<0.05 indicated statistical significance.4.1 We apply the principle component analysis(PCA) to construct the comprehensive evaluation index (f) of MD’s clinical symptoms, based on cumulative contribution rate and eigenvalue size combined with professional knowledge to determine the number of principal components.4.2 Analysis of correlation between subjective evaluation and objective evaluation Wilcoxon and kruskal-wallis rank sum test was used to analyze the influence of general information on the comprehensive evaluation index (f) of MD’s clinical symptoms. Spearman’s rho correlation test was used to analyze the correlation of laboratory tests and the comprehensive evaluation index (f) of MD’s clinical symptoms. Difference analysis using radit test, test the level significance is α=0.05, and P<0.05 indicated statistical significance.Results1 The quantitative results of clinical symptoms with Meniere’s disease:VAS score (X1) of hearing loss was 0-91 points (mean:46.23±18.80); DHI score (X2) was 8-98 points(mean 49.66±15.67), THI score (X3) was 10～100 points(mean 47.53 ±17.44), ear stuffy plug feeling VAS score (X4) was 0-82 points(mean 21.55± 27.54). the comprehensive evaluation index of MD’s clinical symptoms f=0.213ZX1+0.398ZX2+0.370ZX3+0.455ZX4. It simplified data, but contained most of the information and can reflect the severity of the disease on the whole.2 The influence of general information on the comprehensive evaluation index (f) of MD’s clinical symptoms:The difference of the influence of gender, frequency on the comprehensive evaluation index (f) of MD’s clinical symptoms had no statistical significance(P>0.05). The difference of the influence of duration of disease on the comprehensive evaluation index (f) had statistical significance(P<0.05). According to mean rank of the comprehensive evaluation index (f), over 36 months group was more than the other 3 groups, further comparison between 2 groups, the differences between 0～3 months group and 4～12 months,13～36 months, more than 36 months were statistically significant(P<0.05).Between 4-12 months group and 13-36 months group had no significant difference(P>0.05), but with more than 36 months group with significant difference(P<0.05).Between 13-36 months group and more than 36 months group had no significant difference(P>0.05). So data showed that the degree of subjective evaluation has increasing trend when the disease duration of the patients was within one year, but there was no significant difference between the patients more than 1 years.3 The relationship between the comprehensive evaluation index (f) and objective evaluation:correlation coefficient (r) between average threshold tested by pure tone audimetry and the comprehensive evaluation index (f) is 0.389, and P=0.000, it indicated positive correlation between of them. But because of r less than 0.4, the correlation is weak. Compared the correlations between the glycerol test, EcochG, caloric test and the comprehensive evaluation index(f), there is no significant difference(P>0.05).The difference of the comprehensive evaluation index(f) between the glycerol test negative and positive group were performed by means of Radit test, there is no statistically significant difference(P>0.05).And Radit test was used to compared the difference of the comprehensive evaluation index (f)between different groups of EcochG, it shows a statistically significant difference(P<0.05).Further comparison between two groups there is a statistically significant difference between EcochG not elicited group and elicited group, but there is no statistically significant difference between -AP/SP <0.4 group and-AP/SP more than 0.4 group,respectively compared the difference between the comprehensive evaluation index (f) and the average hearing threshold and caloric test with kruskal-wallis rank sum test, according to P<0.05, the data shows that there is a statistically difference both the comprehensive evaluation index (f) of the different average hearing threshold group and caloric test group. There is a statistically significant differences between average threshold further two groups compared to normal group and abnormal group, but there is no significant difference between mild and moderate abnormal group and severe abnormal group; the difference between the caloric test normal group of the comprehensive evaluation index (f) and abnormal group has statistical significance, and the difference of mild to moderate abnormal group and severe abnormal group has statistical significance.Conclusions1 The method of PC A for the subjective evaluation in Meniere’s disease can be constructed as a model of comprehensive evaluation system, which may provide comprehensive informations of clinical original variables, reflect the severity of the disease. And it also can be used as intermediate variables, further to explore the relationship between subjective evaluation and objective evaluation.2 The relationship between subjective evaluation and objective evaluation.2.1 Age, gender and frequency has no effect on the comprehensive subjective evaluation of MD patients’ clinical symptoms, but the course of disease has some degree of influence on the comprehensive subjective evaluation, especially for the patients with recurrenet in 1 year, the comprehensive subjective evaluation score will be increased, with the extension of course. So it is necessary to consider the impact of the duration of disease in the evaluation of subjective feeling of patient’s clinical symptoms,.2.2 There is a positive correlation between objective evaluation of pure tone test result and subjective evaluation, but the correlation is weak. There is no obvious association between the glycerol test, ECochG, caloric test and subjective evaluation, but subjective evaluation has difference between groups of pure tone audiometry and caloric test. Although laboratory results can not reflect the the clinical symptoms of the subjective, it also can provide valuable information for the diagnosis and differential diagnosis in MD patients.