| ObjectivesIn this clinical trail, we use the treatment of the TCM combination of disease and syndrome for menopause syndrome and analysis the effectiveness, to summarize the advantages of Chinese medicine treating menopause syndrome and provide high level of evidence based medicine for developing TCM treatment guidelines.MethodBased on the inclusion criteria and exclusion, we screened for paitents of Advertising recruitment and who go to gynecological outpatient of Guangdong Provincial Hospital seek for TM treatment. Based on the statement of STRAW (Stage of Reproductive Aging Workshop,2001), we devide subjects into two groups, women in menopausal transition and women in postmenopause. The subjects meet the 3 conditions (hot flush and sweating as chief complaint, the standard score of SDS and SAS less than 50 points, meet the criterion of kidney yin difficiency syndrome)were classified as kidney yin difficiency syndrome sub-group. The subjects meet the 3 conditions(hot flush and mental disorder as chief complaint, the standard score of SDS and SAS less than 72 points but more than 50 points, meet the criterion of yin difficiency liver hyperactivity syndrome)were classified as yin difficiency liver hyperactivity syndrome sub-group.Giving Chinese medicine granules or placebo randomized, treat 2 months and follow-up 1 month. Patients need to fill Greene Climacteric Scale and Chinese menopause rating scale for the first visit, the fourth week, the eighth week, the twelfth week. Examinating the safety index, including blood routine, urine routine, stool routine, occult blood, liver function test, kidney function test, gynecological B-ultrasound examination, brest ultrasound. We use SPSS18.0 to analysis all data.Results1.The comparison between treatment group and placebo group of 165 subjects.The treatment group included 83 subjects, and the placebo group included 82 subjects. The independent sample t-test was used to compare the falling scores (total scores of first visit minus total scores for the third visit)of Greene Climacteric Scale and CMRS between groups. The result indicate that the difference of falling score of Greene between groups is statistically significant(P< 0.05). Using covariance analysis method to compare the efficacy difference of two groups after correcting the confounding factors (such as the standard score of SDS, the standard score of SAS, duration of illness, the pressure of working, the frequency for eating soybean, medical treatment of this disease or not, etc). The result of covariance analysis show us that the difference of total score of Greene after treatment is statistically significant between the treatment gourp and the placebo group.2. Deviding all subjects into two parts:menopausal transition women and postmenopausal women, to compare curative effect between groups in different menopausal statu.2.1 The comparison between two groups in menopausal transiton.The treatment group included 38 subjects, and the placebo group included 38 subjects, totally 76 subjects in menopausal transiton. The independent sample t-test was used to compare the difference of falling scores of Greene Climacteric Scale and CMRS between groups, the result is that the difference of falling score of Greene and CMRS is not statistically significant. The results of covariance analysis after correceting the confounding factors show that the efficacy difference between the treatment gourp and the placebo group is not significant.2.2 The comparison between two groups in postmenopause.The treatment group included 45 subjects, and the placebo group included 44 subjects,totally 89 subjects in postmenopause. The independent t-test was used to compare the the difference of falling scores of Greene Climacteric Scale and CMRS between groups, the result show us that the difference of falling score of Greene and CMRS is statistically significant. After correceting the confounding factors, the covariance was use to analysis the efficacy difference between groups.The efficacy difference between two groups is statistically significant.3. Dividing all subjects into two parts:kidney yin difficency syndrome and yin difficiency liver hyperactivity syndrome to compare curative effect between groups in different syndrome3.1 The comparison between groups of kidney yin dificiency syndrome.The treatment group included 36 subjects, and the placebo group included 36 subjects, totally 89 subjects in postmenopause. Using the independent t-test to compare the difference of falling scores of Greene Climacteric Scale and CMRS between groups. The result of the independent t-test is that the difference of falling score of Greene and CMRS is statistically significant (P<0.05). The results of covariance analysis after correcting the confounding factors show that the efficacy differenece is significant.The total score of both Greene and CMRS after treatment is statistical different between groups (p=0.00,p=0.03).5. The comparison between groups of yin dificiency liver hyperactivity syndrome.The treatment group included 47 subjects, and the placebo group included 46 subjects. By using the independent t-test to compare the difference of falling scores of Greene Climacteric Scale and CMRS between groups, the result is that there is no statistically difference between the treatment and the placebo group. The results of covariance analysis after correcting the confounding factors show that the total score of both Greene and CMRS after treatment is not statistical different (P>0.05).Conclusion1. Chinese medicine is effective in treating symptoms related to menopause.2. The efficiency of Chinese medicine is different for different menopausal stage wonen.The Chinese medicine is more effective in postmenopause women.3. Using "TCM combination of disease and syndrome" for treating menopause syndrome,, Chinese medicine is more effective for the women being upset by hot flush and sweating. |
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