Clinical Study On Menopansal Syndrome (Kidney Yin Deficiency Syndrome) By Epimeredi Indica (L.) Rothmale Capsule

Menopansal syndrome is a common disease in gynecology, the incidence rate of perimenopausal women is 85%,10% -30% of women prone to severe symptoms, Seriously affect normal work and life and decrease the quality of life. it need to be actively treated. Epimeredi indica(L.)Rothmale capsule was the II new medicine applied by Shanghai Gangyao Biotechnology Co., Ltd. For the treatment of menopausal syndrome (kidney yin). This is experiment for III clinical trial.Objective:Acrossing the experiment, to make evaluation for clinical effectiveness and safety further about the treatment of Epimeredi indica(L.)/Rothmale capsule on climacteric syndrome (kidney yin deficiency syndrome), and recommend clinical dose.Method:1. Information:a total of 80 cases,whom were diagnosed as perimenopausal syndrome patients,from Chinese medicine hospitals in Hubei province on January 2007- August 2008. According to the ratio of 3:1,they were randomly divided into experimental group (Canton Epimeredi-indica(L.)/Rothmale Capsule+simulation agent) and the control group (Gengnian'an capsule), the treatment group shed 9 cases and the control group 3 patients. Their age, severity, course, clinical symptoms such as through had no significant statistical difference (P>0.05).2. Treatment:the experimental group:Epimeredi indica(L.) Rothmale capsule,each of a bag of medication that 3,2 times a day+simulated agents, each of a bag that 3,1 time with warm water. Control group:Gengnian'an capsule each of a bag 3,3 times a day with warm water.3. Efficacy and safety of indicators:Two groups were observed before treatment, after treatment, observation and recording of a TCM syndrome score; hormone level (E2, P, FSH, LH), B-gynecology, breast examination (breast B-). Before and after treatment the blood, urine, liver and kidney function (ALT, BUN, Cr), ECG test, general physical examination, and pelvic examination.4. Statistical Methods:. A randomized, double-blind, positive controlled design. Non-inferiority test. Measurement data using t test, count data were analyzed by chi-square test, Fisher exact test, etc.; level data analysis using Ridit, CMH method.Results:After 8 weeks and symptoms of TCM treatment group 3 pat ients,18 cases markedly effective in 23 cases,7 cases, total effective ra-te 41.2%, total effective rate was 86.3%; control group total effective r-ate was 29.4%, total effective rate was 82.4%.Two group had no differ-ence by Ridit analysis (P>0.05). Symptoms of experimental group in th-e c-omprehensive effect of Chinese medicine is same to the control gro-up. Decreased the symptom score before and after the effect of contras-t,by testing two drugs are the treatment of female climacteric syndrome were effective drugs, the two groups by t test showed no significant dif-ference (P> 0.05). After 8 weeks the symptom score decreased rate, ex perimental group were same to the control group (P>0.05) by t test, in Kupperman score analysis, the clinical efficacy of 8 weeks after clinica-1 efficiency of the experimental group was 64.7%, total efficiency 86.3 %; control group was 47.1%, total effective rate 88.2%. The efficiency of the experimental group was better than the control group (P<0.05). by Ridit. Kupperman score and total score decreased rate of decline in value, the two drugs are effective drugs.In the safety analysis, this stud-y has no obvious adverse reactions.Conclusion:The extensive wind-kidney capsule can improve women climacteric syndrome of effective drugs, and no apparent side effects, the amount (size 0.4g/tablets), a 3, the second day, is safe and effective dose.