A Clinic Study Of GengnianAnshen Capsules On Perimenopausal Syndrome(Kidney Deficiency Of Both Yin And Yang)through Randomized Controlled Trial

Objection To make further evaluations about clinical effectiveness and drug safety of Geng Nian An Shen Capsule on PMS of Kidney deficiency of both yin and yang syndrome through Phase III clinical trial. We both hope it could provide an effective treatment and method to cure PMS in the future.Method The study is a randomized, double-blind, placebo-controlled method, PMS of Kidney deficiency of both yin and yang syndrome as objects. A total of 64 patients aged 40-55 years old are divided into the test group and the control group, the ratio of the group is 3:1, 48 cases in the test group, and 18 cases in the control group. The courses is 8 weeks. The improvement of TCM syndrome scores, the clinical efficacy(Kupperman) scores, the clinic symptom and the safety indicators and so on are observed in both groups before and after treatment.Results ① The comparison of comprehensive efficacy: The results showed that the total effective rate of the test group and control group was 95.83% and 56.25% respectively, the markedly effective rate of the test group and control group was 54.17% and 12.50%.The results of the test group were better than those of the control group(P<0.05).② The comparison of the primary efficacy index: Flushing times of the face in 24 hours,after treatment, the difference was statistically significant(P<0.05) between the test group than the control group. Comparison of the test group before and after treatment, the difference was statistically significant(P<0.05). ③The comparison of the efficacy of symptoms: After treatment the difference between the two groups of the TCM total clinical symptom scores were statistically significant(P<0.05),the test group was better than the control group.And the efficacy difference in TCM total clinical symptoms before and after treatment in test group were statistically significant(P<0.05). The main symptom of TCM, hectic fever and sweating, after treatment, the difference was statistically significant(P<0.05) between the test group than the control group. Comparison of the test group before and after treatment, the difference was statistically significant(P<0.05).After 8 weeks, Kupperman score between two groups of clinical symptoms were significantly statistically significant(P<0.05).The test group was better than the control group. Comparing before and after treatment, the test group Kupperman scores were significantly decreased(P<0.05). ④ The comparison of hormone: There was no significant difference with the levels of FSH、E2 between the test group and the control group after treatment(P>0.05).⑤Security: In the medication process, the patient is not referred to special discomfort in the experimental group. blood, urine, stool examination, liver and kidney function examination showed no abnormal changes. The uterus and Annex and breast B-us have no obvious abnormalities.Conclusion Gengnian Anshen Capsules is a safe and effective clinical drug therapy for perimenopausal syndrome(kidney deficiency of both yin and yang syndrome),it can effectively improve patients’ TCM clinical syndromes and clinical symptoms. And it proved safe,no significant adverse reactions.