Clinical Research Of Qing-Gan-Jie-Yu Soup For Cure The Stagnation Of Liver-Qi And Kidney Deficiency Of Perimenopausal Syndrome

Objective:To evaluate the clinical efficacy and safety objectively and explore the mechanism of action for Qing-Gan-Jie-Yu decoction treating the Stagnation of Liver-qi and Kidney Deficiency of Perimenopausal Syndrome by observing the clinical symptoms and serum sex hormone levels,which will provide more theoretical basis for traditional Chinese medicine treating PMS.Methods:From January,2015 to December,2016,66 cases with the type Stagnation of Liver-qi and Kidney Deficiency of Perimenopausal Syndrome who attended department of endocrinology of Province Hospital were collected.All of them would be randomly divided into two groups according to registration order.We would give one group(the treatment group)of them with Qing-Gan-Jie-Yu decoction,the other group(the control group)with the Kunbao Pills.The total course of two groups were 4 weeks.Kupperman score、TCM symptom score and the level of serum sex hormone(E2,FSH)of both groups were compared before and after treatment to evaluate the clinical efficacy of Qing-Gan-Jie-Yu decoction.Results:(1)Total curative effect:The total effectiveness rate of the treatment group and the control group was 93.75% and 77.41% separately via the rank sum test,difference between the two groups have statistical significance(P <0.05)to verify the conclusion that the treatment group has the higher effective on total curative effect.(2)Improved kupperman score: The improved KI score of the two groups were decreased significantly after treatment;the KI score of the treatment group is lower than the control group,showing significant difference as compared with control group(P<0.05).(3)Chinese medicine symptom integral comparison: After treatment TCM symptom score of the two groups were significantly lower than before.The TCM symptom grade of treatment group was lower than that of control group and the difference of the TCM symptomscore between the two groups had statistical significance(P <0.05).(4)The symptom of treatment group including baking hot sweat,lumbar debility,temperamental moods insomnia,chest pain,sadness and depression showed marked improved over the control group(P <0.05).(5)Safety evaluation: The patients of treatment groups had not happened the adverse drug reaction in stage of therapy and there were no obvious abnormal changes in the test of all safety indicators showing that the clinical application of Qing-Gan-Jie-Yu decoction would have good safety.Conclusion:Qing-Gan-Jie-Yu decoction can significantly improve the patients clinical symptoms of the type of the Stagnation Liver-qi and Renanl Deficiency of PMS and reduce the improved KI score and TCM symptom score.There were no adverse drug reaction during the treatment process,which proved that Qing-Gan-Jie-Yu decoction is safe and effective in clinical treatment and could be worthy of clinical promotion.