| Objective:Based on the observation of the effect of the traditional Chinese medicine Zi Gui Anshen Decoction on insomnia for deficiency of liver-yin and kidney-yin during perimenopausal period, this research aims at evaluating its efficacy and safety.Methods:This research adopts the randomized controlled research method and its data are from the outpatient wards of Encephalopathy Department of Xiamen Traditional Chinese Medical Hospital affiliated to Fujian University of traditional Chinese Medicine. Among the73insomniac meeting the standardized criteria,37fall into treatment group and the other36, control group. For the insomniac in the treatment group, Zi Gui Anshen Decoction is provided; while for the control group, the Bailemian Capsule is offered. Four weeks work as a course of treatment for these two groups. Efficacy and safety of Zi Gui Anshen Decoction are evaluated on the basis of changes in clinical symptom, in accumulating points of TCM symptom, in hormone and in Liver and kidney function. Meanwhile, statistical analysis is carried out during the evaluation.Results:1.73patients are included in this research, among which70patients finish the clinical observation for2drop in the treatment group and1drop in the control group; with the drop ratio being4.11%.2. The efficiency ratio of treatment group is88.6%which far exceeds that of control group,74.3%(P<0.05). Patients in the treatment group show apparent improvement in the clinical symptoms and also show better scale score change than control group (P<0.05) Though improvement occurs in sex hormones level for both group patients after treating, E2level clearly rises in the treatment and compared with the control group, there is significant difference (P<O.05). 3.In terms of safety, no adverse reaction accurred in the course of medical treatment, and no obnormal findings of liver and kidney in the tests.Conclusion:1.Zi Gui Anshen Decoction helps to improve patients’sleeping conditions significantly and relief related syptoms emerged in perimenopausal period.2.Zi Gui Anshen Decoction has effective regulations of sex hoymones level in the body, helping to rise E2and to reduce FSH and LH levels.3.Zi Gui Anshen Decoction shows favorable safety. |
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