Clinical Observation On Treatment Of Senile Insomnia(the Syndrome Of Qi Deficiency And Phlegm Stasis)by Yiqi Huatan Anshen Decoction

Objective:To observe clinical effects and safety of Yiqi Huatan Anshen decoction to treating Senile Insomnia of Qi Deficiency and Phlegm Stasis Syndrome.Methods:72 Cases of Senile Insomnia with Qi Deficiency and Phlegm Stasis Syndrome were randomly divided in 2 groups,the treatment group(n=36)and the control group(n=36).The control group was treated with estazolam,and the treatment group was added Yiqi Huatan Anshen decoction on the basis of estazolam.The course of treatment was 14 days in two groups.After the end of treatment in both groups,compared with the curative effect of TCM syndrome scores,the Pittsburgh sleep quality index scores and clinical effect before and after treatment.Results:1.Comparison of the curative effect of TCM syndrome: After treatment,the TCM syndrome points of treatment group and control group both decreased than before treatment(P<0.01).And the treatment group patients' syndrome of difficulty falling asleep,wakefulness,dreaminess,tiredness,spontaneous perspiration,laziness to speak,poor appetite was superior to the control group(P<0.05);and the syndrome of fatigue,dizziness,short Tongue,moss white and greasy distinctly preceded the control group(P<0.01).The two groups both distinctly decreased the curative effect of TCM syndrome scores(P<0.01),and the treatment group distinctly preceded the control group(P<0.01).And the treatment group was distinctly superior to the control group in the curative effect of TCM syndrome(P<0.01).2.Comparison of the sleep quality improvement: Two groups both decreased thepoints of PSQI after treatment(P<0.01).And the PSQI various components(sleep quality,sleep time,sleep duration,sleep efficiency,sleep disturbance,daytime dysfunction)in treatment group was all improved better than control group(P<0.01);the item of hypnotic was no difference between two groups(P > 0.05).And two groups both decreased the PSQI scores after treatment(P<0.01),and treatment group obviously better than control group(P < 0.01).Last,the treatment group improved sleep quality was superior to the control group(P<0.05).3.Comparison of the overall curative effect: the total effective rate in the treatment group was 94%,in the control group was 76%.Statistic analysis showed that the treatment group was preceded the control group in the overall curative effect(P<0.05).4.Safety evaluation indicators:Two groups had no difference in general conditions,including temperature,respiration,heart rate,pulse,blood pressure,and blood routine examination,urinalysis,stool routine examination,liver and renal function,ECG,before treatment and after.Two groups without adverse reaction.Conclusion:1.Yiqi Huatan Anshen decoction combines with the estazolam treating Senile Insomnia of Qi Deficiency and Phlegm Stasis Syndrome preceded the only using estazolam in terms of the overall curative effect.2.Yiqi Huatan Anshen decoction combines with the estazolam is evidently better than estazolam in improving the curative effects of TCM syndrome and sleep quality in treating Senile Insomnia of Qi Deficiency and Phlegm Stasis Syndrome.3.Yiqi Huatan Anshen decoction with high safety.