| Objective:This study evaluated the clinical efficacy of Qinpi Ningxin medicine pillow in the treatment of elderly patients with chronic insomnia of deficiency of both heart and spleen by observing the changes of TCM symptom score,PSQI score and 24-hour urinary free cortisol level before and after treatment,and explored the mechanism of Qinpi Ningxin medicine pillow in improving sleep.Methods:60 cases of senile chronic insomnia with deficiency of both heart and spleen were randomly divided into medicine pillow group and control group(30 cases in each group).The medicine pillow group received Qinpi Ningxin medicine pillow combined with Guipi Pills,and the control group received Guipi Pills.A 4-week clinical study was conducted.The TCM symptom score,Pittsburgh sleep quality index(PSQI),Hamilton Anxiety Scale(HAMA)and Hamilton Depression Scale(HAMD)scores of the two groups before and after treatment were compared,and the changes of urinary cortisol before and after treatment were paid attention to,so as to explore the mechanism of Qinpi Ningxin medicine pillow in the treatment of insomnia.Results:1.Comparison of TCM syndrome scores and clinical efficacy:After treatment,the TCM syndrome scores of the two groups were improved,and there were significant differences within the group(P<0.01);after treatment,the two groups of syndrome scores were compared between the groups,which was statistically significant difference(P<0.05);the total effective rate of the medicine pillow group is higher than that of the control group,and there is a statistical difference between the two.2.Comparison of PSQI scores:PSQI scores of the two groups decreased after treatment;there were significant differences between the two groups(P<0.01);the comparison between the two groups after treatment showed statistical differences(P<0.05);medicine pillow group The PSQI score reduction rate is higher.3.Comparison of HAMA and HAMD scores:The HAMA and HAMD scores of the two groups have been improved;before and after comparisons within the group,there are significant statistical differences(P<0.01);the HAMA and HAMD scores of the two groups are compared between groups after treatment,The difference was statistically significant(P<0.05);the improvement was more obvious in the medicine pillow group.4.Comparison of 24-hour urine free cortisol:Both the medicine pillow group and the control group can effectively reduce the 24-hour urine free cortisol level;there are significant statistical differences between before and after the group(P<0.01);After treatment,the levels of cortisol between the two groups were compared,and the difference was statistically significant(P<0.05);the effect of reducing cortisol in the medicine pillow group was more obvious.5.Safety evaluation:There were no special symptoms and allergic reactions in the two groups of patients.The vital signs of the patients were stable before and after the test.Conclusion:1.The topical application of Qinpi Ningxin medicine pillow and Guipi Pills can significantly improve the TCM clinical syndrome scores of elderly patients with insomnia with heart and spleen deficiency syndrome,and at the same time significantly improve the patients’PSQI,HAMA and HAMD scores,which can significantly improve patients’ sleep quality,relieve anxiety and depression symptoms,reduce 24-hour urine free cortisol level,and the effect is better than using Guipi Pills orally alone.2.Qinpi Ningxin medicine pillow can improve the sleep quality of elderly patients with insomnia with heart and spleen deficiency,relieve anxiety and depression,and reduce the level of urinary free cortisol.3.Qinpi Ningxin medicine pillow may play a role in improving sleep by inhibiting the hyperactivity of HPA axis and reducing the level of urine free cortisol. |
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