Clinical Observation Of Wumei Pill In The Treatment Of Insomnia With Difficulty In Sleep Maintenance

Objective:To observe the greatly clinical efficacy of Wumei Pill in the treatment of insomnia with difficulty in sleep maintenance(mixed cold and heat syndrome).According to the changes of PSQI and TCM syndrome score scale before and after treatment and during the follow-up period,I evaluated the curative effect of Wumei Pill in the treatment of insomnia,so as to provide an effective method for the treatment of insomnia.Methods:70 patients with insomnia of cold and heat syndrome of sleep maintenance difficulty in Changzhou Hospital of traditional Chinese medicine were selected and divided into two groups.According to the random number table,the patients were divided into treatment group and control group,35 cases in each group.The control group was treated with estazolam tablets.The treatment group was treated with Wumei Pill.The course of treatment was 4 weeks.The changes of PSQI and TCM syndrome score scale of the two groups before and after treatment and during the follow-up period were observed,and the advantages and disadvantages of Wumei Pill in the treatment of insomnia were analyzed compared with estazolam.Results:In this study,there were 70 cases,one case of shedding,69 cases in fact,35 cases in the treatment group of taking Wumei Pills and 34 cases in the control group of taking estazolam tablets,with good compliance and complete data collection.After 4 weeks of treatment,the clinical observation of the two groups before and after treatment and during the follow-up period can draw the following results.1.In the treatment group,there were 14 males and 21 females with an average age of 57.91 years and an average course of 1.71 years.In the control group,there were 11 males and 23 females with an average age of 63.82 years and an average course of 1.34 years.There was no significant difference in the terms of gender,age and course of disease between the two groups(P>0.05).2.In terms of PSQI,the PSQI scores(except sleep time)and total scores of the treatment group and the control group after treatment were significantly lower than those before treatment(P<0.05).After treatment,the total score of PSQI,sleep quality,sleep time and daytime dysfunction in the treatment group were great significantly lower than those in the control group(P<0.05),however there was no significant difference in sleep time,sleep efficiency and sleep disorder(P>0.05).During the follow-up period,the single item(except hypnotics)and total score of PSQI in the treatment group of taking Wumei Pills were significantly lower than those in the control group of taking estazolam tablets(P<0.05).The single item(except hypnotics)and total score of PSQI in the treatment group:before treatment>after treatment>during the follow-up period(P<0.05).The single item(except hypnotics)and total score of PSQI in the control group of taking estazolam tablets:during the follow-up period>before treatment>after treatment(P<0.05).After treatment,the effective rate was 88.57%in the treatment group of taking Wumei Pills and 61.76%in the control group of taking estazolam tablets.During the follow-up period,the effective rate was 100%in the treatment group of taking Wumei Pills and 0%in the control group of taking estazolam tablets(P<0.05).3.In terms of TCM syndromes,after treatment,the total score of TCM syndrome and each single item(except difficulty in falling asleep)in the treatment group of taking Wumei Pills were significantly lower than those before treatment(P<0.05).The total score of the control group and the scores of frequent awakening,early awakening,short sleep time,irritability and hot flashes were lower than those before treatment(P<0.05),and there was no significant difference in the symptoms of mixed cold and heat in the control group compared with those before treatment(P>0.05).The total score of TCM syndrome in the treatment group of taking Wumei Pills was significantly lower than that in the control group of taking estazolam tablets(P<0.05).The treatment group of taking Wumei Pills was significantly better than the control group of taking estazolam tablets in improving the symptoms of cold and heat(P<0.05).There was no significant difference in improving sleep between these two groups(P>0.05).During the follow-up period,the total score of TCM syndrome and each single item(except acid reflux)in the treatment group of taking Wumei Pills were significantly lower than those in the control group of taking estazolam tablets(P<0.05).The total score of TCM syndrome in the treatment group:before treatment>after treatment>follow-up period(P<0.05).The total score of TCM syndrome in the control group:follow up period≈before treatment(P>0.05)>after treatment(P<0.05).After treatment,the effective rate was 100%in the treatment group of taking Wumei Pills and 85.29%in the control group of taking estazolam tablets,P<0.05.During the follow-up period,the effective rate was 100%in the treatment group of taking Wumei Pills and 0%in the control group of taking estazolam tablets.4.During the four weeks of treatment,the safety indexes of the two groups in this clinical study were normal,and there were no adverse reactions.Conclusions:1.Wumei Pill can warm the upper and clear the lower,balance yin and Yang,and can treat insomnia patients who are easy to wake up at 1-3 o’clock,with mixed signs of cold and heat.2.Wumei Pill has a significant effect in reducing the total score of PSQI,improving sleep quality,efficiency,sleep disorders,daytime dysfunction,and prolonging sleep time in patients with insomnia of difficult sleep maintenance type(mixed cold and heat syndrome);among them,Wumei Pill is significantly better than estazolam in reducing the total score of PSQI,improving sleep quality and daytime dysfunction.3.Wumei Pill can not only improve the sleep quality of insomnia patients with difficulty in sleep maintenance(mixed cold and heat syndrome),but also treat the symptoms of patients with mixed cold and heat:irritability,hot flashes,cold hands and feet,dry mouth,hiccup,acid regurgitation,warm and hot liking,acid and cold waist and knees,clear and long urine,loose and thin stool.4.Wumei Pill has a long-term effect in the treatment of insomnia with difficulty in sleep maintenance(mixed cold and heat syndrome),and the patients can still keep a good sleep after withdrawal.However,estazolam had only immediate effect,and insomnia remained or even worsened after withdrawal.