Study On The Clinical Effect And Mechanism Of Yishenningxin Fang On Primary Insomnia

Objective:To confirm the clinical efficacy of Yishenningxin Fang in the treatment of deficiency of heart and spleen type primary insomnia,and to compare the changes of patients' Self-Rating Depression Scale and Self-Rating Anxiety Scale scores before and after treatment,and to observe the changes in the amount of 5-hydroxytryptamine and melatonin in patients' plasma,so as to further explore the possible mechanism of Yishenningxin Fang in relieving deficiency of heart and spleen type primary insomnia and its associated depression and anxiety.Methods:According to the standard,selecting 140 cases of patients which see doctors at outpatient of insomnia specialized subject and hospitalized patients in Yueyang hospital affiliated to Shanghai university of traditional Chinese medicine,combining traditional Chinese and western medicine in March 2018-December 2018.The patients were randomly divided into treatment group and control group.The treatment group was treated with Yishenningxin Fang,while the control group was treated with Yishen granule for 8 weeks.The TCM syndrome score scale,the SPIEGEL clinical observation questionnaire for insomnia,Pittsburgh Sleep Quality Index(PSQI),Self-Rating Depression Scale(SDS)and Self-Rating Anxiety Scale(SAS)were used to score the patients in the two groups.Woniu Sleep mobile APP(APP)was used for sleep monitoring,as well as monitoring safety indicators and adverse reactions.The levels of 5-hydroxytryptamine(5-HT)and melatonin(MT)in fasting plasma were measured in 35 patients from each of the two groups selecting by systematic sampling method.The changes of scale scores before treatment,4 weeks after treatment and 8weeks after treatment were compared.The changes of sleep monitoring indexes were compared,and the changes of 5-HT and MT in plasma before and after treatment were compared.Results:1.In this study,a total of 140 patients with deficiency of heart and spleen type primary insomnia were included,which were completely randomly divided into the Yishenningxin Fang treatment group(70 cases)and the Yishen granule control group(70 cases).Among the 140 patients,2 patients in the treatment group were excluded due to incomplete data records,3 patients in the treatment group were lost to follow-up,2 patients in the control group were excluded due to incomplete data records,4 patients in the control group were lost to follow-up,and 129 patients completed the trial?There was no difference in age,gender,marital status,education,occupation,working hours,previous medical history and other general conditions between the patients who were removed and exfoliated and those who completed the experiment(P > 0.05).Among the 64 patients in the control group,6 cases were cured clinically,21 cases were obviously effective,24 cases were effective and 13 cases were ineffective,with a total effective rate of 79.69%.Among the 65 patients in the treatment group,13 cases were cured clinically,27 cases were obviously effective,21 cases were effective,4 cases were ineffective,with a total effective rate of 93.85%.The clinical effect of Yishenningxin Fang on deficiency of heart and spleen type primary insomnia was better than Yishen Granule(P < 0.05).2.Both Yishenningxin Fang and Yishen Granule can effectively improve deficiency of heart and spleen type insomnia patients' TCM symptoms such as sleep uneasy,palpitations,forgetfulness,fatigue,dizziness,dull complexion,etc(P < 0.05),and improve the curative effect of TCM syndrome in insomnia patients,but Yishenningxin Fang has more advantages in improving sleep uneasy,palpitations,forgetfulness,fatigue and dizziness symptoms(P < 0.05),and its TCM syndrome efficiency is superior to Yishen Granule(P < 0.05).3.Both Yishenningxin Fang and Yishen Granule can comprehensively improve insomnia by shortening the time of falling asleep,prolonging the total sleep time,reducing the number of night awakenings,increasing the depth of sleep,reducing the frequency of night dreaming,reducing the use of hypnotic drugs,and improving the sensation after waking and daytime dysfunction(P < 0.05),but the effect of Yishenningxin Fang is more significant(P < 0.05).4.Both Yishenningxin Fang and Yishen Granule can effectively increase the duration and proportion of deep sleep,reduce the duration and proportion of light sleep,reduce the duration and proportion of waking and dreaming,and shorten the sleep latency(P< 0.05),but Yishenningxin Fang has more advantages than Yishen Granule(P < 0.05).5.Both Yishenningxin Fang and Yishen Granule can improve the depression and anxiety in patients with insomnia(P < 0.05),but the effect of Yishenningxin Fang is more significant(P < 0.05).6.Both Yishenningxin Fang and Yishen Granule can improve the level of 5-HT in fasting plasma in the morning(P < 0.05),suggesting that the mechanism of the improvement of insomnia,depression and anxiety may be related to the increase of the level of 5-HT in fasting plasma.There was no significant increase in the level of MT in fasting plasma in the two groups(P > 0.05).Conclusion:1.Yishenningxin Fang can significantly improve deficiency of heart and spleen type insomnia patients' TCM symptoms such as sleep uneasy,palpitations,forgetfulness,fatigue,dizziness,etc.2.Yishenningxin Fang can significantly improve insomnia symptoms such as long sleep latency,short total sleep time,frequent night waking,shallow sleep,multiple dreams,poor feeling after waking up,daytime dysfunction and so on,as well as depression and anxiety in patients,and its mechanism may be related to the increase of the level of 5-HT in fasting plasma.3.Yishenningxin Fang can be safely used in patients with insomnia,especially in patients with insomnia accompanied by depression and/or anxiety,without serious adverse events.