Clinical Study on the Treatment of Insomnia in the Elderly with the Spleen-Strengthening,Blood-Activating and Phlegm-Resolving Chinese Herbal Medicine Based on the Theory of "Muscular Atrophy,Qi-Passage Blockage" Recorded in the Huang Di Nei Jing
Objective To explore the clinical efficacy of Chinese herbal medicine with the actions of invigorating spleen,activating blood and resolving phlegm in the treatment of senile insomnia based on the theory of"muscular atrophy,qi-passage blockage"recorded in Huang Di Nei Jing(The Yellow Emperor's Inner Classic,shortened as Nei Jing).Methods A total of 120 elderly patients with insomnia were randomly divided into observation group and control group,with 60 cases in each group.The control group was treated with oral use of Dexzopiclone Tablets,and the observation group was treated with oral use of decoction of Chinese herbal medicine for invigorating spleen,activating blood and resolving phlegm.The course of treatment covered 4 weeks.Before and after treatment,the two groups were observed in the changes of Pittsburgh Sleep Quality Index(PSQI)score,Insomnia Severity Index(ISI)score,polysomnography(PSG)related parameters of total sleep time(TST),number of awakenings(AN)and sleep latency(SL),mean blood flow velocity of anterior cerebral artery(ACA),middle cerebral artery(MCA),and posterior cerebral artery(PCA),and serum levels of 5-hydroxytryptamine(5-HT)and melatonin(MT).After treatment,the clinical efficacy and safety of the two groups were evaluated.Results(1)After 4 weeks of treatment,the total effective rate of the observation group was 93.33%(56/60),which was slightly higher than 90.00%(54/60)of the control group,but the difference was not statistically significant(P>0.05).(2)After treatment,the item scores and total scores of PSQI in the two groups were lower than those before treatment(P<0.05),and the decrease of the scores of sleep quality,sleep time,sleep efficiency,and daytime function as well as total scores in the observation group was significantly superior to that in the control group(P<0.05).However,there was no significant difference of time for falling asleep and sleep disorder scores between the two groups(P>0.05).After 4 weeks of drug withdrawal,the item scores of PSQI in the observation group continued to decrease compared with those after treatment(P<0.05),but there was no significant difference in the control group(P<0.05).(3)After treatment,the ISI scores in the two groups were decreased when compared with those before treatment(P<0.05),and the decrease in the observation group was superior to that in the control group(P<0.05).After 4 weeks of drug withdrawal,the ISI score of the observation group continued to decrease compared with that after treatment(P<0.05),while the control group had no significant change,and the difference was not statistically significant(P>0.05).(4)After treatment,the PSG related parameters such as TST,AN and SL in the two groups were improved when compared with those before treatment(P>0.05),and the improvement of TST and AN in the observation group was superior to that in the control group(P>0.05).(5)After treatment,the mean blood flow velocity of ACA,MCA and PCA in the observation group was improved compared with that before treatment(P<0.05),while there was no significant change in the control group compared with that before treatment(P>0.05).The improvement of the mean blood flow velocity of ACA,MCA and PCA in the observation group was significantly superior to that in the control group(P<0.05).(6)After treatment,the levels of serum 5-HT and MT in the two groups were increased when compared with those before treatment(P<0.05),and the increase in the observation group was superior to that in the control group(P<0.05).(7)The incidence of adverse reactions in the observation group was 5.00%(3/60),which was slightly lower than 13.33%(8/60)in the control group,but the difference was not statistically significant(P>0.05).Conclusion Based on the theory of"muscular atrophy,qi-passage blockage"recorded in Nei Jing,the Chinese herbal medicine for invigorating spleen,activating blood and resolving phlegm exerts certain effect in treating senile insomnia.It can effectively improve the sleep quality and daytime function of patients,enhance sleep efficiency,increase sleep time,reduce the number of awakenings,alleviate the severity of insomnia,improve brain function,and regulate the level of neurotransmitters,with remarkably long-term effect and reliable safety.
theory of"muscular atrophy,qi-passage blockage"insomnia in the elderlyprescription for invigorating spleen,activating blood and resolving phlegmpolysomnogramcerebral blood flow5-hydroxytryptaminemelatonin