Objective:Evaluated the clinical effect of Modified Litan Decoction in the treatment of elderly patients with hypertension and insomnia,whose syndrome belongs to phlegm heat disturbing heart type,in an approach of observing the changes of blood pressure related measurement indexes,PSQI,the syndrome score Traditional Chinese Medicine(TCM)and safety indexes before and after treatment.Methods:A total of 70 elderly people with hypertension and insomnia,whose syndrome belongs to phlegm heat disturbing heart type,were numbered by order.According to the principle of randomization and control,70 patients were evenly distributed to control group and observation group.Based on the routine medication of the patients with the original combined diseases,the patients in the control group were given Valsartan/amlodipine tablets and zopiclone orally,whereas the observation group ones were given Modified Litan Decoction,consisting of 9 g of Pinellia ternate,30 g of raw Gorgon fruit,6 g of Coptis,9 g of Zhuru,9 g of black sesame,6 g of Fructus aurantii Immaturus,12 g of Atractylodes macrocephala,9 g of cypress seed,9 g of tangerine peel,15 g of Poria cocos,6 g of lotus leaf,15 g of shenghangshao,9 g of Peilan and 9 g of Acorus tatarinowii,as well as the treatment given in the control group.The observation’s period was 4 weeks.Observed the change of blood pressure related measurement indexes,PSQ,TCM syndrome score and safety indexes.Data were recorded and statistically analyzed by SPSS 22.0Results:1.Blood pressure:(1)Blood pressure in the consulting room:After treatment,the abnormal blood pressures of two groups were alleviated,The observation group showed a better result(P<0.05).(2)Ambulatory blood pressure:After treatment,the 24hSBP,dSBP,nSBP,24hDBP and dDBP of the two groups dropped significantly(P<0.05),while the nDBP barely changing(P>0.05).The degree of reducing the 24hSBP,dSBP,nSBP of the observation group overwhelmed the control ones(P<0.01).2.Blood pressure variability and blood pressure rhythm:(1)Standard deviation:After treatment,the number of the 24hSBP-SD,dSBP-SD,nSBP-SD of the two groups showed an obvious drop(P<0.05),but the 24hDBP-SD,dDBP-SD and nDBP-SD did not change significantly(P>0.05).The degree of reducing the 24hSBP-SD,dSBP-SD,nSBP-SD of the observation group overwhelmed the control ones(P<0.05).(2)Coefficient of variation:After treatment,the dSBP-CV,nSBP-CV of the control group reduced obviously(P<0.05),and the rest indexes remained at a stable stage(P>0.05).The 24hSBP-CV,dSBP-CV,nSBP-CV in the observation group reduced obviously(P<0.05),while the rest indexes showed minor changes(P>0.05).The degree of reducing the 24hSBP-CV,nSBP-CV of the observation group was more significant(P<0.05).(3)Blood pressure rhythm:After treatment,the blood pressure rhythm in the observation group showed a patent improvement(P<0.01),but not in the control group.3.Sleep quality:After treatment,sleep quality in both groups improved and the observation group showed a more positive result(P<0.01).4.Curative effect of TCM Syndrome:The clinical symptoms in both groups were relieved after treatment,which were relieved better in the observation group(P<0.01),The TCM curative effect of the observation group(90.91%)was more substantial than that in the control one(63.64%)(P<0.01).5.Security:There was no serious adverse event in clinical observation and the safety was good.Conclusion:1.Modified Litan Decoction has a significant regulatory effect of the blood pressure level,systolic blood pressure variability and blood pressure circadian rhythm on elderly patients with hypertension and insomnia(phlegm heat and heart type).2.Modified Litan Decoction has a significant improvement on the sleep quality of elderly patients with hypertension and insomnia(phlegm heat and heart type).3.Modified Litan Decoction can reduce the TCM clinical symptoms of elderly patients with hypertension and insomnia(phlegm heat and heart type).It also can raise the quality of life of the patients.4.Litan Decoction has good safety and no serious adverse reactions. |