| Purpose:A meta-analysis was conducted to assess the effectiveness of Wumei Pill,either as a solitary medication or in combination with western medicine and other treatments for insomnia.We also observed the clinical effect of Wumei Formula Granule on insomnia patients with Jueyin syndrome for 4 weeks,and detected the HPA axis related indicators(ACTH、 CORT)and inflammatory factor IL-1β、TNF-α The change of the level,in order to explore the effectiveness and safety of Wumei Formula Granules in treating insomnia of Jueyin syndrome,as well as its possible mechanism of action,to provide a basis for Wumei Formula Granules in treating insomnia of Jueyin syndrome.Methods:1.Meta analysis of therapeutic effect of Wumei Pill on insomnia.The computer search included five databases,From the inception of the database to December 30,2022,all literatures were scoured,including CNKI,Wan Fang Data,VIP,Pub Med,and EMbase.Randomized controlled studies of Wumei Pill addition and subtraction or Wumei Pill addition and subtraction combined with western medicine and other treatments for insomnia were comprehensively collected,Two researchers independently screened the literature and extracted relevant data,and checked them after completion.In case of disagreement,two researchers should negotiate and the third researcher should decide the final result.Meta analysis was conducted with Rev Man5.4statistical software to statistically describe the clinical efficacy and adverse reactions of Wumei Pill in treating insomnia.2.Clinical observation on the treatment of insomnia of Jueyin syndrome with Wumei Formula Granules30 cases of insomnia with Jueyin syndrome were selected from the outpatient and inpatient departments of TCM in the Second Affiliated Hospital of Dalian Medical University from August 2021 to December 2022,and were treated with Wumei Formula Granule,once in the morning and once in the evening,for four weeks.Scores from the Pittsburgh Sleep Quality Index(PSQI)were compared to those of the Hamilton Anxiety Scale(HAMD),Hamilton Depression Scale(HAMA),and Hyperarousal Scale(HAS).Before and after treatment,the Insomnia Severity Index(ISI)and TCM Syndrome Score Scale were administered to evaluate the clinical efficacy,as well as the serum ACTH,CORT,IL-1β,and TNF-α to investigate its potential mechanism of action.An assessment of the security was done by examining blood routine,urine routine,electrocardiogram,liver and kidney function tests.Results:1.Meta analysis of therapeutic effect of Wumei Pill on insomniaThis meta-analysis finally included 15 articles that met the criteria.A total of 1088 patients with insomnia were included,544 in the treatment group and 544 in the control group.The meta-analysis results show that:15 randomized controlled clinical trials(RCT)literature studies were included in this meta-analysis,and the quality of the included literature was low.Compared with conventional western medicine in the treatment of insomnia,the addition and subtraction of Wumei Pill and the combination of Wumei Pill and western medicine and other therapies can improve the effective rate obtained according to the efficacy evaluation standard of the Clinical Guiding Principles of New Chinese Medicine for the Treatment of Insomnia [RR=6.24,95% CI(3.44,11.31),P<0.0001],and can significantly improve the PSQI score reduction rate as the efficacy evaluation standard [RR=1.27,95% CI(1.51,1.41),P<0.0001],It can improve the effective rate obtained by using the score reduction rate of TCM syndrome scale as the efficacy evaluation standard [RR=8.03,95% CI(4.84,13.30),P < 0.00001],and significantly reduce the PSQI score [WMD=-2.87,95% CI(-3.52,-2.21),P<0.00001],This study,however,has certain restrictions: the amount of documents that can be included is limited,English documents are not allowed,and many documents do not employ the allocation hiding and blind technique.The original literature included is of a low caliber,and there is a certain amount of publication prejudice.Few writings have discussed the safety and adverse effects of the combination of Wumei pills with other therapies and the control group,as well as the addition and subtraction of Wumei pills.A meta analysis evaluation of the safety of Wumei pills’ addition and subtraction,as well as their combination with other therapies,is impossible.The included studies are all about the addition and subtraction of Wumei Pills for insomnia,and there are drug addition and subtraction,so it is impossible to measure the impact of drug addition and subtraction on the efficacy,which increases the heterogeneity of the study.2.Clinical Observation on Wumei Formula Granules in Treating Insomnia of Jueyin1.Syndrome This clinical study included 30 patients with insomnia of Jueyin syndrome,including 23 women and 7 men.The average age was 50±10.64 years old.The patient has a high degree of cooperation,good compliance,and no case falls off.Through analysis and comparison of the changes in the scores of the related scales and the serum ACTH、CORT、IL-1β、TNF-αThe content changes can be concluded as follows: 1.The patients with insomnia of Jueyin syndrome were treated with Wumei Formula Granules for 4 weeks,and the scores of PSQI、HAMD、HAMA、HAS、ISI scales after taking the medicine were significantly lower than those before taking the medicine,the difference was statistically significant(P<0.05).2.After 4 weeks of treatment with Wumei Formula Granules,the symptoms such as difficulty in falling asleep,easy to wake up from 1:00-3:00 in the morning after sleep,difficulty in falling asleep again after waking up,pain in the mouth,anxiety,fatigue and fatigue improved,and the TCM syndrome score decreased significantly compared with that before taking the medicine,with a statistically significant difference(P<0.05).3.After 4 weeks of treatment with Wumei Formula Granules,ACTH、CORT、TNF-α、IL-1 β The content was significantly lower than that before administration,and the difference was statistically significant(P<0.05).Conclusion:1.Meta analysis shows that the addition and subtraction of Wumei Pill,together with conventional western medicine or acupuncture,can improve the patients’ sleep disorder to a certain extent and improve the TCM syndromes,indicating the effectiveness and safety of Wumei Pill in treating insomnia.2.Wumei Formula Granules can significantly improve the sleep quality of insomnia patients with Jueyin syndrome,improve the early awakening at 1:00-3:00,and prolong the sleep time.3.Wumei Formula Granules can significantly improve the symptoms of insomnia patients with Jueyin syndrome,such as difficulty in falling asleep,easy to wake up from 1:00-3:00 in the morning after sleep,difficulty in sleeping again after waking up,pain in the mouth,anxiety,fatigue and fatigue,and improve the TCM syndrome score.4.Wumei formula granules can effectively relieve the anxiety and depression of insomnia patients,and improve the excessive awakening at night.5.Wumei Formula Granules can significantly reduce ACTH、CORT、 IL-1β、TNF-α The preliminary analysis showed that Wumei Formula Granules may improve the sleep quality of insomnia patients with Jueyin syndrome by regulating the HPA axis and the level of inflammatory factors.6.During the 4-week treatment period when the patient took Wumei Formula Granules,there was no obvious adverse reaction,indicating the safety of its clinical application and worthy of further promotion. |
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