| ObjectiveObjective to evaluate the efficacy and safety of traditional Chinese medicine intervention in coronary heart disease with sleep disorders,in order to provide evidence-based medicine for clinical.MethodsBy using the combination of subject words and free words,the Chinese and English databases were systematically searched:CNKI,Wanfang,CBM,VIP,PubMed,EMBASE and the Cochrane Library.We searched the Chinese and English dissertations,academic conferences,journals and magazines on TCM treatment of coronary heart disease with sleep disorders from the date of establishment to December 31,2020.All the retrieved literatures were imported into Noteexpress software,and the duplicate literatures were eliminated.Then two researchers independently read the full text of the remaining literatures in detail,and the unqualified literatures were deleted according to the Na Pai standard.Finally,data extraction and quality evaluation were conducted for the eligible literatures.The six outcome indicators:total effective rate,angina pectoris efficacy,insomnia efficacy,PSQI score,ECG efficacy and adverse reactions were all imported into Revman 5.4 software for heterogeneity test and combined statistics.Funnel plot was used to evaluate the publication bias of the outcome indicators of the included literature?10.ResultsA total of 639 articles were obtained by searching the databases.They were screened strictly according to the inclusion criteria and exclusion criteria.Finally,25 Chinese articles were obtained,all of which were randomized controlled trials.A total of 16 literatures used PSQI as the therapeutic effect observation index,3 of which could not extract the effective data,and the data of the remaining 13 literatures were extracted for heterogeneity test:chi2=11.24,DF=11(P=0.42),I2=2%.The combined effect is MD=-66,95%CI=[-4.70,-2.62],P<0.00001.The diamond representing the comprehensive effect was on the left side of the vertical line,indicating that the PSQI score of the treatment group was lower than that of the control group.A total of 12 articles reported the curative effect of insomnia,one of which showed no significant difference,so the data of the remaining 11 articles were excluded,and the heterogeneity test showed that:chi2=13.20,DF=10(P=0.21),I2=24%.The combined effect was or=5.07,95%CI=[3.67,7.00],P<0.00001,and the diamond was on the right side of the vertical line,indicating that the treatment group had better effect on insomnia.The heterogeneity test:chi2=2.73,DF=6(P=0.84),I2=0%,the combined effect amount or=3.22,95%CI=[2.22,4.68],P<0.00001,the diamond representing the comprehensive effect amount is located on the right side of the vertical line,suggesting that the treatment group has a higher effective rate of improving angina pectoris symptoms.A total of 7 articles reported the curative effect of ECG,and all of them could extract effective data.Chi2=7.78,DF=6(P=0.25),and 12=23%.The combined effect amount or=2.08,95%CI=[1.48,2.94],P<0.00001,the diamond representing the comprehensive effect amount was located on the right side of the vertical line,indicating that the ECG effect of the treatment group was better than that of the control group.A total of 6 articles reported the total effective rate,all of which could extract the effective data.The heterogeneity test of the amount of extracted data:chi2=1.60,DF=5(P=0.90),I2=0%.The combined effect was or=4.78,95%CI=[3.05,7.49],P<0.00001,and the diamond was on the right side of the vertical line,indicating that the total effective rate of the treatment group was higher than that of the control group.A total of 11 articles reported adverse reactions and safety related issues:7 of them clearly reported no adverse reactions during treatment;In one study,there were 8 cases of elevated GPT and 1 case of abnormal RBC and WBC in the control group.Both the treatment group and the control group had symptoms of drowsiness,dizziness,dry mouth and blurred vision,but the treatment group was significantly less than the control group;In one study,12 cases of daytime sleepiness,dizziness and fatigue were found in the control group,and 1 case of nausea was found in the treatment group;In one study,2 cases of mild stomach discomfort and 3 cases of mild hypertension were found in.the treatment group;One article reported that both the treatment group and the control group had mild gastrointestinal reaction,which could relieve itself in a short time.ConclusionThis meta-analysis showed that TCM Intervention of coronary heart disease with sleep disorders had good advantages in improving insomnia,angina pectoris,total effective rate,electrocardiogram,PSQI score and safety.However,due to the small sample size and the lack of standardization of research methods,the level of literature evidence was low,the quality was not high and there was publication bias.To a certain extent,it affects the reliability of the conclusion. |
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