| ObjectiveTo summarize and analyze previous clinical research progr ams and conduct a randomized controlled trial(RCT)based on a systematic review and meta-analysis of existing scientific research results.A Liuzi jue mind-body intervention combined with conventional treatment group(intervention group)was compared with the conventional treatment group(control group)to explore the efficacy and safety of mind-body intervention to improve the prognosis of stable coronary heart disease.Method:1.Systematic review and meta-analysis:We searched databases of Pubmed,Embase,Cochrane library,AMED,China Knowledge Network(CNK1),China Biomedical Literature Database(CBM),VIP Journal Database(VIP)and Wanfang Database from their inception to August 20,2019,and covered only published articles with RCT involving mind-body interventions for the cardiac rehabilitation of patients with stable coronary heart disease.2.Clinical research:48 patients with stable coronary heart disease who were included in the trial were randomly assigned to the intervention group and the control group,24 patients in each group.The random number was issued in an opaque sealed envelope.The intervention group used the standard version of Liuzijue compiled by the General Administration of Sport of China in combination with conventional treatment for 30 minutes each time,three times a week for 8 weeks.The control group only used conventional treatment.The primary outcome was the 6-minute walk test(6-MWT),and the secondary outcomes were left ventricular ejection fraction(LVEF),self-rating anxiety scale(SAS)and adverse event rate.Result1.Systematic review and meta-analysis results:This study included 17 clinical randomized controlled trials with 1,550 patients aged 18-89.Comprehensive results showed that mind-body interventions rehabilitation therapy could improve the stability of patients with coronary heart disease and Seattle angina pectoris scale(MD＝5.52,95%CI[5.23,10.33],P<0.0001)and the stability of the disease compared with the control group.(MD=11.45,95%CI[8.28,14.63],P<0.00001),frequency of angina pectoris(MD＝8.29,95%CI[7.18,9.40],P<0.00001),patient satisfaction(MD＝2.69,95%CI[0.21,5.17],P=0.03),disease awareness(MD=8.85,95%CI[6.86,10.83],P<0.00001);alleviate anxiety in patients with stable coronary heart disease(MD＝-4.71,95%CI[-5.63,-3.79],P<0.00001)and depression(MD＝-5.14,95%CI[-7.86,-2.41],P=0.0002);increase left ventricular ejection fraction(MD=2.83,95%CI[0.72,9.58],P=0.03);but there was no significant difference in the effect of improving 6-minute walking distance compared with the control group(MD=1.63,95%CI[-22.37,25.62],P=0.89).Four studies mentioned adverse events,and no adverse events were reported.Among the included 17 studies,only one was assessmented as a high-quality study,and the quality of clinical trials and the standardization of the process need to be improved.2.Clinical research results:This study included 48 patients with stable coronary heart disease from the Department of Cardiovascular Diseases,Donghua Hospital,Dongguan City,Guangdong Province,and there were no cases of withdrawal.drop out or loss of follow up.The baseline information such as general information and medical history of the two groups were balanced and comparable.2.1 primary outcomeThe 6-minute walking test results showed that the walking distance of the two groups of patients was balanced and comparable before the intervention,and there was no statistical difference(P>0.05).After 8 weeks of intervention,the walking distance of the intervention group was better than that of the control group,and the difference was statistically significant.(P<0.05).2.1 secondary outcome(1)Left ventricular ejection fraction results suggest that there was no statistical difference between the ejection fraction and anxiety level of the two groups of subjects before and after the intervention(P>0.05);(2)The results of the self-assessment scale of anxiety showed that the baseline anxiety levels of the two groups of subjects were comparable and there was no statistical difference before the intervention(P>0.05);after 8 weeks of intervention,the anxiety level of the intervention group was lower than that of the control Group,and the difference was statistically significant(p<0.05).(3)There were no adverse events in the two groups during the research process,which indicates that the mind-body intervention of Liuzijue and the conventional rehabilitation therapy have a good safety in improving the prognosis of patients with stable coronary heart disease.Conclusion1.System review and meta-analysis conclusionMind-body interventions contribute to the prognosis of patients with stable coronary heart disease,and this intervention is safe for patients with stable coronary heart disease.Due to low quality and heterogeneity of the included clinical trials,more RCT with higher quality are needed to explore the role of mind-body interventions in the prognosis of patients with stable coronary heart disease.2.Clinical research conclusionConventional treatment combined with Liuzijue rehabilitation training can effectively improve the exercise endurance of patients with stable coronary heart disease,reduce the anxiety of patients,improve the prognosis of patients with disease,and have good safety.But in terms of improving cardiac ejection fraction,there was no significant difference between two groups. |
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