| Objective:To evaluate the efficacy and safety of intradermal needle in the treatment of Chronic stable angina(CSA),and the regulatory effect of the heart meridian acupoints selection group and the lung meridian acupoints selection group on myocardial ischemia in CSA patients were compared.To provide evidence for the clinical application of intradermal needle on CSA.Methods:1.This is a multi-center,randomized,controlled clinical trial.Subjects were enrolled from 4 centers nationwide.A total of 149 CSA subjects meeting the inclusion criteria were randomly divided into the heart meridian acupoints selection group and the lung meridian acupoints selection group through the central random system.On the basis of drug treatment of coronary heart disease,the heart meridian acupoints selection group was treated with intradermal needle on HT5,HT6,HT7,BL15,and CV14;The lung meridian acupoints selection group was treated with intradermal needle on LU9,LU7,LU6,BL15,and CV14.All subjects were treated with intradermal needle once every 3 days,a total of7 times for 4 weeks.The number of angina attacks within 4 weeks was the primary outcome.The Seattle Angina Scale,Visual Analogue Scale(VAS),Canadian Cardiovascular Society(CCS)angina severity rating,and acupuncture treatment expectation were the secondary outcomes.The clinical effect of intradermal needle on CSA was evaluated at baseline(0week after enrollment),4 weeks after enrollment,and 8 weeks after enrollment.2.To explore the regulatory effect of the heart meridian acupoints selection group and the lung meridian acupoints selection group on myocardial ischemia in CSA patients.The50 CSA patients with myocardial ischemia at baseline were enrolled.The total ischemic burden,maximum ST-segment depression,and total ST-segment depression sequences were taken as evaluation indicators.Using 24-hour dynamic electrocardiogram,the differences of myocardial ischemia before and after treatment,and between the heart meridian acupoints selection group and the lung meridian acupoints selection group were compared.Myocardial ischemia was detected at baseline(0 week after enrollment),4weeks after enrollment and 8 weeks after enrollment,respectively.Results:1.Evaluation of clinical efficacy of intradermal needle on chronic stable angina(1)The baseline characteristics of the heart meridian acupoints selection group and the lung meridian acupoints selection group were comparable.(2)The results of the primary outcome showed that the number of angina attacks within 4 weeks in both the heart meridian acupoints selection group and the lung meridian acupoints selection group decreased continuously at the visiting points.By the end of the4-week follow-up,the number of angina attacks was the lowest.There was no statistically significant difference between the heart meridian acupoints selection group and the lung meridian acupoints selection group at each visiting point(P > 0.05).The generalized estimation equation of repeated measurement data was used for modeling.The results showed that there is no central difference between the results of different centers.In comprehensive evaluation,there was no significant difference in the number of angina attacks within 4 weeks between the heart meridian acupoints selection group and the lung meridian acupoints selection group(P > 0.05).There were significant differences in the number of angina attacks within 4 weeks after treatment and in the 4-week follow-up compared with baseline(P < 0.05).(3)The results of the secondary outcomes showed that after treatment and in the 4-week follow-up,the three dimensions of the Seattle Angina Scale-Angina Stability Scale(SAQ-AS),Angina Frequency Scale(SAQ-AF),Disease Perception Scale(SAQ-DS),VAS score and CCS angina severity in the heart meridian acupoints selection group and the lung meridian acupoints selection group were significantly improved compared with baseline.Intra-group comparison of the standard score of Treatment Satisfaction in the Seattle Angina pectoris scale(SAQ-TS)showed that there were statistically significant differences after treatment and in the 4-week follow-up in the heart meridian acupoints selection group compared with baseline(P < 0.05).However,there was no statistical difference among all visiting points in the lung meridian acupoints selection group(P > 0.05).Intra-group comparison of the standard score of SAQ-AF,SAQ-DS,VAS score and CCS angina severity showed that there was a statistical difference between the 4-week follow-up and after treatment in the heart meridian acupoints selection group(P < 0.05).However,there was no statistical difference between the 4-week follow-up and after treatment in the lung meridian acupoints selections group(P > 0.05).There were no statistically significant differences in the Seattle Angina scale,VAS score and CCS angina severity between the heart meridian acupoints selection group and the lung meridian acupoints selection group(P > 0.05).In the heart meridian acupoints selection group,there was no statistical difference between subjects with high expectation and low expectation in the response to the primary outcome(P > 0.05),and the response rates of the primary outcome of subjects with high expectation and low expectation were 62.86% and 60.00%,respectively.In the lung meridian acupoints selection group,there was statistical difference between subjects with high expectation and low expectation in the response to the primary outcome(P < 0.05),and the response rates of the primary outcome of subjects with high expectation and low expectation were 61.90% and 33.33%,respectively.Binary logistic regression was used to analyze the influence of high expectation and low expectation on the response rate of the primary outcome.The results showed that there was no statistical significance between the influence of high expectation and low expectation on the response rate of primary outcome in the heart meridian acupoints selection group(P > 0.05).In the lung meridian acupoints selection group,the high expectation subjects increased the response rate of the primary outcome with a statistically significant difference(P < 0.05).(4)The results of subgroup analysis showed that there was statistical difference in the number of angina attacks within 4 weeks between the heart meridian acupoints selection group and the lung meridian acupoints selection group after treatment and at 4-week follow-up in subjects under 65 years old and male subjects(P < 0.05).There was a significant difference in the number of angina attacks within 4 weeks between the heart meridian acupoints selection group and the lung meridian acupoints selection group at the4-week follow-up in the subjects with the course of disease over 24 months(P < 0.05).(5)The safety analysis showed that the vital signs of two groups were stable during the study.The adverse events related to intradermal needle were mainly local reactions of acupuncture(pain and bleeding at the acupoints).Other adverse events included hypersensitivity to electrocardiogram electrodes,colds,and insomnia.The severity of adverse events was mild or moderate.No subjects withdrew due to adverse events,and no serious adverse events or deaths occurred.The incidence of adverse events associated with the intradermal needle was 4.73%.There was no significant difference in adverse events between the heart meridian acupoints selection group and the lung meridian acupoints selection group(P > 0.05).(6)The treatment compliance analysis showed that the average treatment compliance rate of all subjects was more than 97%.The average treatment compliance rate of the heart meridian acupoints selection group and lung meridian acupoints selection group was 97.88%and 98.07%,respectively.There was no significant difference in treatment compliance rate between the heart meridian acupoints selection group and the lung meridian acupoints selection group(P > 0.05).2.Study on improvement of myocardial ischemia of chronic stable angina by intradermal needle treatmentAfter intradermal needle treatment,total ischemic burden,maximum ST-segment depression,and total ST-segment depression sequences all decreased.The maximum STsegment depressions at 4-week follow-up in the heart meridian acupoints selection group were statistically different from baseline(P < 0.05).The total ST-segment depression sequences at 4-week follow-up in the lung meridian acupoints selection group were statistically different from baseline(P < 0.05).There were no significant differences in total ischemic burden,maximum ST-segment depression,and total ST-segment depression sequences between the heart meridian acupoints selection group and the lung meridian acupoints selection group(P > 0.05).Conclusion:1.The treatment of chronic stable angina by intradermal needle is safe,effective and compliant,which can improve the symptoms and quality of life of chronic stable angina patients.2.Compared with the lung meridian acupoints selection group,the heart meridian acupoints selection group showed a trend of more sustained therapeutic effect.The efficacy of the heart meridian acupoints selection group was better than that of the lung meridian acupoints selection group for patients under 65 years old,male patients and patients with longer disease course. |
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