| Objective:In this study,we investigated the clinical efficacy of auricular point therapy on patients with atrial fibrillation combined with insomnia through a randomized controlled trial,with a view to enriching the content of atrial fibrillation cardiac rehabilitation and providing an evidence-based basis for the clinical application and promotion of Chinese external therapies in atrial fibrillation cardiac rehabilitation.Methods:1 In this study,50 patients with atrial fibrillation combined with insomnia who met the inclusion criteria were selected and randomly divided into the ear acupuncture group and the control group.2 The ear acupuncture group was treated with conventional atrial fibrillation therapy combined with sleep hygiene education and sleep restriction therapy on top of insomnia auricular point therapy,while The control group was treated with conventional atrial fibrillation therapy combined with sleep hygiene education and sleep restriction therapy in combination with auricular pressure pills at the Shen Men acupuncture point.The duration of treatment is 4 weeks.3 Observations were Pittsburgh Sleep Quality Index(PSQI),Holter(mean ventricular rate),Insomnia Severity Index(ISI),Atrial Fibrillation Effect on Qualityof-life(AFEQT)scores,Hamilton Anxiety Scale(HAMA),Chinese Medicine Symptom Classification and Quantification Scale scores and safety indicators,which were assessed before and after treatment.4 The efficacy was assessed by judging the efficacy criteria of insomnia,and the efficiency was judged by combining the minus rate of the PSQI score.5 Record adverse effects during the trial and evaluate the safety of the treatment method.Results:1 A total of 50 patients with atrial fibrillation combined with insomnia were included in this study,with 1 case of shedding(1 in the auricular group and 0 in the control group)and 49 cases completed,representing a 2%shedding rate.2 The ear acupuncture group was more effective than the control group in improving insomnia.The PSQI scores of both groups after treatment were significantly lower than those before treatment(P<0.001),and the PSQI scores of the ear acupuncture group after treatment were significantly lower than those of the control group(P<0.001).The total effective rate of the ear acupuncture group was 91.67%and the apparent healing rate was 54.17%,while the total effective rate of the control group was 68.00%and the apparent healing rate was 8.00%(P<0.001).Both the ear acupuncture group and the control group showed improvement in six aspects of sleep quality,time to sleep,sleep duration,sleep efficiency,sleep disturbance and daytime dysfunction as assessed by the PSQI,compared to the pre-treatment period,and the efficacy of the ear acupuncture group was better than the control group in five aspects of sleep quality,time to sleep,sleep efficiency,sleep disturbance and daytime dysfunction(P<0.05).However,in this aspect of sleep duration,there was no significant difference between the ear acupuncture group and the control group(P>0.05).The ISI scores were significantly lower in both groups after treatment than before treatment(P<0.001),and the ISI scores were significantly lower in the ear acupuncture group after treatment than in the control group(P<0.001).3 The ear acupuncture group outperformed the control group in terms of improvement in atrial fibrillation episodes and quality of life.The mean ventricular rate was significantly lower in both groups after treatment than before treatment(P<0.001)and was significantly lower in the ear acupuncture group after treatment than in the control group(P<0.05).The results showed that the AFEQT scores in both the ear acupuncture group and the control group were significantly lower than before treatment(P<0.001),and the AFEQT scores in the ear acupuncture group were significantly lower than the control group after treatment(P<0.05).Both groups showed improvement in four areas of AF symptoms,daily activities,treatment anxiety and treatment satisfaction as assessed by AFEQT,compared to the pre-treatment period,and the ear acupuncture group was more effective than the control group in three areas of AF symptoms,treatment anxiety and treatment satisfaction(P<0.05).However,in this aspect of daily activities,there was no significant difference between the ear acupuncture group and the control group(P>0.05).4 The ear acupuncture group outperformed the control group in terms of improvement in anxiety and quantitative TCM symptom classification scores.The results showed that the HAMA scores and quantitative TCM symptom grading scores of patients in both groups improved after treatment compared with those before treatment(P<0.001),and the HAMA scores(P<0.05)and quantitative TCM symptom grading scores(P<0.001)of the ear acupuncture group were significantly lower than those of the control group after treatment.5 Safety evaluation:One patient in the ear acupuncture group developed skin irritation during the treatment and the patient’ s symptoms resolved after stopping the auricular point therapy.Conclusions:Auricular point therapy can effectively improve sleep quality,insomnia severity,quality of life,mean ventricular rate,anxiety and TCM symptoms in patients with atrial fibrillation combined with insomnia,with better efficacy than simple sleep hygiene education and sleep restriction therapy.The results of this study showed good efficacy,mild adverse effects,and high safety of auricular point therapy. |
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