Retrospective cohort study of modified Yiqi Fumai Formula combined with conventional Western medicine for paroxysmal atrial fibrillation with qi deficiency and blood stasis, and phlegm-heat disturbing the heart syndrome

To analyze the short-term and long-term clinical efficacy of modified Yiqi Fumai Formula (YQFMF) combined with conventional Western medicine in patients with paroxysmal atrial fibrillation (PAF) with qi deficiency and blood stasis, and phlegm-heat disturbing the heart syndrome who had not undergone radiofrequency catheter ablation.

A retrospective cohort study was conducted. A total of 132 patients with PAF of the qi deficiency and blood stasis, and phlegm-heat disturbing the heart syndrome, who had not undergone radiofrequency ablation, were enrolled from the outpatient and inpatient departments of cardiology at Dongfang Hospital and Dongzhimen Hospital of Beijing University of Chinese Medicine from January 1, 2021, to December 31, 2023. Based on the exposure factor "treatment with modified YQFMF," patients meeting this criterion were assigned to the integrated Chinese and Western medicine cohort, while those not meeting it were assigned to the Western medicine cohort. All patients were followed up until December 2024. The short-term and long-term clinical efficacy were analyzed for both cohorts. Short-term efficacy included the primary symptom (palpitation) score, effective rate for palpitation symptom, changes in secondary symptoms, and safety indicators. Long-term efficacy assessed the incidence of persistent/long-standing persistent atrial fibrillation (AF). Factors influencing the progression of PAF were also analyzed.

A total of 121 patients with PAF were ultimately included in the study, comprising 52 patients in the integrated Chinese and Western medicine cohort and 69 patients in the Western medicine cohort. With regard to short-term efficacy, compared with the Western medicine cohort, the integrated Chinese and Western medicine cohort demonstrated a reduction in the primary symptom score, a higher effective rate for treat of palpitations, and higher effective rates for the secondary symptoms of fatigue, shortness of breath, sweating, poor sleep, dry mouth, bitter taste in the mouth, and dry stool (P<0.05). There was no statistically significant difference between the two cohorts in the effective rates for the secondary symptoms of feelings of restlessness or yellow urine. No significant adverse reactions occurred during treatment in either cohort. Regarding long-term efficacy, the incidence of persistent/long-standing persistent AF was 5.77% (3/52) in the integrated Chinese and Western medicine cohort and 18.84% (13/69) in the Western medicine cohort, with the difference being statistically significant. Univariate logistic regression analysis indicated that age, disease duration, coexisting heart failure, and the administration of modified YQFMF might be influencing factors for the development of persistent/long-standing persistent AF in PAF patients (P<0.05). Multivariate logistic regression analysis result showed that administration of modified YQFMF was a protective factor against the progression from PAF to persistent/long-standing persistent AF (OR=0.211, 95%CI (0.045~0.985), P<0.05). While age≥80 years was a risk factor (OR=6.589, 95%CI (1.620~26.788), P<0.05).

Modified YQFMF combined with conventional Western medicine can effectively improve the clinical symptoms and enhance the short-term efficacy in patients with PAF and qi deficiency and blood stasis, and phlegm-heat disturbing the heart syndrome who had not undergone radiofrequency ablation. The administration of modified YQFMF may contribute to reducing the incidence of progression from PAF to persistent/long-standing persistent AF and improving long-term outcomes.