Objective

2

To explore the effectiveness and safety of

Shenlong Dingji Formula

（参龙定悸方） on the quality of life in patients with paroxysmal atrial fibrillation （PAF） of

qi

-

yin

deficiency and phlegm-stasis obstructing collaterals syndrome.

Methods

2

A total of 60 patients with PAF of

qi

-

yin

deficiency and phlegm-stasis obstructing collaterals syndrome were recruited and randomly divided into a treatment group and a control group， with 30 patients in each group. The control group received standard western medicine treatment， while the treatment group was additionally given

Shenlong Dingji Formula

orally， one dose per day. Both groups were treated for 4 weeks. The primary outcome measure is the Atrial Fibrillation Effect on Quality of Life （AFEQT） score including scores of four dimensions，i.e. atrial fibrillation-related symptoms， treatment concerns， daily activities， and treatment satisfaction. The secondary outcome measures included the frequency and duration of symptomatic atrial fibrillation episodes and traditional Chinese medicine （TCM） syndrome scores covering symptoms such as palpitations， chest tightness， fatigue， shortness of breath， reluctance to speak， spontaneous sweating， stabbing pain， and insomnia. These indicators were assessed at baseline （before treatment）， after 2-week of treatment， after 4-week of treatment， and 4 weeks after the end of treatment （follow-up）. Ad

ditionally， safety indicators before and after treatment and adverse events occurring during the trial were recorded to evaluate safety.

Results

2

A total of 56 patients completed the study， with 28 in each group. Primary outcome indicators： 1） the treatment group showed significant improvement in the total score of the AFEQT scale， with significantly higher total scores after 2-week treatment， 4-week treatment， and follow-up compared to the previous time point （

P

＜0.05）. In the control group， the AFEQT score significantly increased only after 4-week treatment compared to baseline （

P

＜0.05）. In the treatment group， the AFEQT scores after 2-week， 4-week treatment， and during follow-up were all higher than those of the control group at the corresponding time points （

P

＜0.01）. 2） In the treatment group， there was no statistically significant difference in the AFEQT treatment satisfaction dimension score during follow-up compared to that after 4-week treatment （

P

＞0.05）. However， the scores for all other dimensions at each time point were higher than those at the previous time point （

P

＜0.05）. In the control group， the scores for the atrial fibrillation-related symptom dimension were higher after 2-week and 4-week treatment than those of the previous time points （

P

＜0.05）. For the treatment satisfaction dimension， significant increases were observed only after 2-week and 4-week treatment compared to baseline （

P

＜0.05）. Secondary outcome indicators： 1） In the treatment group， the frequency and duration of symptomatic atrial fibrillation episodes decreased significantly at each time point compared to the previous time point （

P

＜0.05）， except for the duration of trial fibrillation at follow-up. In the control group， the frequency of episodes decreased significantly at all time points compared to baseline （

P

＜0.05）， while the duration of trial fibrill

ation showed a significant reduction at follow-up compared to those after 2-week treatment （

P

＜0.05）. 2） In the treatment group， TCM syndrome scores significantly reduced after 2-week treatment， 4-week treatment， and during follow-up compared to the previous time point and baseline （

P

＜0.05）. In the control group， significant reductions were observed only after 4-week after treatment and during follow-up （

P

＜0.05）. The TCM syndrome scores in the treatment group were lower than those in the control group at the same time points （

P

＜0.01）. No adverse events occurred during the trial in either group， and safety indicators showed no significant changes after treatment.

Conclusion

2

Shenlong Dingji Formula

effectively improves the quality of life， alleviates TCM syndromes， and reduces the frequency and duration of symptomatic atrial fibrillation in patients with PAF of

qi

-

yin

deficiency and phlegm-stasis obstructing collaterals syndrome， and demonstrates good safety.