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Chinese Herbal Medicine Dingji Fumai Decoction for Ventricular Premature Contraction: A Real-World Trial

Chinese herbal medicine Dingji Fumai Decoction (DFD) is widely clinically used for ventricular premature contraction (VPC). This real-word trial was designed to assess the safety and effectiveness of DFD for VPC.

Ventricular premature contraction (VPC) is common, and the incidence increases with age. Although it was 0.6% under the age of 20, the detection rate of 12 lead electrocardiogram was 2.7% over the age of 50 (1). Long-term monitoring showed a 50% incidence of VPC in the population, regardless of the presence or absence of structural heart disease (2, 3). Atherosclerosis Risk in Communities study showed that VPC monitoring in middle-aged patients with or without ischemic heart disease at 2 minutes increased the risk of ischemic heart disease events and death (4, 5). Moreover, the frequency of VPC in the general population is associated with increased cardiovascular risk and mortality (6). In patients without persistent ventricular tachycardia (VT) and structural heart disease, pleomorphic VPC is associated with an increased risk of death and nonfatal cardiovascular adverse events (7). In addition to cardiovascular events, VPC is also associated with stroke (5). As studies have shown, the association between VPC and adverse end point events, VPC, especially pleomorphic and frequent VPC, is considered a risk factor for cardiovascular adverse events and requires treatment to reduce the risk (8). Current pharmacological treatments for VPC include beta-receptor blockers and nondihydropyridine calcium antagonists (9, 10). But CAST showed that antiarrhythmic drugs increased the risk of death in patients with arrhythmia after myocardial infarction (11, 12), the two agents mentioned above can only relieve the symptoms of palpitations in patients (13).

Traditional Chinese medicine (TCM) has been used in clinical practice for more than two thousand years (14), characterizing whole view and syndrome differentiation, and has shown its unique advantages in the prevention, treatment, rehabilitation, and health care of various diseases. TCM has a long history of anti-arrhythmias and great progress has been made in the research on the treatment of arrhythmias in recent years (15–19). Dingji Fumai Decoction (DFD) is an empirical prescription developed by Professor Luo, a national tutor, according to the basic theory of traditional Chinese medicine for the treatment of palpitation (also known as arrhythmia in modern medicine). DFD, consisting of Chuanxiong Rhizoma (Chuanxiong), Jujubae Fructus (Dazao), Poria Cocos (Schw.) Wolf (Fuling), Cinnamomi Ramulus (Guizhi), Silktree Albizia Bark (Hehuanpi), Osdraconis (Fossiliaossiamastodi) (Longgu), Ostrea Gigas Thunberg (Muli), Ziziphi Spinosae Semen (Suanzaoren), Radix Polygalae (Yuanzhi), and Licorice (Gancao), is a multi-herbal medicine for ventricular arrhythmia (VA), especially VPC. Its cocomponents with XinSuNing are Poria Cocos (Schw.) Wolf and Licorice, which significantly restrained arrhythmias induced by the chemical reagents (20). Our previous study showed that DFD has class I antiarrhythmic properties by suppressing Nav_1.5 dose-dependently with an IC₅₀ of 24.0 ± 2.4 mg/mL (21).

So far, it has not been prospectively and systematically tested whether patients with VA can effectively and safely be treated with DFD. The determination of the efficacy and safety of DFD has a potentially high impact on future clinical practice, but science and reasonableness of this strategy has to be assured. The real-world, double-blinded, randomized placebo-controlled trial reported herein the assessed effectiveness and safety of DFD among participants with VPC.