Abstract
Pharmacological antiarrhythmic therapy such as beta-blockers in patients with frequent premature ventricular contractions (PVCs) and concomitant bradycardia is challenging. A traditional Chinese medicine, Shensong Yangxin (SSYX), has been effective in treatment of frequent PVCs and sinus bradycardia (SB) in separate patient cohorts. This double-blind, placebo-controlled, multicentre, randomized clinical trial investigates the acute efficacy of SSYX in reducing PVCs burden in patients with concomitant SB. Patients with symptomatic, frequent PVCs, and SB, defined as mean heart rate (MHR) of 45 to 59 beats per min (bpm), were recruited at 33 medical centres in mainland China and randomly assigned by computer to either SSYX or matching placebo for eight weeks. Patients, investigators, and trial personnel were masked to treatment allocation. Primary endpoints were changes in PVCs burden and MHR as assessed by 24-hour Holter monitoring relative to baseline. Secondary efficacy endpoints were subjective symptom score, ECG, and biochemical parameters. Analysis was based on intention-to-treat principles. 333 patients were randomized, of which 166 received SSYX and 167 placebo. Baseline characteristics did not differ. SSYX reduced PVCs burden by 68.2% (p < 0.001) and increased MHR by 10.9% (p < 0.001) compared to 32.2% and 4.7%, respectively, in the placebo group. SSYX group experienced greater symptomatic improvement (p < 0.001). No differences in reported adverse events were seen (20 versus 23). SSYX is an effective antiarrhythmic therapy for symptomatic, frequent PVCs uniquely suited patients with concomitant SB. Clinical trial number was NCT01750775.
Highlights
Premature ventricular contractions (PVCs) occur commonly in the general population and are generally considered to be a benign condition, provided patients are asymptomatic and free from structural heart disease [1, 2]
Based on the most recent international consensus statements, beta-blockers or nondihydropyridine calcium channel antagonists are considered first-line medication for PVCs suppression in symptomatic patients [5]. Administration of these drugs may be complicated by bradycardia and this complication is relevant since the prevalence of PVCs and bradycardia both increases with advancing age [2]
Baseline Characteristics. 406 patients were assessed for eligibility in this study
Summary
Premature ventricular contractions (PVCs) occur commonly in the general population and are generally considered to be a benign condition, provided patients are asymptomatic and free from structural heart disease [1, 2]. Based on the most recent international consensus statements, beta-blockers or nondihydropyridine calcium channel antagonists are considered first-line medication for PVCs suppression in symptomatic patients [5] Administration of these drugs may be complicated by bradycardia and this complication is relevant since the prevalence of PVCs and bradycardia both increases with advancing age [2]. Double-blind, randomized, placebocontrolled trial of patients with symptomatic bradycardia that did not meet conventional criteria for permanent pacing, SSYX increased MHR by 13.3% without any serious adverse events reported [9] Given these attributes of SSYX, we initiated this study to investigate the clinical efficacy and safety of SSYX for patients with symptomatic frequent PVCs with concomitant bradycardia
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