Chinese Medicine Shensongyangxin Is Effective for Patients with Bradycardia: Results of a Randomized, Double-Blind, Placebo-Controlled Multicenter Trial
To evaluate the efficacy and safety of Shensong Yangxin (SSYX) in patients with bradycardia arrhythmias, a randomized, double-blind, and placebo-controlled study was conducted. Patients with bradycardia were randomly assigned to receive either SSYX (trial group, ) or placebo (control group, ) for 4 weeks. ECG, 24-hour continuous ECG recording, echocardiography, and hepatic and renal function were evaluated at baseline and after treatment. Results showed that the average heart rate, the fastest heart rate, and the lowest heart rate in the trial group were all significantly higher than those in the control group at the end of treatment ( or 0.01, resp.). Compared with pretreatment, the average heart rate, the fastest heart rate, and the lowest heart rate in the trial group all increased significantly after treatment ( or 0.01, resp.). Both the efficacy and the symptom scores in the trial group were significantly better than those in the control group after treatment (both having ). No severe adverse effects were reported. In conclusion, SSYX treatment significantly increased the heart rate in patients with bradycardia without severe side effects. The exact mechanisms remain to be further explored. 1. Introduction Bradycardia is classified as a pulse rate below 60 beats per minute and is a common phenomenon in both healthy and disease conditions [1, 2]. Bradycardia may be a common manifestation of general conduction system disease or iatrogenic, due to medications used for atrial fibrillation rate control [3], which is characterized by a spectrum of arrhythmias including sinus bradycardia, sinus pauses, atrial fibrillation or flutter, and paroxysmal supraventricular tachycardia. The symptoms of bradyarrhythmia are most commonly intermittent syncope or presyncope but may be general and nonspecific. Some patients with sinus node disease are unable to appropriately increase their heart rate with exercise. Others may present with symptoms due to the underlying cause, such as myocardial infarction or drug toxicity. Bradycardia can include sinus-node dysfunction (sick sinus syndrome) and atrioventricular block [4, 5]. The symptoms are often related to the bradycardia itself, as well as dysfunction of the autonomic nerve system (e.g., dizziness, fatigue, weakness, chest distress, or heart failure). In such cases, treatment targeted solely to correct bradycardia may not be effective in elimination of symptoms [6]. Besides, currently available drugs (e.g., atropine, isoproterenol, and theophylline) used to increase sinus rhythm are not tolerated for long term
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