Chin Med J 2011;124(1):76-83
Evaluation of the traditional Chinese medicine Shensongyangxin
capsule on treating premature ventricular contractions: a
randomized, double-blind, controlled multicenter trial
ZOU Jian-gang, ZHANG Jian, JIA Zhen-hua and CAO Ke-jiang
Keywords: premature ventricular contraction; Shensongyangxin capsule;randomized controlled trial
Background Premature ventricular contraction (PVC) is one of the most common kinds of arrhythmias for which the
treatment falls into dilemma. Previous clinical application showed that the traditional Chinese Medicine Shensongyangxin
(SSYX) capsule is efficacious for the treatment of PVCs. This randomized clinical trial aimed to further evaluate the
efficacy and safety of SSYX capsule on treating PVC.
Methods The subjects who had frequent PVCs with or without organic heart disease and normal cardiac function
were enrolled in the study. The primary endpoint was the change of PVC numbers after eight-week medication with
SSYX capsule. The secondary endpoints included change of clinical symptoms related to PVCs and the safety evaluation
of SSYX capsule. Totally 188 PVC patients were randomly enrolled in the non-organic heart disease PVCs trial and orally
took either SSYX capsules or analogues (three times per day, 4 capsules one time). A total of 671 PVCs patients were
randomly enrolled in the organic heart disease PVCs trial, and orally took either SSYX capsules (three times per day, 4
capsules one time) or mexiletine tablet (three times per day, 150 mg one time). The PVCs were monitored and calculated
with 24-hour Holter electrocardiogram. Routine blood, liver and kidney function were tested before and after medication
with SSYX capsule.
Results SSYX capsules significantly decreased the PVCs numbers and alleviated the related symptoms in patients
with or without organic heart disease. In non-organic heart disease group, SSYX capsules and the placebos decreased
the PVCs from 12 561.34±9 777.93 to 4806.87±6507.17, and 12 605.69±8736.34 to 10 364.94±9 903.41, respectively.
The total effective rate was 74.2% and 28.9% in SSYX and placebo groups (P<0.001). In organic heart disease group,
SSYX capsule and mexiletine decreased the PVCs from 8641.01±8923.57 to 3853.68±7096.42, 8621.61±8367.74 to
5648.29±8667.38, respectively. The total effective rate was 65.8% and 50.7% in SSYX and mexiletine groups (P<0.001).
In addition, SSYX capsule significantly alleviated PVCs-related symptoms such as palpitations, chest tightness, insomnia,
fatigue, and night sweats. No adverse cardiac events were observed except some slight gastrointestinal side effects
during the study.
Conclusions Compared with placebo or mexiletine, SSYX capsules have significant therapeutic efficacy in reducing
PVCs numbers and alleviate PVCs-related symptoms.
Chin Med J 2011;124(1):76-83
remature ventricular contraction (PVC), also known
as a premature ventricular complex, is a relatively
common arrhythmia. PVCs can occur not only in healthy
person of any age, but also in heart diseased subjects.1
Effect of most anti-arrhythmic drugs is comparatively
poor on treating PVCs, even some anti-arrhythmic drugs
have proarrhythmia effects. Therefore, it is necessary to
develop safe and effective anti-arrhythmic drugs.2,3 The
traditional Chinese medicine has been used to treat the
disease related to arrhythmia for thousands of years. The
traditional Chinese medicine Shensongyangxin (SSYX)
was approved as an anti-arrhythmic drug by the State
Food and Drug Administration (SFDA) of China in 2003
(File No. Z20030058) and has been commonly used to
treat arrhythmia in China. We conducted this randomized
controlled trial (RCT) to evaluate the efficacy and safety
of SSYX on treating PVCs in non-organic or organic
heart disease subjects.
Patients had to meet all the following criteria for
Department of Cardiology, First Hospital Affiliated to Nanjing
Medical University, Nanjing, Jiangsu 210029, China (Zou JG and
Integration of Traditional and Western Medical Research Academy
of Hebei Province/ Key Research Centre of Collateral Disease of
State Administration of Traditional
Shijiazhuang, Hebei 050035, China (Zhang J and Jia ZH)
Correspondence to: Dr. CAO Ke-jiang, Department of Cardiology,
First Affiliated Hospital of Nanjing Medical University, 300
Guangzhou Road, Nanjing, Jiangsu 210029, China (Email:
Drs. ZOU Jian-gang, ZHANG Jian and JIA Zhen-hua contributed
equally to this work.
The study was supported by a grant from National Basic Research
Program (973 Program) of China (No. 2005CB523301).
Chinese Medical Journal 2011;124(1):76-83
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Edited by WANG Mou-yue